Erivedge Side Effects

Generic Name: vismodegib

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

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:

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

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:

• Absent, missed, or irregular menstrual periods
• change in taste
• decreased appetite
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• hair loss or thinning of the hair
• 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 (63.8%), pruritus
Common (1% to 10%): Rash, madarosis, abnormal hair growth^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (30.4%), diarrhea (29.0%), constipation (21.0%), vomiting (13.8%)
Common (1% to 10%): Dyspepsia, upper abdominal pain, abdominal pain^[Ref]

General

The most frequent adverse drug reactions reported were muscle spasms (74.6%), alopecia (65.2%), dysgeusia (57.2%), weight loss (48.6%), fatigue (44.9%), and nausea (34.8%).^[Ref]

Genitourinary

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

Metabolic

Very common (10% or more): Weight loss (44.9%), decreased appetite (25.4%)
Common (1% to 10%): Dehydration, hyponatremia, azotemia, and hypokalemia^[Ref]

Musculoskeletal

Very common (10% or more): Muscle spasms (71.7%), arthralgia (15.9%)
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 (55.1%), ageusia (10.9%)
Common (1% to 10%): Hypogeusia^[Ref]

Hepatic

Common (1% to 10%): Hepatic enzymes increased^[Ref]

Other

Very common (10% or more): Fatigue (39.9%)
Common (1% to 10%): Pain, asthenia^[Ref]

Renal

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

Some side effects of Erivedge may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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