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.

Warning

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

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

Black, tarry stools
bladder pain
bleeding gums
bloody urine
blurred vision
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
coughing up blood
difficult, burning, or painful urination
ear congestion
fast, pounding, or irregular heartbeat or pulse
frequent urge to urinate
headache
increased fat deposits on the face, neck, and trunk
increased thirst or urination
irregular breathing
loss of appetite
loss of voice
nausea
nervousness
nosebleeds
pain, redness, or swelling in the arm or leg
pale skin
pinpoint red spots on the skin
prolonged bleeding from cuts
red or black, tarry stools
red or dark brown urine
sneezing
sore throat
slow heartbeat
stomach ache
stuffy or runny nose
sweating
unusual bleeding or bruising
unusual tiredness or weakness
vomiting

Rare

Bloating
change in mental status
chest discomfort
constipation
dark or bloody urine
difficulty speaking
increased or decreased urination
indigestion
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
pains in the stomach, side, or abdomen, possibly radiating to the back
seizures
sudden weakness in the arms or legs
swelling of the face, fingers, feet, or lower legs
yellow eyes or skin

Incidence not known

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

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

Change in taste
dry skin
itching skin or rash
lack or loss of strength
loss of taste
pain in the arms or legs
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
difficulty in moving
discoloration of the fingernails or toenails
feeling of fullness
flushing or redness of the skin
jaw pain
joint pain
muscle cramps, spasms, or stiffness
muscle or bone 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.

General

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]

Metabolic

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]

Hematologic

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]

Gastrointestinal

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]

Other

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]

Dermatologic

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]

Respiratory

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]

Genitourinary

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]

Musculoskeletal

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]

Hepatic

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]

Psychiatric

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

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

Cardiovascular

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]