ATAZANAVIR

N/A

Manufactured by E.R. Squibb & Sons, L.L.C.

27,247 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ATAZANAVIR

ATAZANAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by E.R. Squibb & Sons, L.L.C.. The most commonly reported adverse reactions for ATAZANAVIR include DRUG INTERACTION, DEPRESSION, FOETAL EXPOSURE DURING PREGNANCY, ANXIETY, MATERNAL EXPOSURE DURING PREGNANCY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATAZANAVIR.

Top Adverse Reactions

DRUG INTERACTION1,774 reports
DEPRESSION1,309 reports
FOETAL EXPOSURE DURING PREGNANCY1,037 reports
ANXIETY866 reports
MATERNAL EXPOSURE DURING PREGNANCY748 reports
PAIN742 reports
EMOTIONAL DISTRESS649 reports
ANHEDONIA591 reports
ABORTION SPONTANEOUS513 reports
NEPHROLITHIASIS473 reports
RENAL FAILURE472 reports
NAUSEA465 reports
FATIGUE417 reports
CHRONIC KIDNEY DISEASE399 reports
OSTEOPOROSIS397 reports
HYPERBILIRUBINAEMIA389 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES373 reports
BLOOD BILIRUBIN INCREASED368 reports
JAUNDICE367 reports
PREMATURE BABY358 reports
DIARRHOEA353 reports
EXPOSURE DURING PREGNANCY352 reports
ANAEMIA346 reports
PYREXIA344 reports
VOMITING329 reports
RENAL IMPAIRMENT303 reports
VIROLOGIC FAILURE299 reports
ASTHENIA287 reports
ACUTE KIDNEY INJURY284 reports
RASH277 reports
BONE DENSITY DECREASED272 reports
DRUG EXPOSURE DURING PREGNANCY257 reports
ECONOMIC PROBLEM255 reports
BLOOD CREATININE INCREASED253 reports
RENAL FAILURE ACUTE250 reports
HEADACHE242 reports
LIPODYSTROPHY ACQUIRED236 reports
DRUG RESISTANCE227 reports
SUICIDAL IDEATION222 reports
OFF LABEL USE221 reports
OSTEOPENIA219 reports
DRUG INEFFECTIVE216 reports
OSTEONECROSIS213 reports
ABORTION INDUCED201 reports
PSYCHOTIC DISORDER200 reports
ALANINE AMINOTRANSFERASE INCREASED197 reports
DIZZINESS195 reports
DYSPNOEA195 reports
WEIGHT DECREASED194 reports
PREMATURE DELIVERY193 reports
LIVE BIRTH191 reports
DEATH189 reports
INSOMNIA185 reports
ABDOMINAL PAIN183 reports
PRURITUS183 reports
PSYCHIATRIC DECOMPENSATION180 reports
MYOCARDIAL INFARCTION177 reports
GAIT DISTURBANCE174 reports
PARANOIA171 reports
DYSPHAGIA164 reports
ASPARTATE AMINOTRANSFERASE INCREASED163 reports
PNEUMONIA161 reports
MYALGIA159 reports
PREGNANCY159 reports
DEPRESSION SUICIDAL158 reports
TEARFULNESS157 reports
ARTHRALGIA154 reports
DEPRESSIVE SYMPTOM153 reports
HYPERTENSION153 reports
RENAL COLIC150 reports
PROTEINURIA147 reports
CAESAREAN SECTION146 reports
MALAISE146 reports
PSYCHOMOTOR SKILLS IMPAIRED144 reports
STILLBIRTH142 reports
TREATMENT NONCOMPLIANCE142 reports
VIRAL MUTATION IDENTIFIED137 reports
LOW BIRTH WEIGHT BABY132 reports
PATHOGEN RESISTANCE129 reports
BACK PAIN125 reports
THROMBOCYTOPENIA125 reports
RENAL TUBULAR DISORDER124 reports
WEIGHT INCREASED117 reports
HEPATITIS111 reports
CHOLELITHIASIS110 reports
EYELID PTOSIS110 reports
PAIN IN EXTREMITY110 reports
VIRAL LOAD INCREASED110 reports
CUSHING^S SYNDROME109 reports
DIABETES MELLITUS108 reports
END STAGE RENAL DISEASE108 reports
HAEMATURIA107 reports
BONE DEMINERALISATION104 reports
CONDITION AGGRAVATED104 reports
DECREASED APPETITE101 reports
MULTIPLE FRACTURES101 reports
OCULAR ICTERUS100 reports
PANCYTOPENIA99 reports
FANCONI SYNDROME ACQUIRED98 reports
TOXICITY TO VARIOUS AGENTS98 reports

Report Outcomes

Out of 14,254 classified reports for ATAZANAVIR:

Serious 88.9%Non-Serious 11.1%

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

Male7,743 (62.3%)
Female4,607 (37.0%)
Unknown87 (0.7%)

Reports by Age

Age 54905 reports
Age 50310 reports
Age 44305 reports
Age 42249 reports
Age 40237 reports
Age 52234 reports
Age 45232 reports
Age 35230 reports
Age 41227 reports
Age 47226 reports
Age 43224 reports
Age 46223 reports
Age 53219 reports
Age 31210 reports
Age 32204 reports
Age 48202 reports
Age 37201 reports
Age 51199 reports
Age 36195 reports
Age 0188 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 ATAZANAVIR?

This profile reflects 27,247 FDA FAERS reports that mention ATAZANAVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ATAZANAVIR?

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

Who manufactures ATAZANAVIR?

Labeling and FAERS entries often list E.R. Squibb & Sons, L.L.C. in connection with ATAZANAVIR. 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.