ZIDOVUDINE

N/A

Manufactured by ViiV Healthcare Company

26,898 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ZIDOVUDINE

ZIDOVUDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ViiV Healthcare Company. The most commonly reported adverse reactions for ZIDOVUDINE include FOETAL EXPOSURE DURING PREGNANCY, DRUG EXPOSURE DURING PREGNANCY, ANAEMIA, VIROLOGIC FAILURE, DRUG RESISTANCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZIDOVUDINE.

Top Adverse Reactions

FOETAL EXPOSURE DURING PREGNANCY2,131 reports
DRUG EXPOSURE DURING PREGNANCY1,075 reports
ANAEMIA932 reports
VIROLOGIC FAILURE812 reports
DRUG RESISTANCE725 reports
PREMATURE BABY722 reports
EXPOSURE DURING PREGNANCY638 reports
PATHOGEN RESISTANCE573 reports
VIRAL MUTATION IDENTIFIED567 reports
MATERNAL EXPOSURE DURING PREGNANCY507 reports
PYREXIA468 reports
LIPODYSTROPHY ACQUIRED436 reports
PAIN427 reports
TREATMENT FAILURE423 reports
NEUTROPENIA414 reports
DEATH411 reports
VOMITING404 reports
ANXIETY397 reports
DIARRHOEA384 reports
EMOTIONAL DISTRESS377 reports
DRUG INEFFECTIVE357 reports
CAESAREAN SECTION347 reports
DRUG INTERACTION344 reports
ANHEDONIA341 reports
IMMUNE RECONSTITUTION SYNDROME303 reports
TREATMENT NONCOMPLIANCE296 reports
NAUSEA295 reports
ALANINE AMINOTRANSFERASE INCREASED294 reports
HIV INFECTION290 reports
ASPARTATE AMINOTRANSFERASE INCREASED280 reports
BLOOD LACTIC ACID INCREASED276 reports
CHRONIC KIDNEY DISEASE248 reports
MATERNAL DRUGS AFFECTING FOETUS246 reports
MITOCHONDRIAL TOXICITY237 reports
FATIGUE233 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME233 reports
EYELID PTOSIS227 reports
PREGNANCY227 reports
PREMATURE DELIVERY226 reports
DEPRESSION219 reports
HEADACHE210 reports
RENAL FAILURE209 reports
DIPLOPIA208 reports
RENAL IMPAIRMENT208 reports
HYPERTRIGLYCERIDAEMIA193 reports
ASTHENIA189 reports
OSTEOPOROSIS188 reports
RASH186 reports
LOW BIRTH WEIGHT BABY184 reports
WEIGHT DECREASED183 reports
ACUTE KIDNEY INJURY169 reports
LIVE BIRTH169 reports
NO ADVERSE EVENT167 reports
THROMBOCYTOPENIA162 reports
LACTIC ACIDOSIS156 reports
SEPSIS155 reports
BONE DENSITY DECREASED153 reports
VENTRICULAR SEPTAL DEFECT152 reports
ATRIAL SEPTAL DEFECT151 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED151 reports
STILLBIRTH151 reports
ABDOMINAL PAIN150 reports
OFF LABEL USE150 reports
HYPERTENSION147 reports
ABORTION SPONTANEOUS146 reports
DYSPNOEA144 reports
HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION144 reports
PNEUMONIA143 reports
DYSPHAGIA139 reports
SMALL FOR DATES BABY139 reports
BLOOD CREATININE INCREASED136 reports
PANCYTOPENIA136 reports
CONDITION AGGRAVATED135 reports
LYMPHADENOPATHY135 reports
OSTEOPENIA135 reports
GAIT DISTURBANCE130 reports
BLOOD HIV RNA INCREASED127 reports
HEPATOMEGALY123 reports
CONGENITAL ANOMALY122 reports
HAEMOGLOBIN DECREASED122 reports
MALAISE121 reports
MYALGIA121 reports
GENERAL PHYSICAL HEALTH DETERIORATION120 reports
DRUG INDUCED LIVER INJURY119 reports
ECONOMIC PROBLEM119 reports
ABDOMINAL DISTENSION118 reports
NEUROPATHY PERIPHERAL117 reports
LEUKOPENIA116 reports
DIZZINESS115 reports
DECREASED APPETITE114 reports
COUGH112 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED111 reports
HYPERLACTACIDAEMIA111 reports
PREMATURE RUPTURE OF MEMBRANES108 reports
ANAEMIA MACROCYTIC107 reports
NEONATAL DISORDER107 reports
PREMATURE LABOUR107 reports
BLOOD BILIRUBIN INCREASED106 reports
HEPATIC FUNCTION ABNORMAL105 reports
OSTEONECROSIS105 reports

Report Outcomes

Out of 13,209 classified reports for ZIDOVUDINE:

Serious 94.6%Non-Serious 5.4%

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

Male5,187 (54.3%)
Female4,216 (44.2%)
Unknown146 (1.5%)

Reports by Age

Age 0369 reports
Age 1275 reports
Age 35195 reports
Age 52193 reports
Age 37172 reports
Age 42163 reports
Age 54162 reports
Age 45160 reports
Age 3155 reports
Age 38153 reports
Age 40153 reports
Age 36150 reports
Age 30147 reports
Age 34146 reports
Age 32142 reports
Age 28140 reports
Age 33132 reports
Age 43131 reports
Age 41130 reports
Age 50128 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 ZIDOVUDINE?

This profile reflects 26,898 FDA FAERS reports that mention ZIDOVUDINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ZIDOVUDINE?

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

Who manufactures ZIDOVUDINE?

Labeling and FAERS entries often list ViiV Healthcare Company in connection with ZIDOVUDINE. 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.