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Zortress Side Effects

Generic Name: everolimus

Note: This page contains side effects data for the generic drug everolimus. It is possible that some of the dosage forms included below may not apply to the brand name Zortress.

It is possible that some side effects of Zortress may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to everolimus: oral tablet, oral tablet for suspension

As well as its needed effects, everolimus (the active ingredient contained in Zortress) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking everolimus, check with your doctor immediately:

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 everolimus side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

General

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]

Metabolic

Very common (10% or more): Hypercholesterolemia (up to 85%), cholesterol increased (up to 77%), glucose increased (up to 75%), alkaline phosphatase increased (up to 74%), triglycerides increased (up to 73%), bicarbonate decreased (56%), hypertriglyceridemia (up to 52%), creatinine increased (up to 50%), hypophosphatemia (up to 49%), phosphate decreased (up to 40%), calcium decreased (37%), appetite decreased (up to 30%), potassium decreased (29%), weight decreased (up to 28%), anorexia (25%), hyperlipidemia (up to 21%), hyperkalemia (18%), sodium decreased (16%), dyslipidemia (15%), hyperglycemia (14%), hypomagnesemia (14%), hypokalemia (12%), diabetes mellitus (up to 10%)
Common (1% to 10%): Dehydration, blood urea increased, acidosis, gout, hypercalcemia, hyperuricemia, hypocalcemia, hypoglycemia, hyponatremia, iron deficiency, vitamin B12 deficiency, potassium increased[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 92%), elevated partial thromboplastin time (72%), anemia (up to 61%), WBC decreased (up to 58%), lymphocytes decreased (up to 54%), platelets decreased (up to 54%), neutropenia (up to 46%), leukopenia (up to 37%), albumin decreased (up to 33%), neutrophils decreased (up to 31%), lymphopenia (up to 20%), thrombocytopenia (up to 19%)
Common (1% to 10%): Hemorrhage, leukocytosis, lymphadenopathy, pancytopenia
Uncommon (0.1% to 1%): Pure red cell aplasia[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis (up to 78%), diarrhea (Up to 50%), constipation (up to 38%), abdominal pain (up to 36%), nausea (up to 32%), vomiting (up to 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]

Other

Very common (10% or more): Fatigue (up to 45%), peripheral edema (up to 45%), edema (39%), asthenia (up to 33%), pyrexia (up to 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]

Dermatologic

Very common (10% or more): Rash (up to 59%), cellulitis (29%), nail disorders (22%), acne (up to 22%), pruritus (up to 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]

Respiratory

Very common (10% or more): Respiratory tract infection (up to 31%), cough (up to 30%), dyspnea (up to 24%), epistaxis (up to 22%), pneumonitis (up to 19%), oropharyngeal pain (up to 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]

Genitourinary

Very common (10% or more): Amenorrhea (up to 17%), urinary tract infection (up to 16%), hematuria (12%), dysuria (11%), menorrhagia (up to 10%), menstrual irregularities (up to 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]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 20%), back pain (up to 15%), extremity pain (up to 14%), muscle spasms (up to 10%)
Common (1% to 10%): Osteomyelitis, jaw pain, joint swelling, muscular weakness, myalgia, osteonecrosis, osteopenia, osteoporosis, spondylitis[Ref]

Hepatic

Very common (10% or more): AST increased (up to 69%), ALT increased (up to 51%), hepatitis C (up to 11%), bilirubin increased (up to 10%)
Common (1% to 10%): Transaminases increased[Ref]

Nervous system

Very common (10% or more): Headache (up to 30%), dysgeusia (22%), dizziness (up to 12%)
Common (1% to 10%): Tremor, paresthesia, hemiparesis, hypoesthesia, lethargy, neuralgia, somnolence, syncope
Uncommon (0.1% to 1%): Ageusia[Ref]

Psychiatric

Very common (10% or more): Behavioral disturbances (up to 21%), insomnia (up to 17%)
Common (1% to 10%): Depression, agitation, anxiety, hallucination[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 30%)
Common (1% to 10%): Angina pectoris, hot flush, atrial fibrillation, congestive cardiac failure, hypotension, palpitations, tachycardia, venous thromboembolism (including deep vein thrombosis)[Ref]

Immunologic

Very common (10% or more): Infections (50%)
Common (1% to 10%): BK virus infection, bacteremia, candidiasis, influenza, otitis media, sepsis[Ref]

Renal

Common (1% to 10%): Renal failure, proteinuria, pyelonephritis, hydronephrosis, interstitial nephritis, renal artery thrombosis

Ocular

Common (1% to 10%): Cataract, conjunctivitis, blurred vision, eyelid edema[Ref]

Endocrine

Common (1% to 10%): Cushingoid, hyperparathyroidism[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity[Ref]

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([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.

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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