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.
Serious side effects of Vismodegib
Along with its needed effects, vismodegib 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:
More common
- Difficulty in moving
- joint pain
- muscle pain, cramps, spasm, stiffness, tenderness, or weakness
Less common
- Bloody or cloudy urine
- confusion
- decreased urine output
- dizziness
- dry mouth
- fast or irregular heartbeat
- headache
- increased thirst
- loss of consciousness
- 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
- 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
Other side effects of Vismodegib
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
- hair loss or thinning
- loss of taste
- 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]
