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Drug

Cabotegravir Sodium

51 flagged reaction(s) · 780 total co-reports · max PRR 22.4
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