Fosamprenavir Side Effects

Brand Names: Lexiva

Please note - some side effects for Fosamprenavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fosamprenavir - for the Consumer

Fosamprenavir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fosamprenavir:

Diarrhea; headache; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); loss of appetite; signs of infection (eg, fever, chills, sore throat); swollen, reddened, or blistered skin; symptoms of a heart attack (eg, chest pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of kidney stones (eg, lower back or side pain, blood in the urine, painful urination); unusual increase in thirst or urination; unusual tiredness or weakness; weight loss; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fosamprenavir Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fosamprenavir Suspension:

Diarrhea; headache; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); loss of appetite; signs of infection (eg, fever, chills, sore throat); swollen, reddened, or blistered skin; symptoms of a heart attack (eg, chest pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of kidney stones (eg, lower back or side pain, blood in the urine, painful urination); unusual increase in thirst or urination; unusual tiredness or weakness; weight loss; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

Diarrhea, rash, nausea, vomiting, and headache were the most frequent moderate to severe side effects in clinical trials of fosamprenavir. Discontinuations due to side effects were 6.4% in patients receiving fosamprenavir compared to 5.9% in those receiving comparator therapies. The most common side effects leading to fosamprenavir discontinuation (incidence of 1% or less) included diarrhea, nausea, vomiting, increased AST, increased ALT, and rash.

Dermatologic

Dermatologic side effects of moderate to severe intensity have included rash (up to 8%) in patients treated with combination therapy. Skin rash, regardless of causality, occurred in approximately 19% of patients treated with fosamprenavir in studies. Rashes were generally maculopapular and of mild or moderate intensity, some with pruritus. Severe or life-threatening skin reactions, including at least 1 case of Stevens-Johnson syndrome, have been reported during clinical trials. Erythema multiforme has been reported in at least 1 patient receiving fosamprenavir with ritonavir, zidovudine, and lamivudine. Angioedema has been reported during postmarketing experience.

Skin rash, regardless of causality, had a median onset and duration of 11 and 13 days, respectively, and led to discontinuation of fosamprenavir in less than 1% of patients.

Gastrointestinal

Gastrointestinal side effects of moderate to severe intensity have included diarrhea (up to 13%), nausea (up to 7%), vomiting (up to 6%), and abdominal pain (up to 2%) in patients treated with combination therapy.

Metabolic

Metabolic side effects have included increased serum lipase (greater than 2 times ULN; up to 8%), triglycerides (greater than 750 mg/dL; up to 11%), glucose (greater than 251 mg/dL; 2%), and amylase. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance," have been observed in patients receiving antiretroviral therapy, including fosamprenavir. Hypercholesterolemia has been reported during postmarketing experience. New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported during postmarketing experience in HIV-infected patients receiving protease inhibitor therapy; however, causality has not been established.

The mechanism and long-term consequences of body fat redistribution/accumulation are currently unknown and a causal relationship has not been established.

Hepatic

Hepatic side effects have included elevated ALT (greater than 5 times ULN; up to 8%) and AST (greater than 5 times ULN; up to 6%). Liver toxicity has been reported in patients receiving fosamprenavir with ritonavir, zidovudine, and lamivudine.

Nervous system

Nervous system side effects of moderate to severe intensity have included headache (up to 4%) in patients treated with combination therapy. Oral paresthesia has been reported during postmarketing experience.

Other

Other side effects of moderate to severe intensity have included fatigue (up to 4%) in patients treated with combination therapy. Elevated creatine kinase has been reported.

Hematologic

Hematologic side effects have included neutropenia (less than 750 cells/mm3; 3%). Acute hemolytic anemia has been associated with amprenavir. Hematologic side effects associated with protease inhibitors have included spontaneous bleeding in patients with hemophilia A and B. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.

Psychiatric

Psychiatric side effects have included depressive/mood disorders.

Cardiovascular

Cardiovascular side effects have included myocardial infarction during postmarketing experience.

Genitourinary

Genitourinary side effects have included nephrolithiasis during postmarketing experience.

Immunologic

Immunologic side effects have included immune reconstitution syndrome during the initial phase of treatment. Patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections.

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