Everolimus Side Effects
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.
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.
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
- 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
- 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
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- slow heartbeat
- unusual tiredness or weakness
- hostility or irritability
- muscle twitching
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
- lack or loss of strength
- loss of taste
- pain in the arms or legs
- unable to sleep
- 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
Hypersensitivity side effects manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives.
Hematologic side effects including decreased hemoglobin (up to 92%), decreased lymphocytes (up to 51%), decreased platelets (up to 45%), decreased white blood cells (up to 43%), decreased neutrophils (up to 30%), and hemorrhage (up to 3%) have been reported.
Metabolic side effects including increased cholesterol (up to 85%), increased triglycerides (up to 73%), increased glucose (up to 75%), increased creatinine (up to 50%), decreased phosphate (up to 37%), decreased appetite (up to 30%), anorexia (up to 25%), diabetes mellitus (up to 10%), and exacerbation of preexisting diabetes mellitus (up to 2%) have been reported.
Gastrointestinal side effects including stomatitis (up to 86%), diarrhea (up to 50%), abdominal pain (up to 36%), nausea (up to 32%), vomiting (up to 29%), gastroenteritis (up to 18%), constipation (up to 14%), gastric infection (up to 14%), dry mouth (up to 11%), hemorrhoids (up to 5%), and dysphagia (up to 4%) have been reported.
Other side effects including otitis media (up to 36%), body tinea (up to 18%), and otitis externa (up to 14%) have been reported.
General side effects including fatigue (up to 45%), edema (up to 39%), asthenia (up to 33%), pyrexia (up to 32%), mucosal inflammation (up to 19%), decreased weight (up to 28%), and chest pain (up to 5%) have been reported.
Respiratory side effects including upper respiratory tract infection (up to 82%), sinusitis (up to 39%), cough (up to 30%), dyspnea (up to 24%), epistaxis (up to 18%), pneumonitis (up to 17%), nasal congestion (up to 14%, allergic rhinitis (up to 14%), oropharyngeal pain (up to 11%), pharyngitis (up to 11%), pleural effusion (up to 7%), pharyngeal inflammation (up to 7%), pharyngolaryngeal pain (up to 4%), and rhinorrhea (up to 3%) have been reported. Postmarketing reports of pulmonary embolism have been received.
Dermatologic side effects including rash (up to 59%), acneiform dermatitis (up to 25%), nail disorder (up to 22%), pruritus (up to 21%), cellulitis (up to 21%), dry skin (up to 18%), skin infection (up to 18%), contact dermatitis (up to 14%), acne (up to 22%), eczema (up to 10%), hand-foot syndrome (up to 5%), erythema (up to 4%), onychoclasis (up to 4%), pityriasis rosea (4%), and skin lesion (up to 4%) have been reported.
Hepatic side effects including increased aspartate transaminase (AST) (up to 25%), increased alanine transaminase (ALT) (up to 21%), and increased bilirubin (up to 3%) have been reported.
Nervous system side effects including headache/migraine (up to 30%), convulsions (up to 29%), dysgeusia (up to 19%), dizziness (up to 14%), and paresthesia (up to 5%) have been reported.
Musculoskeletal side effects including arthralgia (up to 15%), back pain (up to 15%), pain in extremity (up to 14%) and muscle spasms (up to 10%) have been reported.
Cardiovascular side effects including hypertension (up to 13%), tachycardia (up to 3%), and congestive heart failure (up to 1%) have been reported.
Ocular side effects including ocular hyperemia (up to 4%), eyelid edema (up to 4%) and conjunctivitis (up to 2%) have been reported.
Renal side effects including renal failure (up to 3%) have been reported.
Psychiatric side effects including personality change (up to 18%), insomnia (up to 14%), anxiety (up to 7%), and depression (up to 5%) have been reported.
Genitourinary side effects including proteinuria (up to 7%) have been reported. Postmarketing reports of male infertility have been received.
Endocrine side effects have included postmarketing reports of pancreatitis.
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