Drug · FAERS side-effect profile with label screen

Dolutegravir side effects: what 9,613 FDA adverse event reports show

Dolutegravir Sodium · 1,015 reaction terms · 42,999 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Dolutegravir Sodium (Tivicay)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

9,613 reports · 94% serious · 795 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg .

FDA label, Indications and Usage

What it is

TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 33

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 975 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Blood hiv rna	11	634.3 325.5–1,235.7ROR 635.0 · χ² 4,969 / p <1e-300	267.0 EB05 159.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bone demineralisation	160	415.6 351.6–491.1ROR 423.1 · χ² 55,720 / p <1e-300	338.0 EB05 296.3 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Congenital umbilical hernia	51	367.6 273.7–493.6ROR 369.7 · χ² 15,767 / p <1e-300	283.5 EB05 224.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ectopic kidney	11	313.2 166.9–587.8ROR 313.6 · χ² 2,745 / p <1e-300	186.9 EB05 111.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Temperature regulation disorder	239	287.4 251.6–328.2ROR 295.2 · χ² 60,405 / p <1e-300	250.5 EB05 225.0 · IC025 +7.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Birth mark	23	286.7 186.0–442.1ROR 287.5 · χ² 5,574 / p <1e-300	210.7 EB05 147.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Blood hiv rna increased	124	173.8 144.9–208.3ROR 176.2 · χ² 19,647 / p <1e-300	157.8 EB05 135.8 · IC025 +6.3 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Portal fibrosis	14	165.6 96.3–284.7ROR 165.8 · χ² 1,986 / p <1e-300	128.0 EB05 81.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Foetal death	310	148.7 132.8–166.5ROR 154.0 · χ² 42,607 / p <1e-300	138.6 EB05 126.1 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Congenital skin dimples	13	131.5 75.2–229.9ROR 131.7 · χ² 1,472 / p <1e-300	105.6 EB05 65.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Renal dysplasia	17	108.3 66.6–176.1ROR 108.5 · χ² 1,625 / p <1e-300	93.0 EB05 61.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Food allergy	307	99.0 88.5–110.8ROR 102.5 · χ² 28,485 / p <1e-300	94.5 EB05 85.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Syphilis	26	86.7 58.6–128.1ROR 86.9 · χ² 2,040 / p <1e-300	78.9 EB05 56.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Anhedonia	945	86.5 81.3–92.0ROR 96.6 · χ² 76,997 / p <1e-300	83.3 EB05 78.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hyperferritinaemia	14	81.7 48.0–139.2ROR 81.9 · χ² 1,002 / p 4e-220	71.6 EB05 45.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Plasmablastic lymphoma	10	67.4 36.0–126.4ROR 67.5 · χ² 573 / p 6e-127	58.6 EB05 34.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Meningomyelocele	16	63.3 38.5–104.0ROR 63.4 · χ² 895 / p 6e-197	57.6 EB05 37.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Genotype drug resistance test positive	27	62.4 42.6–91.4ROR 62.6 · χ² 1,529 / p <1e-300	58.4 EB05 42.1 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Economic problem	388	60.4 54.7–66.6ROR 63.1 · χ² 22,036 / p <1e-300	58.7 EB05 54.0 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Fanconi syndrome acquired	44	60.3 44.7–81.2ROR 60.6 · χ² 2,442 / p <1e-300	57.4 EB05 44.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Immune reconstitution inflammatory syndrome	124	59.4 49.7–70.9ROR 60.2 · χ² 6,882 / p <1e-300	57.4 EB05 49.4 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Hydrops foetalis	15	58.7 35.2–98.0ROR 58.8 · χ² 775 / p 8e-171	53.6 EB05 34.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Acquired immunodeficiency syndrome	12	55.8 31.5–98.9ROR 55.9 · χ² 578 / p 5e-128	50.4 EB05 30.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Threatened labour	10	55.2 29.5–103.3ROR 55.2 · χ² 468 / p 4e-104	49.2 EB05 28.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pharmaceutical nomadism	11	54.8 30.1–99.6ROR 54.9 · χ² 516 / p 1e-114	49.3 EB05 29.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Immunodeficiency	327	53.1 47.7–59.1ROR 55.0 · χ² 16,292 / p <1e-300	51.8 EB05 47.2 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Viral load increased	84	51.4 41.4–63.7ROR 51.9 · χ² 4,011 / p <1e-300	49.8 EB05 41.4 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Pulmonary hypoplasia	17	51.1 31.6–82.5ROR 51.1 · χ² 768 / p 3e-169	47.5 EB05 31.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Coeliac disease	209	50.9 44.4–58.2ROR 52.0 · χ² 9,950 / p <1e-300	49.6 EB05 44.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
T-lymphocyte count decreased	13	45.4 26.2–78.5ROR 45.4 · χ² 510 / p 3e-113	42.0 EB05 26.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Osteopenia	290	45.3 40.4–50.8ROR 46.8 · χ² 12,285 / p <1e-300	44.3 EB05 40.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Chronic kidney disease-mineral and bone disorder	19	42.0 26.7–66.1ROR 42.1 · χ² 707 / p 4e-156	39.8 EB05 26.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bursitis	207	40.8 35.6–46.7ROR 41.7 · χ² 7,863 / p <1e-300	40.0 EB05 35.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Renal aplasia	12	40.3 22.8–71.4ROR 40.4 · χ² 415 / p 2e-92	37.5 EB05 22.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Single functional kidney	11	39.5 21.7–71.6ROR 39.5 · χ² 368 / p 2e-82	36.6 EB05 21.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lipodystrophy acquired	34	37.8 27.0–53.1ROR 38.0 · χ² 1,164 / p 2e-255	36.6 EB05 27.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
End stage renal disease	277	35.7 31.8–40.1ROR 36.8 · χ² 9,171 / p <1e-300	35.1 EB05 31.8 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Prescribed overdose	289	35.4 31.6–39.7ROR 36.6 · χ² 9,500 / p <1e-300	34.8 EB05 31.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Superinfection bacterial	11	32.9 18.2–59.7ROR 33.0 · χ² 305 / p 1e-68	30.9 EB05 18.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hiv infection	41	32.2 23.6–43.7ROR 32.3 · χ² 1,190 / p 4e-261	31.3 EB05 24.1 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pain	1,447	5.5 5.3–5.8ROR 6.4 · χ² 5,485 / p <1e-300	5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Anxiety	1,058	8.7 8.2–9.2ROR 9.7 · χ² 7,275 / p <1e-300	8.7 EB05 8.2 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Emotional distress	1,051	20.4 19.3–21.6ROR 23.0 · χ² 19,308 / p <1e-300	20.2 EB05 19.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Anhedonia	945	86.5 81.3–92.0ROR 96.6 · χ² 76,997 / p <1e-300	83.3 EB05 78.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Chronic kidney disease	703	21.6 20.1–23.2ROR 23.4 · χ² 13,738 / p <1e-300	21.4 EB05 20.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Fatigue (tiredness)	642	1.9 1.8–2.1ROR 2.0 · χ² 299 / p 3e-67	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	–	no trial data cached
Exposure during pregnancy	629	23.9 22.1–25.8ROR 25.6 · χ² 13,668 / p <1e-300	23.6 EB05 22.1 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Headache	587	2.2 2.0–2.4ROR 2.3 · χ² 391 / p 2e-87	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Off label use (used outside approved label)	574	1.5 1.4–1.7ROR 1.6 · χ² 115 / p 4e-27	1.5 EB05 1.4 · IC025 +0.5	Reporting / coding artifact	–	no trial data cached
Renal failure (kidney failure)	543	9.5 8.8–10.3ROR 10.1 · χ² 4,144 / p <1e-300	9.5 EB05 8.8 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Rash	503	2.7 2.5–3.0ROR 2.8 · χ² 554 / p 9e-123	2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Foetal exposure during pregnancy	482	13.9 12.8–15.2ROR 14.7 · χ² 5,769 / p <1e-300	13.9 EB05 12.8 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Pyrexia (fever)	463	3.1 2.9–3.4ROR 3.2 · χ² 679 / p 5e-150	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Hypertension (high blood pressure)	452	5.0 4.6–5.5ROR 5.2 · χ² 1,451 / p <1e-300	5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug ineffective (drug did not work)	429	0.8 0.7–0.8ROR 0.7 · χ² 34 / p 3e-9	0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Bone demineralisation — n=160, PRR 415.6
Congenital umbilical hernia — n=51, PRR 367.6
Temperature regulation disorder — n=239, PRR 287.4
Birth mark — n=23, PRR 286.7
Foetal death — n=310, PRR 148.7
Food allergy — n=307, PRR 99.0
Syphilis — n=26, PRR 86.7
Anhedonia — n=945, PRR 86.5
Fanconi syndrome acquired — n=44, PRR 60.3
Immunodeficiency — n=327, PRR 53.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Dolutegravir?

In FDA FAERS, the most frequently co-reported reaction terms for Dolutegravir are pain, anxiety, emotional distress, anhedonia, chronic kidney disease, fatigue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Dolutegravir have an FDA boxed warning?

No. The FDA label retrieved for Dolutegravir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Dolutegravir causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 485bc9db-8665-9f5a-e063-6394a90a7921, effective 20260522; matched on openfda.generic_name.exact:"DOLUTEGRAVIR SODIUM")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,015 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.