Doravirine
Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) antiviral used in combination with other HIV medicines to treat HIV-1 infection in adults and eligible pediatric patients.
🧬 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 2 clinical label sets 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 →
📖 Doravirine: Patient Information Guide
A plain-language walkthrough of Doravirine — 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▾
Doravirine is an antiviral ingredient used as part of combination HIV treatment. It is always taken alongside other HIV medicines — never alone.
- Pifeltro is approved to treat HIV-1 infection in adults and in pediatric patients weighing at least 35 kg (about 77 lbs) who have never taken antiretroviral therapy before.
- Pifeltro is also approved for people already on a stable HIV regimen who are virologically suppressed — meaning their HIV is currently undetectable — and wish to switch, provided they have no history of treatment failure and no known resistance to doravirine.
⚙️How it works▾
Doravirine belongs to a class of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). HIV needs an enzyme called reverse transcriptase to copy its genetic material inside human cells — a step that's essential for the virus to multiply. Doravirine binds to and blocks this enzyme, interfering with viral replication and helping to keep HIV levels in the blood as low as possible.
If HIV is not fully suppressed, the virus can develop mutations (genetic changes) that make it resistant to doravirine. That's why it must be taken consistently and as part of a full combination regimen — skipping doses or using it alone increases the chance of resistance developing.
💊How it's taken▾
Pifeltro tablets are taken by mouth once daily, with or without food — food does not meaningfully affect how the drug is absorbed. There is one important exception: if you are also taking rifabutin (an antibiotic used for tuberculosis), the Pifeltro dose is increased to one tablet twice daily, roughly 12 hours apart, for as long as you take rifabutin.
- Take Pifeltro at the same time each day to keep drug levels steady.
- Pifeltro is only for patients weighing at least 35 kg; safety and dosing for lighter pediatric patients have not been established.
- Always follow your prescriber's instructions exactly — do not adjust your dose on your own.
🤒Side effects — in detail▾
The most commonly reported side effects with Pifeltro-based regimens include:
- Nausea
- Dizziness
- Headache
- Fatigue or tiredness
- Diarrhea
- Abdominal (stomach) pain
- Abnormal or vivid dreams
Most of these are mild. However, if you develop a severe or spreading rash, rash with fever or swollen glands, or any rash involving the mouth or eyes, stop Pifeltro and get medical attention immediately — these can be signs of a serious, potentially life-threatening skin reaction.
⚠️Warnings & precautions▾
- Serious skin reactions: Rarely, doravirine has been associated with Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and DRESS syndrome — all severe, sometimes life-threatening skin and immune reactions. Stop the medication and seek care immediately if a painful rash, blistering, or rash with fever and organ symptoms develops.
- Immune reconstitution syndrome: When your immune system recovers after starting HIV treatment, it can mount an inflammatory response against hidden infections (such as tuberculosis, cytomegalovirus, or Pneumocystis pneumonia) or trigger autoimmune conditions. Report any new or unusual symptoms to your doctor, even months after starting therapy.
- Drug interaction risk: Taking Pifeltro with certain medications can cause doravirine levels to fall too low, making the drug ineffective and potentially allowing HIV resistance to develop. Always review all medications with your prescriber before starting or changing your regimen.
🔀What it interacts with▾
Doravirine is broken down primarily by a liver enzyme called CYP3A. Drugs that speed up or slow down this enzyme can significantly affect doravirine blood levels.
- Contraindicated (must not be combined): carbamazepine, oxcarbazepine, phenobarbital, phenytoin (seizure medicines); enzalutamide (prostate cancer); rifampin, rifapentine (TB medicines); mitotane (cancer drug); St. John's wort herbal supplement — all drastically lower doravirine levels.
- Dose adjustment required: Rifabutin (TB antibiotic) lowers doravirine levels; the Pifeltro dose is doubled to twice daily while taking it.
- Not recommended together: The HIV drugs efavirenz, etravirine, and nevirapine — they lower doravirine levels.
- If stopping a contraindicated drug: Wait at least 4 weeks before starting Pifeltro to allow the interacting drug to clear your system.
- No significant interaction found with: dolutegravir, lamivudine, tenofovir disoproxil fumarate, ritonavir, methadone, antacids, pantoprazole, and some hepatitis C antivirals — but always tell your prescriber everything you take.
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▾
- Drug allergies or reactions: Tell your doctor if you have had a serious reaction to any HIV medicine or other drug before.
- Children and weight: Pifeltro is not recommended for patients weighing less than 35 kg; safety has not been established in that group.
- Pregnancy: If you are pregnant or could become pregnant, discuss this with your doctor. There is no adequate human data on the risk to pregnancy outcomes. A pregnancy registry (Antiretroviral Pregnancy Registry, 1-800-258-4263) tracks outcomes in people who take Pifeltro during pregnancy.
- Breastfeeding: Do not breastfeed while taking Pifeltro. HIV can be passed through breast milk, and the effects of doravirine on a nursing infant are not known.
- Severe liver disease: Pifeltro has not been studied in people with severe hepatic impairment (Child-Pugh Class C); use with caution and discuss with your doctor.
- End-stage kidney disease or dialysis: Pifeltro has not been adequately studied in these patients; talk to your doctor before use.
- Older adults: Use caution in older patients, as age-related changes in kidney, liver, or heart function and a higher chance of other medications may affect Pifeltro therapy.
- All other medications and supplements: Several common drugs and supplements are incompatible with Pifeltro — bring a full list of everything you take to every appointment.
📡Pharmacodynamics — effects in the body▾
In clinical testing, doravirine did not prolong the QT interval (an electrical measurement of heart rhythm) to any meaningful degree, even at doses roughly four times higher than the recommended amount. No clear relationship was found between the dose of doravirine and how well it worked in people with HIV who had not previously been treated, when studied across a range of doses in combination with other antiretrovirals.
🔬Pharmacokinetics — how your body processes it▾
After you take Pifeltro by mouth, doravirine is about 64% absorbed into the bloodstream and reaches peak levels in roughly 2 hours. Food does not meaningfully change how much is absorbed, so it can be taken with or without a meal. Doravirine is primarily broken down by the liver enzyme CYP3A and has a half-life (the time for half the drug to leave the body) of about 15 hours, which is why once-daily dosing works. The drug is mostly eliminated through metabolism rather than being excreted unchanged in the urine.
📦How to store it▾
Store PIFELTRO in the original bottle. protect from moisture. Store PIFELTRO at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Doravirine’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 →
Supplements & herbs that interact with Doravirine
138 supplements and herbal products have documented interactions with Doravirine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 94
- Minor · 41
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 Doravirine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Pifeltro treat, and will it cure my HIV? ▾
Can I take Pifeltro with food, or does it have to be on an empty stomach? ▾
What side effects should I expect, and what would be a reason to call my doctor right away? ▾
Are there any common medicines or supplements I absolutely can't take with Pifeltro? ▾
Is Pifeltro safe to take if I'm pregnant or trying to get pregnant? ▾
Can I breastfeed my baby while taking Pifeltro? ▾
Is Doravirine available over the counter? ▾
When was Doravirine first available? ▾
Who makes Doravirine? ▾
💬 Answers drafted from Doravirine’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 Doravirine comes
Doravirine 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.
Tablet
How this form is used
- Pifeltro is used in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history
- Pifeltro is used to replace a current antiretroviral regimen in adults and eligible pediatric patients who are virologically suppressed (HIV undetectable) on a stable regimen with no history of treatment failure and no known resistance to doravirine
- Pifeltro is taken once daily by mouth, with or without food
- Pifeltro should not be used in patients weighing less than 35 kg
- If Pifeltro is taken with rifabutin, the dose should be increased to one tablet twice daily, approximately 12 hours apart, for the duration of rifabutin use
- Always take Pifeltro as directed by your prescriber and in combination with other prescribed HIV medications
📊 Doravirine across the U.S. market
How Doravirine 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.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Doravirine is used
A general measure of how commonly Doravirine 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 Doravirine 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.
How commonly is Doravirine prescribed? Of the 1,597 medications we measure, Doravirine ranks #901 by Medicaid prescriptions — more than 44% of them.
Utilization by Doravirine 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 Doravirine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 10 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 Doravirine, 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 10 listed Doravirine NDCs with Medicaid activity.
🔍 Compare Doravirine products
A representative set of FDA-listed product records for Doravirine — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | A-S Medication Solutions × 3 listings | NDA | View NDC → |
| 100 mg | Oral | Merck Sharp & Dohme LLC × 4 listings | NDA | View NDC → |
| 100 mg | — | MSD International GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | F.i.s. Fabbrica Italiana Sintetici S.p.a. × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Labs Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 20 kg/100 kg | — | Hovione FarmaCiencia SA | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | Matrix Pharmacorp Private Limited | BULK INGREDIENT | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Doravirine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Doravirine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Doravirine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Doravirine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 2055755 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 2055759In current FDA listingsClinical drug / strength (SCD) 100 MGRxCUI 2055760
Look up RxCUI 2055755 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.
📦 Supply & shortage status
Whether Doravirine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Doravirine belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets 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.