Dolutegravir

Common brands: Tivicay, Truvada, Descovy, Norvir, Epivir

Top reporter: Viiv Healthcare Company

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]Cytochrome P450 3A Inhibitor [EPC]Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]Protease Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
8,900
Total Reports
4,343
Serious Reports
886
Death Reports
30
Reported Reactions
Death Report Ratio: High (9.96%)

Patient Demographics

Male
4,768
Female
2,660

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Dolutegravir.

# Reaction Reports % of Total
1 PAIN 1,437
9.0%
2 ANXIETY 1,055
6.6%
3 EMOTIONAL DISTRESS 1,050
6.6%
4 ANHEDONIA 944
5.9%
5 CHRONIC KIDNEY DISEASE 702
4.4%
6 FATIGUE 631
4.0%
7 EXPOSURE DURING PREGNANCY 619
3.9%
8 HEADACHE 577
3.6%
9 OFF LABEL USE 565
3.6%
10 RENAL FAILURE 541
3.4%
11 RASH 494
3.1%
12 FOETAL EXPOSURE DURING PREGNANCY 479
3.0%
13 PYREXIA 454
2.9%
14 HYPERTENSION 440
2.8%
15 OSTEOPOROSIS 425
2.7%
16 DRUG INEFFECTIVE 419
2.6%
17 DEATH 408
2.6%
18 DEPRESSION 408
2.6%
19 BONE DENSITY DECREASED 400
2.5%
20 ECONOMIC PROBLEM 388
2.4%
21 PRODUCT USE ISSUE 369
2.3%
22 HEPATIC ENZYME INCREASED 363
2.3%
23 RENAL IMPAIRMENT 359
2.3%
24 THROMBOCYTOPENIA 348
2.2%
25 BACK PAIN 347
2.2%
26 PRODUCT DOSE OMISSION ISSUE 342
2.2%
27 HYPERSENSITIVITY 337
2.1%
28 HYPERHIDROSIS 330
2.1%
29 MATERNAL EXPOSURE DURING PREGNANCY 329
2.1%
30 JOINT SWELLING 326
2.1%

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.