Afinitor Side Effects
Generic name: everolimus
Medically reviewed by Drugs.com. Last updated on Sep 29, 2020.
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.
Common side effects of Afinitor 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
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.
Side effects requiring immediate medical attention
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:
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody nose
- chest pain or tightness
- decreased weight
- difficult or labored breathing
- difficulty with swallowing
- 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
- 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
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- slow heartbeat
- stomach ache
- unusual tiredness or weakness
Incidence not known
- decreased awareness or responsiveness
- muscle twitching
- severe sleepiness
- unusual drowsiness, dullness, or feeling of sluggishness
Side effects not requiring immediate medical attention
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:
- 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
- trouble sleeping
- 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%)
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%): Dermatitis acneiform, erythema, folliculitis, hand-foot syndrome, hirsutism, hyperhidrosis, hypertrichosis, night sweats, onychoclasis, onychomycosis, oral herpes skin exfoliation, skin lesion, tinea pedis
Common (1% to 10%): Nasopharyngitis, pharyngitis, pneumonia, pulmonary embolism, bronchitis, sinusitis, pleural effusion, rhinorrhea, atelectasis, nasal congestion, pulmonary edema, sinus congestion, wheezing
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%)
Very common (10% or more): AST increased (69%), ALT increased (51%), hepatitis C (11%), bilirubin increased (10%)
Common (1% to 10%): Transaminases increased[Ref]
Very common (10% or more): Headache (30%), dysgeusia (22%), dizziness (12%)
Uncommon (0.1% to 1%): Ageusia[Ref]
Very common (10% or more): Behavioral disturbances (21%), insomnia (17%)
Very common (10% or more): Hypertension (30%)
Very common (10% or more): Infections (50%)
Common (1% to 10%): Renal failure, proteinuria, pyelonephritis, hydronephrosis, interstitial nephritis, renal artery thrombosis[Ref]
Common (1% to 10%): Cushingoid, hyperparathyroidism, hypothyroidism[Ref]
Common (1% to 10%): Hypersensitivity[Ref]
1. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.
Frequently asked questions
- How long can you take Afinitor for?
- How much does Afinitor cost per month?
- How long can you take everolimus?
- How does Afinitor work?
- What is everolimus used for and how does it work?
More about Afinitor (everolimus)
- During Pregnancy or Breastfeeding
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
- Compare Alternatives
- Pricing & Coupons
- En Español
- 16 Reviews
- Generic Availability
- Drug class: mTOR inhibitors
- FDA Approval History
- Other brands
Related treatment guides
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.