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Afinitor Side Effects

Generic name: everolimus

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 27, 2024.

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

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.

Serious side effects of Afinitor

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

Less common


Incidence not known

Other side effects of Afinitor

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

Less common

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.[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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

Common (1% to 10%): Transaminases increased[Ref]

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[Ref]


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

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


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)[Ref]


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

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


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


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


Common (1% to 10%): Cushingoid, hyperparathyroidism, hypothyroidism[Ref]


Common (1% to 10%): Hypersensitivity[Ref]

Frequently asked questions


1. (2009) "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.