Navane

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

Thiothixene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness, lightheadedness, feeling unsteady, or having trouble keeping your balance
• blurred vision
• dry mouth
• excess saliva
• stuffed nose
• nausea
• vomiting
• constipation
• diarrhea
• changes in appetite
• excessive thirst
• weight gain
• widening or narrowing of the pupils (black circles in the middle of the eyes)
• blank facial expression
• shuffling walk
• unusual, slowed, or uncontrollable movements of any part of the body
• restlessness
• agitation
• difficulty falling asleep or staying asleep
• swelling of the arms, hands, feet, ankles, or lower legs
• breast enlargement
• breast milk production
• missed or irregular menstrual periods
• decreased sexual ability in men
• weakness

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• fever
• muscle stiffness
• falling
• confusion
• fast or irregular heartbeat
• sweating
• neck cramps
• tongue that sticks out of the mouth
• tightness in the throat
• difficulty breathing or swallowing
• fine, worm-like tongue movements
• uncontrollable, rhythmic face, mouth, or jaw movements
• seizures
• rash
• hives
• itching
• vision loss, especially at night
• seeing everything with a brown tint

Thiothixene may cause other side effects. Tell your doctor if you have any unusual problems during your treatment with thiothixene.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Frequency Not Defined

Constipation

Decr sweating

Drowsiness

EPS ( muscle stiffness, dystonia, Parkinsonism, tardive dyskinesia, akathisia) (60%)

Incr appetite

Orthostatic hypotension

Photosensitivity

Wt gain

Xerostomia

Agitation

Allergic dermatitis

Allergic reactions

Anorexia

Anticholinergic effects

Anxiety

Cerebral edema

Depression

Dizziness

Erectile dysfunction

Euphoria

Headache

Ileus

Insomnia

Irregular menses

Lens opacities (prolonged use)

Poikilothermia

Rash

Restlessness

Sedation

Tachycardia

Weakness

Agranulocytosis, blood dyscrasias (rare)

Galactorrhea (rare)

Heat stroke (rare)

NMS (infrequent but serious)

Obstructive hyperbilirubinemia (rare)

Cholestatic jaundice

Confusion

Decr gag reflex

Gynecomastia

Hyperpyrexia

Peripheral edema

Pregnancy Category: C

Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization

Lactation: may be excreted in breast milk; not advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Thiothixene is an antipsychotic medication. It affects the actions of chemicals in your brain.

Thiothixene is used to treat schizophrenia.

Thiothixene may also be used for purposes not listed in this medication guide.

You should not use thiothixene if you are allergic to it, or if you have:

• a blood cell disorder such as anemia, low white blood cell counts, or low platelets; or

• drowsiness, slow breathing, weak pulse, or decreased alertness (such as after drinking alcohol or taking medicines that make you sleepy).

Thiothixene is not approved for use in psychotic conditions related to dementia. Thiothixene may increase the risk of death in older adults with dementia-related conditions.

Long-term use of thiothixene can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take thiothixene, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.

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

• epilepsy or other seizure disorder;

• heart disease;

• a history of low white blood cell (WBC) counts;

• a history of breast cancer; or

• if you are addicted to alcohol.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking thiothixene, do not stop taking it without your doctor's advice.

It is not known whether thiothixene passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Thiothixene should not be given to a child younger than 12 years old.

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

Stop using thiothixene and call your doctor at once if you have:

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• stiffness in your neck, tightness in your throat, trouble breathing or swallowing;

• seizure (convulsions);

• sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, easy bruising or bleeding;

• a light-headed feeling, like you might pass out;

• severe constipation;

• pale or yellowed skin, dark colored urine, confusion; or

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

Older adults may be more likely to have side effects from this medicine.

Common side effects may include:

• dry mouth, increased thirst;

• blurred vision, drowsiness;

• nausea, vomiting, diarrhea, constipation;

• fast heart rate, restless feeling;

• breast swelling or discharge;

• changes in weight or appetite; or

• swelling in your hands or feet.

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.

General

• Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.101 b c u

• Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.101 b u w (See Tardive Dyskinesia under Cautions.)

• For symptomatic relief of psychotic disorders, initial therapeutic response to antipsychotic therapy usually occurs within 2–4 weeks and optimum therapeutic response occurs within 6 months or longer.100 w

Administration

Oral Administration

Thiothixene is administered orally once daily or in divided doses 2 or 3 times daily.101 b c k t u Thiothixene hydrochloride has been given orally and parenterally, but no longer is commercially available in the US.101 c h v

Dosage

Pediatric Patients

Children ≥12 years of age: Initially, 2 mg 3 times daily for mild to moderate psychotic disorders; may gradually increase dosage, if necessary, up to 15 mg daily.101 b c u

For more severe psychotic disorders in children ≥12 years of age: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.101 b c u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.101 b c k u

Daily dosages >60 mg rarely provide additional therapeutic effect.101 b c u

Adults

For mild to moderate psychotic disorders: Initially, 2 mg 3 times daily; may gradually increase dosage, if necessary, up to 15 mg daily.101 b c u

For more severe psychotic disorders: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.101 b c u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.101 b c k u

Daily dosages >60 mg rarely provide additional therapeutic effect.101 b c u

Prescribing Limits

Pediatric Patients

Children ≥12 years of age: Maximum 60 mg daily.101 b c u

Adults

Maximum 60 mg daily.101 b c u

Special Populations

Geriatric Patients

No specific dosage recommendations for geriatric patients, but generally select dosage at the lower end of recommended range; increase dosage more gradually and monitor closely.100 101 b h u w (See Geriatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, who are usually more sensitive than adults to the side effects of thioxanthenes.

Geriatric

Constipation, dizziness or fainting, drowsiness, dryness of mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of thioxanthenes.

Pregnancy

Studies have not been done in pregnant women. Although animal studies have not shown that thioxanthenes cause birth defects, the studies have shown that these medicines cause a decrease in fertility and fewer successful pregnancies.

Breast Feeding

It is not known if thioxanthenes pass into the breast milk. However, similar medicines for nervous, mental, or emotional conditions do pass into breast milk and may cause drowsiness and increase the risk of other problems in the nursing baby. Be sure you have discussed the risks and benefits of this medicine with your doctor.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

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

Using medicines in this class 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.

• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buserelin
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lithium
• Lumefantrine
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Milnacipran
• Mizolastine
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Remifentanil
• Ribociclib
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tiotropium
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zotepine

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Drinking alcohol will add to the central nervous system (CNS) depressant effects of thioxanthenes.

• Blood disease or
• Enlarged prostate or
• Glaucoma or
• Heart or blood vessel disease or
• Lung disease or
• Parkinson's disease or
• Stomach ulcers or
• Urination problems—Thioxanthenes may make the condition worse.

• Liver disease—Higher blood levels of thioxanthenes may occur, increasing the chance of side effects.

• Reye's syndrome—The risk of liver problems may be increased.

• Seizure disorders—The risk of seizures may be increased.

Along with their needed effects, thioxanthenes can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. Some of these side effects, including severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures, may be the sign of a condition called neuroleptic malignant syndrome. You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

• Convulsions (seizures)
• difficulty in breathing
• fast heartbeat
• high fever
• high or low (irregular) blood pressure
• increased sweating
• loss of bladder control
• muscle stiffness (severe)
• unusually pale skin
• unusual tiredness

Check with your doctor as soon as possible if any of the following side effects occur:

• Difficulty in talking or swallowing
• inability to move eyes
• lip smacking or puckering
• loss of balance control
• mask-like face
• muscle spasms, especially of the neck and back
• puffing of cheeks
• rapid or worm-like movements of tongue
• restlessness or need to keep moving (severe)
• shuffling walk
• stiffness of arms and legs
• trembling and shaking of fingers and hands
• twisting movements of body
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs

• Blurred vision or other eye problems
• difficult urination
• fainting
• skin discoloration
• skin rash

• Hot, dry skin or lack of sweating
• increased blinking or spasms of eyelid
• muscle weakness
• sore throat and fever
• uncontrolled twisting movements of neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions
• yellow eyes or skin

• Difficulty in breathing (severe)
• dizziness (severe)
• drowsiness (severe)
• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• small pupils
• unusual excitement
• unusual tiredness or weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decreased sweating
• dizziness, lightheadedness, or fainting
• drowsiness (mild)
• dryness of mouth
• increased appetite and weight
• increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn)
• stuffy nose

• Changes in menstrual period
• decreased sexual ability
• swelling of breasts (in males and females)
• unusual secretion of milk

After you stop taking this medicine your body may need time to adjust, especially if you took this medicine in high doses or for a long time. If you stop taking it too quickly, the following withdrawal effects may occur and should be reported to your doctor:

• Dizziness
• nausea and vomiting
• stomach pain
• trembling of fingers and hands
• uncontrolled, continuing movements of mouth, tongue, or jaw

Although not all of the side effects listed above have been reported for all thioxanthenes, they have been reported for at least one of them. However, since these medicines are very similar, any of the above side effects may occur with any of them.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

1. Worldwide Labeling Safety Report: Dyskinesia and Dyskinesia Tardive and Thiothixene, (16Apr02).
2. Worldwide Labeling Safety Report: Neuroleptic Malignant Syndrome and Thiothixene, (16Apr02).
3. Worldwide Labeling Safety Report: Hyperprolactinemia and Thiothixene, (16Apr02).
4. Ereshefsky L, Saklad SR, Watanabe MD, et al. Thiothixene Pharmacokinetic Interactions: A Study of Hepatic Enzyme Inducers, Clearance Inhibitors, and Demographic Variables. Journal of Clinical Psychopharmacology, 11(5):296–301, (1991).
5. Worldwide Labeling Safety Report: Drug Interaction and Thiothixene, (09May02).
6. McEvoy GK, Miller JL, Snow EK, et al. AHFS Drug Information. American Society of Health-System Pharmacists, Inc., p. 2334–2336, (2002).
7. Worldwide Labeling Safety Report: Menstrual Disorder and Thiothixene, (16Apr02).

NDC 0049-5720-66

100 Capsules

Navane®
(thiothixene)

2 mg

Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

NDC 0049-5740-66

100 Capsules

Navane®
(thiothixene)

10 mg

Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

Applies to thiothixene: oral capsule, oral liquid, oral solution, oral tablet

Along with its needed effects, thiothixene (the active ingredient contained in Navane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking thiothixene:

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

• Abdominal or stomach pain
• back, leg, or stomach pains
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• bloody, black, or tarry stools
• blurred vision
• chest pain
• chills
• clay-colored stools
• confusion
• convulsions
• cough or hoarseness
• dark urine
• difficulty with breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• high fever
• high or low blood pressure
• inability to move the eyes
• inability to sit still
• increased blinking or spasms of the eyelid
• increased sweating
• lightheadedness
• lip smacking or puckering
• loss of appetite
• loss of balance control
• loss of bladder control
• lower back or side pain
• mask-like face
• nausea or vomiting
• need to keep moving
• nosebleeds
• overactive reflexes
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• rapid weight gain
• restlessness
• seizures
• severe muscle stiffness
• shuffling walk
• slowed movements
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sticking out of the tongue
• sweating
• swollen glands
• tic-like (jerky) movements of the head, face, mouth, and neck
• tingling of the hands or feet
• tiredness
• trembling and shaking of the fingers and hands
• trouble with breathing, speaking, or swallowing
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unexplained bleeding or bruising
• unpleasant breath odor
• unusual bleeding or bruising
• unusual facial expressions
• unusual weight gain or loss
• unusually pale skin
• vomiting of blood
• yellowing of the eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking thiothixene:

• Change in consciousness
• depression
• drowsiness
• loss of consciousness
• sudden jerky movements of the body

Some side effects of thiothixene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Absent, missed, or irregular menstrual periods
• anxiety
• constipation
• decreased interest in sexual intercourse
• diarrhea
• dry mouth
• extreme thirst
• hives or welts
• hyperventilation
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the skin to sunlight
• increased sweating
• increased thirst
• increased weight
• irritability
• loss in sexual ability, desire, drive, or performance
• menstrual changes
• nervousness
• redness or other discoloration of the skin
• severe sunburn
• sleeplessness
• stopping of menstrual bleeding
• stuffy nose
• swelling of the breasts or unusual milk production
• trouble with sleeping
• unable to sleep
• watering of mouth

Applies to thiothixene: intramuscular powder for injection, oral capsule, oral concentrate

Nervous system

Frequency not reported: Tardive dyskinesia, extrapyramidal symptoms (e.g., pseudoparkinsonism, akathisia, dystonia), drowsiness, sedation, restlessness, agitation, insomnia, seizures, paradoxical exacerbation of psychotic symptoms[Ref]

Endocrine

Frequency not reported: Hyperprolactinemia, lactation, menstrual irregularities, moderate breast enlargement, galactorrhea, amenorrhea, gynecomastia, impotence[Ref]

Cardiovascular

Frequency not reported: Tachycardia, hypotension, lightheadedness, syncope, nonspecific ECG changes[Ref]

General

-As this drug has certain chemical and pharmacological similarities to the phenothiazines, all the side effects and toxicity associated with phenothiazines should be considered when this drug is used.
-Side effects of phenothiazines (not reported in this drug) include: cerebral edema, cerebrospinal fluid abnormalities, liver damage (jaundice, biliary stasis), eosinophilia, hemolytic anemia, pancytopenia, thrombocytopenic purpura, neutropenia, agranulocytosis, hyperreflexia (in infants whose mothers received phenothiazines), hypoglycemia, hyperglycemia, glycosuria, exfoliative dermatitis, contact dermatitis (in nursing personnel), miosis, mydriasis, adynamic ileus, and systemic lupus erythematosus-like syndrome.[Ref]

Immunologic

Rare (less than 0.1%): Anaphylaxis
Frequency not reported: Allergic reactions (rash, pruritus, urticaria, photosensitivity)[Ref]

Hematologic

Frequency not reported: Leukopenia and leukocytosis (usually transient)[Ref]

Hepatic

Frequency not reported: Elevated serum transaminase and elevated alkaline phosphatase (usually transient)[Ref]

Metabolic

Frequency not reported: Anorexia, increased appetite, increased weight, polydipsia[Ref]

Other

Frequency not reported: Hyperpyrexia, weakness/fatigue, peripheral edema[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, constipation, increased salivation[Ref]

Ocular

Frequency not reported: Blurred vision[Ref]

Dermatologic

Frequency not reported: Increased sweating[Ref]

Respiratory

Frequency not reported: Nasal congestion[Ref]

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