What the label lists and what reports show
Cabotegravir side effects
Cabotegravir's FDA label: “The most common adverse reactions (all grades) observed in at least 1% of participants receiving APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia …” FAERS holds 9,398 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 pain (1,018 reports).
- No generic listed
- Boxed warning
Check it at the source: the cabotegravir FDA label on DailyMed (effective April 11, 2025, ViiV Healthcare Company); 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 APRETUDE?APRETUDE may cause serious side effects including: • Allergic reactions. Call your healthcare provider right away if you develop a rash with APRETUDE. Stop receiving APRETUDE and get medical help right away if you develop a rash with any of the following signs or symptoms: ○ fever ○ generally ill feeling ○ tiredness ○ muscle or joint aches ○ trouble breathing ○ blisters or sores in mouth ○ blisters ○ redness or swelling of the eyes ○ swelling of the mouth, face, lips, or tongue • Liver problems. Liver problems have happened in people with or without a history of liver problems or other risk factors. Your healthcare provider may do blood tests to check your liver function. […]
Source: FDA drug label, ViiV Healthcare Company, effective April 11, 2025 (SPL set 4338428e-43d4-4e02-ac9d-bd98e738a7da), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (all grades) observed in at least 1% of participants receiving APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
Table 4. Adverse Drug Reactions a (All Grades) Reported in at Least 1% of Participants Receiving APRETUDE in Either HPTN 083 or HPTN 084
| Reaction | APRETUDE Every 2 Months (n = 2,281) | TRUVADA Once Daily (n = 2,285) | APRETUDE Every 2 Months (n = 1,614) | TRUVADA Once Daily (n = 1,610) |
|---|---|---|---|---|
| Injection site reactions b | 82% | 35% | 38% | 11% |
| Diarrhea | 4% | 5% | 4% | 4% |
| Headache | 4% | 3% | 12% | 13% |
| Pyrexia c | 4% | <1% | <1% | <1% |
| Fatigue d | 4% | 2% | 3% | 3% |
| Sleep disorders e | 3% | 3% | 1% | 1% |
| Nausea | 3% | 5% | 4% | 8% |
| Dizziness | 2% | 3% | 4% | 6% |
| Flatulence | 1% | 1% | <1% | <1% |
| Abdominal pain f | 1% | 1% | 2% | 2% |
| Vomiting | <1% | 1% | 2% | 5% |
| Myalgia | <1% | <1% | 2% | 1% |
| Rash g | <1% | <1% | 2% | 1% |
| Decreased appetite | <1% | <1% | 2% | 4% |
| Somnolence | <1% | <1% | 2% | 2% |
| Back pain | <1% | <1% | 1% | <1% |
| Upper respiratory tract infection | 0 | <1% | 4% | 4% |
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 described below and in other sections of the labeling: • Hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] • Hepatotoxicity [see Warnings and Precautions ( 5.5 )] • Depressive disorders [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (all grades) observed in at least 1% of participants receiving APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. ( 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. 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 with rates in the clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Experience in Adults The safety assessment of APRETUDE is based on the analysis of data from 2 international, multicenter, double-blind trials, HPTN 083 and HPTN 084 [see Clinical Studies ( 14.1 )]. …
Source: FDA drug label, ViiV Healthcare Company, effective April 11, 2025 (SPL set 4338428e-43d4-4e02-ac9d-bd98e738a7da), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,398 reports list cabotegravir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 183 are coded as a death and 524 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. Reports rose sharply in 2024 (2,940, against a median of 40 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 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?
- Cabotegravir: 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