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, oral tablet for suspension

Along with its needed effects, everolimus (the active ingredient contained in Zortress) 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
  • 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

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
  • 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
  • rash
  • 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

Hypersensitivity

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

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

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

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

Other side effects including otitis media (up to 36%), body tinea (up to 18%), and otitis externa (up to 14%) have been reported.

General

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

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

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

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

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

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

Cardiovascular side effects including hypertension (up to 13%), tachycardia (up to 3%), and congestive heart failure (up to 1%) have been reported.

Ocular

Ocular side effects including ocular hyperemia (up to 4%), eyelid edema (up to 4%) and conjunctivitis (up to 2%) have been reported.

Renal

Renal side effects including renal failure (up to 3%) have been reported.

Psychiatric

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

Genitourinary side effects including proteinuria (up to 7%) have been reported. Postmarketing reports of male infertility have been received.

Endocrine

Endocrine side effects have included postmarketing reports of pancreatitis.

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. Drugs.com 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.

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