Abacavir: adverse event reports filed with FDA

3,867

reports as suspect product

0% of all reports · about 172 a year

108

reports, 12 months to June 2026

145 in the 12 months before

95.3%

marked serious by the reporter

84.3% across the class

12.1%

record death among outcomes, as reported

468 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 Abacavir reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor

1. Virologic failure10.6%411
2. Pyrexiafever9.6%372
3. Treatment failurethe treatment did not work8.4%326
4. Foetal exposure during pregnancythe unborn baby was exposed to the medicine8.3%320
5. Viral mutation identified8%311
6. Pathogen resistance7.9%307
7. Exposure during pregnancythe medicine was taken during pregnancy7.5%290
8. Rashskin rash7.4%286
9. Drug resistance6.6%254
10. Drug ineffectivethe medicine did not work as expected5.4%210
11. Thrombocytopenialow platelets5.4%210
12. Fatiguetiredness5.1%196
13. Treatment noncompliancethe treatment was not taken as directed4.9%188
14. Drug interactionan interaction between medicines4.6%179
15. Hypersensitivityan allergic-type reaction4.6%179
16. Upper respiratory tract infectiona cold or similar infection4.6%178
17. Immune reconstitution inflammatory syndrome4.6%177
18. Hypertensionhigh blood pressure4.5%173
19. Rash erythematousa red rash4.5%173
20. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.5%173
21. Asthmaasthma4.4%172
22. Headachehead pain4.4%172
23. Diarrhoealoose or frequent stools3.8%148
24. Infectionan infection, type not specified3.7%143
25. Drug hypersensitivityan allergic-type reaction to a medicine3.6%140
26. Lipodystrophy acquiredchanges in body fat distribution3.5%137
27. Off label useused for a purpose or in a way not on the label3.5%137
28. Nauseafeeling sick3.5%136
29. Painpain, site not specified3.3%128
30. Vomitingbeing sick3.3%128

Top 30 of 1,053 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. 20.9% 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 3,867 reports.

Drugs most often listed in the same reports

Other products listed in reports where Abacavir 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 Abacavir as a suspect or interacting product; reports listing it only as a concomitant medication (2,133) 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.