Drug
Cabotegravir Sodium
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Drug Level Decreased | 17 | 22.4 | 22.6 | signal |
| 2 | Injection Site Discomfort | 17 | 22.2 | 22.4 | signal |
| 3 | Injection Site Nodule | 17 | 20.9 | 21.1 | signal |
| 4 | Erectile Dysfunction | 28 | 14.6 | 14.9 | signal |
| 5 | Psychotic Disorder | 31 | 14.1 | 14.4 | signal |
| 6 | Injection Site Induration | 13 | 13.5 | 13.6 | signal |
| 7 | Product Administration Error | 15 | 10.1 | 10.2 | signal |
| 8 | Ventricular Fibrillation | 8 | 9.7 | 9.7 | signal |
| 9 | Neoplasm | 8 | 9.4 | 9.4 | signal |
| 10 | Eyelid Oedema | 8 | 9.2 | 9.2 | signal |
| 11 | Hepatitis | 17 | 8.9 | 9.0 | signal |
| 12 | Aggression | 33 | 8.9 | 9.0 | signal |
| 13 | Hepatic Cytolysis | 8 | 8.8 | 8.9 | signal |
| 14 | Muscle Atrophy | 7 | 7.5 | 7.5 | signal |
| 15 | Abortion Induced | 5 | 7.1 | 7.2 | signal |
| 16 | Helicobacter Infection | 5 | 6.6 | 6.6 | signal |
| 17 | Treatment Noncompliance | 26 | 6.4 | 6.5 | signal |
| 18 | Abortion Spontaneous | 19 | 6.4 | 6.4 | signal |
| 19 | Nodule | 6 | 6.2 | 6.2 | signal |
| 20 | Exposure During Pregnancy | 26 | 5.6 | 5.7 | signal |
| 21 | Pharyngeal Swelling | 4 | 5.6 | 5.6 | signal |
| 22 | Product Dispensing Error | 9 | 5.6 | 5.6 | signal |
| 23 | Abscess | 6 | 5.1 | 5.1 | signal |
| 24 | Product Complaint | 9 | 4.9 | 4.9 | signal |
| 25 | Hypertensive Crisis | 4 | 4.8 | 4.8 | signal |
| 26 | Myocarditis | 4 | 4.8 | 4.8 | signal |
| 27 | Injection Site Mass | 13 | 4.7 | 4.8 | signal |
| 28 | Injection Site Pain | 105 | 4.7 | 4.9 | signal |
| 29 | Nightmare | 12 | 4.6 | 4.7 | signal |
| 30 | Polyneuropathy | 4 | 4.5 | 4.5 | signal |
| 31 | Inappropriate Schedule Of Product Administration | 56 | 4.3 | 4.4 | signal |
| 32 | Suicidal Ideation | 29 | 4.3 | 4.3 | signal |
| 33 | Product Dose Omission Issue | 89 | 4.2 | 4.4 | signal |
| 34 | Drug Resistance | 8 | 4.2 | 4.2 | signal |
| 35 | Tuberculosis | 4 | 4.2 | 4.2 | signal |
| 36 | Eosinophilia | 5 | 3.9 | 3.9 | signal |
| 37 | Premature Baby | 8 | 3.6 | 3.6 | signal |
| 38 | Abnormal Dreams | 7 | 3.4 | 3.4 | signal |
| 39 | Incorrect Product Administration Duration | 5 | 3.3 | 3.3 | signal |
| 40 | Foetal Exposure During Pregnancy | 20 | 3.3 | 3.3 | signal |
| 41 | Hepatitis C | 3 | 3.3 | 3.3 | no signal |
| 42 | Uveitis | 3 | 3.0 | 3.0 | no signal |
| 43 | Therapeutic Response Shortened | 7 | 3.0 | 3.0 | signal |
| 44 | Oesophageal Carcinoma | 6 | 2.7 | 2.7 | signal |
| 45 | Exposure Via Skin Contact | 4 | 2.4 | 2.4 | no signal |
| 46 | Suicide Attempt | 10 | 2.2 | 2.2 | signal |
| 47 | Injection Site Reaction | 11 | 2.2 | 2.2 | signal |
| 48 | Injection Site Swelling | 12 | 2.1 | 2.1 | signal |
| 49 | Injection Site Warmth | 3 | 2.0 | 2.0 | no signal |
| 50 | Menstruation Irregular | 3 | 1.5 | 1.5 | no signal |
| 51 | Wrong Technique In Device Usage Process | 3 | 0.9 | 0.9 | no signal |