Prescription medication · Integrase Inhibitor / NRTI Combination

dolutegravir/lamivudine

Also sold as Dovato. Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds).

Data updated 2026-05-15

7,993
FDA reports
9
InteractionsFew interactions
$96.17
Brand price (NADAC)

What the data shows

dolutegravir/lamivudine (Dovato) is a prescription Integrase Inhibitor / NRTI Combination, with 7,993 FDA adverse-event reports on file, with 9 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

dolutegravir/lamivudine (Dovato) is a prescription Integrase Inhibitor / NRTI Combination. Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds).

Dovato is a complete HIV-1 treatment that combines two medicines into one tablet. It is used for adults and adolescents who weigh at least 55 pounds.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$96.17/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds).

Common side effects

Headache, Nausea, Diarrhea

Key warnings

If you have both HIV-1 and hepatitis B, you should be tested for hepatitis B before starting Dovato.

The sections below are summarized in plain English from dolutegravir/lamivudine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Dovato contains two drugs: dolutegravir and lamivudine. Dolutegravir blocks HIV-1 integrase, an enzyme the virus needs to multiply. Lamivudine blocks reverse transcriptase, another enzyme HIV-1 needs to make copies of itself.

Side Effects (from patient reports)

Based on 7,993 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for dolutegravir/lamivudine, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

If you have both HIV-1 and hepatitis B, you should be tested for hepatitis B before starting Dovato. Using Dovato can cause the hepatitis B virus to become resistant to lamivudine. Stopping Dovato can also cause a severe worsening of hepatitis B. Your liver function should be checked regularly.

Known Drug Interactions

major dofetilide

7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. Coadministered Drug Class: Drug Name Effect on Concentration Clinical Comment Antiarrhythmic: Dofetilide ↑Dofetilide Coadministration is contraindicated with DOVATO [see...

Mechanism: One of the medicines in this combination blocks the pathways your kidneys use to get rid of dofetilide. This can lead to dangerously high levels of dofetilide in your system.

moderate metformin

7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. Antidiabetic: Metformin a ↑Metformin Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin.

Mechanism: Dolutegravir blocks the proteins that help your kidneys remove metformin, which can lead to higher levels of metformin in your blood.

moderate oxcarbazepine

Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.

Mechanism: Oxcarbazepine lowers the amount of dolutegravir in your body, which could make your HIV treatment less effective.

moderate phenytoin

Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.

Mechanism: Phenytoin causes your body to clear dolutegravir more quickly, which reduces the amount of medicine available to fight the virus.

moderate phenobarbital

Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.

Mechanism: Phenobarbital speeds up the breakdown of dolutegravir in your system, which can prevent the medication from working properly.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take Dovato with other HIV medicines?
No, Dovato is a complete treatment for HIV-1. Do not take it with other HIV medicines.
What should I do if I have a rash after starting Dovato?
Stop taking Dovato and contact your doctor right away. A rash could be a sign of a serious allergic reaction.
Can Dovato cause liver problems?
Yes, Dovato can cause liver problems. Your doctor may monitor your liver function while you are taking Dovato.
Is Dovato safe for people with kidney problems?
Dovato is not recommended if your creatinine clearance is less than 30 mL/min.
Is Dovato safe for people with liver problems?
Dovato is not recommended if you have severe hepatic impairment (Child-Pugh Score C).
Can Dovato interact with other medicines I am taking?
Yes, Dovato can interact with other medicines. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What if I am co-infected with HIV and Hepatitis B?
All patients with HIV-1 should be tested for HBV prior to or when starting DOVATO. You may need additional treatment for Hepatitis B.
Can Dovato cause hypersensitivity reactions?
Yes, hypersensitivity reactions have been reported with dolutegravir, a component of DOVATO. Stop DOVATO immediately if signs or symptoms of hypersensitivity reactions develop.
What are the ingredients in Dovato?
Each tablet contains 50 mg of dolutegravir and 300 mg of lamivudine.
What does Dovato look like?
Dovato tablets are oval, biconvex, white, film-coated tablets, debossed with “SV 137” on one face.
What are the common side effects of dolutegravir/lamivudine?
The registry lists Headache, Nausea, Diarrhea, Trouble sleeping (insomnia), Tiredness (fatigue) among the most-reported FAERS reaction terms for dolutegravir/lamivudine. The compiled record contains 7,993 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does dolutegravir/lamivudine interact with other medications?
The registry has 9 documented interaction rows for dolutegravir/lamivudine. Notable source-record pairings include dofetilide, metformin, oxcarbazepine. These rows are not a complete medication review.
What drug class is dolutegravir/lamivudine?
dolutegravir/lamivudine belongs to the Integrase Inhibitor / NRTI Combination drug class. It requires a prescription (Rx). Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds).
What pregnancy or breastfeeding source fields are listed for dolutegravir/lamivudine?
The FDA label for dolutegravir/lamivudine contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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What the FDA Data Shows for dolutegravir/lamivudine

The FDA label for dolutegravir/lamivudine (sold under brand names such as Dovato) classifies it as a prescription-only medication in the Integrase Inhibitor / NRTI Combination class. Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds). Official labeling lists 6 commonly reported side effects, including Headache, Nausea, Diarrhea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,993 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: October 29, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page