Abilify Maintena

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine in elderly patients. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Boceprevir
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Ebastine
• Efavirenz
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fentanyl
• Fingolimod
• Flecainide
• Flibanserin
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Levorphanol
• Lopinavir
• Lumefantrine
• Mefloquine
• Meperidine
• Methadone
• Metronidazole
• Mifepristone
• Milnacipran
• Mitotane
• Mizolastine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nelfinavir
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Oxycodone
• Oxymorphone
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Remifentanil
• Ribociclib
• Rifampin
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure, history of or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in the volume of blood) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.

• Depression or
• Diabetes, or family history of or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Reduced white blood cell count, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain aripiprazole. It may not be specific to Abilify Maintena. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It will be given as a shot into a muscle.

This injection is given together with oral medicine for the first dose. The second dose and the injections that follow are given instead of oral medicine. Be sure to keep all appointments for the injections.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Be sure to keep all appointments for the injections.

• Tell all of your health care providers that you take Abilify Maintena. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking Abilify Maintena.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Chance of seizures may be higher. Talk with the doctor.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly infections have rarely happened. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
• Check your blood sugar as you have been told by your doctor.
• Dizziness, sleepiness, and feeling less stable may happen with this medicine. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
• If you are 65 or older, use Abilify Maintena with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Taking Abilify Maintena in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Abilify Maintena, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Abilify Maintena. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Abilify Maintena.

Review Date: October 4, 2017

Aripiprazole is an atypical antipsychotic which is present in Abilify Maintena as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2•H2O and its molecular weight is 466.40. The chemical structure is:

Abilify Maintena (aripiprazole) is an extended-release injectable suspension available in 400-mg or 300-mg strength pre-filled dual chamber syringes and 400-mg or 300-mg strength vials. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster).

Mechanism of Action

The mechanism of action of aripiprazole in the treatment of schizophrenia and bipolar I disorder is unknown.

The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.

Pharmacodynamics

Aripiprazole exhibits high affinity for dopamine D2 and D3 (Kis 0.34 and 0.8 nM respectively), serotonin 5-HT1A and 5-HT2A receptors (Kis 1.7 and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Kis of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC50>1000 nM). Actions at receptors other than D2, 5-HT1A, and 5-HT2A could explain some of the other adverse reactions of aripiprazole (e.g., the orthostatic hypotension observed with aripiprazole may be explained by its antagonist activity at adrenergic alpha1 receptors).

Alcohol

There was no significant difference between oral aripiprazole co-administered with ethanol and placebo co-administered with ethanol on performance of gross motor skills or stimulus response in healthy subjects. As with most psychoactive medications, patients should be advised to avoid alcohol while taking Abilify Maintena.

Pharmacokinetics

Abilify Maintena activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D2 receptors similar to the parent drug and represents about 29% of the parent drug exposure in plasma.

Aripiprazole absorption into the systemic circulation is slow and prolonged following intramuscular injection due to low solubility of aripiprazole particles. Following a single dose administration of Abilify Maintena in the deltoid and gluteal muscle, the extent of absorption (AUCt, AUC∞) of aripiprazole was similar for both injection sites, but the rate of absorption (Cmax) was 31% higher following administration to the deltoid compared to the gluteal site. However, at steady state, AUC and Cmax were similar for both sites of injection. Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to maximum plasma concentrations at a median Tmax of 5 - 7 days for the gluteal muscle and 4 days for the deltoid muscle. After gluteal administration, the mean apparent aripiprazole terminal elimination half-life was 29.9 days and 46.5 days after multiple injections for every 4-week injection of Abilify Maintena 300 mg and 400 mg, respectively. Steady state concentrations for the typical subject were attained by the fourth dose for both sites of administration. Approximate dose-proportional increases in aripiprazole and dehydro-aripiprazole exposure were observed after every four week Abilify Maintena injections of 300 mg and 400 mg.

Elimination of aripiprazole is mainly through hepatic metabolism involving two P450 isozymes, CYP2D6 and CYP3A4. Aripiprazole is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2E1 enzymes. Aripiprazole also does not undergo direct glucuronidation.

Drug Interaction Studies

No specific drug interaction studies have been performed with Abilify Maintena. The information below is obtained from studies with oral aripiprazole.

Effects of other drugs on the exposures of aripiprazole and dehydro-aripiprazole are summarized in Figure 19 and Figure 20, respectively. Based on simulation, a 4.5-fold increase in mean Cmax and AUC values at steady-state is expected when extensive metabolizers of CYP2D6 are administered with both strong CYP2D6 and CYP3A4 inhibitors. After oral administration, a 3-fold increase in mean Cmax and AUC values at steady-state is expected in poor metabolizers of CYP2D6 administered with strong CYP3A4 inhibitors.

  Figure 19: The effects of other drugs on aripiprazole pharmacokinetics   Figure 20: The effects of other drugs on dehydro-aripiprazole pharmacokinetics

The effects of ABILIFY on the exposures of other drugs are summarized in Figure 21. A population PK analysis in patients with major depressive disorder showed no substantial change in plasma concentrations of fluoxetine (20 mg/day or 40 mg/day), paroxetine CR (37.5 mg/day or 50 mg/day), or sertraline (100 mg/day or 150 mg/day) dosed to steady-state. The steady-state plasma concentrations of fluoxetine and norfluoxetine increased by about 18% and 36%, respectively, and concentrations of paroxetine decreased by about 27%. The steady-state plasma concentrations of sertraline and desmethylsertraline were not substantially changed when these antidepressant therapies were coadministered with aripiprazole.

  Figure 21: The effects of oral aripiprazole on pharmacokinetics of other drugs

Studies in Specific Populations

No specific pharmacokinetic studies have been performed with Abilify Maintena in specific populations. All the information is obtained from studies with oral aripiprazole.

Exposures of aripiprazole and dehydro-aripiprazole in specific populations are summarized in Figure 22 and Figure 23, respectively. In addition, in pediatric patients (10 to 17 years of age) administered with oral aripiprazole (20 mg to 30 mg), the body weight corrected aripiprazole clearance was similar to the adults.

Figure 22 Effects of intrinsic factors on aripiprazole pharmacokinetics

Figure 23: Effects of intrinsic factors on dehydro-aripiprazole pharmacokinetics:

How Supplied

Pre-filled Dual Chamber Syringe:

Abilify Maintena (aripiprazole) pre-filled dual chamber syringe for extended-release injectable suspension in single-use syringes is available in 300 mg or 400 mg strength syringes. The pre-filled dual chamber syringe consists of a front chamber that contains the lyophilized powder of aripiprazole monohydrate and a rear chamber that contains sterile water for injection.

The 300 mg kit includes (NDC 59148-045-80):

• 300 mg single-dose pre-filled dual chamber syringe containing Abilify Maintena (aripiprazole) for extended-release injectable suspension lyophilized powder and Sterile Water for Injection • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients • One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

The 400 mg kit includes (NDC 59148-072-80):

• 400 mg single-dose pre-filled dual chamber syringe containing Abilify Maintena (aripiprazole) for extended-release injectable suspension lyophilized powder and Sterile Water for Injection • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients • One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

Single-Use Vial:

Abilify Maintena (aripiprazole) extended-release injectable suspension in single-use vials is available in 300 mg or 400 mg strength vials.

The 300 mg kit includes (NDC 59148-018-71):

• 300 mg single-use vial of Abilify Maintena (aripiprazole) extended-release injectable suspension lyophilized powder • 5 mL single-use vial of Sterile Water for Injection, USP • One 3 mL luer lock syringe with pre-attached 21 gauge, 1.5 inch hypodermic safety needle with needle protection device • One 3 mL luer lock disposable syringe with luer lock tip • One vial adapter • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients • One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

The 400 mg kit includes (NDC 59148-019-71):

• 400 mg single-use vial of Abilify Maintena (aripiprazole) extended-release injectable suspension lyophilized powder • 5 mL single-use vial of Sterile Water for Injection, USP • One 3 mL luer lock syringe with pre-attached 21 gauge, 1.5 inch hypodermic safety needle with needle protection device • One 3 mL luer lock disposable syringe with luer lock tip • One vial adapter • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients • One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

Storage

Pre-filled dual chamber syringe:

Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use.

Vial:

Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

NDC 59148-100-01

5mL

Sterile Water
for Injection, USP

For single use only.

Discard unused portion.

Store at 25 °C (77 °F), excursions
permitted between 15 °C and 30 °C
(59 °F to 86 °F) [See USP].

Rx only

NDC 59148-072-80

400 mg

Abilify Maintena®
(aripiprazole)

for extended release
injectable suspension
Single use only.

Sterile. Discard any
unused portion.

For deltoid or gluteal
intramuscular
injection only.

Usual Dosage:
See package insert.

Rx only

Store below
30°C [86°F].
Protect from light.

Mfd. by:
Otsuka Pharmaceutical
Co., Ltd.

• Otsuka America Pharmaceutical, Inc.

Before you receive Abilify Maintena, tell your healthcare provider if you:

• have never taken aripiprazole before
• have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving Abilify Maintena and during your treatment.
• have or had seizures (convulsions)
• have or had low or high blood pressure
• have or had heart problems or a stroke
• have or had a low white blood cell count
• have any other medical problems including problems that may affect you receiving an injection in your buttocks
• are pregnant or plan to become pregnant. It is not known if Abilify Maintena will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Abilify Maintena can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive Abilify Maintena.

Tell your doctor about all the medicines that you take including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

 

Take Abilify Maintena exactly as prescribed by your doctor.

The recommended starting dose and maintenance dose is 400 mg administered monthly as a single injection. If you have side effects, your dose can be reduced to 300 mg.

In conjunction with first dose, take 14 consecutive days of concurrent oral Abilify (10 mg to 20 mg) or current oral antipsychotic.

Dosage adjustments are required for missed doses.

If you are a known CYP2D6 Poor metabolizers, the recommended starting dose and maintenance dose is 300 mg administered monthly as a single injection.

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Applies to aripiprazole: intramuscular powder for injection extended release, intramuscular solution, intramuscular suspension extended release, oral solution, oral tablet, oral tablet disintegrating

General

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension: The most commonly reported side effects included akathisia, headache, injection site reactions, and insomnia.

Aripiprazole Extended/Prolonged-Release IM Suspension: The most commonly reported side effects included increased weight, headache, akathisia, and insomnia.

Immediate-Release IM Injection: The most commonly reported side effects included extrapyramidal symptoms, headache, nausea, and dizziness.

Oral Formulations: The most commonly reported side effects included extrapyramidal disorder, headache, and somnolence.[Ref]

Psychiatric

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Insomnia, restlessness
Frequency not reported: Anxiety, other compulsive behaviors, suicide
Postmarketing reports: Pathological gambling

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): Insomnia (up to 10.9%)
Common (1% to 10%): Agitation, anxiety, depression, psychotic disorder, restlessness, schizophrenia
Uncommon (0.1% to 1%): Affect lability, apathy, bruxism, decreased libido, delusion, dysphoria, hallucination, hypersexuality, irritability, mood altered, panic reaction, psychotic behavior, sleep disorder, suicidal ideation
Rare (0.01% to 0.1%): Aggression, panic attack
Frequency not reported: Abnormal dreams, bulimia nervosa, completed suicide, hallucination auditory, hyposomnia, middle insomnia, neonatal drug withdrawal syndrome, nervousness, nightmare, other compulsive behaviors, poor quality sleep, suicide attempt, tension
Postmarketing reports: Eating disorder, impulse-control disorders, obsessive-compulsive disorder, pathological gambling

Immediate-Release IM Injection:
Common (1% to 10%): Anxiety, insomnia, restlessness
Uncommon (0.1% to 1%): Depression, hypersexuality
Frequency not reported: Aggression, agitation, anorgasmia, catatonia, completed suicide, delirium, homicidal ideation, libido increased, loss of libido, neonatal drug withdrawal syndrome, nervousness, pathological gambling, sleep talking, sleep walking, suicide attempt, suicidal ideation, tic

Oral Formulations:
Very common (10% or more): Agitation (up to 19%), insomnia (up to 18%), anxiety (up to 17%), restlessness (up to 12%)
Common (1% to 10%): Irritability, suicidal ideation
Uncommon (0.1% to 1%): Abnormal dreams, aggression, anger, anorgasmia, apathy, bruxism, completed suicide, confusional state, delirium, depression, hallucination, hallucination auditory, homicidal ideation, hostility, hypersexuality, intentional self-injury, libido increased, loss of libido, mania, nervousness, nightmare, self-mutilation, suicide attempt, thinking abnormal, tic
Rare (0.01% to 0.1%): Asthenia, blunted affect, bradyphrenia, catatonia, cognitive deterioration, delirium, delusional perception, depressed mood, disorientation, eating disorder, emotional distress, euphoric mood, impulsive behavior, logorrhea, mental status changes, mood altered, mood swings, panic attack, psychomotor retardation, sleep disorder, sleep walking, somatoform disorder
Frequency not reported: Drug withdrawal syndrome neonatal, sleep talking
Postmarketing reports: Impulse-control disorders, obsessive-compulsive disorders, pathological gambling[Ref]

Nervous system

Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole (the active ingredient contained in Abilify Maintena) for the treatment of dementia-related psychosis showed an increased incidence of cerebrovascular side effects, e.g. stroke and transient ischemia attacks, including fatalities. The incidence of these effects may be dose related.

In a dose response analysis, somnolence including sedation was the only adverse reaction determined to have a dose response relationship in adult patients. Somnolence was reported in 12.6% of adult patients with schizophrenia receiving the 30 mg dose.

In pediatric patients 13 to 17 years of age, extrapyramidal disorder, somnolence, and tremor displayed possible dose response relationship in patients with schizophrenia, while extrapyramidal disorder, somnolence, and akathisia displayed possible dose response relationship in pediatric patients with bipolar mania.

Extrapyramidal symptoms were more prevalent with use of the extended-release IM injection compared with oral formulations (18.4% versus 11.7%). Akathisia was the most frequently observed adverse event with the extended-release IM injection; it typically starts around day 10 and lasts a median of 56 days.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Very common (10% or more): Akathisia (up to 11%)
Common (1% to 10%): Dystonia, extrapyramidal symptoms (EPS), headache, other EPS-related events, parkinsonism
Frequency not reported: Cerebrovascular adverse reactions, cognitive/motor impairment, dizziness, increased mortality in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, seizures, stroke, tardive dyskinesia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): EPS (up to 18.4%), headache (up to 14.4%), akathisia (up to 11.5%)
Common (1% to 10%): Dizziness, dyskinesia, extrapyramidal disorder, parkinsonism, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Bradykinesia, cogwheel rigidity, drooling, dysgeusia, dystonia, gait disturbance, hypersomnia, hypertonia, lethargy, movement disorder, parosmia, psychomotor hyperactivity, restless legs syndrome, tardive dyskinesia
Rare (0.01% to 0.1%): Convulsion, memory impairment, oromandibular dystonia
Frequency not reported: Cerebrovascular adverse reaction, cognitive/motor impairment, diabetic hyperosmolar coma, disturbance in attention, grand mal convulsion, hypoesthesia, increased mortality in elderly patients with dementia-related psychosis, migraine, neuroleptic malignant syndrome, seizures, serotonin syndrome, sinus headache, speech disorder, stroke, syncope, tension headache, vertigo

Immediate-Release IM Injection:
Very common (10% or more): EPS (up to 25.8%), headache (up to 12%)
Common (1% to 10%): Akathisia, dizziness, extrapyramidal disorder, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Dystonia, tardive dyskinesia
Frequency not reported: Akinesia, bradykinesia, choreoathetosis, cogwheel rigidity, coordination abnormal, diabetic hyperosmolar coma, grand mal convulsion, hypokinesia, memory impairment, myoclonus, neuroleptic malignant syndrome, parkinsonism, serotonin syndrome, speech disorder, syncope

Oral Formulations:
Very common (10% or more): Extrapyramidal disorder (up to 27.3), headache (up to 27%), somnolence (up to 26.3%), EPS (up to 25.8%), akathisia (up to 25%), sedation (up to 21%), tremor (up to 11.8%)
Common (1% to 10%): Coordination abnormal, disturbance in attention, dizziness, drooling, dystonia, lethargy
Uncommon (0.1% to 1%): Akinesia, bradykinesia, cerebrovascular accident, cogwheel rigidity, dysarthria, gait disturbance, hypertonia, hypoesthesia, hypokinesia, hypotonia, memory impairment, myoclonus, paresthesia, parkinsonism, postural hypotension, psychomotor hyperactivity, speech disorder, tardive dyskinesia
Rare (0.01% to 0.1%): Akinesthesia, ataxia, burning sensation, choreoathetosis, coma, convulsion, depressed level of consciousness, difficulty in walking, dysgeusia, dysphagia, facial palsy, grand mal convulsion, judgement impaired, loss of consciousness, migraine, neuroleptic malignant syndrome, phase sleep rhythm disturbance, positional vertigo, serotonin syndrome, unresponsive to verbal stimuli
Frequency not reported: Diabetic hyperosmolar coma, syncope[Ref]

Metabolic

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Increased weight
Frequency not reported: Metabolic changes
Postmarketing reports: Blood glucose fluctuation

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): Increased weight (up to 21.5%)
Common (1% to 10%): Decreased weight, decreased appetite, diabetes mellitus, waist circumference increased
Uncommon (0.1% to 1%): Appetite disorder, blood cholesterol decreased, blood glucose decreased/increased, blood triglycerides decreased, glycosylated hemoglobin increased, hypercholesterolemia, hyperglycemia, hyperinsulinemia, hyperlipidemia, hypertriglyceridemia, obesity, thirst, waist circumference increased
Frequency not reported: Anorexia, blood insulin increased, diabetic ketoacidosis, gout, hyperuricemia, hypoglycemia, hyponatremia, increased appetite, lactate dehydrogenase increased, metabolic changes, overweight, type 2 diabetes mellitus
Postmarketing reports: Blood glucose fluctuation

Immediate-Release IM Injection:
Common (1% to 10%): Diabetes mellitus
Uncommon (0.1% to 1%): Hyperglycemia
Frequency not reported: Anorexia, blood glucose fluctuated, blood glucose increased, blood insulin increased, blood lactate dehydrogenase increased, diabetic ketoacidosis, glycosylated hemoglobin increased, hypoglycemia, hypokalemia, hyponatremia, weight gain/loss

Oral Formulations:
Common (1% to 10%): Decreased appetite, increased appetite, weight decreased, weight increased
Uncommon (0.1% to 1%): Anorexia, blood glucose increased, carbohydrate tolerance decreased, blood insulin increased, blood lactate dehydrogenase increased, dehydration, diabetes mellitus, diabetes mellitus non-insulin-dependent, glucose tolerance impaired, glycosuria, glycosylated hemoglobin increased, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, hyponatremia, increased appetite, polydipsia
Rare (0.01% to 0.1%): Thirst
Frequency not reported: Diabetic ketoacidosis, hyponatremia
Postmarketing reports: Blood glucose fluctuation[Ref]

Reports of diabetes mellitus included increases in blood insulin, decreases in carbohydrate tolerance, non-insulin dependent diabetes mellitus, impaired glucose tolerance, and glycosuria.

Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean increase in fasting blood glucose of 4.4 mg/dL with a median exposure of 25 days. This was not significantly different from placebo (+2.5 mg/dL, median exposure 22 days). A pooled analysis in pediatric patients revealed a mean change in fasting glucose of 2.4 mg/dL compared with 0.1 mg/dL in placebo treated patients following 12 weeks of therapy. In long-term, open label schizophrenia studies with aripiprazole lauroxil, 14% of patients with HbA1c less than 5.7% at baseline developed levels of 5.7% or higher post-baseline.

Undesirable alterations in lipids have been observed in patients receiving atypical antipsychotics. Analyses of patients receiving this drug are limited due to the small number of patients who received this drug for extended periods in the clinical trials. In long-term, open label schizophrenia studies with aripiprazole lauroxil, shifts in fasting total cholesterol, LDL, and triglycerides from normal to high were reported in 1%, 1%, and 8% of patients.

Weight gain has been observed in patients receiving atypical antipsychotics. Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean change in weight of +0.3 kg (n=1673) with a median exposure of 21 to 25 days compared with a decrease of 0.1 kg in placebo treated patients (n=1100). A pooled analysis in pediatric patients (10 to 17 years) revealed a mean change in weight of +5.8 kg (n=62) compared with +1.4 kg (n=13) in placebo treated patients following 12 weeks of therapy. In a 12-week, fixed dose schizophrenia study in patients receiving with aripiprazole lauroxil, IM weight gain of 7% or greater from baseline was observed in 10% (n=207) and 9% (n=208) of patients receiving 441 mg and 882 mg IM, respectively.

During clinical trials, the percentage of pediatric and adolescent patients by indication with weight gain of 7% or more of body weight compared to placebo was (5.2% vs 1.6%), (26.3% vs 7.1%), and (20% vs 7.6%), respectively for schizophrenia/bipolar mania, irritability associated with autistic disorder, and Tourette's disorder, respectively. Treatment durations were 4 to 6 weeks, 8 weeks, and 8 to 10 weeks, respectively.[Ref]

Hypersensitivity

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Postmarketing reports: Allergic reaction, anaphylactic reaction, angioedema

Aripiprazole Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Hypersensitivity
Rare (0.01% to 0.1%): Drug hypersensitivity
Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema

Immediate-Release IM Injection:
Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema, hypersensitivity

Oral Formulations:
Uncommon (0.1% to 1%): Angioedema
Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Allergic reaction, anaphylactic reaction[Ref]

Gastrointestinal

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Frequency not reported: Constipation, difficulty swallowing, dry mouth, dysphagia, tongue protrusion

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Abdominal discomfort, constipation, diarrhea, dry mouth, dyspepsia, nausea, toothache, vomiting
Uncommon (0.1% to 1%): Frequent bowel movement, gastroesophageal reflux disease, salivary hypersecretion, upper abdominal pain
Rare (0.01% to 0.1%): Swollen tongue
Frequency not reported: Abdominal pain, anal abscess, anorectal discomfort, aphthous stomatitis, appendicitis perforated, colitis, dental caries, difficulty swallowing, diverticulum, dysphagia, gastritis, gastroenteritis, gastroenteritis viral, gingival edema, gingival pain, gingivitis, hemorrhoids, inguinal hernia, loose tooth, oral candidiasis, pancreatitis, periodontitis, poor dental condition, tongue disorder, tongue edema, tongue protrusion, tooth abscess, tooth fracture, tooth impacted, tooth infection, tooth loss

Immediate-Release IM Injection:
Common (1% to 10%): Constipation, dyspepsia, nausea, salivary hypersecretion, vomiting
Uncommon (0.1% to 1%): Dry mouth
Frequency not reported: Abdominal discomfort, diarrhea, dysphagia, gastroesophageal reflux disease, pancreatitis, swollen tongue, stomach discomfort, tongue dry, tongue edema, tongue spasm

Oral Formulations:
Very common (10% or more): Nausea (up to 15%), vomiting (up to 14%), constipation (up to 11%)
Common (1% to 10%): Abdominal discomfort, abdominal pain upper, diarrhea, dry mouth, dyspepsia, salivary hypersecretion, stomach discomfort, toothache
Uncommon (0.1% to 1%): Dysphagia, esophagitis, gastritis, gastroesophageal reflux disease, hypoesthesia oral, swollen tongue
Rare (0.01% to 0.1%): Abdominal distention, abnormal feces, eructation, feces discolored, gastroenteritis, gastroenteritis viral, gastrointestinal disorder, gastrointestinal pain, glossitis, lip dry, mouth injury, oral candidiasis, pancreatitis, paresthesia circumoral, parotid gland enlargement, parotitis, pruritus ani, tongue discoloration
Frequency not reported: Tongue dry, tongue edema, tongue spasm[Ref]

Dermatologic

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Postmarketing reports: Pruritus, urticaria

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Erythema, induration/skin induration, pruritus, rash
Uncommon (0.1% to 1%): Acne, alopecia, eczema, folliculitis, fungal skin infection, rosacea
Frequency not reported: Acarodermatitis, blister, cellulitis, dry skin, excoriation, face edema, furuncle, herpes zoster, hyperhidrosis, hyperkeratosis, impetigo, lice infestation, photosensitivity reaction, pilonidal cyst, psoriasis, rash macula, skin laceration, skin lesion, skin striae, subcutaneous abscess, tinea pedis, urticaria, varicella

Immediate-Release IM Injection:
Frequency not reported: Alopecia, face edema, hirsutism, hyperhidrosis, photosensitivity reaction, pruritus, rash, urticaria

Oral Formulations:
Common (1% to 10%): Acneiform rash, allergic contact rash, drug eruption rash, erythematous rash, exfoliative rash, exfoliative seborrheic dermatitis, generalized rash, hyperhidrosis, macular rash, maculopapular rash, neurodermatitis, papular rah, rash
Uncommon (0.1% to 1%): Alopecia, face edema, photosensitivity reaction, pruritus, urticaria
Rare (0.01% to 0.1%): Body tinea, decubitus ulcer, dry skin, herpes simplex, pemphigus, psoriasis
Frequency not reported: Hirsutism[Ref]

Reports of rash included erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption.[Ref]

Cardiovascular

Collective data from 17 placebo-controlled clinical studies involving the use of atypical antipsychotic agents in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although aripiprazole (the active ingredient contained in Abilify Maintena) was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Aripiprazole is not indicated for use in the treatment of behavioral disorders in elderly patients with dementia.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Frequency not reported: Angina pectoris, orthostatic hypotension, palpitations, tachycardia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Hemorrhage, hypertension
Uncommon (0.1% to 1%): Abnormal electrocardiogram, bradycardia, chest discomfort, decreased blood pressure, electrocardiogram QT prolonged, electrocardiogram T-wave abnormal/amplitude decreased/inversion, increased blood pressure, orthostatic hypotension, peripheral edema, tachycardia, ventricular extrasystole
Rare (0.01% to 0.1%): Sinus tachycardia
Frequency not reported: Acute myocardial infarction, cardiac arrest, chest pain, congestive cardiac failure, contusion, decreased heart rate, deep vein thrombosis, first-degree atrioventricular block, orthostatic hypertension, Torsade de pointes, venous thromboembolism, ventricular arrhythmias

Immediate-Release IM Injection:
Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Increased diastolic blood pressure, orthostatic hypotension
Frequency not reported: Angina pectoris, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, cardiac arrest, cardiopulmonary failure, cardiorespiratory arrest, chest pain, deep vein thrombosis, electrocardiogram QT prolonged, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, peripheral edema, QT prolongation, Torsade de pointes, venous thromboembolism, ventricular arrhythmia

Oral Formulations:
Common (1% to 10%): Chest pain, hypertension, peripheral edema
Uncommon (0.1% to 1%): Angina pectoris, atrial fibrillation, atrioventricular block, bradycardia, cardiopulmonary failure, cardiorespiratory arrest, chest discomfort, edema, electrocardiogram QT prolonged, extrasystole, generalized edema, heart rate increased, hot flush, hypotension, myocardial infarction, myocardial ischemia, orthostatic hypotension, sinus tachycardia, tachycardia
Rare (0.01% to 0.1%): Atrial flutter, electrocardiogram abnormal, electrocardiogram PR prolongation, electrocardiogram T wave inversion, flushing, heart rate irregular, hyperemia, supraventricular tachycardia, ventricular tachycardia
Frequency not reported: Cardiac arrest, deep vein thrombosis, hypotension, palpitations, Torsade de pointes, venous thromboembolism, ventricular arrhythmias[Ref]

Hematologic

Neutropenia has been reported with the extended/prolonged-release IM injection; it typically starts around day 16 and lasts a median of 18 days.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Frequency not reported: Agranulocytosis, leukopenia, neutropenia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Neutropenia
Uncommon (0.1% to 1%): Anemia, neutrophil count decreased, thrombocytopenia, white blood cell count decreased
Frequency not reported: Agranulocytosis, bicytopenia, leukopenia, lymphadenopathy

Immediate-Release IM Injection:
Frequency not reported: Leukopenia, neutropenia, thrombocytopenia

Oral Formulations:
Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia
Rare (0.01% to 0.1%): Eosinophil count increased, eosinophilia, lymphadenopathy, white blood cell count increased[Ref]

Endocrine

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Prolactin levels greater than 1 times the upper limit of normal
Uncommon (0.1% to 1%): Blood prolactin decreased, gynecomastia, hyperprolactinemia
Rare (0.01% to 0.1%): Hypoprolactinemia

Immediate-Release IM Injection:
Uncommon (0.1% to 1%): Hyperprolactinemia
Frequency not reported: Blood prolactin increased, gynecomastia

Oral Formulations:
Very common (10% or more): Serum prolactin levels less than 2 ng/mL (up to 53.3%), serum prolactin levels less than 3 ng/mL (up to 29.5%)
Uncommon (0.1% to 1%): Blood prolactin increased, hyperprolactinemia
Rare (0.01% to 0.1%): Early menarche, gynecomastia[Ref]

Musculoskeletal

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Increased blood creatine phosphokinase
Frequency not reported: Abnormal/prolonged muscle contractions, muscular weakness, neck muscle spasms

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Arthralgia, back pain, increased blood creatine phosphokinase, musculoskeletal pain, musculoskeletal stiffness, myalgia, pain in extremity
Uncommon (0.1% to 1%): Joint range of motion decreased, joint stiffness, muscle rigidity, muscle spasms, muscle tightness, muscle twitching, nuchal rigidity, trismus
Rare (0.01% to 0.1%): Rhabdomyolysis, thrombocytopenia
Frequency not reported: Abnormal/prolonged muscle contractions, ankle fracture, arthritis, foot fracture, joint dislocation, joint sprain, joint swelling, muscle injury, muscle strain, neck muscle spasms, radius fracture, rotator cuff syndrome, skeletal injury, stiffness

Immediate-Release IM Injection:
Frequency not reported: Increased creatine phosphokinase, mobility decreased, muscle tightness, muscular weakness, myalgia, rhabdomyolysis, stiffness

Oral Formulations:
Common (1% to 10%): Arthralgia, blood creatinine phosphokinase increased/creatine phosphokinase increase, muscle rigidity, muscle spasms, musculoskeletal stiffness, myalgia, pain in extremity
Uncommon (0.1% to 1%): mobility decreased, muscle tightness, musculoskeletal rigidity
Rare (0.01% to 0.1%): Bone pain, clavicle fracture, femoral neck fracture, flank pain, hip fracture, humerus fracture, jaw disorder, kyphosis, muscle strain, nuchal rigidity, osteoarthritis, rhabdomyolysis
Frequency not reported: Muscular weakness, stiffness[Ref]

Other

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Frequency not reported: Asthenia, body temperature regulation, falls

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Fatigue, inflammation, swelling
Frequency not reported: Accident, body temperature regulation, carbon monoxide poisoning, deafness, drug toxicity, ear infection, face injury, falls, fungal infection, gunshot wound, herpes virus infection, hypothermia, injury, multiple injuries, pain, procedural pain, sudden unexplained death, temperature regulation disorder, thermal burn, wound

Immediate-Release IM Injection:
Common (1% to 10%): Fatigue
Frequency not reported: Asthenia, fall, heat stroke, hypothermia, pyrexia, sudden unexplained death, temperature regulation disorder

Oral Formulations:
Very common (10% or more): Fatigue (up to 18.5%)
Common (1% to 10%): Asthenia, fall, feeling jittery, pain, pyrexia
Uncommon (0.1% to 1%): Adverse event, chills, discomfort, feeling abnormal
Rare (0.01% to 0.1%): Ear canal erythema, energy increased, facial pain, feeling cold, head lag abnormal, heat stroke, hypoacusis, hypothermia, injury, malaise, open wound, physical examination, sensation of heaviness, smoker, swelling, tenderness, tinnitus, xerosis
Frequency not reported: Sudden unexplained death, temperature regulation disorder[Ref]

In a dose response analysis, fatigue was determined to have a dose response relationship in pediatric patients with incidences of fatigue reported at 3.8%, 22%, and 18.5% in those receiving 5 mg, 10 mg, and 15 mg respectively.[Ref]

Respiratory

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Frequency not reported: Difficulty breathing, throat tightness
Postmarketing reports: Hiccups, laryngospasm, oropharyngeal spasm

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Bronchitis, cough, nasal congestion, nasopharyngitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups, pharyngitis
Frequency not reported: Acute respiratory distress syndrome, allergic rhinitis, aspiration pneumonia, difficulty breathing, dysphonia, dyspnea, epistaxis, laryngospasm, nasal septum deviation, oropharyngeal spasm, paranasal sinus hypersecretion, pulmonary embolism, respiratory tract congestion, rhinalgia, sinus congestion, throat tightness, wheezing

Immediate-Release IM Injection:
Uncommon (0.1% to 1%): Hiccups
Frequency not reported: Aspiration pneumonia, dyspnea, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary embolism

Oral Formulations:
Common (1% to 10%): Cough, dyspnea, epistaxis, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, pneumonia aspiration, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups
Rare (0.01% to 0.1%): Dry throat, hoarseness, lower respiratory tract infection, nasal dryness, painful respiration, paranasal sinus hypersecretion, rhinorrhea, sinus congestion, sinusitis
Frequency not reported: Laryngospasm, oropharyngeal spasm pulmonary embolism[Ref]

Ocular

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Blurred vision, diplopia, eye pain, oculogyric crisis
Frequency not reported: Allergic conjunctivitis, eye irritation, eyelid ptosis, hordeolum

Immediate-Release IM Injection:
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia
Frequency not reported: Oculogyric crisis, photophobia

Oral Formulations:
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, eyelid edema, photophobia, photopsia
Rare (0.01% to 0.1%): Chromotopsia, conjunctivitis, eye disorder, eye movement disorder, eye redness, gaze palsy, lacrimation increased
Frequency not reported: Oculogyric crisis[Ref]

Genitourinary

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Erectile dysfunction
Uncommon (0.1% to 1%): Breast tenderness, ejaculation delayed, galactorrhea, vulvovaginal dryness
Rare (0.01% to 0.1%): Glycosuria, pollakiuria, urinary incontinence
Frequency not reported: Adnexa uteri pain, breast mass, Escherichia urinary tract infection (UTI), mastitis, micturition urgency, ovarian cyst, priapism, protein urine, suprapubic pain, urinary retention, UTIs, vaginal infections, vulvovaginal mycotic infection, white blood cells urine

Immediate-Release IM Injection:
Frequency not reported: Amenorrhea, breast pain, enuresis, erectile dysfunction, priapism, menstruation irregular, nocturia, urinary incontinence, urinary retention

Oral Formulations:
Uncommon (0.1% to 1%): Amenorrhea, breast pain, erectile dysfunction, glucose urine/glucose urine present, incontinence/urinary incontinence, menstruation irregular, nocturia, pollakiuria, polyuria, urinary retention
Rare (0.01% to 0.1%): Bladder discomfort, blood urine present, breast discharge, chromaturia, enuresis, genital pruritus female, micturition urgency, pelvic pain, priapism, proteinuria, sexual dysfunction, urethral discharge, urinary hesitation, urinary tract infection, urine ketone body present, urine output increased, vulvovaginal discomfort[Ref]

Hepatic

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Abnormal liver function test, ALT increased, AST increased, blood bilirubin increased, gamma-glutamyl transferase increased, increased hepatic enzymes
Rare (0.01% to 0.1%): Drug induced liver injury
Frequency not reported: Alkaline phosphatase increased, cholecystitis chronic, cholelithiasis, hepatic cirrhosis, hepatic failure, hepatic steatosis, hepatitis, hepatosplenomegaly, jaundice

Immediate-Release IM Injection:
Frequency not reported: Blood bilirubin increased, hepatic enzyme increased, hepatic failure, hepatitis, increased alkaline phosphatase, increased ALT, increased AST, increased gamma glutamyl transferase, jaundice

Oral Formulations:
Uncommon (0.1% to 1%): Blood bilirubin increased, hepatic enzyme increased
Rare (0.01% to 0.1%): Gamma glutamyl transferase increased, hepatitis, jaundice
Frequency not reported: Hepatic failure, increased alkaline phosphatase, increased ALT, increased AST[Ref]

Local

Aripiprazole (the active ingredient contained in Abilify Maintena) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Injection site pain
Frequency not reported: Induration, redness, swelling

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Injection site induration, injection site pain, injection site reactions
Uncommon (0.1% to 1%): Injection site discomfort, injection site erythema, injection site pruritus, injection site swelling
Frequency not reported: Infusion site hematoma, infusion site swelling, localized infection, vessel puncture site hematoma, vessel puncture site pain

Immediate-Release IM Injection:
Frequency not reported: Injection site reaction, venipuncture site bruise

Oral Formulations:
Rare (0.01% to 0.1%): Local swelling, localized infection[Ref]

Injection site reactions reported with the aripiprazole extended-release IM suspension included pain, erythema, induration, pruritus, swelling, rash, inflammation, and hemorrhage. The mean intensity of injection pain reported with the first injection was 7.1 (visual analog scale 0=no pain to 100=unbearably painful) and 4.8 with the second injection. Injection site reactions with aripiprazole lauroxil extended-release IM suspension were mostly associated with the first injection and decreased with each subsequent injection.[Ref]

Renal

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Glycosuria, nephrolithiasis
Frequency not reported: Cystitis, glucose urine present

Immediate-Release IM Injection:
Frequency not reported: Blood creatinine increased, blood urea increased

Oral Formulations:
Uncommon (0.1% to 1%): Blood creatinine increased, blood urea increased
Rare (0.01% to 0.1%): Oliguria[Ref]

Oncologic

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Frequency not reported: Basal cell carcinoma, breast fibroma, pancreatic carcinoma

Oral Formulations:
Rare (0.01% to 0.1%): Cyst, oral neoplasm, skin papilloma[Ref]

Immunologic

Aripiprazole (the active ingredient contained in Abilify Maintena) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Influenza
Frequency not reported: Influenza-like illness, viral infection

Oral Formulations:
Rare (0.01% to 0.1%): Decreased immune responsiveness[Ref]

Some side effects of Abilify Maintena may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.