Drugs › Hepatitis B virus nucleoside analog reverse transcriptase inhibitor
Brand name · Lamivudine and zidovudine
Combivir: adverse event reports filed with FDA
4,367 reports list it as a suspect or interacting product, 2004–2026. Class: Hepatitis B virus nucleoside analog reverse transcriptase inhibitor.
- 4,367
- reports as suspect product
- 0% of all reports · about 194 a year
- 11
- reports, 12 months to June 2026
- 10 in the 12 months before
- 92.2%
- marked serious by the reporter
- 88.4% across the class
- 9%
- record death among outcomes, as reported
- 393 reports · not verified by FDA
4,367 adverse event reports received by FDA list the brand name Combivir (lamivudine and zidovudine) as a suspect or interacting product, from January 2004 to May 2026. A further 2,167 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 11 reports listed it, up 10% from 10 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 194 reports a year and 0% of the 20,646,523 reports in the database, and 6% of the reports for the hepatitis B 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.
The MedDRA terms listed most often are drug exposure during pregnancy (22.9%), foetal exposure during pregnancy (10.6%) and anaemia (7.3%). A report can list several reactions, so shares add to more than 100%; 1,053 different terms appear across these reports. Drug exposure during pregnancy is recorded in 22.9% of these reports, a larger share than in the median hepatitis B virus nucleoside analog reverse transcriptase inhibitor drug (0.5%).
92.2% of the reports are marked serious by the reporter (88.4% across the class); 9% record death among the outcomes and 28.9% record hospitalisation, as reported. 34.8% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (37.9%). 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 Combivir reports recording the termmedian drug in hepatitis b virus nucleoside analog reverse transcriptase inhibitor
- Drug exposure during pregnancythe medicine was taken during pregnancy22.9%1,001
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine10.6%465
- Anaemialow red blood cells7.3%319
- Abortion spontaneousmiscarriage6.8%298
- Premature babya baby born early5.8%255
- Stillbirth4.5%196
- Maternal exposure during pregnancythe mother took the medicine during pregnancy4.2%183
- Pyrexiafever4.1%179
- Nauseafeeling sick3.6%158
- Diarrhoealoose or frequent stools3.6%156
- Vomitingbeing sick3.4%148
- Exposure during pregnancythe medicine was taken during pregnancy3.3%144
- Abortion induced3%133
- Fatiguetiredness2.7%116
- Caesarean section2.5%108
- Astheniaweakness or lack of energy2.3%102
- Pregnancypregnancy2.2%97
- Dyspnoeashortness of breath2.1%92
- Headachehead pain2.1%92
- Alanine aminotransferase increasedraised liver enzyme (ALT)2%86
- Neutropenialow neutrophils, a type of white blood cell2%86
- Hepatitis1.8%79
- Rashskin rash1.8%77
- Abdominal painstomach or belly pain1.7%76
- Live birth1.7%75
- Aspartate aminotransferase increasedraised liver enzyme (AST)1.6%71
- Pancytopenialow counts of all blood cells1.6%69
- Weight decreasedweight loss1.6%69
- Deaththe patient died; cause not stated by this term1.6%68
- Haemoglobin decreasedlow haemoglobin1.6%68
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 12 drugs in the hepatitis b 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 72,523 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. 34.3% 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 | 2,396 | 54.9% |
| Antiretroviral therapy | 203 | 4.6% |
| Antiviral prophylaxis | 155 | 3.5% |
| Maternal exposure timing unspecified | 133 | 3% |
| Antiviral treatment | 125 | 2.9% |
| Drug exposure during pregnancy | 123 | 2.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 4,367 reports.
In context
| Measure | Combivir | Hepatitis B virus nucleoside analog reverse transcriptase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 4,367 | 72,523 | 20,646,523 |
| Share of that pool | — | 6% | 0% |
| Reports, latest 12 months | 11 | — | 1,332,454 |
| Marked serious | 92.2% | 88.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 90 | 89 | 91 |
| Hospitalisation recorded, per 1,000 reports | 289 | 200 | 213 |
| Consumer-filed share | 24.7% | 21.1% | 45.8% |
| Top term, share of reports | Drug exposure during pregnancy 22.9% | median 0.5% | 0.2% |
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 hepatitis b virus nucleoside analog reverse transcriptase inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Viread | brand | 22,033 | 195 | 94.5% |
| Lamivudine | generic | 17,966 | 271 | 97.6% |
| Tenofovir disoproxil fumarate | generic | 7,400 | 150 | 97.4% |
| Triumeq | brand | 4,823 | 81 | 45.7% |
| Baraclude | brand | 3,308 | 25 | 77.8% |
| Epivir | brand | 3,208 | 14 | 93.1% |
| Dovato | brand | 3,059 | 253 | 33.4% |
| Entecavir | generic | 2,797 | 163 | 87.1% |
| Lamivudine and zidovudine | generic | 1,432 | 8 | 84.2% |
| Adefovir dipivoxil | generic | 1,156 | 3 | 99.2% |
| Tenofovir alafenamide | generic | 974 | 139 | 97.3% |
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 Combivir reports
How many adverse event reports has FDA received for Combivir?
4,367 reports list Combivir as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 11 of them arrived in the latest 12 months. Another 2,167 list it only as a concomitant medication.
What reactions are recorded in Combivir reports?
drug exposure during pregnancy (22.9%), foetal exposure during pregnancy (10.6%), anaemia (7.3%), abortion spontaneous (6.8%) and premature baby (5.8%). 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 Combivir was responsible.
How serious are the reports?
92.2% are marked serious by the reporter. Among the outcomes recorded, 9% of reports include death and 28.9% 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 (34.8%), physician (29.6%) and consumer or non-health professional (24.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Combivir rising?
11 reports in the 12 months to June 2026, up 10% from 10 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 Combivir 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 Combivir?
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 Combivir as a suspect or interacting product; reports listing it only as a concomitant medication (2,167) 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.