TASIMELTEON

N/A

Manufactured by Vanda Pharmaceuticals Inc.

9,924 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TASIMELTEON

TASIMELTEON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Vanda Pharmaceuticals Inc.. The most commonly reported adverse reactions for TASIMELTEON include DRUG INEFFECTIVE, INSOMNIA, PRODUCT DOSE OMISSION ISSUE, MIDDLE INSOMNIA, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TASIMELTEON.

Top Adverse Reactions

DRUG INEFFECTIVE1,635 reports
INSOMNIA727 reports
PRODUCT DOSE OMISSION ISSUE480 reports
MIDDLE INSOMNIA412 reports
SOMNOLENCE408 reports
HEADACHE384 reports
NIGHTMARE268 reports
ABNORMAL DREAMS223 reports
FATIGUE222 reports
THERAPEUTIC PRODUCT EFFECT DECREASED196 reports
SLEEP DISORDER188 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION179 reports
INCORRECT PRODUCT ADMINISTRATION DURATION165 reports
POOR QUALITY SLEEP154 reports
INITIAL INSOMNIA153 reports
NAUSEA145 reports
PRODUCT DOSE OMISSION138 reports
DEATH129 reports
FEELING ABNORMAL125 reports
MALAISE122 reports
ANXIETY113 reports
DIZZINESS104 reports
THERAPEUTIC PRODUCT EFFECT DELAYED93 reports
FALL90 reports
HYPERSOMNIA88 reports
URINARY TRACT INFECTION84 reports
DRUG INTERACTION76 reports
MIGRAINE76 reports
WEIGHT DECREASED73 reports
DEPRESSION72 reports
VOMITING72 reports
COVID 1968 reports
PRODUCT USE ISSUE68 reports
ABDOMINAL DISCOMFORT67 reports
WEIGHT INCREASED62 reports
ILLNESS61 reports
INCORRECT DRUG ADMINISTRATION DURATION61 reports
DIARRHOEA59 reports
DRUG DOSE OMISSION58 reports
MEMORY IMPAIRMENT58 reports
NASOPHARYNGITIS58 reports
PAIN58 reports
COUGH55 reports
ASTHENIA53 reports
ADVERSE EVENT51 reports
DRUG EFFECT DECREASED49 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE49 reports
INFLUENZA48 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE48 reports
ADVERSE DRUG REACTION47 reports
CONSTIPATION45 reports
HALLUCINATION45 reports
OFF LABEL USE45 reports
CONFUSIONAL STATE41 reports
DYSPEPSIA41 reports
PNEUMONIA41 reports
DYSPNOEA40 reports
DECREASED APPETITE39 reports
RASH39 reports
TREMOR38 reports
DISTURBANCE IN ATTENTION37 reports
PRURITUS37 reports
ABDOMINAL PAIN UPPER36 reports
SLEEP DEFICIT36 reports
DRY MOUTH35 reports
SINUSITIS33 reports
AGITATION32 reports
DRUG EFFECT LESS THAN EXPECTED32 reports
HYPERSENSITIVITY32 reports
BACK PAIN31 reports
IRRITABILITY31 reports
MUSCLE SPASMS30 reports
CONDITION AGGRAVATED29 reports
STRESS28 reports
TERMINAL INSOMNIA28 reports
DISCOMFORT26 reports
GASTROOESOPHAGEAL REFLUX DISEASE26 reports
PAIN IN EXTREMITY26 reports
UPPER RESPIRATORY TRACT INFECTION26 reports
BLOOD PRESSURE INCREASED25 reports
INTENTIONAL DOSE OMISSION25 reports
RESTLESSNESS25 reports
HEPATIC ENZYME INCREASED24 reports
SEIZURE24 reports
SOMNAMBULISM24 reports
PRODUCT DOSE OMISSION IN ERROR23 reports
INCORRECT DOSE ADMINISTERED22 reports
INTENTIONAL OVERDOSE21 reports
PERIPHERAL SWELLING21 reports
TREATMENT NONCOMPLIANCE21 reports
AMNESIA20 reports
CARDIAC DISORDER20 reports
DYSPHAGIA20 reports
POLLAKIURIA20 reports
DEPRESSED MOOD19 reports
DRUG HYPERSENSITIVITY19 reports
NERVOUSNESS19 reports
URTICARIA19 reports
ARTHRALGIA18 reports
BALANCE DISORDER18 reports

Report Outcomes

Out of 5,762 classified reports for TASIMELTEON:

Serious 10.3%Non-Serious 89.7%

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

Female3,267 (57.0%)
Male2,465 (43.0%)

Reports by Age

Age 6398 reports
Age 6489 reports
Age 6287 reports
Age 6185 reports
Age 5878 reports
Age 5276 reports
Age 6574 reports
Age 6773 reports
Age 6665 reports
Age 5364 reports
Age 6062 reports
Age 6861 reports
Age 7161 reports
Age 5560 reports
Age 5660 reports
Age 5760 reports
Age 5458 reports
Age 5958 reports
Age 4655 reports
Age 5155 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 TASIMELTEON?

This profile reflects 9,924 FDA FAERS reports that mention TASIMELTEON. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TASIMELTEON?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, INSOMNIA, PRODUCT DOSE OMISSION ISSUE, MIDDLE INSOMNIA, SOMNOLENCE, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TASIMELTEON?

Labeling and FAERS entries often list Vanda Pharmaceuticals Inc. in connection with TASIMELTEON. 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.