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, oral tablet for suspension
Along with its needed effects, everolimus (the active ingredient contained in Afinitor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking everolimus:More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody nose
- chest pain or tightness
- cough or hoarseness
- decreased weight
- difficult or labored breathing
- difficulty with swallowing
- fever or chills
- general feeling of discomfort or illness
- lower back or side pain
- painful or difficult urination
- rapid weight gain
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- tingling of the hands or feet
- Bleeding gums
- bloody urine
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- coughing up blood
- extreme fatigue
- fast, pounding, or irregular heartbeat or pulse
- increased thirst or urination
- irregular breathing
- loss of appetite
- nausea or vomiting
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- slow heartbeat
- unusual tiredness or weakness
- hostility or irritability
- muscle twitching
Some side effects of everolimus may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abdominal or stomach pain
- change in taste
- dry skin
- itching skin
- lack or loss of strength
- loss of taste
- pain in the arms or legs
- unable to sleep
- Back pain
- blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
- bumps on the skin
- burning, dry, or itching eyes
- discoloration of the fingernails or toenails
- flushing or redness of the skin
- full feeling
- jaw pain
- numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
- passing gas
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- sleepiness or unusual drowsiness
For Healthcare Professionals
Applies to everolimus: oral tablet, oral tablet dispersible
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 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 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 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 side effects including otitis media (up to 36%), body tinea (up to 18%), and otitis externa (up to 14%) have been reported.
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 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 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 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 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 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 side effects including hypertension (up to 13%), tachycardia (up to 3%), and congestive heart failure (up to 1%) have been reported.
Ocular side effects including ocular hyperemia (up to 4%), eyelid edema (up to 4%) and conjunctivitis (up to 2%) have been reported.
Renal side effects including renal failure (up to 3%) have been reported.
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 side effects including proteinuria (up to 7%) have been reported. Postmarketing reports of male infertility have been received.
Endocrine side effects have included postmarketing reports of pancreatitis.
More Afinitor resources
- Afinitor Consumer Overview
- Afinitor Advanced Consumer (Micromedex) - Includes Dosage Information
- Afinitor Prescribing Information (FDA)
- Afinitor MedFacts Consumer Leaflet (Wolters Kluwer)
- Afinitor Monograph (AHFS DI)
- Everolimus Professional Patient Advice (Wolters Kluwer)
- Afinitor Disperz tablets for oral suspension MedFacts Consumer Leaflet (Wolters Kluwer)
- Zortress Prescribing Information (FDA)
- Zortress MedFacts Consumer Leaflet (Wolters Kluwer)
- Zortress Consumer Overview
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