Prozac

Name: Prozac

What Is Prozac (Fluoxetine)?

Prozac is the brand name of fluoxetine, a prescription drug used to treat depression.

This antidepressant is in a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs. These medications work by increasing the amount of serotonin in the brain.

In addition to depression, Prozac is used to treat:

  • Obsessive-compulsive disorder (OCD)
  • Binge eating disorder
  • Vomiting in people with moderate to severe bulimia
  • Panic disorder (with or without agoraphobia, the fear of open spaces)

Fluoxetine capsules and tablets sold under the brand name Sarafem are used to treat premenstrual dysphoric disorder (PMDD), a condition in which a woman has symptoms of depression, irritability, and tension before menstruation.

Prozac comes in several forms, including capsules, tablets, liquid, and delayed-release capsules.

Eli Lilly and Company makes Prozac, which was approved by the Food and Drug Administration (FDA) in 1987.

The delayed-release capsule Prozac Weekly is also made by Eli Lilly and Company.

Generic forms of fluoxetine, fluoxetine delayed-release capsules, and Sarafem are also available.

Prozac Warnings

Prozac and other antidepressants are required to carry a black box warning due to the increased risk of suicide when taking the medicine.

Prozac may increase suicidal thoughts or actions in children, teenagers, and young adults within the first several months of treatment or after a change in dose.

Call your doctor immediately if you have any unusual changes in behavior or mood while on Prozac, including:

  • Thoughts about suicide or dying, or suicide attempts
  • New or worsening depression or anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Difficulty sleeping
  • New or worse irritability
  • Being aggressive, angry, or violent
  • Acting on dangerous impulses
  • Extreme increase in activity and talking
  • Decreased need for sleep

Before taking Prozac, tell your doctor if you have a history of seizures; bipolar disorder; liver disease; heart problems, including heart rhythm problems; diabetes; glaucoma; or thoughts of suicide or attempted suicide.

You may not feel the full benefits of Prozac for 4 to 6 weeks or longer after starting the medication.

Before stopping Prozac, talk to your doctor. Stopping suddenly can cause serious side effects. Your doctor will help you safely stop the medication.

Don't take Prozac or other forms of fluoxetine if you're allergic to fluoxetine or any of the inactive ingredients in the various formulations. Cases of severe allergic reactions have been reported and could result in death.

If you are taking a monoamine oxidase inhibitor (MAOI) or if you took an MAOI in the past 14 days, then don't use Prozac. A dangerous drug interaction could occur that may result in death.

Avoid operating heavy machinery, driving a motor vehicle, or performing other dangerous activities until you know how Prozac affects you.

The drug can cause sleepiness and may worsen your ability to make decisions, think clearly, or react quickly.

There is limited information regarding the long-term effects of Prozac on the development and maturation of children and adolescents.

Talk to your child's doctor about monitoring their height and weight when they are taking Prozac.

Prozac and Pregnancy

Prozac might harm a developing fetus.

Before taking Prozac, tell your doctor if you are pregnant or might become pregnant. The benefits and risks of Prozac in the third trimester of pregnancy should be very closely evaluated.

Babies of mothers who have been exposed to the medication at this time have had various side effects.

Before taking Prozac, tell your doctor if you are breastfeeding, because the medication passes into breast milk.

Taking Prozac while you are breastfeeding is not recommended.

Prozac and Weight Gain

Weight gain is a side effect of many antidepressants, including Prozac.

A study published in 2014 in the journal JAMA Psychiatry found that people taking Prozac and other SSRIs gained one to two pounds over the course of a year; weight gain varied, depending on the SSRI used.

Some other reports indicate that up to 25 percent of antidepressant users experience a weight gain of more than 10 pounds. This may be due to increased appetite among people taking antidepressants.

Other users have reported weight loss while using Prozac; more research is needed to determine how Prozac and other SSRIs may contribute to weight changes.

If you're concerned about weight gain or loss while taking Prozac, talk with your doctor.

Prozac for Dogs and Cats

Prozac is sometimes prescribed for dogs or cats under the care of a veterinarian.

The drug may be prescribed for behaviors such as tail chasing, constant licking, or other obsessive-compulsive behaviors.

Do not give your dog or cat Prozac — or any other medication — without first speaking with your pet's veterinarian.

Use Prozac and all other drugs according to the instructions that your pet's veterinarian provides.

Uses of Prozac

Prozac is a prescription medicine used to treat the following conditions:

  • Depression (known medically as major depressive disorder (MDD) or clinical depression)
  • Obsessive compulsive disorder (OCD) 
  • Bulimia nervosa 
  • Panic disorder 
  • Depression associated with bipolar disorder, taken with olanzapine (Symbyax)
  • Treatment-resistant depression (depression that has not gotten better with at least 2 other treatments), taken with olanzapine (Symbyax)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Eli Lilly and Company

Side Effects of Prozac

Prozac may cause serious side effects. See "Drug Precautions" section.

Common possible side effects in people who take Prozac include: 

  • unusual dreams 
  • sexual problems 
  • loss of appetite, diarrhea, indigestion, nausea or vomiting, weakness, or dry mouth 
  • flu symptoms 
  • feeling tired or fatigued 
  • change in sleep habits
  • yawning 
  • sinus infection or sore throat 
  • tremor or shaking 
  • sweating 
  • feeling anxious or nervous 
  • hot flashes 
  • rash 
 Other side effects in children and adolescents include: 
  • increased thirst 
  • abnormal increase in muscle movement or agitation 
  • nose bleed 
  • urinating more often 
  • heavy menstrual periods 
  • possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with Prozac
 Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Prozac. For more information, ask your healthcare provider or pharmacist.

Prozac FDA Warning

WARNING–SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of fProzac or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Prozac is approved for use in pediatric patients with MDD and Obsessive Compulsive Disorder (OCD). 

When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for olanzapine and fluoxetine hydrochloride capsules.

Before Using Prozac

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children. However, safety and efficacy have not been established to treat depression in children younger than 8 years of age, and to treat obsessive-compulsive disorder in children younger than 7 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa or panic disorder. 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 fluoxetine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) than younger adults, which may require caution and an adjustment in the dose for patients receiving fluoxetine.

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 taking 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
  • Bepridil
  • Bromopride
  • Cisapride
  • Clorgyline
  • Dronedarone
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Rasagiline
  • Saquinavir
  • Selegiline
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • 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.

  • Abciximab
  • Abiraterone
  • Acecainide
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Ajmaline
  • Alfentanil
  • Alfuzosin
  • Almotriptan
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amphetamine
  • Amtolmetin Guacil
  • Anagrelide
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Apixaban
  • Apomorphine
  • Aprindine
  • Ardeparin
  • Argatroban
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Aspirin
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bemiparin
  • Benzphetamine
  • Bivalirudin
  • Bretylium
  • Brexpiprazole
  • Bromfenac
  • Brompheniramine
  • Bufexamac
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Butorphanol
  • Cangrelor
  • Carbamazepine
  • Celecoxib
  • Certoparin
  • Chloral Hydrate
  • Chloroquine
  • Chlorpheniramine
  • Chlorpromazine
  • Choline Salicylate
  • Cilostazol
  • Cinacalcet
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonixin
  • Clopidogrel
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Dasatinib
  • Defibrotide
  • Degarelix
  • Delamanid
  • Dermatan Sulfate
  • Desipramine
  • Desirudin
  • Deslorelin
  • Desmopressin
  • Desvenlafaxine
  • Deutetrabenazine
  • Dexfenfluramine
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Dextromethorphan
  • Dibenzepin
  • Diclofenac
  • Dicumarol
  • Diflunisal
  • Dihydrocodeine
  • Dipyridamole
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Drotrecogin Alfa
  • Droxicam
  • Duloxetine
  • Ebastine
  • Edoxaban
  • Efavirenz
  • Eletriptan
  • Eliglustat
  • Enflurane
  • Enoxaparin
  • Epoprostenol
  • Eptifibatide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Famotidine
  • Felbamate
  • Felbinac
  • Fenfluramine
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Fingolimod
  • Flecainide
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Fluphenazine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Frovatriptan
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Heparin
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxytryptophan
  • Hydroxyzine
  • Ibuprofen
  • Ibutilide
  • Iloperidone
  • Iloprost
  • Imipramine
  • Indomethacin
  • Iobenguane I 123
  • Isoflurane
  • Isradipine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Lepirudin
  • Leuprolide
  • Levofloxacin
  • Levomilnacipran
  • Levorphanol
  • Lidoflazine
  • Lisdexamfetamine
  • Lofepramine
  • Lorcaserin
  • Lornoxicam
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Melitracen
  • Meloxicam
  • Meperidine
  • Methadone
  • Methamphetamine
  • Metronidazole
  • Mifepristone
  • Milnacipran
  • Mirtazapine
  • Mizolastine
  • Morniflumate
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nabumetone
  • Nadroparin
  • Nafarelin
  • Nalbuphine
  • Naproxen
  • Naratriptan
  • Nebivolol
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Oxaprozin
  • Oxycodone
  • Oxymorphone
  • Oxyphenbutazone
  • Paliperidone
  • Palonosetron
  • Panobinostat
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Pentosan Polysulfate Sodium
  • Perphenazine
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Pimavanserin
  • Pirmenol
  • Piroxicam
  • Pitolisant
  • Posaconazole
  • Prajmaline
  • Pranoprofen
  • Prasugrel
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Quetiapine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Reviparin
  • Ribociclib
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Rivaroxaban
  • Rizatriptan
  • Rofecoxib
  • Safinamide
  • Salicylic Acid
  • Salsalate
  • Selexipag
  • Sematilide
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sibutramine
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • St John's Wort
  • Sufentanil
  • Sulfamethoxazole
  • Sulfinpyrazone
  • Sulindac
  • Sulpiride
  • Sultopride
  • Sumatriptan
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Terbinafine
  • Tetrabenazine
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tizanidine
  • Tolfenamic Acid
  • Tolmetin
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Treprostinil
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Triptorelin
  • Tryptophan
  • Valbenazine
  • Valdecoxib
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilazodone
  • Vinflunine
  • Vorapaxar
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Warfarin
  • Zolmitriptan
  • Zotepine
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Buspirone
  • Cyproheptadine
  • Delavirdine
  • Digoxin
  • Ginkgo
  • Lithium
  • Phenytoin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • Bipolar disorder (mood disorder with mania and depression), or risk of or
  • Bleeding problems or
  • Diabetes or
  • Glaucoma (angle-closure type) or
  • Hyponatremia (low sodium in the blood) or
  • Mania, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Heart attack or stroke, recent or history of or
  • Heart failure or
  • Heart rhythm problems (eg, QT prolongation), or history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Before taking this medicine

Do not use Prozac if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you can take Prozac. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

You should not use Prozac if you are allergic to fluoxetine, if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Paxil, Pexeva, Symbyax, Viibryd, or Zoloft.

Some medicines can interact with fluoxetine and cause a serious condition called serotonin syndrome. Be sure your doctor knows about all other medicines you use. Ask your doctor before making any changes in how or when you take your medications.

To make sure Prozac is safe for you, tell your doctor if you have:

  • cirrhosis of the liver;

  • kidney disease;

  • diabetes;

  • narrow-angle glaucoma;

  • seizures or epilepsy;

  • bipolar disorder (manic depression);

  • a history of drug abuse or suicidal thoughts; or

  • if you are being treated with electroconvulsive therapy (ECT).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking Prozac during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

Fluoxetine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Prozac is not approved for use by anyone younger than 18 years old.

Prozac side effects

Get emergency medical help if you have signs of an allergic reaction to Prozac: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Prozac side effects may include:

  • sleep problems (insomnia), strange dreams;

  • headache, dizziness, vision changes;

  • tremors or shaking, feeling anxious or nervous;

  • pain, weakness, yawning, tired feeling;

  • upset stomach, loss of appetite, nausea, vomiting, diarrhea;

  • dry mouth, sweating, hot flashes;

  • changes in weight or appetite;

  • stuffy nose, sinus pain, sore throat, flu symptoms; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Prozac?

Taking Prozac with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with fluoxetine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other antidepressant;

  • St. John's Wort;

  • tryptophan (sometimes called L-tryptophan);

  • a blood thinner - warfarin, Coumadin, Jantoven;

  • medicine to treat anxiety, mood disorders, thought disorders, or mental illness - amitriptyline, buspirone, desipramine, lithium, nortriptyline, and many others;

  • medicine to treat ADHD or narcolepsy - Adderall, Concerta, Ritalin, Vyvanse, Zenzedi, and others;

  • migraine headache medicine - rizatriptan, sumatriptan, zolmitriptan, and others; or

  • narcotic pain medicine - fentanyl, tramadol.

This list is not complete and many other drugs can interact with fluoxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Bottom Line

Prozac may be used for the treatment of depression and other mood disorders. It is more likely to cause insomnia than drowsiness.

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