Zortress 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 Zortress.
Some side effects of Zortress may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to everolimus: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking everolimus (the active ingredient contained in Zortress) hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Afinitor and call your doctor at once if you have a serious side effect such as:
new or worsening cough, wheezing, feeling short of breath;
stabbing chest pain, cough with yellow or green mucus;
white patches or sores inside your mouth or on your lips;
swelling, rapid weight gain, urinating less than usual or not at all;
fever, chills, sore throat, body aches, flu symptoms, feeling weak or tired;
pain or burning when you urinate;
pain or fullness in your ear, hearing problems;
pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
nausea, pain in your upper stomach, itching, joint pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).
Less serious side effects of everolimus may include:
diarrhea, constipation, mild nausea or vomiting, weight loss;
dry skin, acne, mild itching or skin rash;
cold symptoms such as stuffy nose, sneezing, sore throat;
unusual taste in your mouth;
pain in your arms and legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to everolimus: oral tablet
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 (the active ingredient contained in Zortress) 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.
More Zortress resources
- Zortress Prescribing Information (FDA)
- Zortress MedFacts Consumer Leaflet (Wolters Kluwer)
- Zortress Advanced Consumer (Micromedex) - Includes Dosage Information
- Zortress Consumer Overview
- Everolimus Professional Patient Advice (Wolters Kluwer)
- Afinitor Prescribing Information (FDA)
- Afinitor Monograph (AHFS DI)
- Afinitor Consumer Overview
- Afinitor MedFacts Consumer Leaflet (Wolters Kluwer)
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