AMANTADINE

N/A

Manufactured by Adamas Pharma, LLC

34,976 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMANTADINE

AMANTADINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Adamas Pharma, LLC. The most commonly reported adverse reactions for AMANTADINE include FALL, HALLUCINATION, DRUG INEFFECTIVE, FATIGUE, DYSKINESIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMANTADINE.

Top Adverse Reactions

FALL1,701 reports
HALLUCINATION1,230 reports
DRUG INEFFECTIVE1,209 reports
FATIGUE1,068 reports
DYSKINESIA1,033 reports
DIZZINESS906 reports
GAIT DISTURBANCE862 reports
DEATH817 reports
TREMOR771 reports
NAUSEA658 reports
PARKINSON^S DISEASE646 reports
ASTHENIA624 reports
BALANCE DISORDER602 reports
CONDITION AGGRAVATED597 reports
CONFUSIONAL STATE592 reports
URINARY TRACT INFECTION590 reports
SOMNOLENCE583 reports
INSOMNIA553 reports
CONSTIPATION528 reports
OFF LABEL USE502 reports
HEADACHE475 reports
ANXIETY430 reports
PAIN428 reports
PRODUCT DOSE OMISSION ISSUE428 reports
DEPRESSION427 reports
HALLUCINATION, VISUAL423 reports
MALAISE422 reports
WEIGHT DECREASED392 reports
MULTIPLE SCLEROSIS RELAPSE379 reports
FEELING ABNORMAL372 reports
COUGH367 reports
DYSPNOEA358 reports
MEMORY IMPAIRMENT352 reports
PERIPHERAL SWELLING338 reports
MOBILITY DECREASED330 reports
MUSCULAR WEAKNESS330 reports
PNEUMONIA316 reports
DRY MOUTH310 reports
VOMITING295 reports
DYSPHAGIA288 reports
PAIN IN EXTREMITY271 reports
ON AND OFF PHENOMENON269 reports
SEIZURE266 reports
MUSCULOSKELETAL STIFFNESS263 reports
BACK PAIN262 reports
DRUG INTERACTION262 reports
MUSCLE SPASMS262 reports
FREEZING PHENOMENON259 reports
DIARRHOEA258 reports
HYPOAESTHESIA256 reports
SPEECH DISORDER255 reports
HYPOTENSION247 reports
DECREASED APPETITE235 reports
HYPERTENSION222 reports
DEVICE ISSUE220 reports
AGITATION218 reports
MULTIPLE SCLEROSIS215 reports
PYREXIA214 reports
DEHYDRATION211 reports
DYSTONIA208 reports
LOSS OF CONSCIOUSNESS204 reports
COVID 19201 reports
PARAESTHESIA200 reports
SLEEP DISORDER199 reports
VISION BLURRED195 reports
ARTHRALGIA193 reports
THERAPEUTIC RESPONSE SHORTENED192 reports
VISUAL IMPAIRMENT189 reports
GENERAL PHYSICAL HEALTH DETERIORATION187 reports
HYPERHIDROSIS184 reports
PSYCHOTIC DISORDER178 reports
OEDEMA PERIPHERAL177 reports
RASH177 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE176 reports
CONTUSION174 reports
COGNITIVE DISORDER172 reports
PRURITUS170 reports
DELUSION169 reports
MUSCLE RIGIDITY167 reports
WEIGHT INCREASED164 reports
GAIT INABILITY163 reports
PRODUCT DOSE OMISSION160 reports
THERAPY CESSATION159 reports
UNEVALUABLE EVENT158 reports
AGGRESSION157 reports
HOSPITALISATION155 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION150 reports
BLOOD PRESSURE INCREASED147 reports
DELIRIUM145 reports
DEPRESSED MOOD144 reports
TOXICITY TO VARIOUS AGENTS144 reports
ABNORMAL DREAMS141 reports
PRODUCT USE IN UNAPPROVED INDICATION141 reports
DEVICE DISLOCATION140 reports
DYSSTASIA135 reports
ADVERSE DRUG REACTION134 reports
HEAD INJURY133 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES133 reports
ACUTE KIDNEY INJURY132 reports
NASOPHARYNGITIS132 reports

Report Outcomes

Out of 14,720 classified reports for AMANTADINE:

Serious 59.7%Non-Serious 40.3%

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

Female7,618 (56.1%)
Male5,948 (43.8%)
Unknown11 (0.1%)

Reports by Age

Age 70337 reports
Age 67303 reports
Age 69299 reports
Age 72298 reports
Age 75293 reports
Age 66289 reports
Age 71284 reports
Age 68279 reports
Age 73274 reports
Age 74274 reports
Age 65254 reports
Age 78244 reports
Age 77240 reports
Age 63228 reports
Age 64225 reports
Age 76222 reports
Age 59208 reports
Age 62200 reports
Age 57194 reports
Age 60194 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 AMANTADINE?

This profile reflects 34,976 FDA FAERS reports that mention AMANTADINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMANTADINE?

Frequently reported terms in FAERS include FALL, HALLUCINATION, DRUG INEFFECTIVE, FATIGUE, DYSKINESIA, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMANTADINE?

Labeling and FAERS entries often list Adamas Pharma, LLC in connection with AMANTADINE. 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.