What the label lists and what reports show
Cabotegravir and rilpivirine side effects
Cabotegravir and rilpivirine's FDA label: “The most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.” FAERS holds 6,104 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 (622 reports).
- No generic listed
Check it at the source: the cabotegravir and rilpivirine FDA label on DailyMed (effective November 26, 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 CABENUVA?CABENUVA may cause serious side effects including: • Allergic reactions. Call your healthcare provider right away if you develop a rash with CABENUVA . Stop receiving CABENUVA 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 • Post-injection reactions. Post-injection reaction symptoms have happened within minutes in some people after receiving their rilpivirine injection. Most symptoms resolved within minutes after the injection. […]
Source: FDA drug label, ViiV Healthcare Company, effective November 26, 2025 (SPL set 1698baf3-f895-4c42-a1b1-e9ee3f20da36), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.
Table 6. Injection Site Reactions (Grades 1 to 3) Reported in at Least 1% of Participants in FLAIR and ATLAS (Pooled Analysis) and ATLAS-2M Trials (Week 48 Analysis)
| Reaction | Injection Site Reactions Cabotegravir plus Rilpivirine Once Monthly (n = 591) | FLAIR and ATLAS Cabotegravir plus Rilpivirine Once Every 2 Months (n = 522) | ATLAS-2M Cabotegravir plus Rilpivirine Once Monthly (n = 523) |
|---|---|---|---|
| Any injection site reaction | 83% | 75% | 75% |
| Pain/discomfort | 79% | 73% | 71% |
| Nodules | 14% | 10% | 17% |
| Induration | 12% | 8% | 7% |
| Swelling | 8% | 6% | 5% |
| Erythema | 4% | 2% | 3% |
| Pruritus | 4% | 5% | 5% |
| Bruising/discoloration | 3% | 2% | 2% |
| Warmth | 2% | 1% | 2% |
| Hematoma | 2% | <1% | 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 described below and in other sections of the labeling: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] • Post-injection reactions [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Depressive disorders [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. ( 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 CABENUVA is based on the analysis of pooled 48-week data from 1,182 virologically suppressed participants with HIV-1 infection in 2 international, multicenter, open-label pivotal trials, FLAIR and ATLAS, and 1,045 virologically suppressed participants from the ATLAS-2M trial [see Clinical Studies ( 14.1 )]. …
Source: FDA drug label, ViiV Healthcare Company, effective November 26, 2025 (SPL set 1698baf3-f895-4c42-a1b1-e9ee3f20da36), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,104 reports list cabotegravir and rilpivirine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 113 are coded as a death and 252 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 2025 (1,510, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 15 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 and rilpivirine: 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