Prescription medicine
Fosamprenavir First approved as Lexiva
Fosamprenavir (Lexiva) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the fosamprenavir FDA label on DailyMed (effective September 15, 2023, Mylan Pharmaceuticals Inc.); the NDA 21548 record on Drugs@FDA; every fosamprenavir label on DailyMed.
Highlights of the record
FDA label of September 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
Forms and strengths
- 700 mg
Film-coated tablet; coated tablet.
On the market
- Earliest approval on file
- October 20, 2003 Lexiva, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first April 15, 2016; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 130 through July 30, 2026
What is fosamprenavir used for?
From the label: indications and usageFosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir plus ritonavir in protease inhibitor-experienced patients:
The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2) ]. […]
Conditions named in the indications of fosamprenavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Protease Inhibitor.
Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed
What does the patient leaflet for fosamprenavir 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 fosamprenavir calcium tablets?Fosamprenavir calcium tablets can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with fosamprenavir calcium tablets. See the section “Who should not take fosamprenavir calcium tablets?” Fosamprenavir calcium tablets can cause serious side effects, including: • Severe skin reactions. Fosamprenavir calcium tablets may cause severe or life-threatening skin reactions or rash. If you get a rash with any of the following symptoms, stop taking fosamprenavir calcium tablets and call your healthcare provider or get medical help right away: o hives or sores in your mouth, or your skin blisters and peels o trouble swallowing or breathing o swelling of your face, eyes, lips, tongue, or throat For more information about side effects, see “What are the possible side effects of fosamprenavir calcium tablets?”
From the patient leaflet: How should I store fosamprenavir calcium tablets?Store fosamprenavir calcium tablets at room temperature between 20° to 25°C (68° to 77°F). • Keep the bottle of fosamprenavir calcium tablets tightly closed. • Fosamprenavir calcium tablets come in a child-resistant package. Keep fosamprenavir calcium tablets and all medicines out of the reach of children.
Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed
Is there a generic for fosamprenavir (Lexiva)?
The FDA approved the first generic fosamprenavir on April 15, 2016. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fosamprenavir from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2016 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fosamprenavir label say about other medicines?
The fosamprenavir label names 81 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name fosamprenavir. 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 |
|---|---|---|
| Alfuzosin | contraindications | Alfuzosin o Antiarrhythmics: Flecainide (with ritonavir ), propafenone (with ritonavir ) o Antimycobacterial: |
| Alprazolam | drug interactions | Concomitant Drug Class/Drug Name: Benzodiazepines: Alprazolam, clorazepate, diazepam, flurazepam; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Benzodiazepines; Clinical Comment: Clinical significance is unknown. A decrease in benzodiazepine dose may be needed. |
| Amiodarone | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: Amiodarone, disopyramide, lidocaine (systemic), and quinidine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antiarrhythmics; Clinical Comment: Therapeutic concentration monitoring, if available, is recommended for antiarrhythmics. |
| Amitriptyline | drug interactions | Concomitant Drug Class/Drug Name: Tricyclic antidepressants: Amitriptyline, imipramine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Tricyclics; Clinical Comment: Therapeutic concentration monitoring is recommended for tricyclic antidepressants. |
| Amlodipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Calcium channel blockers; Clinical Comment: Use with caution. … |
| Atazanavir | drug interactions | HIV protease inhibitor: Atazanavir Fosamprenavir: Interaction has not been evaluated. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: Atorvastatin a; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Atorvastatin; Clinical Comment: Titrate atorvastatin dose carefully and use the lowest necessary dose; do not exceed atorvastatin 20 mg/day. |
| Bosentan | drug interactions | Concomitant Drug Class/Drug Name: Endothelin-receptor antagonist: Bosentan; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Bosentan; Clinical Comment: Coadministration of bosentan in patients on fosamprenavir: In patients who have been receiving fosamprenavir for at least 10 days, start bosentan at 62.5 … |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine, phenobarbital, phenytoin; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir; Clinical Comment: Use with caution. … |
| Cimetidine | drug interactions | Concomitant Drug Class/Drug Name: Histamine H 2 -receptor antagonists: Cimetidine, famotidine, nizatidine, ranitidine; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir Fosamprenavir/ ritonavir: Interaction not evaluated; Clinical Comment: Use with caution. … |
| Clorazepate | drug interactions | Concomitant Drug Class/Drug Name: Benzodiazepines: Alprazolam, clorazepate, diazepam, flurazepam; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Benzodiazepines; Clinical Comment: Clinical significance is unknown. A decrease in benzodiazepine dose may be needed. |
| Colchicine | drug interactions | Concomitant Drug Class/Drug Name: Anti-gout: Colchicine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Colchicine; Clinical Comment: Patients with renal or hepatic impairment should not be given colchicine with fosamprenavir/ritonavir. … |
| Cyclosporine | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Immunosuppressants; Clinical Comment: Therapeutic concentration monitoring is recommended for immunosuppressant agents. |
| Dasatinib | drug interactions | Concomitant Drug Class/Drug Name: Antineoplastics: Dasatinib, nilotinib, ibrutinib, vinblastine, everolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antineoplastics; Clinical Comment: Fosamprenavir or fosamprenavir/ritonavir may increase plasma concentrations of antineoplastics metabolized by … |
Every other medicine the fosamprenavir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroid: Dexamethasone; Effect on Concentration of Amprenavir or Concomitant Drug: ↓ Amprenavir; Clinical Comment: Use with caution. … |
| Diazepam | drug interactions | Concomitant Drug Class/Drug Name: Benzodiazepines: Alprazolam, clorazepate, diazepam, flurazepam; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Benzodiazepines; … |
| Dihydroergotamine | contraindications | Rifampin o Antipsychotic: Lurasidone (with ritonavir ), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: |
| Diltiazem | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Disopyramide | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: Amiodarone, disopyramide, lidocaine (systemic), and quinidine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antiarrhythmics; … |
| Dolutegravir | drug interactions | Concomitant Drug Class/Drug Name: HIV integrase inhibitor: Dolutegravir; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir/ ritonavir: ↓ Dolutegravir; … |
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Efavirenz; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir; … |
| Ergotamine | contraindications | Rifampin o Antipsychotic: Lurasidone (with ritonavir ), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: |
| Esomeprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton pump inhibitors: Esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole; … |
| Estradiol and norethindrone | drug interactions | Oral contraceptives: Ethinyl estradiol/norethindrone Fosamprenavir: ↓ Amprenavir ↓ Ethinyl estradiol Alternative methods of non-hormonal contraception are recommended. |
| Everolimus | drug interactions | Concomitant Drug Class/Drug Name: Antineoplastics: Dasatinib, nilotinib, ibrutinib, vinblastine, everolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antineoplastics; … |
| Famotidine | drug interactions | Concomitant Drug Class/Drug Name: Histamine H 2 -receptor antagonists: Cimetidine, famotidine, nizatidine, ranitidine; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ … |
| Felodipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Fentanyl | drug interactions | Concomitant Drug Class/Drug Name: Fentanyl; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Fentanyl; Clinical Comment: Careful monitoring of therapeutic effects and adverse effects of … |
| Flecainide | contraindications | Alfuzosin o Antiarrhythmics: Flecainide (with ritonavir ), propafenone (with ritonavir ) o Antimycobacterial: |
| Flurazepam | drug interactions | Concomitant Drug Class/Drug Name: Benzodiazepines: Alprazolam, clorazepate, diazepam, flurazepam; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Benzodiazepines; … |
| Fluticasone | drug interactions | Coadministration of fluticasone and fosamprenavir/ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. |
| Ibrutinib | drug interactions | Concomitant Drug Class/Drug Name: Antineoplastics: Dasatinib, nilotinib, ibrutinib, vinblastine, everolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antineoplastics; … |
| Imipramine | drug interactions | Concomitant Drug Class/Drug Name: Tricyclic antidepressants: Amitriptyline, imipramine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Tricyclics; … |
| Isradipine | drug interactions | … nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Calcium channel blockers; … |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: Ketoconazole, itraconazole; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Ketoconazole ↑ Itraconazole; … |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: Ketoconazole, itraconazole; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Ketoconazole ↑ Itraconazole; … |
| Lansoprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton pump inhibitors: Esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole; … |
| Lidocaine | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: Amiodarone, disopyramide, lidocaine (systemic), and quinidine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antiarrhythmics; … |
| Lomitapide | contraindications | Lomitapide, lovastatin, simvastatin o Non-nucleoside reverse transcriptase inhibitor: Delavirdine o PDE5 inhibitor: |
| Lopinavir and ritonavir | drug interactions | HIV protease inhibitors: Lopinavir/ritonavir ↓ Amprenavir ↓ Lopinavir An increased rate of adverse events has been observed. |
| Lovastatin | contraindications | Lomitapide, lovastatin, simvastatin o Non-nucleoside reverse transcriptase inhibitor: Delavirdine o PDE5 inhibitor: |
| Lurasidone | contraindications | Rifampin o Antipsychotic: Lurasidone (with ritonavir ), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: |
| Maraviroc | drug interactions | Concomitant Drug Class/Drug Name: HIV CCR5 co-receptor antagonist: Maraviroc; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir/ ritonavir: ↓ Amprenavir ↑ Maraviroc; … |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesic: Methadone; Effect on Concentration of Amprenavir or Concomitant Drug: ↓ Methadone; … |
| Methylergonovine | contraindications | Rifampin o Antipsychotic: Lurasidone (with ritonavir ), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: |
| Midazolam | contraindications | Sildenafil (REVATIO ® ) (for treatment of pulmonary arterial hypertension) o Sedative/hypnotics: Midazolam, triazolam |
| Nelfinavir | drug interactions | Concomitant Drug Class/Drug Name: HIV protease inhibitors: Indinavir, nelfinavir; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↑ Amprenavir Effect on indinavir and … |
| Nevirapine | drug interactions | Concomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Nevirapine; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir ↑ Nevirapine; … |
| Nicardipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Nifedipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Nilotinib | drug interactions | Concomitant Drug Class/Drug Name: Antineoplastics: Dasatinib, nilotinib, ibrutinib, vinblastine, everolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antineoplastics; … |
| Nimodipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Nisoldipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Nizatidine | drug interactions | Concomitant Drug Class/Drug Name: Histamine H 2 -receptor antagonists: Cimetidine, famotidine, nizatidine, ranitidine; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ … |
| Omeprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton pump inhibitors: Esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole; … |
| Pantoprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton pump inhibitors: Esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole; … |
| Paroxetine | drug interactions | Concomitant Drug Class/Drug Name: Antidepressant: Paroxetine, trazodone; Effect on Concentration of Amprenavir or Concomitant Drug: ↓ Paroxetine; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine, phenobarbital, phenytoin; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine, phenobarbital, phenytoin; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir; … |
| Pimozide | contraindications | Rifampin o Antipsychotic: Lurasidone (with ritonavir ), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: |
| Propafenone | contraindications | Alfuzosin o Antiarrhythmics: Flecainide (with ritonavir ), propafenone (with ritonavir ) o Antimycobacterial: |
| Quetiapine | drug interactions | Consider alternative antiretroviral therapy to avoid increases in quetiapine drug exposures. |
| Quinidine | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: Amiodarone, disopyramide, lidocaine (systemic), and quinidine; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antiarrhythmics; … |
| Rabeprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton pump inhibitors: Esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole; … |
| Raltegravir | drug interactions | Concomitant Drug Class/Drug Name: HIV integrase inhibitor: Raltegravir; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ Amprenavir ↓ Raltegravir Fosamprenavir/ ritonavir … |
| Ranitidine | drug interactions | Concomitant Drug Class/Drug Name: Histamine H 2 -receptor antagonists: Cimetidine, famotidine, nizatidine, ranitidine; Effect on Concentration of Amprenavir or Concomitant Drug: Fosamprenavir: ↓ … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterial: Rifabutin; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Rifabutin and rifabutin metabolite; … |
| Rifampin | contraindications | Rifampin o Antipsychotic: Lurasidone (with ritonavir ), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: |
| Ritonavir | contraindications | The list of contraindicated drugs applies to the use of fosamprenavir with or without ritonavir, unless otherwise indicated. |
| Salmeterol | drug interactions | Concomitant Drug Class/Drug Name: Inhaled beta-agonist: Salmeterol; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Salmeterol; … |
| Sildenafil | contraindications | Sildenafil (REVATIO ® ) (for treatment of pulmonary arterial hypertension) o Sedative/hypnotics: Midazolam, triazolam |
| Simvastatin | contraindications | Lomitapide, lovastatin, simvastatin o Non-nucleoside reverse transcriptase inhibitor: Delavirdine o PDE5 inhibitor: |
| Sirolimus | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Immunosuppressants; … |
| Tacrolimus | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Immunosuppressants; … |
| Tadalafil | drug interactions | Concomitant Drug Class/Drug Name: PDE5 inhibitors: Sildenafil, tadalafil, vardenafil; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Sildenafil ↑ Tadalafil ↑ Vardenafil; … |
| Trazodone | drug interactions | Concomitant Drug Class/Drug Name: Antidepressant: Paroxetine, trazodone; Effect on Concentration of Amprenavir or Concomitant Drug: ↓ Paroxetine; … |
| Triazolam | contraindications | Sildenafil (REVATIO ® ) (for treatment of pulmonary arterial hypertension) o Sedative/hypnotics: Midazolam, triazolam |
| Vardenafil | drug interactions | Concomitant Drug Class/Drug Name: PDE5 inhibitors: Sildenafil, tadalafil, vardenafil; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Sildenafil ↑ Tadalafil ↑ Vardenafil; … |
| Verapamil | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem, felodipine, nifedipine, nicardipine, nimodipine, verapamil, amlodipine, nisoldipine, isradipine; … |
| Vinblastine | drug interactions | Concomitant Drug Class/Drug Name: Antineoplastics: Dasatinib, nilotinib, ibrutinib, vinblastine, everolimus; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Antineoplastics; … |
| Warfarin | drug interactions | Anticoagulant: Warfarin Concentrations of warfarin may be affected. |
Other labels that name fosamprenavir
Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed
What do FAERS reports show for fosamprenavir?
The FDA Adverse Event Reporting System holds 130 reports that list fosamprenavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 21 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.
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 fosamprenavir?
44 other medicines are given the same way (oral) and in the same FDA class as fosamprenavir 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 |
|---|---|---|---|---|
| Darunavir | HIV | 13 labelers | $1.16 per tablet 600 mg tablet | No current entry |
| 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 |
| Cobicistat and darunavir | HIV | none listed | $79.99 per tablet 800 mg-150 mg tablet | No current entry |
| Nelfinavir | HIV | none listed | n/a | No current entry |
| Atazanavir and cobicistat | HIV | none listed | $52.05 per tablet 300 mg-150 mg tablet | A presentation being discontinued |
| Cobicistat, darunavir, emtricitabine and tenofovir alafenamide | HIV | none listed | $152.87 per tablet 800-150-200-10 mg tablet | No current entry |
Every medicine labeled for the same conditions as fosamprenavir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fosamprenavir
- 44 medicines for the same use
- Other protease inhibitors
- the pharmacologic class, with prices and generics
- Fosamprenavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other