Prescription medicine
Cobicistat and darunavir Brand names: Prezcobix
Cobicistat and darunavir (Prezcobix) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $79.99 per Prezcobix 800 mg-150 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the cobicistat and darunavir FDA label on DailyMed (effective February 1, 2026, Janssen Products, LP); the NDA 205395 record on Drugs@FDA; every cobicistat and darunavir label on DailyMed.
Highlights of the record
FDA label of February 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Popula
Forms and strengths
- 600 mg / 90 mg
- 675 mg / 150 mg
- 800 mg / 150 mg
Film-coated tablet; tablet for suspension.
On the market
- Earliest approval on file
- January 29, 2015 Prezcobix, Janssen Prods; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 6, 2032 Prezcobix tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $79.99 per tablet Prezcobix 800 mg-150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,754 through July 30, 2026
What is cobicistat and darunavir used for?
From the label: indications and usagePREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Populations (8.4) and Clinical Studies (14) ]. […]
Conditions named in the indications of cobicistat and darunavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cytochrome P450 3A Inhibitor and Protease Inhibitor.
Source: FDA drug label (PREZCOBIX), Janssen Products, LP, effective February 1, 2026 (SPL set 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f), via openFDA; the full label on DailyMed
What does the patient leaflet for cobicistat and darunavir 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 PREZCOBIX and PREZCOBIX PED?PREZCOBIX and PREZCOBIX PED may cause serious side effects, including: Liver problems. People taking PREZCOBIX or PREZCOBIX PED may develop liver problems which may be life-threatening and can lead to death. Your healthcare provider should do blood tests before and during your treatment with PREZCOBIX or PREZCOBIX PED. If you have chronic hepatitis B or C or other liver problems, your healthcare provider may check your blood tests more often because you have an increased risk of developing liver problems. Tell your healthcare provider right away if you develop any new or worsening signs or symptoms of liver problems, including: tiredness dark (tea colored) urine yellowing of your skin or whites of your eyes pale colored stools (bowel movements) nausea vomiting pain or tenderness on your right side below your ribs loss of appetite Severe skin reactions or rash. Skin rash is common during treatment with PREZCOBIX or PREZCOBIX PED but can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking PREZCOBIX or PREZCOBIX PED and call your healthcare provider right away if you develop a severe rash or a rash with any of the following symptoms: fever tiredness muscle or joint pain blisters or skin lesions mouth sores or ulcers red or inflamed eyes, like "pink eye" (conjunctivitis) Kidney problems. PREZCOBIX and PREZCOBIX PED when taken with certain other medicines can cause new or worsening kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and during treatment with PREZCOBIX or PREZCOBIX PED. See " What are the possible side effects of PREZCOBIX or PREZCOBIX PED? " for more information about side effects.
From the patient leaflet: How should I store PREZCOBIX or PREZCOBIX PED?Store PREZCOBIX or PREZCOBIX PED at room temperature between 68 °F to 77 °F (20 °C to 25 °C). PREZCOBIX and PREZCOBIX PED come in a bottle with a child-resistant cap. Store PREZCOBIX PED tablets for oral suspension in the original container to protect from light. Keep the container tightly closed. Keep PREZCOBIX, PREZCOBIX PED and all medicines out of reach of children.
Source: FDA drug label (PREZCOBIX), Janssen Products, LP, effective February 1, 2026 (SPL set 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f), via openFDA; the full label on DailyMed
Is there a generic for cobicistat and darunavir (Prezcobix)?
No generic cobicistat and darunavir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Prezcobix tablets: the compound patent runs to September 3, 2029, and the last listed entry to October 6, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2032 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 and darunavir (Prezcobix)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $79.99 per Prezcobix 800 mg-150 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.
- Prezcobix 800 mg-150 mg tablet (brand)
$80.00
$79.55
January 2024October 2026
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Prezcobix 800 mg-150 mg tablet | Brand | $79.99 per tablet | $2,399.81 | +0.2% |
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 and darunavir label say about other medicines?
The cobicistat and darunavir label names 127 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name cobicistat and darunavir. 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 |
|---|---|---|
| Abacavir | drug interactions | Drugs without Clinically Significant Interactions with PREZCOBIX or PREZCOBIX PED Clinically relevant drug-drug interactions have not been observed or are not anticipated with concomitant use of darunavir and cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir … |
| 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: e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ antiarrhythmics; … |
| Amitriptyline | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g. amitriptyline, desipramine, imipramine, nortriptyline; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ TCAs; … |
| Amlodipine | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g. amlodipine, diltiazem, felodipine, nifedipine, verapamil; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ calcium channel blockers; … |
| Apixaban | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticoagulants: Direct Oral Anticoagulants (DOACs) apixaban; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ apixaban; Clinical Comment: Due to potentially increased bleeding risk, dosing recommendations for co-administration of apixaban with … |
| 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: atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ atorvastatin ↑ fluvastatin ↑ pravastatin ↑ rosuvastatin pitavastatin: effect unknown; … |
| Avanafil | drug interactions | Concomitant Drug Class/Drug Name Examples: Phosphodiesterase PDE-5 inhibitors: e.g. avanafil, sildenafil, tadalafil, vardenafil; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ PDE-5 inhibitors; … |
| 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: dexamethasone (systemic) Corticosteroids primarily metabolized by CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; … |
| Bosentan | drug interactions | Concomitant Drug Class/Drug Name Examples: Endothelin receptor antagonists: bosentan; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ darunavir ↓ cobicistat ↑ bosentan; Clinical Comment: Initiation of bosentan in patients taking PREZCOBIX or PREZCOBIX PED: In patients who have been receiving … |
| Budesonide | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids: dexamethasone (systemic) Corticosteroids primarily metabolized by CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; … |
| 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 and darunavir 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ beta-blockers; … |
| Ciclesonide | drug interactions | … Corticosteroids primarily metabolized by CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; … |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name Examples: Antibacterials: clarithromycin, erythromycin, telithromycin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ darunavir ↑ cobicistat … |
| Clonazepam | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticonvulsants that are metabolized by CYP3A: e.g. clonazepam; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ clonazepam; … |
| Clopidogrel | drug interactions | Concomitant Drug Class/Drug Name Examples: clopidogrel; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ clopidogrel active metabolite; … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ immunosuppressants; … |
| Dabigatran | drug interactions | Concomitant Drug Class/Drug Name Examples: dabigatran etexilate edoxaban; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ dabigatran ↑ edoxaban; … |
| Dasatinib | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticancer agents: dasatinib, nilotinib; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ anticancer agent; … |
| Desipramine | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g. amitriptyline, desipramine, imipramine, nortriptyline; … |
| Dexamethasone | drug interactions | Concomitant Drug Class/Drug Name Examples: Corticosteroids: dexamethasone (systemic) Corticosteroids primarily metabolized by CYP3A: e.g. … |
| Diazepam | drug interactions | Concomitant Drug Class/Drug Name Examples: metabolized by CYP3A: e.g. buspirone, diazepam, estazolam, zolpidem; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ … |
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name Examples: digoxin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ 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; … |
| Disopyramide | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Dolutegravir | drug interactions | … with concomitant use of darunavir and cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine … |
| Dronedarone | contraindications | … Antimycobacterial: rifampin Antipsychotics: lurasidone, pimozide Cardiac Disorders: dronedarone, ivabradine, ranolazine Ergot derivatives, e.g. … |
| Drospirenone | drug interactions | Concomitant Drug Class/Drug Name Examples: drospirenone/ethinylestradiol; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ drospirenone ↓ ethinylestradiol; … |
| Edoxaban | drug interactions | Concomitant Drug Class/Drug Name Examples: dabigatran etexilate edoxaban; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ dabigatran ↑ edoxaban; … |
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name Examples: efavirenz; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ cobicistat ↓ darunavir; … |
| 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 … |
| Emtricitabine | drug interactions | … cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ darunavir ↑ cobicistat … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ … |
| Etravirine | drug interactions | Concomitant Drug Class/Drug Name Examples: etravirine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ cobicistat darunavir: effect unknown; … |
| Everolimus | drug interactions | Concomitant Drug Class/Drug Name Examples: Immunosuppressant /neoplastic: everolimus; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ immunosuppressants; … |
| Felodipine | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g. amlodipine, diltiazem, felodipine, nifedipine, verapamil; … |
| Fentanyl | drug interactions | Concomitant Drug Class/Drug Name Examples: Narcotic analgesics metabolized by CYP3A: e.g. fentanyl, oxycodone; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ fentanyl ↑ … |
| Fesoterodine | drug interactions | Concomitant Drug Class/Drug Name Examples: fesoterodine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ fesoterodine; … |
| Flecainide | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Fluticasone | drug interactions | … primarily metabolized by CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; … |
| Fluvastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ atorvastatin ↑ … |
| 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; … |
| Irinotecan | drug interactions | Concomitant Drug Class/Drug Name Examples: irinotecan; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: Discontinue PREZCOBIX or PREZCOBIX PED at least 1 week prior to starting … |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name Examples: Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ darunavir ↑ … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ darunavir ↑ … |
| Lamivudine | drug interactions | … emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications (antacids, H 2 -receptor antagonists, proton pump inhibitors). |
| Lidocaine | drug interactions | Concomitant Drug Class/Drug Name Examples: 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. … |
| Maraviroc | drug interactions | Concomitant Drug Class/Drug Name Examples: maraviroc; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ maraviroc; Clinical Comment: Maraviroc is a substrate of CYP3A. … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↓ … |
| Metoprolol | drug interactions | Concomitant Drug Class/Drug Name Examples: β-Blockers: e.g. carvedilol, metoprolol, timolol; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ beta-blockers; … |
| Mexiletine | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Midazolam | contraindications | … pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam PREZCOBIX or PREZCOBIX PED is contraindicated in patients receiving certain co-administered drugs for … |
| Mometasone | drug interactions | … betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ darunavir ↓ cobicistat ↑ … |
| 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 … |
| Nevirapine | drug interactions | Concomitant Drug Class/Drug Name Examples: nevirapine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ cobicistat darunavir: effect unknown; … |
| Nifedipine | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g. amlodipine, diltiazem, felodipine, nifedipine, verapamil; … |
| Nilotinib | drug interactions | Concomitant Drug Class/Drug Name Examples: Anticancer agents: dasatinib, nilotinib; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ anticancer agent; … |
| Nortriptyline | drug interactions | Concomitant Drug Class/Drug Name Examples: Tricyclic Antidepressants (TCAs): e.g. amitriptyline, desipramine, imipramine, nortriptyline; … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ fentanyl ↑ … |
| Paroxetine | drug interactions | Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs): e.g. paroxetine, sertraline SSRIs: effects unknown When co-administering with SSRIs, TCAs, or trazodone, careful dose titration of … |
| Perphenazine | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. perphenazine, risperidone, thioridazine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ 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. … |
| Pitavastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ atorvastatin ↑ … |
| Posaconazole | drug interactions | Concomitant Drug Class/Drug Name Examples: Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ darunavir ↑ … |
| Prasugrel | drug interactions | Concomitant Drug Class/Drug Name Examples: prasugrel; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↔ prasugrel active metabolite; … |
| Pravastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ atorvastatin ↑ … |
| Prednisolone | drug interactions | … CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↓ darunavir ↓ … |
| 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: e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Quetiapine | drug interactions | Concomitant Drug Class/Drug Name Examples: quetiapine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ quetiapine; … |
| Quinidine | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine; … |
| Raltegravir | drug interactions | … concomitant use of darunavir and cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ rifabutin 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 of Darunavir, Cobicistat, or Concomitant Drug: ↓ darunavir; … |
| Rilpivirine | drug interactions | … anticipated with concomitant use of darunavir and cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine … |
| Risperidone | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. perphenazine, risperidone, thioridazine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ antipsychotic; … |
| Ritonavir | drug interactions | Switching from darunavir co-administered with ritonavir to PREZCOBIX or PREZCOBIX PED in patients on bosentan: |
| Rivaroxaban | drug interactions | Concomitant Drug Class/Drug Name Examples: rivaroxaban; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ rivaroxaban; … |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name Examples: atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ atorvastatin ↑ … |
| Salmeterol | drug interactions | Concomitant Drug Class/Drug Name Examples: Inhaled beta agonist: salmeterol; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ salmeterol; … |
| Sertraline | drug interactions | Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs): e.g. paroxetine, sertraline SSRIs: effects unknown When co-administering with SSRIs, TCAs, or trazodone, careful dose titration of … |
| 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 of Darunavir, Cobicistat, or Concomitant Drug: ↑ immunosuppressants; … |
| Solifenacin | drug interactions | Concomitant Drug Class/Drug Name Examples: solifenacin; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ solifenacin; … |
| Tacrolimus | drug interactions | Concomitant Drug Class/Drug Name Examples: Immunosuppressants: cyclosporine, sirolimus, tacrolimus; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ immunosuppressants; … |
| Tadalafil | drug interactions | Concomitant Drug Class/Drug Name Examples: Phosphodiesterase PDE-5 inhibitors: e.g. avanafil, sildenafil, tadalafil, vardenafil; … |
| Tenofovir alafenamide | drug interactions | … dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications (antacids, H 2 -receptor … |
| Tenofovir disoproxil | warnings and precautions | Onset or Worsening Renal Impairment When Used With Tenofovir Disoproxil Fumarate Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported when cobicistat, a … |
| Thioridazine | drug interactions | Concomitant Drug Class/Drug Name Examples: e.g. perphenazine, risperidone, thioridazine; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ antipsychotic; … |
| Ticagrelor | drug interactions | Concomitant Drug Class/Drug Name Examples: ticagrelor; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ ticagrelor; … |
| Timolol | drug interactions | Concomitant Drug Class/Drug Name Examples: β-Blockers: e.g. carvedilol, metoprolol, timolol; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ beta-blockers; … |
| Tramadol | drug interactions | Concomitant Drug Class/Drug Name Examples: tramadol; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ tramadol; … |
| Trazodone | drug interactions | … SSRIs: effects unknown 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 of Darunavir, Cobicistat, or Concomitant Drug: ↓ darunavir ↓ cobicistat ↑ … |
| Triazolam | contraindications | … arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam PREZCOBIX or PREZCOBIX PED is contraindicated in patients receiving certain co-administered drugs for which altered … |
| Vardenafil | drug interactions | Concomitant Drug Class/Drug Name Examples: Phosphodiesterase PDE-5 inhibitors: e.g. avanafil, sildenafil, tadalafil, vardenafil; … |
| Verapamil | drug interactions | Concomitant Drug Class/Drug Name Examples: Calcium channel blockers: e.g. amlodipine, diltiazem, felodipine, nifedipine, verapamil; … |
| 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 the international normalized ratio (INR) when co-administering with warfarin. |
| Zidovudine | drug interactions | … emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications (antacids, H 2 -receptor antagonists, proton pump inhibitors). |
| Zolpidem | drug interactions | Concomitant Drug Class/Drug Name Examples: metabolized by CYP3A: e.g. buspirone, diazepam, estazolam, zolpidem; Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug: ↑ … |
Source: FDA drug label (PREZCOBIX), Janssen Products, LP, effective February 1, 2026 (SPL set 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f), via openFDA; the full label on DailyMed
What do FAERS reports show for cobicistat and darunavir?
The FDA Adverse Event Reporting System holds 1,754 reports that list cobicistat and darunavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 135 are coded as a death and 397 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 and darunavir?
38 other medicines are given the same way (oral) and in the same FDA class as cobicistat and darunavir 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 |
|---|---|---|---|---|
| Atazanavir | HIV | 4 labelers | $2.23 per capsule 300 mg capsule | 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 |
| Fosamprenavir | HIV | 2 labelers | n/a | No current entry |
| Nelfinavir | HIV | none listed | n/a | No current entry |
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| 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 |
Every medicine labeled for the same conditions as cobicistat and darunavir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cobicistat and darunavir
- 38 medicines for the same use
- Other cytochrome p450 3a inhibitors
- the pharmacologic class, with prices and generics
- Cobicistat and darunavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other