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Fosamprenavir

Fosamprenavir is an HIV protease inhibitor used together with other antiretroviral medicines to treat HIV-1 infection.

Brand name Lexiva
Drug classes Cytochrome P450 3a4 Inducers
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026
Fosamprenavir at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Fosamprenavir (Lexiva) is an HIV protease inhibitor that the gut converts to amprenavir, which blocks the enzyme HIV needs to build working virus particles; always combined with other HIV medicines and often boosted with ritonavir, it is an older option now rarely chosen first, on the market since about 2010 and available generically. Most people tolerate it fairly well, noticing diarrhea, nausea or headache most. Stop it and get help right away for a severe rash, or a moderate one with whole-body symptoms, which can signal Stevens-Johnson syndrome, a dangerous skin reaction. Tell every prescriber you take it, given its many drug interactions, and keep up with liver tests.

Clinical pearls

  • The liquid has its own food rule: adults take it on an empty stomach, while children take it with food.
  • It contains a sulfonamide part, so mention any sulfa allergy before your first dose.
  • It can make combined hormonal birth control less effective, so use an additional or alternative method.
  • Avoid St. John’s wort and the cholesterol drugs simvastatin and lovastatin, which should not be combined with it.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2003
Companies listing it with the FDA2
FDA label last updatedSep 15, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Fosamprenavir, written from its FDA label.

What Fosamprenavir is used for

▾

Fosamprenavir is used for one condition, always alongside other HIV medicines.

  • Fosamprenavir Calcium tablets: treatment of HIV-1 infection in combination with other antiretroviral agents.
  • For people who have used protease inhibitors before, once-daily dosing with ritonavir is not recommended for adults or any children.

How Fosamprenavir works

▾

Fosamprenavir is converted to amprenavir in the gut wall as it is absorbed. Amprenavir attaches to the active site of HIV-1 protease, an enzyme the virus needs to process its proteins.

With protease blocked, the virus makes immature particles that cannot infect new cells.

Fosamprenavir dosage

▾

Fosamprenavir is taken by mouth as tablets or oral suspension. Depending on the plan, it is taken once or twice daily, with or without ritonavir.

  • Tablets: with or without food.
  • Oral suspension: adults without food; children with food.
  • Repeat the oral suspension dose if vomiting occurs within 30 minutes.
  • Children's doses are based on body weight and should not exceed the adult dose.

Follow your prescriber's directions and your label.

Dosing details from the FDA-approved label

From the Fosamprenavir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Therapy-Naive Adults
    • Fosamprenavir calcium tablets 1,400 mg twice daily (without ritonavir)
    • Or 1,400 mg once daily plus ritonavir 200 mg once daily
    • Or 1,400 mg once daily plus ritonavir 100 mg once daily
    • Or 700 mg twice daily plus ritonavir 100 mg twice daily
    • Maximum: Higher-than-approved dose combinations of fosamprenavir calcium tablets plus ritonavir are not recommended due to an increased risk of transaminase elevations
    • Tablets may be taken with or without food
  • Protease Inhibitor-Experienced Adults
    • Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily
    • Tablets may be taken with or without food
  • Pregnant Patients
    • Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily
    • Only to be considered in patients already on a stable twice-daily regimen of fosamprenavir calcium/ritonavir 700 mg/100 mg prior to pregnancy and virologically suppressed (HIV-1 RNA less than 50 copies per mL)
  • Pediatric Patients (aged at least 4 weeks to 18 years)
    • Twice daily with ritonavir using oral suspension:
    • Maximum: Should not exceed the adult dose; with ritonavir, do not exceed fosamprenavir calcium 700 mg/ritonavir 100 mg twice daily
    • Dose by body weight; oral suspension taken with food in pediatric patients; adult 1,400 mg twice daily regimen without ritonavir may be used at least 47 kg
  • Mild Hepatic Impairment (Child-Pugh Score 5 to 6)
    • 700 mg twice daily without ritonavir (therapy-naive) or 700 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced)
    • Use with caution at a reduced dosage
  • Moderate Hepatic Impairment (Child-Pugh Score 7 to 9)
    • 700 mg twice daily without ritonavir (therapy-naive) or 450 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced)
    • Use with caution at a reduced dosage
  • Severe Hepatic Impairment (Child-Pugh Score 10 to 15)
    • 350 mg twice daily without ritonavir (therapy-naive) or 300 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced)
    • Use with caution at a reduced dosage
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Therapy-Naive Adults: Fosamprenavir calcium tablets 1,400 mg twice daily; fosamprenavir calcium tablets 1,400 mg once daily plus ritonavir 200 mg once daily; fosamprenavir calcium tablets 1,400 mg once daily plus ritonavir 100 mg once daily; fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily. (2.2) Protease Inhibitor-Experienced Adults: Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily. (2.2) Pregnant Patients: Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily should only be considered in women who are already on a stable twice-daily regimen of fosamprenavir calcium /ritonavir 700 mg/100 mg prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL). (2.2) Pediatric Patients (aged at least 4 weeks to 18 years): Dosage should be calculated based on body weight (kg) and should not exceed adult dose. (2.3) Hepatic Impairment: Recommended adjustments for patients with mild, moderate, or severe hepatic impairment. (2.4) Dosing Considerations Fosamprenavir calcium tablets may be taken with or without food. (2.1) Fosamprenavir Calcium Oral Suspension: Adults should take without food; pediatric patients should take with food. (2.1) 2.1 General Dosing Information Fosamprenavir calcium tablets may be taken with or without food. Adults should take fosamprenavir calcium oral suspension without food. Pediatric patients should take fosamprenavir calcium oral suspension with food [see Clinical Pharmacology (12.3)] . If emesis occurs within 30 minutes after dosing, re-dosing of fosamprenavir calcium oral suspension should occur. Higher-than-approved dose combinations of fosamprenavir calcium tablets plus ritonavir are not recommended due to an increased risk of transaminase elevations [see Overdosage (10)] . When fosamprenavir calcium tablets are used in combination with ritonavir, prescribers should consult the full prescribing information for ritonavir. 2.2 Adults Therapy-Naive Adults Fosamprenavir calcium tablets 1,400 mg twice daily (without ritonavir). Fosamprenavir calcium tablets 1,400 mg once daily plus ritonavir 200 mg once daily. Fosamprenavir calcium tablets 1,400 mg once daily plus ritonavir 100 mg once daily. Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Fosamprenavir side effects

▾

Most side effects are digestive or skin-related.

Common side effects

  • Diarrhea
  • Rash
  • Nausea
  • Vomiting
  • Headache
  • Tiredness (fatigue)

When to get medical help

  • Get medical help right away for a severe or life-threatening rash, including signs of Stevens-Johnson syndrome (a serious skin reaction). Stop the drug and call your doctor for a severe rash, or a moderate rash with body-wide symptoms.
  • Call your doctor if you have signs of liver problems. Liver enzyme (transaminase) increases can occur, especially with hepatitis B or C.
  • Tell your doctor if you notice new or worsening diabetes symptoms or high blood sugar.
  • Report symptoms of kidney stones (nephrolithiasis) to your doctor.
  • Call your doctor if you have unusual bleeding and have hemophilia.
  • Tell your doctor about new symptoms of inflammation or infection soon after starting HIV treatment (immune reconstitution syndrome).
  • Swelling of the face, lips or tongue (angioedema) or heart attack have been reported after approval and need urgent care.

Vomiting and low neutrophils (a type of white blood cell) were more frequent in children than in adults. Seek help for a severe rash, signs of liver problems, or swelling of the face or lips.

Fosamprenavir warnings and precautions

▾
  • Drug interactions can be serious or life-threatening.
  • Severe skin reactions, including Stevens-Johnson syndrome, require stopping the drug.
  • Liver enzyme increases, especially with higher-than-approved doses or hepatitis B or C.
  • High blood sugar, new or worse diabetes, and raised cholesterol and triglycerides.
  • Immune reconstitution syndrome, body fat increase, kidney stones, and bleeding in hemophilia.
  • Rare hemolytic anemia (red blood cell breakdown) was reported with amprenavir.

Fosamprenavir interactions

▾

Fosamprenavir affects and is affected by liver enzymes, so many medicines can interact.

  • Contraindicated: alfuzosin, rifampin, pimozide, cisapride, ergot derivatives, lovastatin, simvastatin, lomitapide, delavirdine, midazolam, triazolam, sildenafil (Revatio), St. John's wort. Other drugs are contraindicated when taken with ritonavir.
  • Warfarin: INR monitoring is needed.
  • Antacids and some seizure medicines: may lower amprenavir levels.
  • Ketoconazole, itraconazole, colchicine, trazodone: may need dose changes.
  • Hormonal birth control: may be less effective.

Interactions listed in the FDA-approved label

From the Fosamprenavir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • CYP3A4 inducers (e.g., rifampin): May decrease amprenavir concentrations and reduce its therapeutic effect.
  • CYP3A4 inhibitors: May increase amprenavir concentrations and increase the incidence of adverse effects.
  • Delavirdine: Increases amprenavir and decreases delavirdine, which may lead to loss of virologic response and possible resistance to delavirdine. Coadministration is contraindicated.
  • Efavirenz: Decreases amprenavir. An additional 100 mg/day (300 mg total) of ritonavir is recommended with fosamprenavir/ritonavir once daily; no change in ritonavir dose with twice daily.
  • Nevirapine: Decreases amprenavir and increases nevirapine. Coadministration with fosamprenavir without ritonavir is not recommended; no dosage adjustment when given with fosamprenavir/ritonavir twice daily.
  • Lopinavir/ritonavir: Decreases amprenavir and lopinavir; an increased rate of adverse events has been observed. Appropriate doses of the combination with respect to safety and efficacy have not been established.
  • Dolutegravir: Decreases dolutegravir with fosamprenavir/ritonavir. The recommended dose of dolutegravir is 50 mg twice daily when coadministered with fosamprenavir/ritonavir.
  • Alfuzosin: Increases alfuzosin, with potential hypotension. Coadministration is contraindicated.
  • Flecainide, propafenone: Increases antiarrhythmic concentrations, with potential for serious and/or life-threatening reactions such as cardiac arrhythmias if fosamprenavir is co-prescribed with ritonavir. Coadministration is contraindicated.
  • Warfarin: Concentrations of warfarin may be affected. It is recommended that INR be monitored.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Coadministration of fosamprenavir with drugs that induce CYP3A4 may decrease amprenavir (active metabolite) concentrations leading to potential loss of virologic activity. ( 7 , 12.3 ) • Coadministration with drugs that inhibit CYP3A4 may increase amprenavir concentrations. ( 7 , 12.3 ) • Coadministration of fosamprenavir or fosamprenavir and ritonavir may result in clinically significant interactions with drugs metabolized by CYP3A4. ( 7 ) • Coadministration of fosamprenavir and ritonavir may result in clinically significant interactions with drugs metabolized by CYP2D6. ( 7 ) 7.1 Cytochrome P450 Inhibitors and Inducers Amprenavir, the active metabolite of fosamprenavir, is an inhibitor of CYP3A4 metabolism and therefore should not be administered concurrently with medications with narrow therapeutic windows that are substrates of CYP3A4. Data also suggest that amprenavir induces CYP3A4. Amprenavir is metabolized by CYP3A4. Coadministration of fosamprenavir and drugs that induce CYP3A4, such as rifampin, may decrease amprenavir concentrations and reduce its therapeutic effect. Coadministration of fosamprenavir and drugs that inhibit CYP3A4 may increase amprenavir concentrations and increase the incidence of adverse effects. The potential for drug interactions with fosamprenavir changes when fosamprenavir is coadministered with the potent CYP3A4 inhibitor ritonavir. The magnitude of CYP3A4-mediated drug interactions (effect on amprenavir or effect on coadministered drug) may change when fosamprenavir is coadministered with ritonavir. Because ritonavir is a CYP2D6 inhibitor, clinically significant interactions with drugs metabolized by CYP2D6 are possible when coadministered with fosamprenavir plus ritonavir. Ritonavir also appears to induce CYP3A, CYP1A2, CYP2C9, CYP2C19, and CYP2B6, as well as other enzymes, including glucuronosyl transferase.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿143 supplements and herbs with documented Fosamprenavir interactions, ranked by severity Check Fosamprenavir against a supplement or herb →

Before taking Fosamprenavir

▾
  • Do not use if allergic to fosamprenavir or amprenavir.
  • Use caution with a sulfa allergy.
  • Liver disease or hepatitis B or C: more monitoring and dose adjustments.
  • Pregnancy: limited data; viral load should be monitored closely.
  • Breastfeeding is not recommended.
  • Children: weight-based dosing; not studied under 4 weeks.

Fosamprenavir overdose

▾

In a healthy volunteer study, high doses with ritonavir raised liver enzymes (ALT and AST), which went back to normal after stopping. There is no known antidote. Overdose care means monitoring for toxicity and supportive treatment.

How your body processes Fosamprenavir

▾

Fosamprenavir is quickly converted to amprenavir in the gut wall. Amprenavir peaks in about 1.5 to 4 hours and has a half-life of about 7.7 hours. It is broken down in the liver by CYP3A4 and cleared mostly as metabolites in feces and urine.

Food does not change absorption of the tablets, but it lowers absorption of the oral suspension.

How to store Fosamprenavir

▾

Store at 20° C to 25° C (68° F to 77° F) . Protect from moisture.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

143

Supplements & herbs that interact with Fosamprenavir

143 supplements and herbal products have documented interactions with Fosamprenavir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 100
  • Minor · 40
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ASTAXANTHIN Moderate +135 more
Every supplement checked against Fosamprenavir — ranked by severity The full interaction hub: 3 major · 100 moderate · 40 minor · every one linked to its full report. Check Fosamprenavir against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Fosamprenavir: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Fosamprenavir — the kind of thing our pharmacy team would talk through with you at the counter.

What is fosamprenavir for?

▾
It treats HIV-1 infection. You take it together with other HIV medicines, not by itself. It blocks an enzyme the virus needs to make working copies of itself.

Do I take it with food?

▾
Tablets can be taken with or without food. If you or your child uses the oral suspension, adults should take it without food and children should take it with food. If a child vomits within 30 minutes of a suspension dose, the dose needs to be repeated.

What side effects should I expect?

▾
The most common are diarrhea, rash, nausea, vomiting and headache. Mild rashes often settle. But call your doctor right away for a severe rash, blistering, or rash with fever or feeling unwell.

Can I take my other medicines and supplements with it?

▾
Not always. Fosamprenavir interacts with many drugs, and some combinations are not allowed, including simvastatin, lovastatin, rifampin and St. John's wort. Always check with me before starting anything new, even over-the-counter products.

Is it safe in pregnancy?

▾
Data are limited. If you were already stable on the twice-daily regimen with ritonavir and your virus is suppressed, your doctor may consider continuing it. Your viral load needs close monitoring. Breastfeeding is not recommended because HIV can pass to the baby.

Does it affect birth control?

▾
It may make combined hormonal birth control less effective. Use an effective alternative or add a barrier method such as condoms.

Is Fosamprenavir available over the counter?

▾
No. Fosamprenavir is a prescription medicine: every Fosamprenavir product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Fosamprenavir first available?

▾
The earliest FDA record we hold for Fosamprenavir is from 2003: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Fosamprenavir was first used.

Who makes Fosamprenavir?

▾
2 companies currently list Fosamprenavir products in the FDA's NDC Directory, including Mylan Pharmaceuticals Inc., Sun Pharmaceutical Industries, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Fosamprenavir on HelloPharmacist

📊Fosamprenavir supplement interactions143 checked — ranked by severity 🌿Drug & Supplement CheckerFosamprenavir vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fosamprenavir NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Fosamprenavir Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Fosamprenavir forms and strengths (how it comes)

Fosamprenavir is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fosamprenavir inactive ingredients by manufacturer.

Tablet

By mouth
Brands Lexiva
How this form is used
What it may be used for
  • Fosamprenavir Calcium tablets are used with other antiretroviral medicines to treat HIV-1 infection.
Important instructions
  • Fosamprenavir Calcium tablets may be taken with or without food.
Available strengths 1 strength
700 mg
6 FDA-listed product records ⓘ

Fosamprenavir on the U.S. market: products, makers and brands

How Fosamprenavir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 2 Fosamprenavir product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2003. Brand names on the directory include Lexiva; the rest are generics.

1
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
1
Brand names
2
FDA-listed product records ⓘ
2003
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Mylan Pharmaceuticals Inc.50%
Sun Pharmaceutical Industries, Inc.50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Compare Fosamprenavir products

A representative set of FDA-listed product records for Fosamprenavir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
700 mg Oral Mylan Pharmaceuticals Inc. ANDA View NDC →
700 mg Oral Sun Pharmaceutical Industries, Inc. ANDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Fosamprenavir NDCs →

Fosamprenavir recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Fosamprenavir recalls since July 2021.

✅No Fosamprenavir recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fosamprenavir RxCUI 358262 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 597266 No current FDA listing
    Clinical drug / strength (SCD) 50 MG/ML RxCUI 597267
  2. Dose form (SCDF) Oral Tablet RxCUI 402366 In current FDA listings
    Clinical drug / strength (SCD) 700 MG RxCUI 402109

Look up RxCUI 358262 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Fosamprenavir brand names

Fosamprenavir is sold under one brand name in the FDA directory — Lexiva. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lexiva

Who makes Fosamprenavir: manufacturers and labelers

2 companies list Fosamprenavir products with the FDA. By number of product records, the largest are Mylan Pharmaceuticals Inc., Sun Pharmaceutical Industries, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Mylan Pharmaceuticals Inc. 1 Sun Pharmaceutical Industries, Inc. 1

Fosamprenavir drug class (RxNorm)

Fosamprenavir belongs to the Protease inhibitors class.

Drug family (ATC) Protease inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Fosamprenavir page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 15, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fosamprenavir.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fosamprenavir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
2
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Sep 15, 2023
Composite sections available
20
Linked SPL Set ID
3a1424d8-844c-4e24-9ebd-b2c2b61b61a3
Linked SPL Document ID
88dccf91-6e62-4f5f-849d-1ffa8bf8df9d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →