Prescription medicine
Cobicistat, darunavir, emtricitabine and tenofovir alafenamide Brand names: Symtuza
Cobicistat, darunavir, emtricitabine and tenofovir alafenamide (Symtuza) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $152.87 per Symtuza 800-150-200-10 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the cobicistat, darunavir, emtricitabine and tenofovir alafenamide FDA label on DailyMed (effective April 17, 2026, Janssen Products LP); the NDA 210455 record on Drugs@FDA; every cobicistat, darunavir, emtricitabine and tenofovir alafenamide label on DailyMed.
Highlights of the record
FDA label of April 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B.
Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of SYMTUZA. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue SYMTUZA. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of SYMTUZA. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageINDICATIONS AND USAGE SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: who have no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associa
Forms and strengths
- 800 mg / 150 mg / 200 mg / 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 17, 2018 Symtuza, Janssen Prods; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 19, 2038 Symtuza tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $152.87 per tablet Symtuza 800-150-200-10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,719 through July 30, 2026
What is cobicistat, darunavir, emtricitabine and tenofovir alafenamide used for?
From the label: indications and usageINDICATIONS AND USAGE SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: who have no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. […]
Conditions named in the indications of cobicistat, darunavir, emtricitabine and tenofovir alafenamide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cytochrome P450 3A Inhibitor, Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Protease Inhibitor.
Source: FDA drug label (Symtuza), Janssen Products LP, effective April 17, 2026 (SPL set 85a17d00-6b7c-41ea-a6b3-5ad924820dab), via openFDA; the full label on DailyMed
What does the patient leaflet for cobicistat, darunavir, emtricitabine and tenofovir alafenamide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SYMTUZA?SYMTUZA can cause serious side effects, including: Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before starting treatment with SYMTUZA. If you have HBV infection and take SYMTUZA, your HBV may get worse (flare-up) if you stop taking SYMTUZA. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not stop taking SYMTUZA without first talking to your healthcare provider. Do not run out of SYMTUZA. Refill your prescription or talk to your healthcare provider before your SYMTUZA is all gone. If you stop taking SYMTUZA, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking SYMTUZA. Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with SYMTUZA. Liver problems can also happen during treatment with SYMTUZA in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with SYMTUZA. Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, vomiting, or stomach-area pain. SYMTUZA may cause severe or life-threatening skin reactions or rash. […]
From the patient leaflet: How should I store SYMTUZA?Store SYMTUZA tablets at room temperature between 68°F to 77°F (20°C to 25°C). The SYMTUZA bottle contains a desiccant and has a child-resistant cap. Keep the SYMTUZA container tightly closed with the desiccant inside of it to protect SYMTUZA from moisture. Keep SYMTUZA out of reach of children.
Source: FDA drug label (Symtuza), Janssen Products LP, effective April 17, 2026 (SPL set 85a17d00-6b7c-41ea-a6b3-5ad924820dab), via openFDA; the full label on DailyMed
Is there a generic for cobicistat, darunavir, emtricitabine and tenofovir alafenamide (Symtuza)?
No generic cobicistat, darunavir, emtricitabine and tenofovir alafenamide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Symtuza tablets: the compound patent runs to August 15, 2032, and the last listed entry to July 19, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cobicistat, darunavir, emtricitabine and tenofovir alafenamide (Symtuza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $152.87 per Symtuza 800-150-200-10 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Symtuza 800-150-200-10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Symtuza 800-150-200-10 mg tablet | Brand | $152.87 per tablet | $4,586.02 | +0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the cobicistat, darunavir, emtricitabine and tenofovir alafenamide label say about other medicines?
The cobicistat, darunavir, emtricitabine and tenofovir alafenamide label names 120 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.6) ]. |
| Alfuzosin | contraindications | Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g. … |
| Amiodarone | drug interactions | Concomitant Drug Class/Drug Name Examples: Other antiarrhythmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; Effect on Concentration: ↑ antiarrhythmics; Clinical Comment: Clinical monitoring is recommended upon co-administration with antiarrhythmics. |
| Amitriptyline | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g., amitriptyline, desipramine, imipramine, nortriptyline; Effect on Concentration: ↑ TCAs |
| Amlodipine | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g., amlodipine, diltiazem, felodipine, nifedipine, verapamil; Effect on Concentration: ↑ calcium channel blockers; Clinical Comment: Clinical monitoring is recommended for co-administration with calcium channel blockers metabolized by CYP3A. |
| Apixaban | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticoagulants: Direct Oral Anticoagulants (DOACs) apixaban; Effect on Concentration: ↑ apixaban; Clinical Comment: Due to potentially increased bleeding risk, dosing recommendations for co-administration of apixaban with SYMTUZA depend on the apixaban dose. … |
| Artemether and lumefantrine | drug interactions | Antimalarial: artemether/lumefantrine artemether: effect unknown lumefantrine: effect unknown Monitor for a potential decrease of antimalarial efficacy or potential QT prolongation. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ fluvastatin ↑ pravastatin ↑ rosuvastatin pitavastatin: effect unknown; … |
| Avanafil | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., avanafil, sildenafil, tadalafil, vardenafil; Effect on Concentration: Co-administration with avanafil is not recommended because a safe and effective avanafil dosage regimen has not been established. … |
| Beclomethasone | drug interactions | … can increase the risk for Cushing's syndrome and adrenal suppression. Alternative corticosteroids including beclomethasone, prednisone, and prednisolone (for which PK and/or PD are less affected by strong CYP3A inhibitors relative to other steroids) should be considered, particularly for long term use. |
| Betamethasone | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids primarily metabolized by CYP3A: e.g., betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration: ↑ corticosteroids; … |
| Bosentan | drug interactions | Concomitant Drug Class/Drug Name Examples: Endothelin receptor antagonists: bosentan; Effect on Concentration: ↓ darunavir ↓ cobicistat ↑ bosentan; Clinical Comment: Initiation of bosentan in patients taking SYMTUZA: In patients who have been receiving SYMTUZA for at least 10 days, start bosentan at 62.5 mg once daily … |
| Budesonide | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids primarily metabolized by CYP3A: e.g., betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration: ↑ corticosteroids; … |
| Buprenorphine | drug interactions | A dose adjustment for buprenorphine, buprenorphine/naloxone, or methadone may be needed. Monitor clinical signs and symptoms. |
Every other medicine the cobicistat, darunavir, emtricitabine and tenofovir alafenamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine and naloxone | drug interactions | A dose adjustment for buprenorphine, buprenorphine/naloxone, or methadone may be needed. Monitor clinical signs and symptoms. |
| Buspirone | drug interactions | Concomitant Drug Class/Drug Name Examples: metabolized by CYP3A: e.g., buspirone, diazepam, estazolam, zolpidem; Effect on Concentration: ↑ sedatives/hypnotics; … |
| Carbamazepine | contraindications | Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial … |
| Carvedilol | drug interactions | Concomitant Drug Class/Drug Name Examples: β-Blockers: e.g., carvedilol, metoprolol, timolol; Effect on Concentration: ↑ beta-blockers; … |
| Ciclesonide | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids primarily metabolized by CYP3A: e.g., betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; … |
| Cidofovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name Examples: Antibacterials: clarithromycin, erythromycin, telithromycin; Effect on Concentration: ↑ darunavir ↑ cobicistat ↑ antibacterial; … |
| Clonazepam | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticonvulsants that are metabolized by CYP3A: e.g., clonazepam; Effect on Concentration: ↑ clonazepam; … |
| Clopidogrel | drug interactions | Concomitant Drug Class/Drug Name Examples: clopidogrel; Effect on Concentration: ↓ clopidogrel active metabolite; Clinical Comment: Co-administration of SYMTUZA and clopidogrel is not recommended due … |
| Colchicine | contraindications | Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial … |
| Cyclosporine | drug interactions | Concomitant Drug Class/Drug Name Examples: Immunosuppressants: cyclosporine, sirolimus, tacrolimus; Effect on Concentration: ↑ immunosuppressants; … |
| Dabigatran | drug interactions | Concomitant Drug Class/Drug Name Examples: dabigatran etexilate edoxaban; Effect on Concentration: ↑ dabigatran ↑ edoxaban; … |
| Dasatinib | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticancer agents: dasatinib, nilotinib; Effect on Concentration: ↑ anticancer agent; … |
| Desipramine | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g., amitriptyline, desipramine, imipramine, nortriptyline; Effect on Concentration: ↑ TCAs |
| Dexamethasone | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids: dexamethasone (systemic); Effect on Concentration: ↓ darunavir ↓ cobicistat; … |
| Diazepam | drug interactions | Concomitant Drug Class/Drug Name Examples: metabolized by CYP3A: e.g., buspirone, diazepam, estazolam, zolpidem; Effect on Concentration: ↑ sedatives/hypnotics; … |
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name Examples: digoxin; Effect on Concentration: ↑ digoxin; Clinical Comment: When co-administering with digoxin, titrate the digoxin dose and monitor digoxin … |
| Dihydroergotamine | contraindications | … Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine Herbal product: |
| Diltiazem | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g., amlodipine, diltiazem, felodipine, nifedipine, verapamil; Effect on Concentration: ↑ calcium channel blockers; … |
| Disopyramide | drug interactions | Concomitant Drug Class/Drug Name Examples: Other antiarrhythmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Dronedarone | contraindications | … Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine Herbal … |
| Drospirenone | drug interactions | … drosperinone ↓ ethinylestradiol; Clinical Comment: For co-administration with drospirenone, clinical monitoring is recommended due to the potential for hyperkalemia. |
| Edoxaban | drug interactions | Concomitant Drug Class/Drug Name Examples: dabigatran etexilate edoxaban; Effect on Concentration: ↑ dabigatran ↑ edoxaban; … |
| Elbasvir and grazoprevir | contraindications | St. John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 … |
| Ergotamine | contraindications | … dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine Herbal product: |
| Erythromycin | drug interactions | Concomitant Drug Class/Drug Name Examples: Antibacterials: clarithromycin, erythromycin, telithromycin; Effect on Concentration: ↑ darunavir ↑ cobicistat ↑ antibacterial; … |
| Eslicarbazepine | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticonvulsants with CYP3A induction effects that are NOT contraindicated: e.g., eslicarbazepine, oxcarbazepine; … |
| Estazolam | drug interactions | Concomitant Drug Class/Drug Name Examples: metabolized by CYP3A: e.g., buspirone, diazepam, estazolam, zolpidem; Effect on Concentration: ↑ sedatives/hypnotics; … |
| Everolimus | drug interactions | Immunosuppressant /neoplastic: everolimus Co-administration of everolimus and SYMTUZA is not recommended. irinotecan Discontinue SYMTUZA at least 1 week prior to starting irinotecan therapy. |
| Felodipine | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g., amlodipine, diltiazem, felodipine, nifedipine, verapamil; Effect on Concentration: ↑ calcium channel blockers; … |
| Fentanyl | drug interactions | Concomitant Drug Class/Drug Name Examples: Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone; Effect on Concentration: ↑ fentanyl ↑ oxycodone; … |
| Fesoterodine | drug interactions | Concomitant Drug Class/Drug Name Examples: fesoterodine; Effect on Concentration: ↑ fesoterodine; Clinical Comment: When fesoterodine is co-administered with SYMTUZA, do not exceed a fesoterodine … |
| Flecainide | drug interactions | Concomitant Drug Class/Drug Name Examples: Other antiarrhythmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Fluticasone | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids primarily metabolized by CYP3A: e.g., betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; … |
| Fluvastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ fluvastatin ↑ pravastatin ↑ rosuvastatin … |
| Ganciclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Gentamicin | drug interactions | … ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.6) ]. |
| Glecaprevir and pibrentasvir | drug interactions | Hepatitis C virus (HCV): Direct-Acting Antivirals: elbasvir/grazoprevir ↑ elbasvir/grazoprevir Co-administration is contraindicated due to potential for the increased risk of alanine transaminase … |
| Imipramine | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g., amitriptyline, desipramine, imipramine, nortriptyline; Effect on Concentration: ↑ TCAs |
| Irinotecan | drug interactions | Immunosuppressant /neoplastic: everolimus Co-administration of everolimus and SYMTUZA is not recommended. irinotecan Discontinue SYMTUZA at least 1 week prior to starting irinotecan therapy. |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name Examples: Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole; Effect on Concentration: ↑ darunavir ↑ cobicistat; … |
| Ivabradine | contraindications | … Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine Herbal product: |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name Examples: Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole; Effect on Concentration: ↑ darunavir ↑ cobicistat; … |
| Lidocaine | drug interactions | Concomitant Drug Class/Drug Name Examples: Other antiarrhythmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Lomitapide | contraindications | St. John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 … |
| Lovastatin | contraindications | St. John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 … |
| Lurasidone | contraindications | … and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine … |
| Methadone | drug interactions | A dose adjustment for buprenorphine, buprenorphine/naloxone, or methadone may be needed. Monitor clinical signs and symptoms. |
| Methylergonovine | contraindications | … ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine Herbal product: |
| Methylprednisolone | drug interactions | … metabolized by CYP3A: e.g., betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration: ↑ corticosteroids; … |
| Metoprolol | drug interactions | Concomitant Drug Class/Drug Name Examples: β-Blockers: e.g., carvedilol, metoprolol, timolol; Effect on Concentration: ↑ beta-blockers; … |
| Mexiletine | drug interactions | Concomitant Drug Class/Drug Name Examples: Other antiarrhythmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Midazolam | contraindications | … pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam SYMTUZA is contraindicated to be co-administered with certain drugs for which altered plasma … |
| Mometasone | drug interactions | … betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration: ↑ corticosteroids; … |
| Naloxegol | contraindications | … modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension Sedatives/hypnotics: orally … |
| Nifedipine | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g., amlodipine, diltiazem, felodipine, nifedipine, verapamil; Effect on Concentration: ↑ calcium channel blockers; … |
| Nilotinib | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticancer agents: dasatinib, nilotinib; Effect on Concentration: ↑ anticancer agent; … |
| Nortriptyline | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g., amitriptyline, desipramine, imipramine, nortriptyline; Effect on Concentration: ↑ TCAs |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticonvulsants with CYP3A induction effects that are NOT contraindicated: e.g., eslicarbazepine, oxcarbazepine; … |
| Oxycodone | drug interactions | Concomitant Drug Class/Drug Name Examples: Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone; Effect on Concentration: ↑ fentanyl ↑ oxycodone; … |
| Paroxetine | drug interactions | Concomitant Drug Class/Drug Name Examples: Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs): e.g., paroxetine, sertraline; Effect on Concentration: SSRIs: effects unknown; … |
| Perphenazine | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., perphenazine, risperidone, thioridazine; Effect on Concentration: ↑ antipsychotic; … |
| Phenobarbital | contraindications | Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial … |
| Phenytoin | contraindications | Alpha 1-adrenoreceptor antagonist: alfuzosin Anticonvulsants: carbamazepine, phenobarbital, phenytoin Anti-gout: colchicine, in patients with renal and/or hepatic impairment Antimycobacterial … |
| Pimozide | contraindications | … impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine … |
| Pitavastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ fluvastatin ↑ pravastatin ↑ rosuvastatin … |
| Posaconazole | drug interactions | Concomitant Drug Class/Drug Name Examples: Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole; Effect on Concentration: ↑ darunavir ↑ cobicistat; … |
| Prasugrel | drug interactions | Concomitant Drug Class/Drug Name Examples: prasugrel; Effect on Concentration: ↔ prasugrel active metabolite; Clinical Comment: No dose adjustment is needed when prasugrel is co-administered with … |
| Pravastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ fluvastatin ↑ pravastatin ↑ rosuvastatin … |
| Prednisolone | drug interactions | … CYP3A: e.g., betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration: ↑ corticosteroids; … |
| Prednisone | drug interactions | … suppression. Alternative corticosteroids including beclomethasone, prednisone, and prednisolone (for which PK and/or PD are less affected by strong CYP3A inhibitors relative to other steroids) should … |
| Propafenone | drug interactions | Concomitant Drug Class/Drug Name Examples: Other antiarrhythmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Quetiapine | drug interactions | Concomitant Drug Class/Drug Name Examples: quetiapine; Effect on Concentration: ↑ quetiapine; Clinical Comment: Initiation of SYMTUZA in patients taking quetiapine: Consider alternative … |
| Quinidine | drug interactions | … disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; Effect on Concentration: ↑ antiarrhythmics; … |
| Ranolazine | contraindications | … Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine Herbal product: |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name Examples: rifabutin; Effect on Concentration: ↑ rifabutin ↓ TAF cobicistat: effects unknown darunavir: effects unknown; … |
| Rifampin | contraindications | … in patients with renal and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g. … |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name Examples: rifapentine; Effect on Concentration: ↓ darunavir ↓ TAF; Clinical Comment: Co-administration with rifapentine is not recommended. |
| Risperidone | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., perphenazine, risperidone, thioridazine; Effect on Concentration: ↑ antipsychotic; … |
| Ritonavir | drug interactions | Drug interaction trials have been conducted with darunavir co-administered with ritonavir or cobicistat or with emtricitabine and tenofovir prodrugs. |
| Rivaroxaban | drug interactions | Concomitant Drug Class/Drug Name Examples: rivaroxaban; Effect on Concentration: ↑ rivaroxaban; Clinical Comment: Co-administration of rivaroxaban with SYMTUZA is not recommended because it may lead … |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ fluvastatin ↑ pravastatin ↑ rosuvastatin … |
| Salmeterol | drug interactions | Concomitant Drug Class/Drug Name Examples: salmeterol; Effect on Concentration: ↑ salmeterol; Clinical Comment: Co-administration with salmeterol is not recommended and may result in increased risk … |
| Sertraline | drug interactions | Concomitant Drug Class/Drug Name Examples: Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs): e.g., paroxetine, sertraline; Effect on Concentration: SSRIs: effects unknown; … |
| Sildenafil | contraindications | … lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam … |
| Simvastatin | contraindications | St. John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 … |
| Sirolimus | drug interactions | Concomitant Drug Class/Drug Name Examples: Immunosuppressants: cyclosporine, sirolimus, tacrolimus; Effect on Concentration: ↑ immunosuppressants; … |
| Solifenacin | drug interactions | Concomitant Drug Class/Drug Name Examples: solifenacin; Effect on Concentration: ↑ solifenacin; Clinical Comment: When solifenacin is co-administered with SYMTUZA, do not exceed a solifenacin dose of … |
| Tacrolimus | drug interactions | Concomitant Drug Class/Drug Name Examples: Immunosuppressants: cyclosporine, sirolimus, tacrolimus; Effect on Concentration: ↑ immunosuppressants; … |
| Tadalafil | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., avanafil, sildenafil, tadalafil, vardenafil; Effect on Concentration: Co-administration with avanafil is not recommended because a safe and effective … |
| Thioridazine | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., perphenazine, risperidone, thioridazine; Effect on Concentration: ↑ antipsychotic; … |
| Ticagrelor | drug interactions | Concomitant Drug Class/Drug Name Examples: Platelet aggregation inhibitor: ticagrelor; Effect on Concentration: ↑ticagrelor; … |
| Timolol | drug interactions | Concomitant Drug Class/Drug Name Examples: β-Blockers: e.g., carvedilol, metoprolol, timolol; Effect on Concentration: ↑ beta-blockers; … |
| Tramadol | drug interactions | Concomitant Drug Class/Drug Name Examples: tramadol; Effect on Concentration: ↑ tramadol; Clinical Comment: A dose decrease may be needed for tramadol with concomitant use. |
| Trazodone | drug interactions | … unknown; Clinical Comment: When co-administering with SSRIs, TCAs, or trazodone, careful dose titration of the antidepressant to the desired effect, including using the lowest feasible initial or … |
| Triamcinolone | drug interactions | … betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration: ↑ corticosteroids; … |
| Triazolam | contraindications | … arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam SYMTUZA is contraindicated to be co-administered with certain drugs for which altered plasma concentrations are … |
| Valacyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Valganciclovir | drug interactions | … are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.6) ]. |
| Vardenafil | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g., avanafil, sildenafil, tadalafil, vardenafil; Effect on Concentration: Co-administration with avanafil is not recommended because a safe and effective … |
| Verapamil | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g., amlodipine, diltiazem, felodipine, nifedipine, verapamil; Effect on Concentration: ↑ calcium channel blockers; … |
| Vinblastine | drug interactions | Consult the dasatinib and nilotinib prescribing information for dosing instructions. vinblastine, vincristine For vincristine and vinblastine, consider temporarily withholding the … |
| Vincristine | drug interactions | Consult the dasatinib and nilotinib prescribing information for dosing instructions. vinblastine, vincristine For vincristine and vinblastine, consider temporarily withholding the … |
| Voriconazole | drug interactions | Monitor for increased itraconazole or ketoconazole adverse reactions. voriconazole voriconazole: effects unknown Co-administration with voriconazole is not recommended unless benefit/risk assessment … |
| Warfarin | drug interactions | Other Anticoagulants warfarin warfarin: effect unknown Monitor international normalized ratio (INR) upon co-administration of SYMTUZA with warfarin. |
| Zolpidem | drug interactions | Concomitant Drug Class/Drug Name Examples: metabolized by CYP3A: e.g., buspirone, diazepam, estazolam, zolpidem; Effect on Concentration: ↑ sedatives/hypnotics; … |
Check cobicistat, darunavir, emtricitabine and tenofovir alafenamide against other medicines
Source: FDA drug label (Symtuza), Janssen Products LP, effective April 17, 2026 (SPL set 85a17d00-6b7c-41ea-a6b3-5ad924820dab), via openFDA; the full label on DailyMed
What do FAERS reports show for cobicistat, darunavir, emtricitabine and tenofovir alafenamide?
The FDA Adverse Event Reporting System holds 2,719 reports that list cobicistat, darunavir, emtricitabine and tenofovir alafenamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 109 are coded as a death and 303 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cobicistat, darunavir, emtricitabine and tenofovir alafenamide?
31 other medicines are given the same way (oral) and in the same FDA class as cobicistat, darunavir, emtricitabine and tenofovir alafenamide or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Atazanavir | HIV | 4 labelers | $2.23 per capsule 300 mg capsule | No current entry |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Lamivudine and zidovudine | HIV | 7 labelers | $0.771 per tablet Lamivudine-zidovudine tablet | No current entry |
| Ritonavir | HIV | 7 labelers | $0.607 per tablet 100 mg tablet | A presentation being discontinued |
| Lopinavir and ritonavir | HIV | 3 labelers | $4.46 per tablet 200-50 mg tablet | A presentation being discontinued |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cobicistat, darunavir, emtricitabine and tenofovir alafenamide
- 31 medicines for the same use
- Other cytochrome p450 3a inhibitors
- the pharmacologic class, with prices and generics
- Cobicistat, darunavir, emtricitabine and tenofovir alafenamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other