AMANTADINE HYDROCHLORIDE

N/A

Manufactured by Bionpharma Inc.

10,217 FDA adverse event reports analyzed

Last updated: 2026-04-15

About AMANTADINE HYDROCHLORIDE

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

Top Adverse Reactions

FALL384 reports
FATIGUE310 reports
GAIT DISTURBANCE267 reports
DRUG INEFFECTIVE260 reports
HALLUCINATION240 reports
TREMOR219 reports
ASTHENIA207 reports
DEPRESSION192 reports
DYSKINESIA191 reports
MULTIPLE SCLEROSIS RELAPSE191 reports
DIZZINESS187 reports
NAUSEA177 reports
CONDITION AGGRAVATED167 reports
URINARY TRACT INFECTION163 reports
HEADACHE161 reports
BALANCE DISORDER159 reports
CONFUSIONAL STATE157 reports
OFF LABEL USE156 reports
INSOMNIA154 reports
PAIN152 reports
SPEECH DISORDER149 reports
CONSTIPATION146 reports
DYSPNOEA144 reports
ANXIETY139 reports
SOMNOLENCE138 reports
DEATH133 reports
MULTIPLE SCLEROSIS133 reports
HALLUCINATION, VISUAL131 reports
PNEUMONIA125 reports
DIARRHOEA120 reports
MUSCULAR WEAKNESS114 reports
HYPOTENSION109 reports
DRUG INTERACTION107 reports
VOMITING107 reports
PYREXIA103 reports
CONVULSION102 reports
MEMORY IMPAIRMENT102 reports
HYPOAESTHESIA97 reports
MALAISE97 reports
WEIGHT DECREASED95 reports
FLUSHING93 reports
DYSPHAGIA92 reports
MUSCLE SPASMS90 reports
AGITATION88 reports
HYPERTENSION86 reports
DEHYDRATION84 reports
LOSS OF CONSCIOUSNESS83 reports
PAIN IN EXTREMITY82 reports
DECREASED APPETITE81 reports
DELIRIUM78 reports
INFLUENZA LIKE ILLNESS78 reports
MUSCULOSKELETAL STIFFNESS77 reports
MYOCLONUS77 reports
OEDEMA PERIPHERAL77 reports
PRODUCT DOSE OMISSION ISSUE74 reports
FEELING ABNORMAL73 reports
PARKINSON^S DISEASE73 reports
ARTHRALGIA70 reports
BACK PAIN70 reports
COGNITIVE DISORDER69 reports
MYOCARDIAL INFARCTION67 reports
TOXICITY TO VARIOUS AGENTS66 reports
DELUSION65 reports
DYSARTHRIA65 reports
PARAESTHESIA65 reports
CHEST PAIN64 reports
PSYCHOTIC DISORDER64 reports
NEUROLEPTIC MALIGNANT SYNDROME63 reports
PATHOLOGICAL GAMBLING61 reports
MOBILITY DECREASED60 reports
RASH60 reports
CEREBROVASCULAR ACCIDENT59 reports
PARKINSON'S DISEASE59 reports
PRURITUS57 reports
ANAEMIA55 reports
PERIPHERAL SWELLING55 reports
ABDOMINAL PAIN54 reports
ABNORMAL BEHAVIOUR53 reports
VISUAL IMPAIRMENT53 reports
WEIGHT INCREASED53 reports
ABDOMINAL PAIN UPPER52 reports
HYPERHIDROSIS52 reports
COUGH51 reports
ON AND OFF PHENOMENON51 reports
PULMONARY EMBOLISM49 reports
AMNESIA48 reports
DYSTONIA48 reports
DRY MOUTH47 reports
SYNCOPE47 reports
URINARY INCONTINENCE47 reports
ALOPECIA46 reports
DISTURBANCE IN ATTENTION46 reports
OVERDOSE46 reports
DYSSTASIA45 reports
INFLUENZA45 reports
VISION BLURRED45 reports
CEREBRAL HYPOPERFUSION44 reports
MUSCLE RIGIDITY44 reports
AGGRESSION43 reports
EMOTIONAL DISTRESS43 reports

Report Outcomes

Out of 4,758 classified reports for AMANTADINE HYDROCHLORIDE:

Serious 74.2%Non-Serious 25.8%

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

Female2,727 (60.3%)
Male1,792 (39.6%)
Unknown4 (0.1%)

Reports by Age

Age 6799 reports
Age 5991 reports
Age 5888 reports
Age 6087 reports
Age 6180 reports
Age 6980 reports
Age 6478 reports
Age 6878 reports
Age 5076 reports
Age 6375 reports
Age 6574 reports
Age 7074 reports
Age 7273 reports
Age 7473 reports
Age 6272 reports
Age 5670 reports
Age 5368 reports
Age 7568 reports
Age 5767 reports
Age 5564 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 HYDROCHLORIDE?

This profile reflects 10,217 FDA FAERS reports that mention AMANTADINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMANTADINE HYDROCHLORIDE?

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

Who manufactures AMANTADINE HYDROCHLORIDE?

Labeling and FAERS entries often list Bionpharma Inc. in connection with AMANTADINE HYDROCHLORIDE. 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.