OSELTAMIVIR

N/A

Manufactured by Amneal Pharmaceuticals NY LLC

19,111 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OSELTAMIVIR

OSELTAMIVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. The most commonly reported adverse reactions for OSELTAMIVIR include OFF LABEL USE, DRUG INEFFECTIVE, NO ADVERSE EVENT, VOMITING, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OSELTAMIVIR.

Top Adverse Reactions

OFF LABEL USE1,776 reports
DRUG INEFFECTIVE713 reports
NO ADVERSE EVENT582 reports
VOMITING444 reports
NAUSEA443 reports
HEADACHE381 reports
PNEUMONIA368 reports
CONDITION AGGRAVATED333 reports
INFLUENZA329 reports
PRODUCT USE IN UNAPPROVED INDICATION328 reports
DRUG INTOLERANCE325 reports
DYSPNOEA283 reports
ABDOMINAL PAIN280 reports
SEPSIS260 reports
DIARRHOEA259 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION254 reports
PYREXIA250 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME246 reports
HYPERSENSITIVITY243 reports
GENERAL PHYSICAL HEALTH DETERIORATION227 reports
HYPONATRAEMIA226 reports
SWELLING FACE226 reports
CONSTIPATION220 reports
ABDOMINAL DISTENSION217 reports
NEUTROPENIA213 reports
DEATH210 reports
FOETAL EXPOSURE DURING PREGNANCY210 reports
ANGIOEDEMA204 reports
DYSPHONIA204 reports
SWOLLEN TONGUE202 reports
STRESS199 reports
ASCITES196 reports
ANAEMIA193 reports
APPENDICITIS191 reports
CARDIOGENIC SHOCK187 reports
MATERNAL EXPOSURE DURING PREGNANCY186 reports
APPENDICOLITH184 reports
SOMNOLENCE181 reports
VENTRICULAR FIBRILLATION181 reports
RASH178 reports
ACUTE KIDNEY INJURY168 reports
PAIN167 reports
NORMAL NEWBORN160 reports
FATIGUE159 reports
PULMONARY EMBOLISM156 reports
BACTERIAL INFECTION150 reports
BLOOD PHOSPHORUS INCREASED147 reports
DRUG INTERACTION146 reports
DRUG HYPERSENSITIVITY143 reports
DRY MOUTH143 reports
SWELLING142 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE137 reports
SLEEP DISORDER137 reports
BLOOD CHOLESTEROL INCREASED136 reports
THROMBOSIS136 reports
CHRONIC KIDNEY DISEASE135 reports
RESPIRATORY FAILURE135 reports
INTENTIONAL PRODUCT MISUSE132 reports
MYASTHENIA GRAVIS131 reports
DIABETES MELLITUS130 reports
RENAL FAILURE130 reports
NEURALGIA122 reports
DRUG EXPOSURE DURING PREGNANCY121 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION120 reports
PATHOGEN RESISTANCE120 reports
BRADYCARDIA117 reports
HYPERPHOSPHATAEMIA117 reports
ANXIETY115 reports
BLOOD URIC ACID INCREASED114 reports
HYPERTENSION113 reports
COUGH112 reports
HYPOPHOSPHATAEMIA112 reports
EXPOSURE DURING PREGNANCY110 reports
DIZZINESS107 reports
ACUTE RESPIRATORY DISTRESS SYNDROME106 reports
END STAGE RENAL DISEASE101 reports
THROMBOCYTOPENIA98 reports
COVID 1997 reports
INSOMNIA97 reports
PREMATURE DELIVERY96 reports
PREGNANCY93 reports
ASTHENIA92 reports
ANALGESIC THERAPY89 reports
PREMATURE BABY89 reports
PRURITUS88 reports
ASPARTATE AMINOTRANSFERASE INCREASED86 reports
IRON DEFICIENCY86 reports
ASTHMA85 reports
BLOOD CREATININE INCREASED85 reports
MALAISE85 reports
DRUG THERAPY84 reports
CONFUSIONAL STATE82 reports
LOWER RESPIRATORY TRACT INFECTION81 reports
HYPOXIA80 reports
SLEEP DISORDER THERAPY80 reports
PRODUCT DOSE OMISSION ISSUE79 reports
HALLUCINATION77 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED76 reports
INTENTIONAL PRODUCT USE ISSUE76 reports
CHEST PAIN71 reports

Report Outcomes

Out of 7,572 classified reports for OSELTAMIVIR:

Serious 74.6%Non-Serious 25.4%

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

Female3,332 (51.3%)
Male3,149 (48.5%)
Unknown18 (0.3%)

Reports by Age

Age 80269 reports
Age 41208 reports
Age 6196 reports
Age 4089 reports
Age 6089 reports
Age 6588 reports
Age 3387 reports
Age 6485 reports
Age 5284 reports
Age 7282 reports
Age 3781 reports
Age 4378 reports
Age 5878 reports
Age 4975 reports
Age 5975 reports
Age 6775 reports
Age 5373 reports
Age 6273 reports
Age 7173 reports
Age 672 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 OSELTAMIVIR?

This profile reflects 19,111 FDA FAERS reports that mention OSELTAMIVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OSELTAMIVIR?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, NO ADVERSE EVENT, VOMITING, NAUSEA, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OSELTAMIVIR?

Labeling and FAERS entries often list Amneal Pharmaceuticals NY LLC in connection with OSELTAMIVIR. 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.