Afinitor Side Effects

Generic name: everolimus

Note: This document contains side effect information about everolimus. Some of the dosage forms listed on this page may not apply to the brand name Afinitor.

Some side effects of Afinitor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to everolimus: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking everolimus (the active ingredient contained in Afinitor) hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Zortress. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, or flu symptoms.

Zortress can cause a blood clot in the blood vessels of your transplanted organ, especially within 30 days after transplant. Tell your doctor right away if you have: shortness of breath, fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urinating, jaundice (yellowing of your skin or eyes), or pain in your stomach, groin, lower back, or side.

Call your doctor at once if you have these other side effects:

• pain or burning when you urinate;

• redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;

• new or worsening cough, wheezing, breathing problems;

• stabbing chest pain, cough with yellow or green mucus;

• pale skin, feeling light-headed, rapid heart rate, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• white patches or sores inside your mouth or on your lips;

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure).

Common side effects may include:

• swelling in your legs, ankles, or feet;

• diarrhea, constipation; or

• mild stomach discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to everolimus: oral tablet

Hypersensitivity

Hypersensitivity side effects manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus (the active ingredient contained in Afinitor) and other rapamycin derivatives.

Hematologic

Hematologic side effects including decreased hemoglobin (up to 92%), decreased lymphocytes (up to 51%), decreased platelets (up to 45%), decreased white blood cells (up to 43%), decreased neutrophils (up to 30%), and hemorrhage (up to 3%) have been reported.

Metabolic

Metabolic side effects including increased cholesterol (up to 85%), increased triglycerides (up to 73%), increased glucose (up to 75%), increased creatinine (up to 50%), decreased phosphate (up to 37%), decreased appetite (up to 30%), anorexia (up to 25%), diabetes mellitus (up to 10%), and exacerbation of preexisting diabetes mellitus (up to 2%) have been reported.

Gastrointestinal

Gastrointestinal side effects including stomatitis (up to 86%), diarrhea (up to 50%), abdominal pain (up to 36%), nausea (up to 32%), vomiting (up to 29%), gastroenteritis (up to 18%), constipation (up to 14%), gastric infection (up to 14%), dry mouth (up to 11%), hemorrhoids (up to 5%), and dysphagia (up to 4%) have been reported.

Other

Other side effects including otitis media (up to 36%), body tinea (up to 18%), and otitis externa (up to 14%) have been reported.

General

General side effects including fatigue (up to 45%), edema (up to 39%), asthenia (up to 33%), pyrexia (up to 32%), mucosal inflammation (up to 19%), decreased weight (up to 28%), and chest pain (up to 5%) have been reported.

Respiratory

Respiratory side effects including upper respiratory tract infection (up to 82%), sinusitis (up to 39%), cough (up to 30%), dyspnea (up to 24%), epistaxis (up to 18%), pneumonitis (up to 17%), nasal congestion (up to 14%, allergic rhinitis (up to 14%), oropharyngeal pain (up to 11%), pharyngitis (up to 11%), pleural effusion (up to 7%), pharyngeal inflammation (up to 7%), pharyngolaryngeal pain (up to 4%), and rhinorrhea (up to 3%) have been reported. Postmarketing reports of pulmonary embolism have been received.

Dermatologic

Dermatologic side effects including rash (up to 59%), acneiform dermatitis (up to 25%), nail disorder (up to 22%), pruritus (up to 21%), cellulitis (up to 21%), dry skin (up to 18%), skin infection (up to 18%), contact dermatitis (up to 14%), acne (up to 22%), eczema (up to 10%), hand-foot syndrome (up to 5%), erythema (up to 4%), onychoclasis (up to 4%), pityriasis rosea (4%), and skin lesion (up to 4%) have been reported.

Hepatic

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

Nervous system

Nervous system side effects including headache/migraine (up to 30%), convulsions (up to 29%), dysgeusia (up to 19%), dizziness (up to 14%), and paresthesia (up to 5%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 15%), back pain (up to 15%), pain in extremity (up to 14%) and muscle spasms (up to 10%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (up to 13%), tachycardia (up to 3%), and congestive heart failure (up to 1%) have been reported.

Ocular

Ocular side effects including ocular hyperemia (up to 4%), eyelid edema (up to 4%) and conjunctivitis (up to 2%) have been reported.

Renal

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

Psychiatric

Psychiatric side effects including personality change (up to 18%), insomnia (up to 14%), anxiety (up to 7%), and depression (up to 5%) have been reported.

Genitourinary

Genitourinary side effects including proteinuria (up to 7%) have been reported. Postmarketing reports of male infertility have been received.

Endocrine

Endocrine side effects have included postmarketing reports of pancreatitis.

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