Everolimus Side Effects

Some side effects of everolimus 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: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Afinitor and call your doctor at once if you have a serious side effect such as:

• new or worsening cough, wheezing, feeling short of breath;

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

• seizure (convulsions);

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

• swelling, rapid weight gain, urinating less than usual or not at all;

• fever, chills, sore throat, body aches, flu symptoms, feeling weak or tired;

• pain or burning when you urinate;

• pain or fullness in your ear, hearing problems;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

• nausea, pain in your upper stomach, itching, joint pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Less serious side effects of everolimus may include:

• diarrhea, constipation, mild nausea or vomiting, weight loss;

• dry skin, acne, mild itching or skin rash;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• unusual taste in your mouth;

• headache; or

• pain in your arms and legs.

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 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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