Zidovudine: adverse event reports filed with FDA

8,510

reports as suspect product

0% of all reports · about 378 a year

121

reports, 12 months to June 2026

130 in the 12 months before

95%

marked serious by the reporter

84.3% across the class

14.3%

record death among outcomes, as reported

1,217 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Zidovudine reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor

1. Foetal exposure during pregnancythe unborn baby was exposed to the medicine17.4%1,483
2. Virologic failure8.6%731
3. Drug resistance7.5%637
4. Exposure during pregnancythe medicine was taken during pregnancy6.5%555
5. Viral mutation identified6.2%531
6. Pathogen resistance6.1%521
7. Anaemialow red blood cells5.9%503
8. Drug exposure during pregnancythe medicine was taken during pregnancy5.5%470
9. Treatment failurethe treatment did not work4.9%413
10. Premature babya baby born early4.8%409
11. Lipodystrophy acquiredchanges in body fat distribution4.4%378
12. Maternal exposure during pregnancythe mother took the medicine during pregnancy4.4%376
13. Deaththe patient died; cause not stated by this term4%339
14. Vomitingbeing sick3.1%264
15. HIV infectionHIV infection3.1%262
16. Treatment noncompliancethe treatment was not taken as directed3.1%262
17. Drug ineffectivethe medicine did not work as expected3%257
18. Pyrexiafever3%255
19. Immune reconstitution syndrome2.8%236
20. Immune reconstitution inflammatory syndrome2.6%221
21. Mitochondrial toxicity2.6%218
22. Eyelid ptosis2.5%214
23. Diarrhoealoose or frequent stools2.5%210
24. Drug interactionan interaction between medicines2.4%202
25. Diplopiadouble vision2.3%196
26. Alanine aminotransferase increasedraised liver enzyme (ALT)2.2%186
27. Maternal drugs affecting foetus2.1%176
28. Aspartate aminotransferase increasedraised liver enzyme (AST)1.9%163
29. Premature delivery1.9%159
30. Caesarean section1.8%155

Top 30 of 1,556 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 80,988 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 27.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 8,510 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zidovudine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Zidovudine as a suspect or interacting product; reports listing it only as a concomitant medication (1,700) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.