Afinitor Side Effects

Please note - some side effects for Afinitor 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 Afinitor - for the Consumer

Afinitor

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 Afinitor:

Cough; diarrhea; dry skin, pain, swelling, or soreness of the mouth or tongue; fingernail or toenail changes; headache; itching; loss of appetite; nausea; nosebleed; stomach pain or upset; taste changes; trouble sleeping; vomiting; tiredness or weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; flushing, tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); arm or leg pain; bloody stools; chest pain; decreased, difficult, or painful urination; dry mouth or increased thirst; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening cough; numbness or tingling; severe or persistent diarrhea, nausea, stomach pain, or vomiting; severe or persistent dizziness or headache; severe or persistent tiredness or weakness; shortness of breath, or other breathing problems; swelling of the arms, hands, feet, or ankles; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; unusual drowsiness); unusual bruising or bleeding; yellowing of the eyes or skin.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Afinitor Side Effects - for the Professional

Afinitor

Most common adverse reactions (incidence ≥30%) are stomatitis, infections, asthenia, fatigue, cough, and diarrhea. (6.1)

Side Effects by Body System

Hematologic

Hematologic side effects including decreased hemoglobin (92%), decreased lymphocytes (51%), decreased platelets (23%), decreased neutrophils (14%), and hemorrhage (3%) have been reported.

Metabolic

Metabolic side effects including increased cholesterol (77%), increased triglycerides (73%), increased glucose (57%), increased creatinine (50%), decreased phosphate (37%), anorexia (25%), exacerbation of preexisting diabetes mellitus (2%), and new onset of diabetes mellitus (less than 1%) have been reported.

Gastrointestinal

Gastrointestinal side effects including stomatitis (44%), diarrhea (30%), nausea (26%), vomiting (20%), abdominal pain (9%), dry mouth (8%), hemorrhoids (5%), and dysphagia (4%) have been reported.

General

General side effects including asthenia (33%), fatigue (31%), peripheral edema (25%), pyrexia (20%), mucosal inflammation (19%), decreased weight (9%), chest pain (5%), and chills (4%) have been reported.

Dermatologic

Dermatologic side effects including rash (29%), pruritus (14%), dry skin (13%), hand-foot syndrome (5%), nail disorder (5%), erythema (4%), onychoclasis (4%), skin lesion (4%), and acneiform dermatitis (3%) have been reported.

Hepatic

Hepatic side effects including increased aspartate transaminase (AST) (25%), increased alanine transaminase (ALT) (21%), and increased bilirubin (3%) have been reported.

Musculoskeletal

Musculoskeletal side effects including pain in extremity (10%) and jaw pain (3%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (4%), tachycardia (3%), and congestive heart failure (1%) have been reported.

Renal

Renal side effects including renal failure (3%) have been reported.

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