Navane Side Effects
Generic name: thiothixene
Note: This document contains side effect information about thiothixene. Some of the dosage forms listed on this page may not apply to the brand name Navane.
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.
For the Consumer
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:Rare
- difficulty with swallowing
- fast heartbeat
- 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
- 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
- clay-colored stools
- cough or hoarseness
- dark urine
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fever with or without chills
- general body swelling
- general feeling of tiredness or weakness
- 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
- 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
- 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
- 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
- swollen glands
- tic-like (jerky) movements of the head, face, mouth, and neck
- tingling of the hands or feet
- 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:Symptoms of overdose
- Change in consciousness
- 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:Incidence not known
- Absent, missed, or irregular menstrual periods
- decreased interest in sexual intercourse
- dry mouth
- extreme thirst
- hives or welts
- inability to have or keep an erection
- increased appetite
- increased sensitivity of the skin to sunlight
- increased sweating
- increased thirst
- increased weight
- loss in sexual ability, desire, drive, or performance
- menstrual changes
- redness or other discoloration of the skin
- severe sunburn
- 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 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 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.
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 side effects have included bizarre nightmares involving torture, worsening of underlying psychiatric illness, and agitation.
Endocrine side effects including hyperprolactinemia, galactorrhea, amenorrhea, and (less frequently) hyponatremia have been reported.
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 side effects including cases of reversible thrombocytopenia and leukopenia have been reported rarely.
Genitourinary side effects including priapism, urinary incontinence, nocturnal enuresis, and spontaneous ejaculation have been reported.
Immunologic side effects including Raynaud's phenomenon and a lupus-like syndrome have been reported.
Cardiovascular side effects including nonspecific EKG changes of uncertain clinical significance, orthostatic hypotension, tachycardia, and syncope have been reported.
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 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.
More Navane resources
- Navane Concise Consumer Information (Cerner Multum)
- Navane Prescribing Information (FDA)
- Navane MedFacts Consumer Leaflet (Wolters Kluwer)
- Navane Monograph (AHFS DI)
- Navane Advanced Consumer (Micromedex) - Includes Dosage Information
- Thiothixene Prescribing Information (FDA)
- Thiothixene Professional Patient Advice (Wolters Kluwer)
- thiothixene Advanced Consumer (Micromedex) - Includes Dosage Information
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