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Afinitor Prescription
Generic Name: everolimus (E ver OH li mus (a FIN i tor))
Brand Names: Afinitor
Afinitor prevents the growth of cancer cells and is used to treat advanced kidney cancer. Learn about side effects, interactions and indications.
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Afinitor Drug Information:

Afinitor (Everolimus) is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. Afinitor is used to treat certain types of kidney cancer, breast cancer, or brain tumor. It is also used to treat certain types of advanced or progressive tumors of the stomach, intestines, or pancreas. Afinitor is also used to treat certain types of seizures or non-cancerous (benign) tumors of the brain or kidney in people with a genetic condition called tuberous sclerosis complex. Learn more

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Afinitor Side Effects

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.

In Summary

Common side effects of Afinitor include: infection, decreased hemoglobin, increased serum glucose, lymphocytopenia, and stomatitis. Other side effects include: pneumonitis, pneumonia, and increased hdl cholesterol. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to everolimus: oral tablet, oral tablet for suspension


Oral route (Tablet)

Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Immunosuppression increases susceptibility to infection and risk of malignancies, such as lymphoma and skin cancer. Increased risk of kidney arterial and venous thrombosis resulting in graft loss was reported within the first 30 days posttransplantation. To avoid nephrotoxicity, reduce doses of cyclosporine when used in combination with everolimus and monitor cyclosporine and everolimus whole blood trough concentrations. Do not use in heart transplantation; serious infections and increased mortality within the first 3 months posttransplant was observed.

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
  • chills
  • cough
  • decreased weight
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • fever
  • general feeling of discomfort or illness
  • hoarseness
  • 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

Less common

  • Bleeding gums
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing up blood
  • extreme tiredness or weakness
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst or urination
  • irregular breathing
  • loss of appetite
  • nausea
  • nervousness
  • nosebleeds
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow heartbeat
  • stomach ache
  • sweating
  • unusual tiredness or weakness
  • vomiting

Incidence not known

  • Agitation
  • confusion
  • decreased awareness or responsiveness
  • depression
  • dizziness
  • hostility
  • irritability
  • muscle twitching
  • seizures
  • severe sleepiness
  • unusual drowsiness, dullness, or feeling of sluggishness

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

  • Change in taste
  • dry skin
  • itching skin or rash
  • lack or loss of strength
  • loss of taste
  • pain in the arms or legs
  • stomach pain
  • trouble sleeping

Less common

  • 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
  • feeling of fullness
  • flushing or redness of the skin
  • jaw pain
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • passing of gas
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to everolimus: oral tablet, oral tablet dispersible


The most common side effects included stomatitis, infection, rash, fatigue, diarrhea, edema, peripheral edema, anemia, nausea, hyperlipidemia, headache, abdominal pain, fever, asthenia, cough, constipation, hypertension, urinary tract infection, leukopenia, and decreased appetite.


Very common (10% or more): Hypercholesterolemia (85%), cholesterol increased (77%), glucose increased (75%), alkaline phosphatase increased (74%), triglycerides increased (73%), bicarbonate decreased (56%), hypertriglyceridemia (52%), creatinine increased (50%), hypophosphatemia (49%), phosphate decreased (40%), calcium decreased (37%), appetite decreased (30%), potassium decreased (29%), weight decreased (28%), anorexia (25%), hyperlipidemia (21%), hyperkalemia (18%), sodium decreased (16%), dyslipidemia (15%), hyperglycemia (14%), hypomagnesemia (14%), hypokalemia (12%), diabetes mellitus (10%)

Common (1% to 10%): Dehydration, blood urea increased, acidosis, gout, hypercalcemia, hyperuricemia, hypocalcemia, hypoglycemia, hyponatremia, iron deficiency, vitamin B12 deficiency, potassium increased


Very common (10% or more): Decreased hemoglobin (92%), elevated partial thromboplastin time (72%), anemia (up to 61%), WBC decreased (58%), lymphocytes decreased (54%), platelets decreased (54%), neutropenia (46%), leukopenia (37%), albumin decreased (33%), neutrophils decreased (31%), lymphopenia (20%), thrombocytopenia (19%)

Common (1% to 10%): Hemorrhage, leukocytosis, lymphadenopathy, pancytopenia

Uncommon (0.1% to 1%): Pure red cell aplasia


Very common (10% or more): Stomatitis (78%), diarrhea (50%), constipation (38%), abdominal pain (36%), nausea (32%), vomiting (29%), dry mouth (up to 11%), gastroenteritis (10%)

Common (1% to 10%): Abdominal distention, dyspepsia, dysphagia, epigastric discomfort, flatulence, gastritis, gastroesophageal reflux disease, gingival hypertrophy, hematemesis, hemorrhoids, ileus, mouth ulceration, oral candidiasis, oral pain, peritonitis


Very common (10% or more): Fatigue (45%), peripheral edema (45%), edema (39%), asthenia (33%), pyrexia (31%), mucosal inflammation (19%), incision site pain (16%), procedural pain (15%)

Common (1% to 10%): Mucosal inflammation, irritability, blood lactate dehydrogenase increased, non-cardiac chest pain, chills, incisional hernia, edema


Very common (10% or more): Rash (59%), cellulitis (29%), nail disorders (22%), acne (22%), pruritus (21%), dry skin (13%), alopecia (10%)

Common (1% to 10%): Dermatitis acneiform, erythema, folliculitis, hand-foot syndrome, hirsutism, hyperhidrosis, hypertrichosis, night sweats, onychoclasis, onychomycosis, oral herpes skin exfoliation, skin lesion, tinea pedis

Uncommon (0.1% to 1%): Angioedema, herpes zoster


Very common (10% or more): Respiratory tract infection (31%), cough (30%), dyspnea (24%), epistaxis (22%), pneumonitis (19%), oropharyngeal pain (11%), streptococcal pharyngitis (10%)

Common (1% to 10%): Nasopharyngitis, pharyngitis, pneumonia, pulmonary embolism, bronchitis, sinusitis, pleural effusion, rhinorrhea, atelectasis, nasal congestion, pulmonary edema, sinus congestion, wheezing

Uncommon (0.1% to 1%): Hemoptysis, acute respiratory distress syndrome


Very common (10% or more): Amenorrhea (17%), urinary tract infection (16%), hematuria (12%), dysuria (11%), menorrhagia (10%), menstrual irregularities (10%)

Common (1% to 10%): Urethritis, bladder spasm, micturition urgency, pollakiuria, polyuria, pyuria, urinary retention, erectile dysfunction ovarian cyst, scrotal edema, blood luteinizing hormone increased, vaginal hemorrhage, blood follicle stimulating hormone increased, metrorrhagia, dysmenorrhea, delayed menstruation


Very common (10% or more): Arthralgia (20%), back pain (15%), extremity pain (14%), muscle spasms (10%)

Common (1% to 10%): Osteomyelitis, jaw pain, joint swelling, muscular weakness, myalgia, osteonecrosis, osteopenia, osteoporosis, spondylitis


Very common (10% or more): AST increased (69%), ALT increased (51%), hepatitis C (11%), bilirubin increased (10%)

Common (1% to 10%): Transaminases increased

Nervous system

Very common (10% or more): Headache (30%), dysgeusia (22%), dizziness (12%)

Common (1% to 10%): Tremor, paresthesia, hemiparesis, hypoesthesia, lethargy, neuralgia, somnolence, syncope

Uncommon (0.1% to 1%): Ageusia


Very common (10% or more): Behavioral disturbances (21%), insomnia (17%)

Common (1% to 10%): Depression, agitation, anxiety, hallucination


Very common (10% or more): Hypertension (30%)

Common (1% to 10%): Angina pectoris, hot flush, atrial fibrillation, congestive cardiac failure, hypotension, palpitations, tachycardia, venous thromboembolism (including deep vein thrombosis)


Very common (10% or more): Infections (50%)

Common (1% to 10%): BK virus infection, bacteremia, candidiasis, influenza, otitis media, sepsis


Common (1% to 10%): Renal failure, proteinuria, pyelonephritis, hydronephrosis, interstitial nephritis, renal artery thrombosis


Common (1% to 10%): Cataract, conjunctivitis, blurred vision, eyelid edema


Common (1% to 10%): Cushingoid, hyperparathyroidism


Common (1% to 10%): Hypersensitivity

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.

Source: Drugs.com Afinitor (www.drugs.com/afinitor.html).