Everolimus Side Effects

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

Applies to everolimus: oral tablet, oral tablet for suspension.

Important warnings This medicine can cause some serious health issues

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 everolimus

Along with its needed effects, everolimus 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 everolimus

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]

Immunologic

• Very common (10% or more): Infections (50%)
• Common (1% to 10%): BK virus infection, bacteremia, candidiasis, influenza, otitis media, sepsis^[Ref]

Renal

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

Ocular

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

Endocrine

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

Hypersensitivity

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

Frequently asked questions

• How much does Afinitor cost per month?
• How long can you take Afinitor for?
• How long can you take everolimus?
• What is everolimus used for and how does it work?
• How does Afinitor work?

Further information

Everolimus side effects can vary depending on the individual. 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.

Medical Disclaimer