Cabotegravir

Common brands: Apretude, Rilpivirine, Edurant, Biktarvy, Vocabria

Top reporter: Viiv Healthcare Company

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Cytochrome P450 3A Inhibitor [EPC]Atypical Antipsychotic [EPC]
7,871
Total Reports
6,927
Serious Reports
90
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.14%)

Patient Demographics

Male
4,136
Female
1,349

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Cabotegravir.

# Reaction Reports % of Total
1 PRODUCT DOSE OMISSION ISSUE 1,116
13.6%
2 OFF LABEL USE 1,041
12.7%
3 INJECTION SITE PAIN 910
11.1%
4 VIRAL LOAD INCREASED 433
5.3%
5 PAIN 398
4.9%
6 VIROLOGIC FAILURE 269
3.3%
7 PRODUCT USE IN UNAPPROVED THERAPEUTIC ENVIRONMENT 252
3.1%
8 PYREXIA 252
3.1%
9 PATHOGEN RESISTANCE 249
3.0%
10 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 246
3.0%
11 PRODUCT COMPLAINT 222
2.7%
12 DRUG INEFFECTIVE 201
2.5%
13 FATIGUE 185
2.3%
14 PRODUCT STORAGE ERROR 185
2.3%
15 INJECTION SITE NODULE 177
2.2%
16 VIRAL MUTATION IDENTIFIED 163
2.0%
17 BLOOD HIV RNA INCREASED 160
2.0%
18 HEADACHE 155
1.9%
19 EXPOSURE DURING PREGNANCY 154
1.9%
20 DEPRESSION 149
1.8%
21 INJECTION SITE SWELLING 144
1.8%
22 HIV INFECTION 142
1.7%
23 RASH 136
1.7%
24 CONDITION AGGRAVATED 134
1.6%
25 WRONG TECHNIQUE IN DEVICE USAGE PROCESS 134
1.6%
26 NAUSEA 119
1.5%
27 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE 117
1.4%
28 INCORRECT DOSE ADMINISTERED 114
1.4%
29 INJECTION SITE REACTION 114
1.4%
30 ARTHRALGIA 113
1.4%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.