Lexiva Side Effects

Please note - some side effects for Lexiva may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lexiva - for the Consumer

Lexiva

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 Lexiva:

Changes in body fat distribution; 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; unusual increase in thirst or urination; weight loss; yellowing of skin or eyes.

Lexiva 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 Lexiva Suspension:

Changes in body fat distribution; 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; unusual increase in thirst or urination; weight loss; yellowing of skin or eyes.

Lexiva Side Effects - for the Professional

Lexiva

• In adults the most common adverse reactions (incidence≥4%) are diarrhea, rash, nausea, vomiting, headache. (6.1)
• Vomiting was more frequent in pediatrics than in adults. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

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. Diarrhea, nausea, vomiting, increased AST, increased ALT, and rash most often resulted in discontinuation of fosamprenavir (incidence of 1% or less). 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.

Dermatologic

Dermatologic side effects have been reported frequently. Skin rash occurred in 19% of HIV-1 infected patients treated with fosamprenavir in studies. Severe or life-threatening rash, including Stevens-Johnson syndrome, occurred in less than 1% of patients. Erythema multiforme has been reported in at least one patient receiving fosamprenavir with ritonavir, zidovudine, and lamivudine. Maculopapular rash and pruritus have been reported in patients receiving fosamprenavir with ritonavir. Angioedema has been reported during postmarketing experience.

Endocrine

New onset and exacerbation of preexisting diabetes mellitus have been reported during postmarketing surveillance in patients receiving protease inhibitor therapy. Careful monitoring of blood glucose levels should be done and either initiation or dose adjustments of insulin or oral hypoglycemic agents may be needed.

Endocrine side effects have included hyperglycemia (greater than 251 mg/dL), hypertriglyceridemia (greater than 750 mg/dL), and hypercholesterolemia. In addition, redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, and abdominal pain.

Nervous system

Nervous system side effects have included depressive/mood disorders, headaches, and oral/perioral paresthesias.

Other

Other side effects have included fatigue and elevated creatine kinase.

Hematologic

Hematologic side effects have included neutropenia (less than 750 cells/mm3). 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.

Metabolic

Metabolic side effects have included increased serum lipase (greater than 2 times ULN), triglyceride levels, and amylase.

Hepatic

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

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.

Other

Redistribution and accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement and cushingoid appearance has been observed in patients receiving antiretroviral therapy.

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