FDA-filed SPL labeling · retrieved through openFDA

Nirmatrelvir and Ritonavir

Nirmatrelvir and ritonavir (Paxlovid) is an antiviral combination used to treat mild-to-moderate COVID-19 in adults who are at high risk of becoming seriously ill.

Brand names PaxlovidNorvir
Rx
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 effectiveFeb 19, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2023
FDA-listed product records ⓘ14
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
💊
HelloPharmacist Editorial Team Bottom Line
Paxlovid (nirmatrelvir/ritonavir) is an effective oral antiviral that reduces the risk of hospitalization and death from COVID-19 in high-risk adults — but it must be started within 5 days of symptoms. Its biggest challenge is drug interactions: ritonavir affects how your body processes dozens of other medications, so a full medication review before starting is essential. Work closely with your prescriber and pharmacist to make sure it is safe with everything else you take.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Paxlovid can cause dangerous interactions with many common medications. Ritonavir — one of the two ingredients in Paxlovid — is a strong inhibitor of an enzyme (CYP3A) that the body uses to break down many drugs. When Paxlovid is taken alongside certain other medications, those drugs can build up to levels that cause severe, life-threatening, or even fatal reactions. Before starting Paxlovid, your prescriber must review every medication you are taking. Some drugs will need their dose adjusted, some will need to be temporarily stopped, and some cannot be used with Paxlovid at all. The benefit of Paxlovid in reducing COVID-19 hospitalization and death must always be weighed against the risk of these interactions for each individual patient.

Read the full warning on DailyMed →

📖 Nirmatrelvir and Ritonavir: Patient Information Guide

A plain-language walkthrough of Nirmatrelvir and Ritonavir — 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▾

Paxlovid (nirmatrelvir/ritonavir) is approved for the following use:

  • Treatment of mild-to-moderate COVID-19 in adults who are at high risk of progressing to severe disease, including hospitalization or death
  • Treatment must be initiated as soon as possible after diagnosis and within 5 days of symptom onset
  • Paxlovid is not approved for pre-exposure or post-exposure prevention (prophylaxis) of COVID-19
⚙️How it works▾

Nirmatrelvir targets and blocks a critical enzyme called the main protease (Mpro) that the SARS-CoV-2 virus relies on to replicate. Without this enzyme functioning, the virus cannot make copies of itself, and the infection is brought under control. Ritonavir is included not to fight the virus, but to inhibit the CYP3A enzyme in your liver that would otherwise break nirmatrelvir down too quickly — keeping nirmatrelvir at levels high enough to work.

Ritonavir itself is classified as an HIV-1 protease inhibitor, but it has no meaningful activity against the COVID-19 virus. Its role here is entirely as a pharmacokinetic booster for nirmatrelvir.

💊How it's taken▾

Paxlovid is taken by mouth twice daily for 5 days. The nirmatrelvir tablets and the ritonavir tablet are taken together at the same time each day, with or without food. Treatment should begin as soon as possible after a confirmed COVID-19 diagnosis and within 5 days of when symptoms started.

  • People with moderate kidney impairment may require a dose adjustment — follow your prescriber's guidance
  • Paxlovid is not approved for use in patients under 18 years of age
  • Always follow the exact instructions from your prescriber and on your prescription label
🤒Side effects — in detail▾

The most commonly reported side effects with Paxlovid (occurring in at least 1% of patients and more often than with placebo) are:

  • Dysgeusia — an altered or strange taste in the mouth
  • Diarrhea
  • High blood pressure
  • Muscle aches

Serious reactions to watch for include signs of a severe allergic reaction (trouble breathing, swelling, severe rash or skin blistering) and signs of liver problems (yellowing of skin or eyes, dark urine). Stop Paxlovid and seek medical help immediately if any of these occur. Severe, life-threatening adverse reactions have also been reported due to drug interactions with other medications.

⚠️Warnings & precautions▾
  • Drug interactions (most critical): Ritonavir dramatically raises blood levels of many other medications. This can cause life-threatening or fatal reactions. The most serious cases reported involved calcineurin inhibitors (tacrolimus, cyclosporine) and calcium channel blockers. A full medication review is mandatory before starting Paxlovid.
  • Severe allergic reactions: Anaphylaxis (a life-threatening allergic response), toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported. Discontinue immediately and get emergency care if signs appear.
  • Liver toxicity: Liver enzyme elevations, clinical hepatitis, and jaundice have occurred with ritonavir. Use with extra caution in people with pre-existing liver disease.
  • HIV resistance risk: In people with uncontrolled or undiagnosed HIV infection, ritonavir may cause the virus to become resistant to HIV protease inhibitor medications.
🔀What it interacts with▾

Paxlovid has a large number of significant drug interactions because ritonavir is a strong CYP3A inhibitor and also affects CYP2D6, P-gp, and OATP1B1 enzymes. Key interactions include:

  • Contraindicated combinations (must NOT be used together): Certain heart rhythm drugs (amiodarone, dronedarone, flecainide, quinidine), the sedatives triazolam and oral midazolam, lovastatin and simvastatin (cholesterol drugs), lurasidone, pimozide, sildenafil (when used for pulmonary arterial hypertension), alfuzosin, ranolazine, and others — elevated levels can cause life-threatening reactions
  • Strong CYP3A inducers: Rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort, and others — these lower Paxlovid levels and can make it stop working; they are contraindicated
  • Blood thinners: Warfarin (INR monitoring needed), rivaroxaban (avoid), apixaban (dose-dependent guidance), dabigatran (possible dose reduction needed) — bleeding risk may increase
  • Calcium channel blockers (amlodipine, diltiazem, verapamil, others) — levels increase; monitoring and possible dose reduction needed
  • Hormonal contraceptives: Combined hormonal birth control may be less effective — use an alternative or additional barrier method
  • Immunosuppressants like tacrolimus and cyclosporine — levels can rise dangerously; close monitoring required
  • Other anticancer, antifungal, antipsychotic, and anti-HIV medications — many require dose adjustments or avoidance; always review with a pharmacist or prescriber

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▾
  • People with kidney disease: Paxlovid exposure increases with worsening kidney function; a dose adjustment is needed for moderate impairment and specific guidance applies for severe impairment
  • People with liver disease or hepatitis: Use with caution; ritonavir has been associated with liver toxicity
  • People who are pregnant: Insufficient data exist on nirmatrelvir in pregnancy; untreated COVID-19 also carries fetal risks — discuss with your doctor
  • People who are breastfeeding: Small amounts of both nirmatrelvir and ritonavir pass into breast milk; discuss risks and benefits with your doctor
  • People using combined hormonal contraceptives: Use an alternative or additional barrier method during treatment
  • People with undiagnosed or uncontrolled HIV: Ritonavir may cause HIV resistance to protease inhibitors
  • Children under 18: The correct dose has not been established; Paxlovid is not approved for pediatric patients
  • Older adults: Used safely in people 65 and older, but careful drug interaction review is especially important in this group
  • Anyone with a prior serious allergic reaction to nirmatrelvir or ritonavir must not take Paxlovid
🚑If you take too much▾

There is no specific antidote for a Paxlovid overdose. If too much is taken, treatment focuses on supportive care — monitoring vital signs and watching for symptoms. If you suspect an overdose, contact a poison control center or seek emergency medical care right away.

📡Pharmacodynamics — effects in the body▾

At doses three times higher than the recommended level, nirmatrelvir does not cause any clinically meaningful changes to the heart's electrical activity (specifically, it does not prolong the QTc interval, which is a measure of heart rhythm). This means Paxlovid is not expected to cause dangerous heart rhythm problems at normal therapeutic doses.

🔬Pharmacokinetics — how your body processes it▾

After oral dosing, nirmatrelvir reaches peak blood levels in about 3 hours and ritonavir in about 4 hours. Nirmatrelvir is primarily cleared through the kidneys, while ritonavir is mainly broken down by the liver. Both have a half-life of roughly 6 hours, meaning the body eliminates about half of each drug in that time. Because ritonavir inhibits the breakdown of nirmatrelvir, steady therapeutic levels of nirmatrelvir are reached by the second day of treatment. Nirmatrelvir exposure increases substantially in people with moderate-to-severe kidney impairment, which is why dose adjustments are required in those patients.

📦How to store it▾

Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

📄 Written from Nirmatrelvir and Ritonavir’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 →

176

Supplements & herbs that interact with Nirmatrelvir and Ritonavir

176 supplements and herbal products have documented interactions with Nirmatrelvir and Ritonavir 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 · 6
  • Moderate · 134
  • Minor · 36
Every supplement checked against Nirmatrelvir and Ritonavir — ranked by severity The full interaction hub: 6 major · 134 moderate · 36 minor · every one linked to its full report. Check Nirmatrelvir and Ritonavir 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 Nirmatrelvir and Ritonavir — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Paxlovid and why was it prescribed to me? ▾
Paxlovid is a combination of two medicines — nirmatrelvir and ritonavir — taken together as an oral antiviral treatment. It was prescribed because you have COVID-19 and are considered at high risk for getting seriously ill, which means you could end up in the hospital or worse without treatment. Nirmatrelvir blocks the virus from multiplying, and ritonavir keeps nirmatrelvir working at full strength in your body. It's important to start it quickly — within 5 days of when your symptoms began.
Does it matter if I take Paxlovid with food or on an empty stomach? ▾
No — you can take Paxlovid with or without food, whichever works better for you. What does matter is that you take it around the same time every day and complete all 5 days of treatment, even if you start feeling better sooner. Stopping early could allow the virus to rebound.
Why is it so important to tell my pharmacist about all my other medications? ▾
This is genuinely one of the most important things about Paxlovid. Ritonavir — one of the two ingredients — is a strong inhibitor of liver enzymes that break down many common medications. When those drugs can't be cleared properly, their levels can rise to dangerous or even life-threatening levels. Some medications absolutely cannot be taken with Paxlovid, others need a temporary dose adjustment, and some need extra monitoring. This includes certain heart drugs, blood thinners, cholesterol medications, and many others. Please share every prescription, over-the-counter medication, and supplement you take — including herbal products like St. John's Wort.
What side effects should I expect, and when should I actually call my doctor? ▾
The most common side effects are a strange or metallic taste in your mouth (called dysgeusia) and diarrhea — both are generally manageable and go away after the 5-day course ends. You should call your doctor or get emergency help right away if you notice signs of a serious allergic reaction like hives, difficulty breathing, or swelling of the face or throat, or if you develop a severe, blistering skin rash, or yellowing of the skin or eyes. These more serious reactions are uncommon but need immediate attention.
I'm pregnant — is Paxlovid safe for my baby? ▾
This is a real conversation to have with your doctor, because there are risks on both sides. We don't have enough human data yet on nirmatrelvir specifically during pregnancy to say it's completely risk-free. On the other hand, untreated COVID-19 during pregnancy carries its own serious risks for both you and your baby. Your doctor will weigh those factors together to make the best decision for your situation. Don't stop or avoid treatment without talking to your healthcare provider first.
I'm on birth control pills — do I need to worry about that? ▾
Yes, this is worth knowing. Paxlovid can reduce how well combined hormonal contraceptives (like the pill) work, which could increase your risk of an unintended pregnancy. During your 5-day course of Paxlovid, use an additional or alternative method of contraception, such as a condom or other barrier method. Talk to your pharmacist or doctor if you have questions about what method would work best for you.
Is Nirmatrelvir and Ritonavir available over the counter? ▾
Nirmatrelvir and Ritonavir 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 Nirmatrelvir and Ritonavir first available? ▾
Nirmatrelvir and Ritonavir has been available in the United States since at least 2023, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Nirmatrelvir and Ritonavir’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

📊 Nirmatrelvir and Ritonavir across the U.S. market

How Nirmatrelvir and Ritonavir 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
Manufacturers
1
Brand names
14
FDA-listed product records ⓘ
2023
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Kit (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

📈 How widely Nirmatrelvir and Ritonavir is used

A general measure of how commonly Nirmatrelvir and Ritonavir 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 Nirmatrelvir and Ritonavir 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.

151,858
Medicaid prescriptions filled (Q1–Q4 2025)
$215.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nirmatrelvir and Ritonavir prescribed? Of the 1,597 medications we measure, Nirmatrelvir and Ritonavir ranks #433 by Medicaid prescriptions — more than 73% of them.

Where Nirmatrelvir and Ritonavir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Nirmatrelvir and Ritonavir 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.

Other Nirmatrelvir and Ritonavir products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

151,858 Medicaid prescriptions (Q1–Q4 2025) 100% of Nirmatrelvir and Ritonavir prescriptions shown $215.4M gross reimbursement (before rebates) ≈ $1,419 per prescription (gross)

Summed across the 5 of 9 listed NDC products with Medicaid activity.

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 Nirmatrelvir and Ritonavir, 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 5 of 9 listed Nirmatrelvir and Ritonavir NDCs with Medicaid activity.

🔍 Compare Nirmatrelvir and Ritonavir products

A representative set of FDA-listed product records for Nirmatrelvir and Ritonavir — 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.)

Manufacturer / Labeler Category ⓘ Details
💊Kits
Pfizer Laboratories Div Pfizer Inc × 8 listings NDA View NDC →
Pfizer Laboratories Div Pfizer Inc × 6 listings EMERGENCY USE AUTHORIZATION View NDC →

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Nirmatrelvir and Ritonavir NDCs →

🏷️ Sold under these brand names

Paxlovid Norvir

🏭 Manufacturers & labelers

Pfizer Laboratories Div Pfizer Inc 14

🔬 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 Feb 19, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nirmatrelvir and Ritonavir.
📈
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 Nirmatrelvir and Ritonavir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
14
Distinct labelers/manufacturers represented
1
Linked representative label ⓘ
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Feb 19, 2026
Composite sections available
23
Linked SPL Set ID
8a99d6d6-fd9e-45bb-b1bf-48c7f761232a
Linked SPL Document ID
d20f905e-5c85-4ad4-ab46-871ce4f6669e
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. Pfizer Laboratories Div Pfizer Inc 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.