TETRABENAZINE

N/A

Manufactured by Lundbeck Pharmaceuticals LLC

13,933 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TETRABENAZINE

TETRABENAZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lundbeck Pharmaceuticals LLC. The most commonly reported adverse reactions for TETRABENAZINE include DEATH, OFF LABEL USE, DRUG INEFFECTIVE, DEPRESSION, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TETRABENAZINE.

Top Adverse Reactions

DEATH1,213 reports
OFF LABEL USE1,121 reports
DRUG INEFFECTIVE695 reports
DEPRESSION475 reports
SOMNOLENCE452 reports
FATIGUE360 reports
FALL314 reports
HOSPITALISATION296 reports
INSOMNIA276 reports
INTENTIONAL PRODUCT USE ISSUE274 reports
ANXIETY263 reports
DRUG ADMINISTRATION ERROR241 reports
CONDITION AGGRAVATED224 reports
DRUG DOSE OMISSION224 reports
DYSKINESIA224 reports
TREMOR221 reports
TREATMENT NONCOMPLIANCE195 reports
PRESCRIBED OVERDOSE194 reports
MOVEMENT DISORDER188 reports
SUICIDAL IDEATION176 reports
NAUSEA169 reports
DYSPHAGIA163 reports
GAIT DISTURBANCE158 reports
TARDIVE DYSKINESIA157 reports
DIZZINESS149 reports
FEELING ABNORMAL149 reports
AGITATION138 reports
RESTLESSNESS132 reports
VOMITING128 reports
PNEUMONIA126 reports
MALAISE123 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION121 reports
DYSTONIA119 reports
PARKINSONISM114 reports
BALANCE DISORDER112 reports
HEADACHE112 reports
ASTHENIA105 reports
CONFUSIONAL STATE105 reports
PAIN104 reports
WEIGHT DECREASED103 reports
MEDICATION ERROR97 reports
AGGRESSION96 reports
ABNORMAL BEHAVIOUR92 reports
WEIGHT INCREASED89 reports
CRYING87 reports
DYSPNOEA86 reports
SPEECH DISORDER86 reports
INCORRECT DOSE ADMINISTERED84 reports
DIARRHOEA83 reports
SEDATION82 reports
MUSCLE SPASMS81 reports
MUSCULOSKELETAL STIFFNESS81 reports
ANGER80 reports
HUNTINGTON^S DISEASE80 reports
DECREASED APPETITE79 reports
MEMORY IMPAIRMENT79 reports
IRRITABILITY75 reports
URINARY TRACT INFECTION74 reports
DEPRESSED MOOD73 reports
DRUG INTERACTION71 reports
HYPERSOMNIA70 reports
HALLUCINATION69 reports
HYPERHIDROSIS69 reports
NO ADVERSE EVENT68 reports
PRODUCT USE IN UNAPPROVED INDICATION67 reports
LETHARGY66 reports
TIC66 reports
HOSPICE CARE62 reports
UNEVALUABLE EVENT62 reports
DEHYDRATION60 reports
CHOREA59 reports
ADVERSE EVENT56 reports
DYSARTHRIA53 reports
DISTURBANCE IN ATTENTION52 reports
BACK PAIN51 reports
CONSTIPATION51 reports
ADVERSE DRUG REACTION50 reports
HYPOTENSION50 reports
OVERDOSE50 reports
PAIN IN EXTREMITY50 reports
SLEEP DISORDER50 reports
INVESTIGATION49 reports
ABDOMINAL DISCOMFORT48 reports
CEREBROVASCULAR ACCIDENT47 reports
COUGH47 reports
EMOTIONAL DISORDER46 reports
SEIZURE46 reports
DROOLING44 reports
EXTRAPYRAMIDAL DISORDER44 reports
LOSS OF CONSCIOUSNESS44 reports
PYREXIA44 reports
AKATHISIA43 reports
MUSCULAR WEAKNESS43 reports
PNEUMONIA ASPIRATION43 reports
ABDOMINAL PAIN UPPER42 reports
MUSCLE TWITCHING42 reports
COGNITIVE DISORDER41 reports
DISEASE PROGRESSION41 reports
MOOD ALTERED41 reports
EATING DISORDER39 reports

Report Outcomes

Out of 7,236 classified reports for TETRABENAZINE:

Serious 55.4%Non-Serious 44.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,131 (58.2%)
Male2,958 (41.6%)
Unknown14 (0.2%)

Reports by Age

Age 69104 reports
Age 62101 reports
Age 5999 reports
Age 6598 reports
Age 6497 reports
Age 6896 reports
Age 6395 reports
Age 5793 reports
Age 5890 reports
Age 5485 reports
Age 5384 reports
Age 7184 reports
Age 6183 reports
Age 6782 reports
Age 5681 reports
Age 6681 reports
Age 6077 reports
Age 7277 reports
Age 5274 reports
Age 7072 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with TETRABENAZINE?

This profile reflects 13,933 FDA FAERS reports that mention TETRABENAZINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TETRABENAZINE?

Frequently reported terms in FAERS include DEATH, OFF LABEL USE, DRUG INEFFECTIVE, DEPRESSION, SOMNOLENCE, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TETRABENAZINE?

Labeling and FAERS entries often list Lundbeck Pharmaceuticals LLC in connection with TETRABENAZINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.