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Erivedge Side Effects

Generic name: vismodegib

Medically reviewed by Drugs.com. Last updated on May 22, 2022.

Note: This document contains side effect information about vismodegib. Some of the dosage forms listed on this page may not apply to the brand name Erivedge.

For the Consumer

Applies to vismodegib: oral capsule

Warning

Oral route (Capsule)

Vismodegib can result in embryo-fetal death or severe birth defects when administered to a pregnant woman. Animal data indicate vismodegib is embryotoxic, fetotoxic, and teratogenic. Pregnancy status should be verified 7 days prior to treatment initiation. Advise pregnant women of the potential risks to a fetus. Advise female patients to use effective contraception during and after vismodegib therapy. Advise male patients of the potential risk of vismodegib exposure through semen and recommend use of condoms with a pregnant partner or female partner of reproductive potential.

Side effects requiring immediate medical attention

Along with its needed effects, vismodegib (the active ingredient contained in Erivedge) 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 vismodegib:

Less common

  • Bloody or cloudy urine
  • confusion
  • decreased urine output
  • dizziness
  • dry mouth
  • fast or irregular heartbeat
  • headache
  • increased thirst
  • loss of consciousness
  • muscle pain or cramps
  • nausea
  • pain in the lower back or side
  • seizures
  • swelling of the face, ankles, or hands
  • thirst
  • unusual tiredness or weakness
  • vomiting

Incidence not known

  • Black, tarry stools
  • blistering, peeling, loosening of the skin
  • chest pain
  • chills
  • cough
  • diarrhea
  • itching skin
  • joint or muscle pain
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in the mouth or on the lips
  • sore throat
  • swollen glands
  • trouble breathing
  • unusual bleeding or bruising
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of vismodegib 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

  • Absent, missed, or irregular menstrual periods
  • change in taste
  • constipation
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement
  • difficulty with moving
  • hair loss or thinning
  • loss of taste
  • muscle spasm or stiffness
  • pain in the joints
  • stopping of menstrual bleeding
  • weight loss

For Healthcare Professionals

Applies to vismodegib: oral capsule

Dermatologic

Very common (10% or more): Alopecia (64%), pruritus

Common (1% to 10%): Rash, madarosis, abnormal hair growth

Postmarketing reports: Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia, systemic symptoms[Ref]

Gastrointestinal

Very common (10% or more): Nausea (31%), diarrhea (29%), constipation (21%), vomiting (14%)

Common (1% to 10%): Dyspepsia, upper abdominal pain, abdominal pain[Ref]

General

The most frequent adverse drug reactions reported were muscle spasms (75%), alopecia (65%), dysgeusia (57%), weight loss (49%), fatigue (45%), and nausea (35%).[Ref]

Genitourinary

Very common (10% or more): Amenorrhea[Ref]

Metabolic

Very common (10% or more): Weight loss (45%), decreased appetite (25%)

Common (1% to 10%): Dehydration, hyponatremia, azotemia, and hypokalemia[Ref]

Musculoskeletal

Very common (10% or more): Muscle spasms (72%), arthralgia (16%)

Common (1% to 10%): Pain in extremity, back pain, musculoskeletal chest pain, myalgia, flank pain, musculoskeletal pain[Ref]

Nervous system

Very common (10% or more): Dysgeusia (55%), ageusia (11%)

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

Hepatic

Common (1% to 10%): Hepatic enzymes increased

Postmarketing reports: Drug-induced liver injury[Ref]

Other

Very common (10% or more): Fatigue (40%)

Common (1% to 10%): Pain, asthenia[Ref]

Renal

Common (1% to 10%): Elevated blood urea nitrogen[Ref]

References

1. "Product Information. Erivedge (vismodegib)." Genentech (2012):

Further information

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.

Medical Disclaimer