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Afinitor Disperz Side Effects

Generic Name: everolimus

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 Disperz.

In Summary

Common side effects of Afinitor Disperz 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

Along with its needed effects, everolimus (the active ingredient contained in Afinitor Disperz) 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
  • 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
  • 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.[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


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.

Some side effects of Afinitor Disperz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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.