What the label lists and what reports show
Lamivudine and zidovudine side effects
Lamivudine and zidovudine's FDA label: “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.” FAERS holds 7,703 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (601 reports).
- Generic listed
- Boxed warning
Check it at the source: the lamivudine and zidovudine FDA label on DailyMed (effective August 22, 2023, ViiV Healthcare Company); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost 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.
Table 1. Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300 mg per Day and RETROVIR 600 mg per Day
| Adverse Reaction | EPIVIR plus RETROVIR (n = 251) Body as a whole |
|---|---|
| Headache | 35% |
| Malaise & fatigue | 27% |
| Fever or chills | 10% |
| Nausea | 33% |
| Diarrhea | 18% |
| Nausea & vomiting | 13% |
| Anorexia and/or decreased appetite | 10% |
| Abdominal pain | 9% |
| Abdominal cramps | 6% |
| Dyspepsia | 5% |
| Neuropathy | 12% |
| Insomnia & other sleep disorders | 11% |
| Dizziness | 10% |
| Depressive disorders | 9% |
| Nasal signs & symptoms | 20% |
| Cough | 18% |
| Skin rashes | 9% |
| Musculoskeletal pain | 12% |
| Myalgia | 8% |
| Arthralgia | 5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, ViiV Healthcare Company, effective August 22, 2023 (SPL set 16da660b-9981-4d24-a14a-94c7744fce4f), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,703 reports list lamivudine and zidovudine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 594 are coded as a death and 2,265 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lamivudine and zidovudine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions