EFAVIRENZ

N/A

Manufactured by Aurobindo Pharma Limited

18,805 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EFAVIRENZ

EFAVIRENZ is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for EFAVIRENZ include VIROLOGIC FAILURE, DRUG INTERACTION, DRUG RESISTANCE, VIRAL MUTATION IDENTIFIED, PATHOGEN RESISTANCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EFAVIRENZ.

Top Adverse Reactions

VIROLOGIC FAILURE952 reports
DRUG INTERACTION749 reports
DRUG RESISTANCE735 reports
VIRAL MUTATION IDENTIFIED674 reports
PATHOGEN RESISTANCE623 reports
FOETAL EXPOSURE DURING PREGNANCY613 reports
DEPRESSION450 reports
TREATMENT FAILURE423 reports
MATERNAL EXPOSURE DURING PREGNANCY417 reports
ANAEMIA407 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME376 reports
PYREXIA376 reports
VOMITING346 reports
DEATH339 reports
DIARRHOEA302 reports
ABORTION SPONTANEOUS294 reports
NAUSEA279 reports
IMMUNE RECONSTITUTION SYNDROME277 reports
DRUG INEFFECTIVE263 reports
TREATMENT NONCOMPLIANCE256 reports
RENAL IMPAIRMENT241 reports
EXPOSURE DURING PREGNANCY239 reports
LIPODYSTROPHY ACQUIRED230 reports
RASH228 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES214 reports
ALANINE AMINOTRANSFERASE INCREASED210 reports
NEUROTOXICITY195 reports
OFF LABEL USE187 reports
ASTHENIA182 reports
ASPARTATE AMINOTRANSFERASE INCREASED178 reports
ACUTE KIDNEY INJURY177 reports
OSTEOPOROSIS173 reports
CONDITION AGGRAVATED167 reports
HEADACHE161 reports
DYSPNOEA160 reports
FATIGUE155 reports
HYPERTENSION150 reports
WEIGHT DECREASED150 reports
DRUG INDUCED LIVER INJURY148 reports
LACTIC ACIDOSIS147 reports
DIZZINESS140 reports
TOXICITY TO VARIOUS AGENTS139 reports
RENAL FAILURE136 reports
NERVOUS SYSTEM DISORDER128 reports
NEUTROPENIA127 reports
ABDOMINAL PAIN125 reports
STILLBIRTH124 reports
MALAISE123 reports
CONFUSIONAL STATE122 reports
INSOMNIA122 reports
ABORTION INDUCED121 reports
ANXIETY120 reports
COUGH120 reports
MYALGIA120 reports
PREGNANCY119 reports
HEPATITIS117 reports
SEPSIS115 reports
HEPATOTOXICITY109 reports
DRUG EXPOSURE DURING PREGNANCY108 reports
INTENTIONAL PRODUCT USE ISSUE107 reports
PANCYTOPENIA107 reports
EYELID PTOSIS104 reports
PNEUMONIA102 reports
PULMONARY TUBERCULOSIS102 reports
MITOCHONDRIAL TOXICITY101 reports
TUBERCULOSIS101 reports
LYMPHADENOPATHY100 reports
MYOCARDIAL INFARCTION100 reports
PAIN99 reports
PREMATURE BABY97 reports
RENAL FAILURE ACUTE97 reports
NEPHROPATHY TOXIC95 reports
DYSLIPIDAEMIA94 reports
NEUROPATHY PERIPHERAL94 reports
PRODUCT USE IN UNAPPROVED INDICATION92 reports
BLOOD HIV RNA INCREASED91 reports
DECREASED APPETITE91 reports
GENERAL PHYSICAL HEALTH DETERIORATION91 reports
HAEMOGLOBIN DECREASED91 reports
DIABETES MELLITUS88 reports
DIPLOPIA88 reports
BLOOD CREATININE INCREASED87 reports
HYPERLIPIDAEMIA87 reports
BLOOD BILIRUBIN INCREASED86 reports
PREMATURE DELIVERY86 reports
DEHYDRATION85 reports
HIV INFECTION85 reports
HYPERSENSITIVITY84 reports
ARTHRALGIA82 reports
ACUTE MYOCARDIAL INFARCTION80 reports
SOMNOLENCE79 reports
PRURITUS76 reports
LEUKOPENIA73 reports
PSYCHOTIC DISORDER73 reports
RESPIRATORY FAILURE73 reports
HYPOTENSION72 reports
MULTIPLE DRUG RESISTANCE72 reports
PORTAL HYPERTENSION72 reports
PROGRESSIVE EXTERNAL OPHTHALMOPLEGIA72 reports
HEPATIC FUNCTION ABNORMAL71 reports

Report Outcomes

Out of 11,001 classified reports for EFAVIRENZ:

Serious 97.0%Non-Serious 3.0%

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

Male4,645 (61.5%)
Female2,850 (37.8%)
Unknown54 (0.7%)

Reports by Age

Age 54326 reports
Age 35212 reports
Age 43205 reports
Age 39192 reports
Age 45187 reports
Age 37175 reports
Age 30174 reports
Age 38158 reports
Age 40158 reports
Age 41157 reports
Age 42151 reports
Age 52151 reports
Age 34146 reports
Age 36142 reports
Age 33140 reports
Age 32137 reports
Age 44137 reports
Age 46136 reports
Age 31133 reports
Age 47124 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 EFAVIRENZ?

This profile reflects 18,805 FDA FAERS reports that mention EFAVIRENZ. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EFAVIRENZ?

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

Who manufactures EFAVIRENZ?

Labeling and FAERS entries often list Aurobindo Pharma Limited in connection with EFAVIRENZ. 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.