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Everolimus Side Effects

For the Consumer

Applies to everolimus: oral tablet, oral tablet for suspension

In addition to its needed effects, some unwanted effects may be caused by everolimus. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • diarrhea
  • 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
Less common:
  • 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
  • nervousness
  • nosebleeds
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow heartbeat
  • stomachache
  • sweating
  • unusual tiredness or weakness
Incidence not known:
  • Agitation
  • confusion
  • depression
  • dizziness
  • hostility or irritability
  • lethargy
  • muscle twitching
  • seizures
  • stupor

Minor Side Effects

Some of the side effects that can occur with everolimus may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Abdominal or stomach pain
  • change in taste
  • dry skin
  • itching skin or rash
  • lack or loss of strength
  • loss of taste
  • pain in the arms or legs
  • unable to sleep
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
  • 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


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 (up to 85%), cholesterol increased (up to 77%), glucose increased (up to 75%), alkaline phosphatase increased (up to 74%), triglycerides increased (up to 73%), bicarbonate decreased (56%), hypertriglyceridemia (up to 52%), creatinine increased (up to 50%), hypophosphatemia (up to 49%), phosphate decreased (up to 40%), calcium decreased (37%), appetite decreased (up to 30%), potassium decreased (29%), weight decreased (up to 28%), anorexia (25%), hyperlipidemia (up to 21%), hyperkalemia (18%), sodium decreased (16%), dyslipidemia (15%), hyperglycemia (14%), hypomagnesemia (14%), hypokalemia (12%), diabetes mellitus (up to 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 (up to 92%), elevated partial thromboplastin time (72%), anemia (up to 61%), WBC decreased (up to 58%), lymphocytes decreased (up to 54%), platelets decreased (up to 54%), neutropenia (up to 46%), leukopenia (up to 37%), albumin decreased (up to 33%), neutrophils decreased (up to 31%), lymphopenia (up to 20%), thrombocytopenia (up to 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 (up to 78%), diarrhea (Up to 50%), constipation (up to 38%), abdominal pain (up to 36%), nausea (up to 32%), vomiting (up to 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 (up to 45%), peripheral edema (up to 45%), edema (39%), asthenia (up to 33%), pyrexia (up to 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 (up to 59%), cellulitis (29%), nail disorders (22%), acne (up to 22%), pruritus (up to 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 (up to 31%), cough (up to 30%), dyspnea (up to 24%), epistaxis (up to 22%), pneumonitis (up to 19%), oropharyngeal pain (up to 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 (up to 17%), urinary tract infection (up to 16%), hematuria (12%), dysuria (11%), menorrhagia (up to 10%), menstrual irregularities (up to 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 (up to 20%), back pain (up to 15%), extremity pain (up to 14%), muscle spasms (up to 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 (up to 69%), ALT increased (up to 51%), hepatitis C (up to 11%), bilirubin increased (up to 10%)
Common (1% to 10%): Transaminases increased[Ref]

Nervous system

Very common (10% or more): Headache (up to 30%), dysgeusia (22%), dizziness (up to 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 (up to 21%), insomnia (up to 17%)
Common (1% to 10%): Depression, agitation, anxiety, hallucination[Ref]


Very common (10% or more): Hypertension (up to 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


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


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


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


1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.

4. "Product Information. Zortress (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.

Not all side effects for everolimus may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.