What the label lists and what reports show
Abacavir and lamivudine side effects
Abacavir and lamivudine's FDA label: “The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo …” FAERS holds 196 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 headache (17 reports).
- Generic listed
- Boxed warning
Check it at the source: the abacavir and lamivudine FDA label on DailyMed (effective March 3, 2025, Macleods Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of abacavir and lamivudine tablets?Abacavir and lamivudine tablets can cause serious side effects including: See “What is the most important information I should know about abacavir and lamivudine tablets?” Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis: feel very weak or tired feel cold, especially in your arms and legs unusual (not normal) muscle pain feel dizzy or light-headed trouble breathing have a fast or irregular heartbeat stomach pain with nausea and vomiting Severe liver problems. In some cases, severe liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). […]
Source: FDA drug label (Abacavir and Lamivudine), Aurobindo Pharma Limited, effective May 19, 2024 (SPL set deda1a24-2f51-4601-9881-347f47270940), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea.
Table 1. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2-4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA30021) through 48 Weeks of Treatment
This table is printed in the Abacavir and Lamivudine label published by Cipla USA Inc. of January 18, 2022; the label quoted above does not print one.
| Adverse Event | ZIAGEN 600 mg q.d. plus EPIVIR plus Efavirenz (n = 384) | ZIAGEN 300 mg b.i.d. plus EPIVIR plus Efavirenz (n = 386) |
|---|---|---|
| Drug hypersensitivity a,b | 9% | 7% |
| Insomnia | 7% | 9% |
| Depression/Depressed mood | 7% | 7% |
| Headache/Migraine | 7% | 6% |
| Fatigue/Malaise | 6% | 8% |
| Dizziness/Vertigo | 6% | 6% |
| Nausea | 5% | 6% |
| Diarrhea a | 5% | 6% |
| Rash | 5% | 5% |
| Pyrexia | 5% | 3% |
| Abdominal pain/gastritis | 4% | 5% |
| Abnormal dreams | 4% | 5% |
| Anxiety | 3% | 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: • Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions ( 5.2 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.3 )]. • Immune reconstitution syndrome [see Warnings and Precautions ( 5.4 )]. • Myocardial infarction [see Warnings and Precautions ( 5.5 )]. The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or or 1-855-926-3384 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Macleods Pharmaceuticals Limited, effective March 3, 2025 (SPL set d36624c8-d773-4f99-81fc-433fae17feb3), via openFDA; the full label on DailyMed
What do FAERS reports show?
196 reports list abacavir and lamivudine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 35 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 17 reactions below, 6 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.
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?
- Abacavir and lamivudine: 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