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Cabotegravir Side Effects

The most commonly reported side effects of cabotegravir include product dose omission issue, injection site pain, and off label use, based on 13,994 FDA adverse event reports from 2014 to 2025. 1.9% of reports found the drug to be ineffective.

Cabotegravir side effects

Percentages show how often each reaction appears relative to total reports for cabotegravir.

1
Product Dose Omission Issue12.7%1,776
2
Injection Site Pain10.8%1,512
3
Off Label Use10.3%1,436
4
Viral Load Increased6.5%913
5
Pain4.9%686
6
Virologic Failure4.1%578
7
Product Use In Unapproved Therapeutic Environment3.9%547
8
Pathogen Resistance3.6%502
9
Product Complaint2.8%387
10
Inappropriate Schedule Of Product Administration2.7%380
11
Pyrexia2.7%379
12
Product Storage Error2.6%359
13
Injection Site Nodule2.5%345
14
Fatigue2.4%336
15
Blood Hiv Rna Increased2.3%320

These are voluntary reports and do not establish that cabotegravir caused these reactions.

Report severity

23.6%Serious3,298 reports
4.8%Hospitalizations665 reports
1.8%Fatal255 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cabotegravir drug interactions

Other drugs that appear in adverse event reports alongside cabotegravir. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Rilpivirine78.5%10,982
2
Dolutegravir1.4%191
3
Emtricitabine1.2%174
4
Tenofovir1.2%173
5
Lenacapavir1.2%167
6
Lamivudine1.0%136
7
Abacavir0.5%68
8
Bictegravir0.4%57
9
Hydrochlorothiazide0.4%54
10
Darunavir0.4%53
11
Metformin0.4%50
12
Amphetamine0.3%45
13
Trazodone-hydrochloride0.3%44
14
Ritonavir0.3%42
15
Cocaine-hydrochloride0.3%42

Taken alongside

1
Tenofovir4.8%677
2
Emtricitabine4.8%665
3
Rilpivirine4.5%626
4
Bictegravir3.1%432
5
Dolutegravir1.6%217
6
Lamivudine1.0%144
7
Albuterol0.9%123
8
Atorvastatin-calcium0.9%121
9
Cobicistat0.8%113
10
Rosuvastatin0.7%99
11
Ergocalciferol0.7%96
12
Abacavir0.6%86
13
Amlodipine0.6%81
14
Darunavir0.6%77
15
Bupropion0.5%72

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports cabotegravir side effects

18.4% of cabotegravir adverse event reports involve female patients and 50.9% involve male patients. The largest age group is adult at 92%. These figures reflect who reports side effects, not underlying risk.

Sex

Female18.4%
Male50.9%
Unknown30.7%

Age group

< 20.4%
2–11<0.1%
12–170.4%
18–6492.2%
65+6.9%

What is cabotegravir used for

Conditions and purposes for which patients were taking cabotegravir when the adverse event was reported.

Acquired Immunodeficiency SyndromeAntiretroviral TherapyAntiviral ProphylaxisAsymptomatic Hiv InfectionAbdominal PainAcquired Immunodeficiency SyndromeActinic KeratosisAcute Hiv InfectionAdverse Drug ReactionAdverse EventAlcoholismAnal SexAnkylosing SpondylitisAntiretroviral TherapyAntiviral Prophylaxis

Showing 15 of 154 indications

Cabotegravir brand names and reporting trend

Cabotegravir is sold under brand names including Cabenuva Kit, Vocabria.

Brand names

Cabenuva Kit13,829
Vocabria84

Quarterly reports (20142025)

2014202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking cabotegravir with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.