Drug · FAERS side-effect profile with label screen

Dolutegravir and Lamivudine side effects: what 3,524 FDA adverse event reports show

Dolutegravir Sodium And Lamivudine · 79 reaction terms · 3,597 drug–reaction co-reports · data 2026-09-14

Drug class

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Dolutegravir Sodium And Lamivudine (Dovato)

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

Who reports

3,524 reports · 38% serious · 118 with death outcome · 26% female

openFDA FAERS counts, all years, deduplication not applied

Used for

DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in .

FDA label, Indications and Usage

What it is

DOVATO is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an integrase strand transfer inhibitor (INSTI), and lamivudine (also known as 3TC), a nucleoside analogue reverse transcriptase inhibitor (NRTI). DOVATO tablets are for oral administration.

FDA label, Description section

Boxed warning

PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO.

FDA 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 2Labeled (related wording) 4Reporting / coding artifact 14Lab value / disease marker 2Not in label — unassessed 18

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.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 39 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
Product dose omission in error	224	50.0 44.0–56.8ROR 53.3 · χ² 10,624 / p <1e-300	49.4 EB05 44.2 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 99% consumer	no trial data cached
Intentional dose omission	109	23.8 19.8–28.6ROR 24.5 · χ² 2,349 / p <1e-300	23.6 EB05 20.1 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 98% consumer	no trial data cached
Product dose omission issue	1,093	22.9 21.8–24.1ROR 32.7 · χ² 23,089 / p <1e-300	22.8 EB05 21.7 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Anhedonia	92	20.7 16.9–25.3ROR 21.2 · χ² 1,702 / p <1e-300	20.6 EB05 17.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.3	no trial data cached
Osteopenia	38	14.8 10.8–20.4ROR 15.0 · χ² 476 / p 1e-105	14.6 EB05 10.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 24.6	no trial data cached
Inability to afford medication	17	10.3 6.4–16.5ROR 10.3 · χ² 133 / p 4e-31	9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Treatment noncompliance	89	9.7 7.9–12.0ROR 10.0 · χ² 691 / p 2e-152	9.5 EB05 7.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 9.6	no trial data cached
Neurotoxicity	26	8.9 6.1–13.1ROR 9.0 · χ² 174 / p 4e-40	8.1 EB05 5.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.7 · 100% consumer	no trial data cached
Inappropriate schedule of product administration	256	8.6 7.7–9.7ROR 9.2 · χ² 1,728 / p <1e-300	8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 96% consumer	no trial data cached
Osteoporosis	58	8.4 6.5–10.8ROR 8.5 · χ² 370 / p 1e-82	8.0 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Bone density decreased	41	7.7 5.7–10.4ROR 7.8 · χ² 232 / p 9e-53	7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 13.9	no trial data cached
Helicobacter infection	12	7.0 4.0–12.3ROR 7.0 · χ² 56 / p 4e-14	5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Extra dose administered	46	6.9 5.1–9.1ROR 6.9 · χ² 224 / p 5e-51	6.5 EB05 5.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=2 · 93% consumer	no trial data cached
Product use issue	195	6.2 5.4–7.1ROR 6.5 · χ² 853 / p 1e-187	6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 1.6 · 76% consumer	no trial data cached
Vitamin d deficiency	10	6.1 3.3–11.3ROR 6.1 · χ² 38 / p 4e-10	4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Adverse drug reaction	89	5.9 4.8–7.3ROR 6.0 · χ² 360 / p 2e-80	5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 1.2 · 98% consumer	no trial data cached
Glomerular filtration rate decreased	12	5.9 3.3–10.4ROR 5.9 · χ² 44 / p 2e-11	4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 7.4	no trial data cached
Hepatitis c	11	5.4 3.0–9.7ROR 5.4 · χ² 35 / p 2e-9	4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.7	no trial data cached
Economic problem	13	5.0 2.9–8.6ROR 5.0 · χ² 38 / p 4e-10	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.4	no trial data cached
Emotional distress	102	5.0 4.1–6.0ROR 5.1 · χ² 323 / p 1e-72	4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Chronic kidney disease	61	4.7 3.7–6.1ROR 4.8 · χ² 176 / p 2e-40	4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Foot fracture	15	4.7 2.8–7.8ROR 4.7 · χ² 40 / p 1e-10	4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Depressed mood	41	4.6 3.4–6.3ROR 4.7 · χ² 113 / p 9e-27	4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 2.1 · 85% consumer	no trial data cached
Renal impairment	60	4.3 3.3–5.5ROR 4.3 · χ² 147 / p 4e-34	4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.7	no trial data cached
Dysstasia	20	4.1 2.6–6.3ROR 4.1 · χ² 43 / p 3e-11	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Exposure during pregnancy	41	3.9 2.9–5.3ROR 4.0 · χ² 86 / p 7e-21	3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7 · ♀ 100% (drug 26%)	no trial data cached
Illness	64	3.8 3.0–4.8ROR 3.8 · χ² 129 / p 3e-30	3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3 · 95% consumer	no trial data cached
Proteinuria	11	3.5 1.9–6.3ROR 3.5 · χ² 17 / p 2e-5	3.1 EB05 1.9 · IC025 +0.6	Not in label — unassessed	serious PRR 5.4	no trial data cached
Erectile dysfunction	15	3.5 2.1–5.7ROR 3.5 · χ² 24 / p 5e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Nightmare	20	3.4 2.2–5.3ROR 3.4 · χ² 32 / p 8e-9	3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Gastritis	15	3.4 2.0–5.6ROR 3.4 · χ² 23 / p 8e-7	3.1 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Blood triglycerides increased	10	3.4 1.8–6.2ROR 3.4 · χ² 14 / p 8e-5	3.0 EB05 1.8 · IC025 +0.5	Labeled (related wording) related wording	serious PRR 7.2	no trial data cached
Anxiety	155	3.2 2.8–3.8ROR 3.3 · χ² 239 / p 3e-54	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · 76% consumer	no trial data cached
Transaminases increased	12	3.2 1.8–5.6ROR 3.2 · χ² 16 / p 3e-5	2.9 EB05 1.8 · IC025 +0.6	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Product administration error	10	3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4	2.7 EB05 1.6 · IC025 +0.4	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Osteonecrosis (bone death)	15	2.7 1.6–4.5ROR 2.7 · χ² 14 / p 8e-5	2.5 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 4.1	no trial data cached
Incorrect dose administered	98	2.6 2.1–3.1ROR 2.6 · χ² 95 / p 9e-23	2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 0.6 · 98% consumer	no trial data cached
Renal injury	13	2.6 1.5–4.4ROR 2.6 · χ² 11 / p 5e-4	2.4 EB05 1.5 · IC025 +0.3	Labeled (related wording) related wording	serious PRR 3.9	no trial data cached
Drug resistance	11	2.5 1.4–4.6ROR 2.6 · χ² 9 / p 0.001	2.4 EB05 1.4 · IC025 +0.2	Reporting / coding artifact	serious PRR 1.6	no trial data cached
Foetal exposure during pregnancy	32	2.3 1.7–3.3ROR 2.4 · χ² 23 / p 7e-7	2.3 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 3.7 · 100% clinician	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
Product dose omission issue	1,093	22.9 21.8–24.1ROR 32.7 · χ² 23,089 / p <1e-300	22.8 EB05 21.7 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Inappropriate schedule of product administration	256	8.6 7.7–9.7ROR 9.2 · χ² 1,728 / p <1e-300	8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 96% consumer	no trial data cached
Product dose omission in error	224	50.0 44.0–56.8ROR 53.3 · χ² 10,624 / p <1e-300	49.4 EB05 44.2 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 99% consumer	no trial data cached
Product use issue	195	6.2 5.4–7.1ROR 6.5 · χ² 853 / p 1e-187	6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 1.6 · 76% consumer	no trial data cached
Anxiety	155	3.2 2.8–3.8ROR 3.3 · χ² 239 / p 3e-54	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · 76% consumer	no trial data cached
Intentional dose omission	109	23.8 19.8–28.6ROR 24.5 · χ² 2,349 / p <1e-300	23.6 EB05 20.1 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 98% consumer	no trial data cached
Emotional distress	102	5.0 4.1–6.0ROR 5.1 · χ² 323 / p 1e-72	4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Incorrect dose administered	98	2.6 2.1–3.1ROR 2.6 · χ² 95 / p 9e-23	2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 0.6 · 98% consumer	no trial data cached
Anhedonia	92	20.7 16.9–25.3ROR 21.2 · χ² 1,702 / p <1e-300	20.6 EB05 17.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.3	no trial data cached
Adverse drug reaction	89	5.9 4.8–7.3ROR 6.0 · χ² 360 / p 2e-80	5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 1.2 · 98% consumer	no trial data cached
Treatment noncompliance	89	9.7 7.9–12.0ROR 10.0 · χ² 691 / p 2e-152	9.5 EB05 7.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 9.6	no trial data cached
Illness	64	3.8 3.0–4.8ROR 3.8 · χ² 129 / p 3e-30	3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3 · 95% consumer	no trial data cached
Chronic kidney disease	61	4.7 3.7–6.1ROR 4.8 · χ² 176 / p 2e-40	4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Renal impairment	60	4.3 3.3–5.5ROR 4.3 · χ² 147 / p 4e-34	4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.7	no trial data cached
Osteoporosis	58	8.4 6.5–10.8ROR 8.5 · χ² 370 / p 1e-82	8.0 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	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.

Anhedonia — n=92, PRR 20.7
Osteopenia — n=38, PRR 14.8
Neurotoxicity — n=26, PRR 8.9
Osteoporosis — n=58, PRR 8.4
Extra dose administered — n=46, PRR 6.9
Emotional distress — n=102, PRR 5.0
Chronic kidney disease — n=61, PRR 4.7
Depressed mood — n=41, PRR 4.6
Dysstasia — n=20, PRR 4.1
Nightmare — n=20, PRR 3.4

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 and Lamivudine?

In FDA FAERS, the most frequently co-reported reaction terms for Dolutegravir and Lamivudine are anxiety, emotional distress, anhedonia, chronic kidney disease, renal impairment, osteoporosis. 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 and Lamivudine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO.

Do FAERS signals prove that Dolutegravir and Lamivudine 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 68e45422-43ed-4cfb-9356-fae88d14a53a, effective 20251029; matched on openfda.generic_name.exact:"DOLUTEGRAVIR SODIUM AND LAMIVUDINE")
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, 79 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.