ATAZANAVIR SULFATE

N/A

Manufactured by Aurobindo Pharma Limited

6,992 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ATAZANAVIR SULFATE

ATAZANAVIR SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for ATAZANAVIR SULFATE include DRUG INTERACTION, DEPRESSION, MATERNAL EXPOSURE DURING PREGNANCY, FOETAL EXPOSURE DURING PREGNANCY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATAZANAVIR SULFATE.

Top Adverse Reactions

DRUG INTERACTION938 reports
DEPRESSION780 reports
MATERNAL EXPOSURE DURING PREGNANCY419 reports
FOETAL EXPOSURE DURING PREGNANCY326 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES224 reports
ABORTION SPONTANEOUS192 reports
PREMATURE BABY132 reports
ANXIETY126 reports
PSYCHIATRIC DECOMPENSATION121 reports
SUICIDAL IDEATION119 reports
PSYCHOTIC DISORDER115 reports
DEPRESSION SUICIDAL110 reports
PARANOIA109 reports
TEARFULNESS109 reports
DEPRESSIVE SYMPTOM100 reports
PSYCHOMOTOR SKILLS IMPAIRED97 reports
PREMATURE DELIVERY84 reports
LIPODYSTROPHY ACQUIRED83 reports
LIVE BIRTH82 reports
ABORTION INDUCED81 reports
EYELID PTOSIS70 reports
ANAEMIA67 reports
DRUG RESISTANCE65 reports
INTENTIONAL PRODUCT USE ISSUE65 reports
CAESAREAN SECTION63 reports
DYSPHAGIA63 reports
BLOOD BILIRUBIN INCREASED61 reports
MITOCHONDRIAL TOXICITY61 reports
DIPLOPIA60 reports
PRESCRIBED OVERDOSE56 reports
DRUG EXPOSURE DURING PREGNANCY53 reports
OFF LABEL USE53 reports
LOW BIRTH WEIGHT BABY52 reports
NAUSEA52 reports
PRODUCT USE IN UNAPPROVED INDICATION52 reports
ACUTE KIDNEY INJURY50 reports
STILLBIRTH50 reports
VIRAL MUTATION IDENTIFIED48 reports
ALANINE AMINOTRANSFERASE INCREASED47 reports
VOMITING47 reports
VIROLOGIC FAILURE45 reports
HYPERBILIRUBINAEMIA44 reports
NORMAL NEWBORN42 reports
PREGNANCY42 reports
PSYCHOMOTOR RETARDATION41 reports
ASPARTATE AMINOTRANSFERASE INCREASED37 reports
RENAL FAILURE ACUTE37 reports
NEPHROLITHIASIS36 reports
DIARRHOEA35 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION35 reports
MYALGIA35 reports
PYREXIA35 reports
HAEMATURIA33 reports
BILIRUBIN CONJUGATED INCREASED32 reports
DEATH32 reports
HEADACHE32 reports
FATIGUE31 reports
NO ADVERSE EVENT31 reports
DIZZINESS30 reports
EXPOSURE DURING PREGNANCY29 reports
PREGNANCY ON CONTRACEPTIVE29 reports
JAUNDICE28 reports
PULMONARY EMBOLISM28 reports
SEPSIS28 reports
BLOOD LACTIC ACID INCREASED27 reports
OPHTHALMOPLEGIA27 reports
SEIZURE27 reports
FEBRILE NEUTROPENIA26 reports
INFECTION25 reports
PNEUMONIA25 reports
VENTRICULAR SEPTAL DEFECT24 reports
CEREBRAL ISCHAEMIA23 reports
CYSTITIS NONINFECTIVE23 reports
THROMBOSIS23 reports
TUMOUR LYSIS SYNDROME23 reports
DRUG INEFFECTIVE21 reports
RENAL FAILURE21 reports
HYPERTENSION20 reports
PREMATURE RUPTURE OF MEMBRANES20 reports
RENAL IMPAIRMENT20 reports
SMALL FOR DATES BABY19 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME18 reports
DYSPNOEA16 reports
FOETAL GROWTH RESTRICTION16 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR16 reports
MALAISE16 reports
PATHOGEN RESISTANCE16 reports
TOXICITY TO VARIOUS AGENTS16 reports
TREATMENT NONCOMPLIANCE16 reports
ABDOMINAL PAIN15 reports
HOSPITALISATION15 reports
PATENT DUCTUS ARTERIOSUS15 reports
RASH15 reports
TRISOMY 2115 reports
BLOOD HIV RNA INCREASED14 reports
CALCULUS URINARY14 reports
CD4 LYMPHOCYTES DECREASED14 reports
CUSHING^S SYNDROME14 reports
DEPRESSED MOOD14 reports
DRUG LEVEL INCREASED14 reports

Report Outcomes

Out of 2,946 classified reports for ATAZANAVIR SULFATE:

Serious 95.0%Non-Serious 5.0%

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

Male1,602 (60.9%)
Female1,021 (38.8%)
Unknown6 (0.2%)

Reports by Age

Age 54567 reports
Age 099 reports
Age 4486 reports
Age 3158 reports
Age 3054 reports
Age 3550 reports
Age 4248 reports
Age 3246 reports
Age 3643 reports
Age 141 reports
Age 3340 reports
Age 3839 reports
Age 3737 reports
Age 4037 reports
Age 3434 reports
Age 2832 reports
Age 4130 reports
Age 2929 reports
Age 4327 reports
Age 5027 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 SULFATE?

This profile reflects 6,992 FDA FAERS reports that mention ATAZANAVIR SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ATAZANAVIR SULFATE?

Frequently reported terms in FAERS include DRUG INTERACTION, DEPRESSION, MATERNAL EXPOSURE DURING PREGNANCY, FOETAL EXPOSURE DURING PREGNANCY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, ABORTION SPONTANEOUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ATAZANAVIR SULFATE?

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