FDA-filed SPL labeling · retrieved through openFDA

Molnupiravir

Molnupiravir (Lagevrio) is an antiviral medicine authorized under emergency use to treat mild-to-moderate COVID-19 in adults who are at high risk of becoming seriously ill.

Brand name Lagevrio
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 11, 2025
AvailabilityRx
Earliest approval/marketing year 2010
FDA-listed product records 17
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Molnupiravir at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Lagevrio (molnupiravir) is an oral antiviral authorized under emergency use to treat mild-to-moderate COVID-19 in adults at high risk of serious illness, when other options aren't accessible or appropriate. It must be started within 5 days of symptoms and taken for the full 5-day course. It is not recommended during pregnancy and is not authorized for anyone under 18 — talk to your doctor or pharmacist about whether it's the right choice for you.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Lagevrio is authorized under an Emergency Use Authorization (EUA) — it has not gone through the full standard FDA approval process. There are important requirements that come with this:

Lagevrio may cause harm to an unborn baby. Animal studies showed birth defects and fetal death at higher doses. Women who could become pregnant must use reliable contraception during treatment and for 4 days after the last dose. Men with partners who could become pregnant should use contraception during treatment and for at least 3 months after the last dose. Lagevrio should only be prescribed to a pregnant person if a doctor determines the benefits outweigh the risks — and that conversation must be documented. A pregnancy registry is available at https://covid-pr.pregistry.com or 1-800-616-3791. Your doctor is also required to give you a Fact Sheet explaining the benefits, risks, and available alternatives before you start treatment.

Read the full warning on DailyMed →

📖 Molnupiravir: Patient Information Guide

A plain-language walkthrough of Molnupiravir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Molnupiravir (available as Lagevrio) is an antiviral authorized under an Emergency Use Authorization (EUA) for a specific group of adults with COVID-19.

  • Lagevrio is authorized to treat mild-to-moderate COVID-19 in adults who are at high risk of the disease becoming severe, leading to hospitalization or death
  • Lagevrio is intended only for adults for whom other COVID-19 treatments that are FDA-approved or authorized are not accessible or clinically appropriate
  • Lagevrio is not authorized for use in patients under 18 years of age
  • Lagevrio is not authorized for use beyond 5 consecutive days — it has not been evaluated for longer-term treatment
⚙️How it works

Molnupiravir is a prodrug, meaning it isn't active on its own — your body converts it into a compound called NHC after you swallow it. NHC gets taken up by cells and works by inserting itself into the COVID-19 virus's genetic copying machinery (its RNA polymerase). This causes the virus to make so many errors when copying its own genetic code that it essentially self-destructs — a process scientists call viral lethal mutagenesis or error catastrophe. The result is that the virus can't replicate effectively.

In lab studies, NHC showed activity against multiple SARS-CoV-2 variants including Alpha, Beta, Delta, Omicron, and others. No amino acid changes linked to resistance to NHC have been identified in clinical trials of Lagevrio to date.

💊How it's taken

Lagevrio comes as capsules taken by mouth twice a day — every 12 hours — for a total of 5 days. It can be taken with or without food, though food reduces the peak concentration slightly without affecting overall absorption. Treatment must begin within 5 days of symptom onset to be effective.

  • Take every dose at the same time each day to stay on schedule
  • If you miss a dose by 10 hours or less, take it right away and continue your regular schedule
  • If you miss a dose by more than 10 hours, skip it — never double up
  • Complete the full 5-day course even if you feel better; stopping early may reduce effectiveness
🤒Side effects — in detail

Most people tolerate Lagevrio well — the side effects reported in clinical trials were generally mild. Common side effects included:

  • Diarrhea
  • Nausea
  • Dizziness
  • Headache

Because clinical data are still limited, unexpected side effects may emerge with wider use. Stop taking Lagevrio and seek emergency care immediately if you develop signs of a serious allergic reaction (anaphylaxis) — such as hives, swelling of the face or throat, or difficulty breathing.

⚠️Warnings & precautions
  • Risk of fetal harm: Animal studies showed that molnupiravir caused birth defects and fetal death at higher doses. Lagevrio is not recommended during pregnancy. Women who could become pregnant must use effective contraception during treatment and for 4 days after the last dose. Men with partners who could become pregnant should use contraception during treatment and for at least 3 months after the last dose.
  • Not for children under 18: Lagevrio may damage developing bone and cartilage. It is not authorized for pediatric use.
  • Allergic reactions including anaphylaxis: Serious allergic reactions have been reported. Stop the medication immediately and get medical help if you develop signs of anaphylaxis.
  • Limited safety data: Lagevrio is authorized under an EUA with limited clinical experience. Serious or unexpected adverse events may not yet have been fully identified.
  • Breastfeeding: Breastfeeding is not recommended during treatment or for 4 days after the last dose due to unknown risk to the infant.
🔀What it interacts with

Based on currently available data, no drug interactions with Lagevrio have been formally identified. However, this picture is incomplete — no clinical drug interaction studies have been conducted, including with other COVID-19 treatments.

  • In laboratory studies, molnupiravir and NHC did not appear to interfere with common liver enzymes (CYP enzymes) or major drug transporters — suggesting a lower likelihood of interactions, but this has not been confirmed in people
  • The interaction between Lagevrio and other medications used for COVID-19 has not been evaluated in clinical trials
  • Always tell your doctor and pharmacist about every medication, supplement, or herbal product you take before starting Lagevrio

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Pregnancy: Lagevrio is not recommended if you are pregnant — animal studies showed serious harm to fetuses. A pregnancy test may be needed before starting treatment. If pregnant, discuss risks and benefits carefully with your doctor.
  • Breastfeeding: Do not breastfeed during treatment or for 4 days after the last dose; potential risk to the infant cannot be ruled out.
  • Women who could become pregnant: Use reliable contraception during treatment and for 4 days after the last dose.
  • Men with partners who could become pregnant: Use reliable contraception during treatment and for at least 3 months after the last dose.
  • Children under 18: Lagevrio is not authorized for pediatric patients due to potential bone and cartilage toxicity.
  • Older adults (65+): No dose adjustment needed — clinical trial data showed no difference in safety compared to younger adults.
  • Kidney impairment: No dose adjustment is recommended, but data in people with very severe kidney impairment or on dialysis are limited.
  • Liver impairment: No dose adjustment is currently recommended; severe hepatic impairment has not been fully studied.
🚑If you take too much

There is no human experience with Lagevrio overdose. If an overdose is suspected, treatment is supportive — meaning doctors will monitor your condition and treat symptoms as they arise. Hemodialysis (kidney dialysis) is not expected to remove the active drug effectively from the body.

📡Pharmacodynamics — effects in the body

The relationship between blood levels of NHC (the active form of molnupiravir) and its antiviral effect in people has not been formally established through clinical studies. In laboratory and animal studies, NHC demonstrated activity against SARS-CoV-2 and multiple variants by causing the virus to accumulate fatal errors in its genetic code.

🔬Pharmacokinetics — how your body processes it

After you swallow molnupiravir, it is quickly converted into its active form, NHC, which reaches peak blood levels in about 1.5 hours. NHC is not meaningfully bound to proteins in the blood (0% protein binding) and is broken down through the body's normal pathways for processing natural building blocks called pyrimidines — not through the liver's CYP enzyme system. The effective half-life (the time it takes for half the drug to clear from the body) is about 3.3 hours, and very little is eliminated through the kidneys, which is why kidney disease does not significantly affect how the drug is processed.

📦How to store it

Store LAGEVRIO capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) .

📄 Written from Molnupiravir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Molnupiravir

17 supplements and herbal products have documented interactions with Molnupiravir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Molnupiravir — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Molnupiravir against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Molnupiravir — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Lagevrio and why did my doctor prescribe it for COVID-19?
Lagevrio is an antiviral pill that works by scrambling the COVID-19 virus's ability to copy itself — basically causing it to make so many mistakes it can't survive. Your doctor prescribed it because you have mild-to-moderate COVID-19 and are considered at high risk of getting seriously ill, and other treatment options weren't a good fit for you. Keep in mind it's authorized under emergency use, not a full FDA approval, so it's meant for a specific group of patients.
How do I take it, and does it matter if I take it with food?
You take Lagevrio twice a day — roughly every 12 hours — for exactly 5 days. You can take it with or without food, whichever is easier for you. The most important thing is to start it as soon as possible after your COVID-19 diagnosis and within 5 days of your symptoms starting. And please finish all 5 days, even if you're feeling better — stopping early could mean the virus wasn't fully controlled.
What side effects should I watch out for?
Most people who took Lagevrio in studies tolerated it well. The side effects that were reported include diarrhea, nausea, dizziness, and headache — generally mild. That said, because this medication is relatively new and data are still being gathered, unexpected reactions could show up. If you develop hives, swelling of your face or throat, or trouble breathing, that could be a serious allergic reaction — stop the medication and get emergency help right away.
I'm a woman who could get pregnant — is there anything special I need to know?
Yes, this is really important. Animal studies showed that molnupiravir can cause serious harm to a developing baby, including birth defects. Lagevrio is not recommended during pregnancy. You should use a reliable form of birth control throughout the 5 days of treatment and for 4 days after your last dose. Before starting, your doctor may check whether you're pregnant. If you find out you're pregnant during or after treatment, contact your doctor right away and ask about the pregnancy registry.
Can I take Lagevrio with my other medications?
So far, no specific drug interactions with Lagevrio have been identified, and lab studies suggest it's unlikely to interfere with common drug-processing enzymes in the liver. But — and this is important — no real-world drug interaction studies have actually been done yet, including with other COVID-19 treatments. Always give your doctor and pharmacist a full list of everything you take, including over-the-counter medicines and supplements, so they can watch for anything unexpected.
I'm breastfeeding — can I still take this medication?
Breastfeeding is not recommended while you're taking Lagevrio or for 4 days after your last dose. We don't have data on whether the medication passes into breast milk in people, but there's a potential risk to your baby that can't be ruled out. One option your doctor may suggest is pumping and discarding your milk during this time, then resuming breastfeeding after the 4 days are up. Talk to your healthcare provider about what makes the most sense for you and your baby.
Is Molnupiravir available over the counter?
Molnupiravir is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Molnupiravir first available?
Molnupiravir has been available in the United States since at least 2010, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Molnupiravir?
Molnupiravir is supplied by 14 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Divi's Laboratories Limited, A-S Medication Solutions.

💬 Answers drafted from Molnupiravir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Molnupiravir comes

Molnupiravir is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Lagevrio
How this form is used
What it may be used for
  • Lagevrio capsules are authorized under an EUA to treat mild-to-moderate COVID-19 in adults at high risk of severe illness, hospitalization, or death
  • Lagevrio is used when other FDA-approved or authorized COVID-19 treatments are not accessible or clinically appropriate for the patient
Important instructions
  • Lagevrio capsules are taken by mouth every 12 hours for 5 days, with or without food — complete the full course even if you feel better
  • Lagevrio treatment should begin as soon as possible after a COVID-19 diagnosis and within 5 days of symptom onset
  • Lagevrio capsules may be opened and mixed with water for administration through a nasogastric, orogastric, gastrostomy (12F or larger), or gastrojejunostomy (14F or larger) tube — follow your healthcare provider's instructions for this method
  • If you miss a Lagevrio dose by more than 10 hours, skip it and take the next dose at the regular time — never take two doses at once
Available strengths 1 strength
6 FDA-listed product records

📊 Molnupiravir across the U.S. market

How Molnupiravir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
14
Manufacturers
1
Brand names
17
FDA-listed product records
2010
First marketed

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Merck Sharp & Dohme LLC18%
Divi's Laboratories Limited12%
A-S Medication Solutions6%
American Pacific Corporation6%
Biophore India Pharmaceuticals Pvt. Ltd6%
Darmerica, Llc6%
Other makers47%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Molnupiravir is used

A general measure of how commonly Molnupiravir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Molnupiravir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

597
Medicaid prescriptions filled (Q1–Q4 2025)
$545,841 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Molnupiravir prescribed? Of the 1,596 medications we measure, Molnupiravir ranks #1,348 by Medicaid prescriptions — more than 16% of them.

Where Molnupiravir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Molnupiravir product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

molnupiravir 200 MG Oral Capsule

597 Medicaid prescriptions (Q1–Q4 2025) 100% of Molnupiravir prescriptions shown $545,841 gross reimbursement (before rebates) ≈ $914 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2587906

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Molnupiravir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 6 listed Molnupiravir NDCs with Medicaid activity.

🔍 Compare Molnupiravir products

A representative set of FDA-listed product records for Molnupiravir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Molnupiravir NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Molnupiravir RxCUI 2587901 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Capsule RxCUI 2587905 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 2587906

Look up RxCUI 2587901 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Lagevrio

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 3 Divi's Laboratories Limited 2 A-S Medication Solutions 1 American Pacific Corporation 1 Biophore India Pharmaceuticals Pvt. Ltd 1 Darmerica, Llc 1 MSN Laboratories Private Limited 1 Optimus Drugs Private Limited 1 Patheon Inc. 1 Patheon Pharmaceuticals Inc. 1 Qingdao Biopeptek Co., Ltd. 1 Shandong Lixin Pharmaceutical Co., Ltd. 1 Shanghai Desano Chemical Pharmaceutical Co., Ltd. 1 SMS Pharmaceuticals Limited 1

RxNorm drug class

Molnupiravir belongs to the Nucleosides and nucleotides excl. reverse transcriptase inhibitors class.

Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 11, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Molnupiravir.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Molnupiravir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
17
Distinct labelers/manufacturers represented
14
Linked representative label
Merck Sharp & Dohme LLC
Linked label effective
Jul 11, 2025
Composite sections available
21
Linked SPL Set ID
1b0da643-ab23-4a0b-a9ec-a434522446d0
Linked SPL Document ID
270e4c5e-9ddd-4c2a-8cb3-0976c35d65fe
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.