Ziagen: adverse event reports filed with FDA

1,554

reports as suspect product

0% of all reports · about 69 a year

7

reports, 12 months to June 2026

8 in the 12 months before

90.3%

marked serious by the reporter

84.3% across the class

10.6%

record death among outcomes, as reported

165 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 Ziagen reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor

1. Pyrexiafever12.2%189
2. Nauseafeeling sick6.3%98
3. Diarrhoealoose or frequent stools5.8%90
4. Rashskin rash5.1%80
5. Vomitingbeing sick4.8%75
6. Abdominal painstomach or belly pain4.2%65
7. Renal impairmentreduced kidney function4.1%64
8. Hypersensitivityan allergic-type reaction3.9%60
9. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.6%56
10. Lipodystrophy acquiredchanges in body fat distribution3.6%56
11. Fatiguetiredness3.4%53
12. Renal failurekidney failure3.3%51
13. Myocardial infarctionheart attack3.2%50
14. Malaisegeneral feeling of being unwell3.2%49
15. Headachehead pain3.1%48
16. Deaththe patient died; cause not stated by this term2.9%45
17. Astheniaweakness or lack of energy2.8%44
18. Myalgiamuscle pain2.7%42
19. Anaemialow red blood cells2.6%40
20. Drug exposure during pregnancythe medicine was taken during pregnancy2.6%40
21. Dyspnoeashortness of breath2.3%36
22. Pruritusitching2.3%36
23. Blood creatinine increasedraised creatinine, a kidney test2.3%35
24. Mitochondrial toxicity2.2%34
25. Drug hypersensitivityan allergic-type reaction to a medicine2.1%33
26. Hypertensionhigh blood pressure2.1%33
27. Alanine aminotransferase increasedraised liver enzyme (ALT)2%31
28. Eyelid ptosis1.7%27
29. Aspartate aminotransferase increasedraised liver enzyme (AST)1.7%26
30. Hepatitis1.7%26

Top 30 of 631 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. 20.3% 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 1,554 reports.

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 Ziagen as a suspect or interacting product; reports listing it only as a concomitant medication (1,202) 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.