Darunavir, Cobicistat, Emtricitabine, and Tenofovir
Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide are four antiretroviral ingredients combined in one tablet to treat HIV-1 infection in adults and certain adolescents.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important warning for people who have both HIV and hepatitis B (HBV): If you are infected with both HIV-1 and hepatitis B, stopping Symtuza — or any medication containing emtricitabine or tenofovir — can cause a sudden, severe worsening of your hepatitis B. This can be serious enough to cause liver failure. If you stop Symtuza for any reason, your doctor needs to monitor your liver function closely with blood tests and clinical check-ins for at least several months afterward. In some cases, additional hepatitis B treatment may be needed. Never stop Symtuza without talking to your doctor first.
📖 Darunavir, Cobicistat, Emtricitabine, and Tenofovir: Patient Information Guide
A plain-language walkthrough of Darunavir, Cobicistat, Emtricitabine, and Tenofovir — 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▾
Symtuza — a fixed-dose combination of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide — is approved as a complete HIV-1 treatment regimen.
- Symtuza treats HIV-1 infection in adults and pediatric patients weighing at least 40 kg (about 88 lbs)
- Symtuza can be used in patients who have never taken HIV treatment before (treatment-naive)
- Symtuza can be used in patients already on a stable antiretroviral regimen with HIV-1 RNA below 50 copies/mL for at least 6 months, with no known resistance to darunavir or tenofovir (virologically suppressed)
⚙️How it works▾
Symtuza attacks HIV using two different mechanisms at once. Darunavir is a protease inhibitor — it blocks an enzyme (HIV protease) that the virus needs to cut and assemble new copies of itself. Without this step, new virus particles can't mature and infect more cells. Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) — they block a different enzyme (reverse transcriptase) that HIV uses to convert its genetic material into a form it can insert into your cells. Cobicistat is a booster: it isn't active against HIV itself, but it inhibits an enzyme in the liver (CYP3A) that would otherwise break down darunavir too quickly, keeping darunavir at effective levels in the blood.
Because the combination hits HIV at two different points in its life cycle, it is much harder for the virus to develop resistance than it would be against a single drug.
💊How it's taken▾
Symtuza is taken as one tablet by mouth once daily. It must be taken with food — eating significantly increases absorption of darunavir and cobicistat. If swallowing the whole tablet is difficult, it may be split in two using a tablet-cutter; take both pieces right away after splitting.
- Take at roughly the same time each day to keep drug levels steady
- If you miss a dose, take it as soon as you remember — but if it's almost time for your next dose, skip the missed one; never double up
- Symtuza is not recommended for patients with creatinine clearance below 30 mL/min or with severe liver impairment
🤒Side effects — in detail▾
Most people tolerate Symtuza well; the most common side effects reported in clinical trials were generally mild to moderate:
- Diarrhea
- Rash — usually mild, often appearing in the first four weeks and resolving with continued use
- Nausea
- Fatigue
- Headache
- Abdominal discomfort
- Flatulence
Stop Symtuza and get medical help right away if you develop a severe rash with blistering, peeling, mouth sores, or fever — this can signal a rare but dangerous skin reaction. Also contact your doctor promptly for signs of liver problems (yellowing skin or eyes, dark urine), kidney issues, or unusual muscle weakness.
⚠️Warnings & precautions▾
- Hepatitis B flare on stopping: In patients co-infected with HIV and hepatitis B, stopping Symtuza can trigger a sudden, severe hepatitis B worsening that may lead to liver failure. Never stop without talking to your doctor first.
- Liver toxicity: Drug-induced liver injury, including some fatalities, has been reported with the darunavir component. Regular liver monitoring is essential, especially if you already have liver disease.
- Severe skin reactions: Rare but potentially life-threatening reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred. Discontinue Symtuza immediately if a severe rash develops.
- Kidney concerns: Symtuza is not recommended if creatinine clearance falls below 30 mL/min. The cobicistat component raises measured creatinine without actually reducing kidney function — your doctor will interpret this carefully.
- Lactic acidosis: A rare but serious buildup of lactic acid in the blood has been linked to the NRTI components. Symptoms include unusual muscle weakness, trouble breathing, and stomach pain.
- Drug interactions: Symtuza has many significant interactions. Always have every prescriber and pharmacist review your full medication list before starting or adding any drug.
- Immune reconstitution syndrome: When HIV treatment starts working, the recovering immune system can overreact to hidden infections, causing inflammation — notify your doctor about any new symptoms after starting therapy.
- Blood sugar and fat changes: New or worsened diabetes and changes in body fat distribution have been reported with HIV protease inhibitors.
🔀What it interacts with▾
Symtuza affects and is affected by many medications — always review your full medication list with your pharmacist or doctor before starting anything new.
- Contraindicated drugs (never combine): rifampin, carbamazepine, phenobarbital, phenytoin, St. John's wort, lovastatin, simvastatin, lurasidone, pimozide, dronedarone, ivabradine, ranolazine, alfuzosin, oral midazolam, triazolam, sildenafil (for pulmonary arterial hypertension), elbasvir/grazoprevir, and lomitapide — risk of life-threatening toxicity or complete loss of HIV control
- Blood thinners (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban): Symtuza can raise their levels, increasing bleeding risk; dose adjustments and close monitoring are needed
- Certain antibiotics (clarithromycin, erythromycin): levels of both the antibiotic and Symtuza components can rise; consider alternatives
- Antifungals (itraconazole, ketoconazole, isavuconazole): mutual increase in drug levels; monitor closely
- Antidepressants (tricyclics, SSRIs, trazodone): levels may increase; start at the lowest feasible dose and monitor response
- Cancer drugs (vincristine, vinblastine, dasatinib, nilotinib): levels may rise significantly; dose reductions or temporary suspension of Symtuza may be needed
- NSAIDs and nephrotoxic drugs: Combining with drugs that stress the kidneys can increase the risk of kidney damage, since emtricitabine and tenofovir are cleared by the kidneys
- Rifabutin: Co-use is not recommended; if necessary, a reduced every-other-day rifabutin dose is required with close monitoring
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▾
- Get tested for hepatitis B before starting — stopping Symtuza can cause dangerous HBV flare-ups in co-infected patients
- Tell your doctor about any kidney disease — Symtuza is not recommended if creatinine clearance is below 30 mL/min
- Tell your doctor about liver disease — Symtuza is not recommended in severe liver impairment (Child-Pugh Class C)
- Do not use during pregnancy — darunavir and cobicistat levels drop substantially in the second and third trimesters; switch to an alternative regimen if you become pregnant
- Do not breastfeed while taking Symtuza
- Not approved for use in pediatric patients weighing less than 40 kg
- Tell your doctor if you have a sulfa (sulfonamide) allergy — darunavir contains a sulfonamide group; watch for rash
- Tell your doctor if you have hemophilia — increased bleeding has been reported with HIV protease inhibitors
🚑If you take too much▾
There is no specific antidote for a Symtuza overdose. If too much is taken, treatment is supportive — monitoring vital signs and overall clinical status. Darunavir and cobicistat are highly protein-bound and are unlikely to be removed by dialysis; hemodialysis can remove a meaningful portion of the emtricitabine and tenofovir components. If you suspect an overdose, contact a poison control center or seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
Cobicistat raises measured serum creatinine (a standard kidney marker) by blocking the kidney's secretion of creatinine — but studies confirm it does not actually reduce true kidney filtration (glomerular filtration rate). This effect appears within about two weeks of starting Symtuza and reverses after stopping. At the doses used in Symtuza, cobicistat is unlikely to cause clinically meaningful changes in heart rhythm (PR or QT interval prolongation), and darunavir and tenofovir alafenamide also showed no significant QT effects in dedicated cardiac studies.
🔬Pharmacokinetics — how your body processes it▾
All four components of Symtuza are absorbed when taken by mouth, reaching peak blood levels within about 30 minutes (tenofovir alafenamide) to 3 hours (darunavir and cobicistat). Taking Symtuza with a meal — especially a high-fat meal — substantially increases absorption of darunavir and cobicistat, which is why food is required. Darunavir and cobicistat are heavily bound to blood proteins and are metabolized mainly by liver enzymes (CYP3A), with most of each drug eliminated in the feces. Emtricitabine is cleared primarily by the kidneys (about 70% in urine), and tenofovir is also renally eliminated, making kidney function an important consideration for both dosing and drug interactions.
📦How to store it▾
Store at 20°C–25°C (between 68°F–77°F); with excursions permitted to 15°C–30°C (59°F–86°F). protect from moisture.
📄 Written from Darunavir, Cobicistat, Emtricitabine, and Tenofovir’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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir
188 supplements and herbal products have documented interactions with Darunavir, Cobicistat, Emtricitabine, and Tenofovir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 144
- Minor · 37
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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Symtuza do — does it cure HIV? ▾
Does it matter when I take it, or whether I eat first? ▾
What side effects should I actually expect, and what do I need to call the doctor about? ▾
I take a lot of other medications — is that going to be a problem? ▾
I also have hepatitis B — do I need to be extra careful? ▾
Can I take Symtuza if I'm pregnant or planning to get pregnant? ▾
Is Darunavir, Cobicistat, Emtricitabine, and Tenofovir available over the counter? ▾
When was Darunavir, Cobicistat, Emtricitabine, and Tenofovir first available? ▾
Who makes Darunavir, Cobicistat, Emtricitabine, and Tenofovir? ▾
💬 Answers drafted from Darunavir, Cobicistat, Emtricitabine, and Tenofovir’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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir comes
Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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
- Symtuza is used as a complete once-daily oral regimen for HIV-1 infection in adults and pediatric patients weighing at least 40 kg
- Symtuza is approved for HIV-treatment-naive patients (those who have never taken antiretrovirals before)
- Symtuza is approved for patients who are already virologically suppressed on a stable antiretroviral regimen for at least 6 months with no known resistance to darunavir or tenofovir
- Symtuza: take one tablet by mouth once daily with food — food is required for proper absorption
- Symtuza: if you cannot swallow the whole tablet, split it with a tablet-cutter and take both pieces immediately
- Symtuza: not recommended in patients with creatinine clearance below 30 mL/min or with severe liver impairment
- Symtuza: not recommended during pregnancy — if you become pregnant while taking it, talk to your doctor about switching to an alternative regimen
📊 Darunavir, Cobicistat, Emtricitabine, and Tenofovir across the U.S. market
How Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Darunavir, Cobicistat, Emtricitabine, and Tenofovir is used
A general measure of how commonly Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir prescribed? Of the 1,597 medications we measure, Darunavir, Cobicistat, Emtricitabine, and Tenofovir ranks #619 by Medicaid prescriptions — more than 61% of them.
Utilization by Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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.
cobicistat 150 MG / darunavir 800 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2049671
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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir, 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 3 listed Darunavir, Cobicistat, Emtricitabine, and Tenofovir NDCs with Medicaid activity.
🔍 Compare Darunavir, Cobicistat, Emtricitabine, and Tenofovir products
A representative set of FDA-listed product records for Darunavir, Cobicistat, Emtricitabine, and Tenofovir — 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 | ||||
| DARUNAVIR 800 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 150; 800; 200; 10 mg/1; mg/1; mg/1; mg | Oral | Janssen Products LP × 2 listings | NDA | View NDC → |
| DARUNAVIR 800 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir — 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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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 Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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.
📦 Supply & shortage status
Whether Darunavir, Cobicistat, Emtricitabine, and Tenofovir 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
Darunavir, Cobicistat, Emtricitabine, and Tenofovir belongs to the Cytochrome P450 3A 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 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. Janssen Products LP 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.