Drugs › Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor
Generic name
Abacavir sulfate: adverse event reports filed with FDA
840 reports list it as a suspect or interacting product, 2004–2026. Class: Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor.
- 840
- reports as suspect product
- 0% of all reports · about 37 a year
- 66
- reports, 12 months to June 2026
- 112 in the 12 months before
- 98%
- marked serious by the reporter
- 84.3% across the class
- 20.4%
- record death among outcomes, as reported
- 171 reports · not verified by FDA
Between January 2004 and June 2026, 840 adverse event reports received by FDA list abacavir sulfate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (337) are left out of every figure here.
In the 12 months to June 2026, 66 reports listed it, down 41% from 112 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 37 reports a year and 0% of the 20,646,523 reports in the database, and 1% of the reports for the human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded exposure during pregnancy (37.9%), headache (33.6%) and hypertension (33.3%). A report can list several reactions, so shares add to more than 100%; 302 different terms appear across these reports. Exposure during pregnancy is recorded in 37.9% of these reports, a larger share than in the median human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor drug (1.7%).
98% of the reports are marked serious by the reporter (84.3% across the class); 20.4% record death among the outcomes and 17.6% record hospitalisation, as reported. 59.2% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (25.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 sulfate reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor
- Exposure during pregnancythe medicine was taken during pregnancy37.9%318
- Headachehead pain33.6%282
- Hypertensionhigh blood pressure33.3%280
- Hepatic enzyme increasedraised liver enzymes33.1%278
- Off label useused for a purpose or in a way not on the label33%277
- Hyperhidrosisexcessive sweating32.7%275
- Immunodeficiency32.6%274
- Hypersensitivityan allergic-type reaction32.5%273
- Joint swellinga swollen joint32.5%273
- Painpain, site not specified32.4%272
- Product use issuea problem in how the product was used32.4%272
- Intentional product misusedeliberate use not as intended32.3%271
- Food allergy32.1%270
- Prescribed overdose31.8%267
- Infusion related reactiona reaction during or soon after an infusion31.4%264
- Overdosea dose above the recommended amount31.4%264
- Pyrexiafever25.2%212
- Rashskin rash24.5%206
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease23.6%198
- Thrombocytopenialow platelets23.5%197
- Upper respiratory tract infectiona cold or similar infection23.5%197
- Rash erythematousa red rash23%193
- Asthmaasthma22.9%192
- Treatment failurethe treatment did not work22.7%191
- Drug intolerancethe medicine was not tolerated22.6%190
- Fluid retentionthe body holding extra fluid22.6%190
- Foetal death22.5%189
- Psoriasispsoriasis, a skin condition22.4%188
- Temperature regulation disorder22.1%186
Top 30 of 302 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 10.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hiv infection | 317 | 37.7% |
| Antiretroviral therapy | 15 | 1.8% |
| Foetal exposure during pregnancy | 5 | 0.6% |
| Acquired immunodeficiency syndrome | 4 | 0.5% |
| Drug exposure during pregnancy | 4 | 0.5% |
| Hiv test positive | 2 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 840 reports.
In context
| Measure | Abacavir sulfate | Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 840 | 80,988 | 20,646,523 |
| Share of that pool | — | 1% | 0% |
| Reports, latest 12 months | 66 | — | 1,332,454 |
| Marked serious | 98% | 84.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 204 | 66 | 91 |
| Hospitalisation recorded, per 1,000 reports | 176 | 167 | 213 |
| Consumer-filed share | 11.5% | 18.9% | 45.8% |
| Top term, share of reports | Exposure during pregnancy 37.9% | median 1.7% | 0.3% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Truvada | brand | 38,638 | 844 | 85.7% |
| Zidovudine | generic | 8,510 | 121 | 95% |
| Biktarvy | brand | 6,739 | 677 | 54.7% |
| Complera | brand | 6,535 | 95 | 86.9% |
| Emtricitabine | generic | 3,870 | 73 | 97.7% |
| Abacavir | generic | 3,867 | 108 | 95.3% |
| Emtricitabine and tenofovir disoproxil fumarate | generic | 3,518 | 5 | 98% |
| Descovy | brand | 3,123 | 318 | 46.3% |
| Retrovir | brand | 2,026 | 11 | 93.7% |
| Ziagen | brand | 1,554 | 7 | 90.3% |
| Odefsey | brand | 1,035 | 33 | 51.9% |
| Emtriva | brand | 733 | 9 | 94.3% |
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.
Questions about Abacavir sulfate reports
How many adverse event reports has FDA received for Abacavir sulfate?
840 reports list Abacavir sulfate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 66 of them arrived in the latest 12 months. Another 337 list it only as a concomitant medication.
What reactions are recorded in Abacavir sulfate reports?
exposure during pregnancy (37.9%), headache (33.6%), hypertension (33.3%), hepatic enzyme increased (33.1%) and off label use (33%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Abacavir sulfate was responsible.
How serious are the reports?
98% are marked serious by the reporter. Among the outcomes recorded, 20.4% of reports include death and 17.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (59.2%), physician (18.3%) and consumer or non-health professional (11.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Abacavir sulfate rising?
66 reports in the 12 months to June 2026, down 41% from 112 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Abacavir sulfate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Abacavir sulfate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 sulfate as a suspect or interacting product; reports listing it only as a concomitant medication (337) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.