Navane Side Effects

Generic Name: thiothixene

Note: This page contains side effects data for the generic drug thiothixene. It is possible that some of the dosage forms included below may not apply to the brand name Navane.

It is possible that some side effects of Navane may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, thiothixene (the active ingredient contained in Navane) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking thiothixene, check with your doctor immediately:

Rare
  • 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
Incidence not known
  • 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

If any of the following symptoms of overdose occur while taking thiothixene, get emergency help immediately:

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

Some thiothixene side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known
  • 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

For Healthcare Professionals

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

Nervous system

Nervous system side effects are common and include drowsiness, dystonia, akathisia, and other extrapyramidal effects in up to 46% of treated patients. Patients with renal insufficiency may be particularly prone to the extrapyramidal effects of thiothixene (the active ingredient contained in Navane)

Akathisia has been reported in up to 20% of patients receiving a single dose of thiothixene and 63% of patients receiving chronic treatment. Laryngeal-pharyngeal dystonia has also been reported rarely. In some cases, dystonia has been associated with rhabdomyolysis leading to acute renal failure.

Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden, or diphenhydramine.

Other

Other side effects including tardive dyskinesia have been reported and may be irreversible. Neuroleptic malignant syndrome has been reported to occur in as many as 0.5% to 1.0% of patients taking neuroleptic agents. Thiothixene has been specifically implicated. Sudden death after parenteral administration of thiothixene (the active ingredient contained in Navane) has been rarely reported in patients without underlying medical illness.

Involuntary rhythmical movements of the tongue, face and mouth characterize tardive dyskinesia. Early recognition of premonitory symptoms of tardive dyskinesia (like hyperkinetic dysarthria and fine vermiform movements of the tongue) may allow discontinuation of thiothixene before irreversible dyskinesia ensues. Tardive dyskinesia has been reported to occur in patients taking as little as 5 mg of thiothixene daily for eight months.

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy and intensive monitoring and supportive care are indicated.

Gastrointestinal

The anticholinergic effects of thiothixene (the active ingredient contained in Navane) have been implicated as a cause of esophageal atony and esophageal dilatation in one patient. That patient was also taking benztropine. The esophageal atony and dilatation resolved after dose reductions.

Gastrointestinal side effects including nausea, vomiting, constipation, excessive salivation, and dry mouth have been reported.

Psychiatric

Psychiatric side effects have included bizarre nightmares involving torture, worsening of underlying psychiatric illness, and agitation.

Endocrine

Endocrine side effects including hyperprolactinemia, galactorrhea, amenorrhea, and (less frequently) hyponatremia have been reported.

Ocular

Ocular side effects including pigmentary retinopathy and lenticular pigmentation have been reported.

Some clinicians have recommended periodic slit lamp examination for patients on chronic thiothixene therapy.

Hematologic

Hematologic side effects including cases of reversible thrombocytopenia and leukopenia have been reported rarely.

Genitourinary

Genitourinary side effects including priapism, urinary incontinence, nocturnal enuresis, and spontaneous ejaculation have been reported.

Immunologic

Immunologic side effects including Raynaud's phenomenon and a lupus-like syndrome have been reported.

Cardiovascular

Cardiovascular side effects including nonspecific EKG changes of uncertain clinical significance, orthostatic hypotension, tachycardia, and syncope have been reported.

Hypersensitivity

Hypersensitivity side effects including a telangiectatic macular eruption of the palms has been reported. Thiothixene (the active ingredient contained in Navane) may also predispose patients to photosensitivity.

Oncologic

Oncologic side effects including endometrial adenocarcinoma have been reported in association with thiothixene (the active ingredient contained in Navane) induced hyperprolactinemia.

Some investigators have suggested that endometrial sampling be performed in women taking neuroleptics if warranted by clinical suspicion.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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