What the label lists and what reports show
Lenacapavir side effects
Lenacapavir's FDA label: “Most common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea and injection site reactions.” FAERS holds 462 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 injection site discharge (141 reports).
- No generic listed
Check it at the source: the lenacapavir FDA label on DailyMed (effective August 27, 2026, Gilead Sciences, Inc.); 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 SUNLENCA?SUNLENCA may cause serious side effects, including: Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicine. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you develop any new symptoms after starting your HIV-1 medicine. Injection site reactions may happen when you receive SUNLENCA injections and may include swelling, pain, redness, skin hardening, small mass or lump, and itching. Hardened skin or lumps at the injection site usually can be felt but not seen. If you develop hardened skin or a lump, it may take longer than other reactions at the injection site to go away, and the injection site may not completely heal on its own. Tell your healthcare provider if you get any injection site reactions. […]
Source: FDA drug label, Gilead Sciences, Inc., effective August 27, 2026 (SPL set e5652804-29c4-40d7-aeb2-0142ed2a7b5b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea and injection site reactions.
Table 7 Selected Laboratory Abnormalities (Grades 3 to 4) Reported in ≥ 2% of Participants Receiving SUNLENCA in CAPELLA (Week 52 Analysis)
| Laboratory Parameter Abnormality | SUNLENCA + Background Regimen (N=72) Frequencies are based on treatment-emergent… ALT= alanine aminotransferase; AST= aspartate aminotransferase; ULN = upper limit of… |
|---|---|
| Creatinine ( >1.8 × ULN or ≥1.5 × baseline) | 13% |
| Glycosuria (>2+) Grade 3 only (no Grade 4 values reported). | 6% |
| Hyperglycemia (fasting) (>250 mg/dL) | 5% |
| Proteinuria (>2+) | 4% |
| ALT (≥5 × ULN) | 3% |
| AST (≥5 × ULN) | 3% |
| Direct Bilirubin (>ULN) | 3% |
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: Immune Reconstitution Syndrome [see Warnings and Precautions (5.1) ] Injection Site Reactions [see Warnings and Precautions (5.3) ]. Most common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea and injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of HIV-1 in Heavily Treatment-Experienced Adults The primary safety assessment of SUNLENCA was based on data from heavily treatment-experienced adult participants with HIV who received SUNLENCA in a Phase 2/3 trial (CAPELLA; N=72) through Week 52 (median duration on study of 71 weeks) [see Clinical Studies (14.1) ], as well as supportive data in treatment-naïve adult participants with HIV who received SUNLENCA in a Phase 2 trial (CALIBRATE; N=157) through Week 54 (median duration of exposure of 66 weeks). …
Source: FDA drug label, Gilead Sciences, Inc., effective August 27, 2026 (SPL set e5652804-29c4-40d7-aeb2-0142ed2a7b5b), via openFDA; the full label on DailyMed
What do FAERS reports show?
462 reports list lenacapavir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 8 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 24 reactions below, 3 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?
- Lenacapavir: 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