Lexiva Side Effects

Generic name: fosamprenavir

Medically reviewed by Drugs.com. Last updated on Dec 2, 2024.

Note: This document provides detailed information about Lexiva.

Applies to fosamprenavir: oral suspension, oral tablet Side Effects associated with fosamprenavir. Some dosage forms listed on this page may not apply specifically to the brand name Lexiva.

Applies to fosamprenavir: oral suspension, oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), delavirdine (Rescriptor®), flecainide (Tambocor®), lomitapide (Juxtapid®), lovastatin (Altocor®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, itching, white spots in the mouth or on the lips, or redness of the skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder, such as Graves disease, polymyositis, or Guillain-Barré syndrome.

Tell your doctor if you are also using sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). Using these medicines together with fosamprenavir (the active ingredient contained in Lexiva) may increase your risk of having side effects such as low blood pressure, changes in vision, or prolonged erection of the penis.

Birth control pills may not work as well while you are using fosamprenavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, a diaphragm, or contraceptive foam or jelly.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

This medicine may cause bleeding problems, especially in patients with hemophilia (bleeding disorder). Check with your doctor right away if you or your child have back pain, blood in the eyes, blood in the urine, black, tarry stools, bruises or purple areas on the skin, decreased alertness, dizziness, headache, joint pain or swelling, nosebleeds, or coughing up blood.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your risk of having kidney stones. Check with your doctor right away if you or your child have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

Tell your doctor that you or your child are using this medicine before you have any medical tests. The results of some tests may be affected by this medicine.

Fosamprenavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (eg, nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. If you have any questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Lexiva

Along with its needed effects, fosamprenavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fosamprenavir:

Other side effects of Lexiva

Some side effects of fosamprenavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to fosamprenavir: oral suspension, oral tablet.

General adverse events

Diarrhea, rash, nausea, vomiting, and headache were the most frequent moderate to severe side effects in clinical trials. Discontinuations due to side effects were 6.4% in patients using this drug compared to 5.9% in those using comparator therapies; the most common side effects leading to discontinuation of this drug (incidence up to 1%) included diarrhea, nausea, vomiting, increased AST, increased ALT, and rash.^[Ref]

Dermatologic

• Very common (10% or more): Skin rash (up to 19%)
• Common (1% to 10%): Rash/cutaneous reactions (including erythematous or maculopapular cutaneous eruptions [with or without pruritus])
• Rare (0.01% to 0.1%): Severe and/or life-threatening skin reactions (including Stevens-Johnson syndrome)
• Frequency not reported: Erythema multiforme, pruritus
• Postmarketing reports: Angioedema

Protease inhibitors:

• Frequency not reported: Lipohypertrophy^[Ref]

Skin rash (regardless of causality) was reported in about 19% of patients. Rashes were generally maculopapular and of mild or moderate intensity, some with pruritus. Rash had a median onset and duration of 11 and 13 days, respectively, and led to discontinuation of this drug in less than 1% of patients.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 13%)
• Common (1% to 10%): Nausea, vomiting, abdominal pain, increased serum lipase, loose stools, gastritis, abdominal distension, upper abdominal pain, flatulence
• Uncommon (0.1% to 1%): Gastroesophageal reflux disease
• Frequency not reported: Increased amylase
• Postmarketing reports: Oral paresthesia^[Ref]

Increased serum lipase (greater than 2 times the upper limit of normal [2 x ULN]) has been reported in up to 8% of patients.

Vomiting was reported more often in pediatric patients than adult patients.^[Ref]

Other

• Very common (10% or more): Increased fasting triglycerides (up to 11%)
• Common (1% to 10%): Fatigue
• Uncommon (0.1% to 1%): Pyrexia, increased cholesterol

Antiretroviral therapy:

• Frequency not reported: Increased weight, increased blood lipids^[Ref]

Increased fasting triglycerides (greater than 750 mg/dL) have been reported in up to 11% of patients.^[Ref]

Hepatic

• Common (1% to 10%): Elevated ALT, elevated AST
• Frequency not reported: Liver toxicity^[Ref]

Elevated ALT (greater than 5 x ULN) and AST (greater than 5 x ULN) have been reported in up to 8% and up to 6% of patients, respectively.^[Ref]

Hematologic

• Common (1% to 10%): Decreased absolute neutrophil count, neutropenia

Amprenavir:

• Frequency not reported: Acute hemolytic anemia

Protease inhibitors:

• Frequency not reported: Spontaneous bleeding in patients with hemophilia A and B^[Ref]

Decreased absolute neutrophil count (less than 750 cells/mm3) has been reported in 3% of patients.

Neutropenia was reported more often in pediatric patients than adult patients.^[Ref]

Metabolic

• Common (1% to 10%): Increased glucose, hyperlipidemia, hypertriglyceridemia
• Uncommon (0.1% to 1%): Anorexia
• Frequency not reported: Hyperglycemia, increased body fat
• Postmarketing reports: Hypercholesterolemia

Protease inhibitors:

• Frequency not reported: Hypertriglyceridemia, hypercholesterolemia, resistance to insulin
• Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis

Antiretroviral therapy:

• Frequency not reported: Increased glucose^[Ref]

Increased glucose (greater than 251 mg/dL) has been reported in 2% of patients.^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness^[Ref]

Hypersensitivity

• Common (1% to 10%): Drug hypersensitivity^[Ref]

Cardiovascular

• Postmarketing reports: Myocardial infarction^[Ref]

Renal

• Postmarketing reports: Nephrolithiasis^[Ref]

Musculoskeletal

• Frequency not reported: Elevated creatine kinase, osteonecrosis

Protease inhibitors:

• Rare (0.01% to 0.1%): Rhabdomyolysis
• Frequency not reported: Increased creatine phosphokinase, myalgia, myositis^[Ref]

Psychiatric

• Frequency not reported: Depressive/mood disorders^[Ref]

Immunologic

• Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)^[Ref]

See also:

Further information

Lexiva side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer