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Dolutegravir Side Effects

The most commonly reported side effects of dolutegravir include product dose omission issue, pain, and anxiety, based on 26,543 FDA adverse event reports from 2010 to 2025. 3.8% of reports found the drug to be ineffective.

Dolutegravir side effects

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

1
Product Dose Omission Issue9.4%2,501
2
Pain8.7%2,305
3
Anxiety7.3%1,942
4
Emotional Distress6.6%1,756
5
Anhedonia6.0%1,581
6
Foetal Exposure During Pregnancy4.7%1,242
7
Chronic Kidney Disease4.5%1,203
8
Exposure During Pregnancy4.4%1,181
9
Fatigue4.4%1,155
10
Headache3.8%1,008
11
Drug Ineffective3.8%1,005
12
Virologic Failure3.8%1,003
13
Renal Failure3.7%983
14
Off Label Use3.7%982
15
Rash3.3%863

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

Report severity

69.2%Serious18,374 reports
20.1%Hospitalizations5,343 reports
7.0%Fatal1,858 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dolutegravir drug interactions

Other drugs that appear in adverse event reports alongside dolutegravir. 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
Lamivudine42.7%11,326
2
Abacavir25.3%6,704
3
Tenofovir25.0%6,631
4
Emtricitabine20.6%5,476
5
Rilpivirine8.3%2,213
6
Ritonavir7.0%1,869
7
Darunavir6.8%1,804
8
Efavirenz5.4%1,442
9
Cobicistat3.4%915
10
Raltegravir-potassium2.9%783
11
Zidovudine2.6%697
12
Fluconazole2.2%577
13
Elvitegravir2.0%530
14
Albuterol1.9%512
15
Rituximab1.9%509

Taken alongside

1
Tenofovir12.7%3,366
2
Lamivudine12.2%3,247
3
Emtricitabine12.0%3,198
4
Abacavir9.0%2,389
5
Ritonavir6.2%1,648
6
Darunavir5.6%1,483
7
Rilpivirine4.2%1,118
8
Acetaminophen3.9%1,022
9
Atorvastatin-calcium3.6%953
10
Aspirin3.6%944
11
Cobicistat3.5%927
12
Albuterol3.2%855
13
Ergocalciferol3.2%854
14
Amlodipine3.2%853
15
Raltegravir-potassium3.1%828

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 dolutegravir side effects

25.8% of dolutegravir adverse event reports involve female patients and 53.2% involve male patients. The largest age group is adult at 85%. These figures reflect who reports side effects, not underlying risk.

Sex

Female25.8%
Male53.2%
Unknown21.0%

Age group

< 23.9%
2–110.3%
12–170.9%
18–6484.7%
65+10.1%

What is dolutegravir used for

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

Acquired Immunodeficiency SyndromeAcute Hiv InfectionAnal CancerAntifungal ProphylaxisAntiretroviral TherapyAntiviral ProphylaxisAntiviral TreatmentAnxietyAsymptomatic Hiv InfectionAcquired Immunodeficiency SyndromeAcute Hiv InfectionAdverse Drug ReactionAnal FissureAntiretroviral TherapyAntiviral Treatment

Showing 15 of 219 indications

Dolutegravir brand names and reporting trend

Dolutegravir is sold under several brand names including Dolutegravir, Juluca, Dolutegravir Lamivudine Tenofovir Alafenamide.

Brand names

Dolutegravir8,226
Juluca973
Dolutegravir Lamivudine Tenofovir Alafenamide24
Dolutegravir And Lamivudine8

Quarterly reports (20102025)

20102016202020242025

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

Taking dolutegravir with another medication?

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