This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Lamivudine And Zidovudine (zidovudine)

hepatitis b virus nucleoside analog reverse transcriptase inhibitor

Last updated: October 14, 2026

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Lamivudine And Zidovudine is the brand name for zidovudine, a hepatitis b virus nucleoside analog reverse transcriptase inhibitor. According to the FDA-approved label, & USAGE Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. FAERS contains 10,308 submissions naming this drug from 2002 through 2026; the top three reactions cited are foetal exposure during pregnancy, virologic failure, and drug resistance.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Lamivudine And Zidovudine. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Lamivudine And Zidovudine. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 10,308 FAERS submissions that named Lamivudine And Zidovudine. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Lamivudine And Zidovudine. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Lamivudine And Zidovudine. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

1 INDICATIONS & USAGE Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)

Adverse Reactions (from label)

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions (5.1)]. • Symptomatic myopathy [see Boxed Warning, Warnings and Precautions (5.2)]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.3)]. • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.4)]. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.5)]. • Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions (5.5)]. • Pancreatitis [see Warnings and Precautions (5.6)]. • Immune reconstitution syndrome [see Warnings and Precautions (5.7)]. • Lipoatrophy [see Warnings and Precautions (5.8)]. • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in clinical trials of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. (6. (continues in label)

FDA label effective date: 2023-03-29

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.