DARUNAVIR

N/A

Manufactured by Janssen Products LP

26,718 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DARUNAVIR

DARUNAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Products LP. The most commonly reported adverse reactions for DARUNAVIR include FOETAL EXPOSURE DURING PREGNANCY, DRUG INTERACTION, PAIN, EMOTIONAL DISTRESS, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DARUNAVIR.

Top Adverse Reactions

FOETAL EXPOSURE DURING PREGNANCY1,150 reports
DRUG INTERACTION982 reports
PAIN889 reports
EMOTIONAL DISTRESS812 reports
ANXIETY811 reports
ANHEDONIA704 reports
CHRONIC KIDNEY DISEASE569 reports
EXPOSURE DURING PREGNANCY565 reports
MATERNAL EXPOSURE DURING PREGNANCY535 reports
DEATH497 reports
DIARRHOEA497 reports
RENAL FAILURE497 reports
ACUTE KIDNEY INJURY485 reports
VIROLOGIC FAILURE474 reports
OSTEOPOROSIS436 reports
DEPRESSION431 reports
DRUG INEFFECTIVE430 reports
DRUG RESISTANCE418 reports
RENAL IMPAIRMENT407 reports
OFF LABEL USE406 reports
NAUSEA405 reports
FATIGUE401 reports
ANAEMIA365 reports
ABORTION SPONTANEOUS364 reports
RASH361 reports
PREMATURE BABY338 reports
PYREXIA331 reports
DEVICE ISSUE327 reports
BONE DENSITY DECREASED322 reports
TREATMENT NONCOMPLIANCE317 reports
ECONOMIC PROBLEM293 reports
VOMITING291 reports
PATHOGEN RESISTANCE285 reports
TREATMENT FAILURE284 reports
ASTHENIA260 reports
VIRAL MUTATION IDENTIFIED254 reports
HEADACHE253 reports
BLOOD CREATININE INCREASED248 reports
LIPODYSTROPHY ACQUIRED244 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME230 reports
OSTEOPENIA227 reports
OSTEONECROSIS225 reports
END STAGE RENAL DISEASE196 reports
MALAISE191 reports
DYSPNOEA189 reports
HYPERTENSION189 reports
WEIGHT DECREASED188 reports
PNEUMONIA187 reports
THROMBOCYTOPENIA183 reports
INSOMNIA181 reports
ARTHRALGIA178 reports
WEIGHT INCREASED177 reports
TOXICITY TO VARIOUS AGENTS175 reports
CONDITION AGGRAVATED173 reports
CUSHING^S SYNDROME170 reports
GAIT DISTURBANCE166 reports
ABDOMINAL PAIN163 reports
PRURITUS162 reports
MYOCARDIAL INFARCTION160 reports
PREMATURE DELIVERY157 reports
DIZZINESS152 reports
CD4 LYMPHOCYTES DECREASED150 reports
MYALGIA145 reports
LOW BIRTH WEIGHT BABY141 reports
NEUTROPENIA140 reports
RENAL FAILURE ACUTE140 reports
BACK PAIN139 reports
MULTIPLE FRACTURES135 reports
BLOOD HIV RNA INCREASED133 reports
HOSPITALISATION133 reports
NEPHROLITHIASIS133 reports
LIVE BIRTH131 reports
PANCYTOPENIA131 reports
NEUROPATHY PERIPHERAL129 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES128 reports
VIRAL LOAD INCREASED127 reports
GENERAL PHYSICAL HEALTH DETERIORATION125 reports
DRUG EXPOSURE DURING PREGNANCY124 reports
FOETAL GROWTH RESTRICTION124 reports
CEREBROVASCULAR ACCIDENT121 reports
OVERDOSE120 reports
ALANINE AMINOTRANSFERASE INCREASED119 reports
EYELID PTOSIS119 reports
MITOCHONDRIAL TOXICITY118 reports
DIPLOPIA117 reports
HEPATOCELLULAR INJURY117 reports
RASH MACULO PAPULAR115 reports
DYSLIPIDAEMIA114 reports
TOOTH LOSS112 reports
HYPOTENSION110 reports
PAIN IN EXTREMITY110 reports
SEPSIS110 reports
DIABETES MELLITUS108 reports
DYSPHAGIA108 reports
RHABDOMYOLYSIS108 reports
BONE LOSS107 reports
CONFUSIONAL STATE107 reports
FALL106 reports
DRUG DOSE OMISSION105 reports
COUGH102 reports

Report Outcomes

Out of 14,891 classified reports for DARUNAVIR:

Serious 87.9%Non-Serious 12.1%

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

Male7,663 (63.2%)
Female4,315 (35.6%)
Unknown151 (1.2%)

Reports by Age

Age 52340 reports
Age 50317 reports
Age 53281 reports
Age 54244 reports
Age 43240 reports
Age 51238 reports
Age 47237 reports
Age 57235 reports
Age 55228 reports
Age 58228 reports
Age 39224 reports
Age 46221 reports
Age 35212 reports
Age 48211 reports
Age 42206 reports
Age 49206 reports
Age 45202 reports
Age 56194 reports
Age 40193 reports
Age 44187 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 DARUNAVIR?

This profile reflects 26,718 FDA FAERS reports that mention DARUNAVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DARUNAVIR?

Frequently reported terms in FAERS include FOETAL EXPOSURE DURING PREGNANCY, DRUG INTERACTION, PAIN, EMOTIONAL DISTRESS, ANXIETY, ANHEDONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DARUNAVIR?

Labeling and FAERS entries often list Janssen Products LP in connection with DARUNAVIR. 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.