NEVIRAPINE

N/A

Manufactured by Amneal Pharmaceuticals LLC

16,383 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NEVIRAPINE

NEVIRAPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for NEVIRAPINE include FOETAL EXPOSURE DURING PREGNANCY, DRUG RESISTANCE, VIROLOGIC FAILURE, VIRAL MUTATION IDENTIFIED, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NEVIRAPINE.

Top Adverse Reactions

FOETAL EXPOSURE DURING PREGNANCY1,112 reports
DRUG RESISTANCE1,028 reports
VIROLOGIC FAILURE800 reports
VIRAL MUTATION IDENTIFIED694 reports
DEATH496 reports
EXPOSURE DURING PREGNANCY454 reports
HIV INFECTION432 reports
DRUG INEFFECTIVE406 reports
PATHOGEN RESISTANCE382 reports
TREATMENT FAILURE335 reports
ANAEMIA332 reports
PYREXIA330 reports
DRUG EXPOSURE DURING PREGNANCY315 reports
LIPODYSTROPHY ACQUIRED314 reports
PREMATURE BABY252 reports
MATERNAL EXPOSURE DURING PREGNANCY239 reports
VOMITING217 reports
DRUG INTERACTION211 reports
RASH211 reports
ALANINE AMINOTRANSFERASE INCREASED193 reports
STEVENS JOHNSON SYNDROME190 reports
IMMUNE RECONSTITUTION SYNDROME175 reports
DIARRHOEA174 reports
ABORTION SPONTANEOUS168 reports
EYELID PTOSIS168 reports
HEPATOTOXICITY168 reports
ASPARTATE AMINOTRANSFERASE INCREASED166 reports
NAUSEA164 reports
CAESAREAN SECTION162 reports
MITOCHONDRIAL TOXICITY157 reports
DIPLOPIA142 reports
STILLBIRTH135 reports
PNEUMONIA132 reports
TREATMENT NONCOMPLIANCE129 reports
EXPOSURE DURING BREAST FEEDING125 reports
HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION124 reports
FATIGUE121 reports
NEUROPATHY PERIPHERAL119 reports
DYSPNOEA114 reports
LACTIC ACIDOSIS113 reports
FOETAL EXPOSURE DURING DELIVERY112 reports
OFF LABEL USE110 reports
PREMATURE DELIVERY110 reports
VENTRICULAR SEPTAL DEFECT107 reports
WEIGHT DECREASED105 reports
ASTHENIA103 reports
ABDOMINAL PAIN101 reports
SEPSIS101 reports
MATERNAL DRUGS AFFECTING FOETUS100 reports
HEADACHE99 reports
PREGNANCY99 reports
BLOOD CREATININE INCREASED98 reports
COUGH98 reports
DEVELOPMENTAL DELAY97 reports
NEUTROPENIA96 reports
MALAISE95 reports
TOXIC EPIDERMAL NECROLYSIS92 reports
TUBERCULOSIS92 reports
PORTAL HYPERTENSION91 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME87 reports
BLOOD HIV RNA INCREASED86 reports
MYALGIA86 reports
HEPATIC FAILURE85 reports
HEPATITIS84 reports
ACUTE KIDNEY INJURY83 reports
SPEECH DISORDER DEVELOPMENTAL83 reports
MULTIPLE DRUG RESISTANCE81 reports
PROGRESSIVE EXTERNAL OPHTHALMOPLEGIA81 reports
HYPERTENSION79 reports
RENAL FAILURE77 reports
DYSPHAGIA76 reports
LOW BIRTH WEIGHT BABY76 reports
RASH MACULO PAPULAR72 reports
DIZZINESS70 reports
LYMPHADENOPATHY70 reports
HAEMOGLOBIN DECREASED68 reports
TOXICITY TO VARIOUS AGENTS67 reports
RENAL IMPAIRMENT65 reports
GASTROENTERITIS64 reports
JAUNDICE64 reports
BLOOD BILIRUBIN INCREASED63 reports
ASCITES62 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED62 reports
OSTEOPOROSIS61 reports
VIRAL LOAD INCREASED61 reports
HYPERSENSITIVITY60 reports
PROTEINURIA60 reports
DEPRESSION59 reports
HEPATOMEGALY59 reports
DECREASED APPETITE58 reports
SMALL FOR DATES BABY58 reports
VOLVULUS58 reports
CONDITION AGGRAVATED57 reports
CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY57 reports
DYSLIPIDAEMIA57 reports
PRE ECLAMPSIA57 reports
SPEECH DISORDER57 reports
DANDY WALKER SYNDROME56 reports
POLYDACTYLY56 reports
PORTAL VEIN THROMBOSIS56 reports

Report Outcomes

Out of 8,926 classified reports for NEVIRAPINE:

Serious 96.5%Non-Serious 3.5%

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

Male2,681 (51.6%)
Female2,427 (46.7%)
Unknown91 (1.8%)

Reports by Age

Age 52138 reports
Age 39126 reports
Age 36113 reports
Age 34107 reports
Age 40103 reports
Age 2597 reports
Age 3894 reports
Age 3393 reports
Age 4188 reports
Age 5488 reports
Age 3185 reports
Age 3585 reports
Age 3780 reports
Age 4380 reports
Age 5080 reports
Age 4279 reports
Age 4579 reports
Age 3077 reports
Age 374 reports
Age 2872 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 NEVIRAPINE?

This profile reflects 16,383 FDA FAERS reports that mention NEVIRAPINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NEVIRAPINE?

Frequently reported terms in FAERS include FOETAL EXPOSURE DURING PREGNANCY, DRUG RESISTANCE, VIROLOGIC FAILURE, VIRAL MUTATION IDENTIFIED, DEATH, EXPOSURE DURING PREGNANCY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NEVIRAPINE?

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