Vismodegib Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 17, 2024.
Applies to vismodegib: oral capsule.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits. Blood and urine tests may be needed to check for any unwanted effects or problems that may be caused by this medicine.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor will give you a pregnancy test 7 days before you start using this medicine to make sure you are not pregnant. Use a highly effective form of birth control during treatment and for 24 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Male patients (including those who had a vasectomy) should use condoms and spermicides as forms of birth control during treatment with this medicine and for 3 months after the last dose.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), which maybe life-threatening. Check with your doctor right away if you have black, tarry stools, blistering, peeling, loosening of the skin, chills, cough, diarrhea, itching, muscle or joint pain, irritated eyes, red skin lesions, often with a purple center, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, unusual tiredness or weakness.
This medicine may cause muscle problems. Check with your doctor right away if you have difficulty in moving, joint pain, or muscle pain, cramps, spasm, stiffness, tenderness, or weakness.
Do not donate blood or blood products during treatment with this medicine and for 24 months after the last dose.
For male patients: Do not donate semen during treatment with this medicine and for 3 months after the last dose.
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 side effects
- difficulty in moving
- joint pain
- muscle pain, cramps, spasm, stiffness, tenderness, or weakness
Less common side effects
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 side effects
- 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.
General adverse events
The most frequent adverse drug reactions reported were muscle spasms (75%), alopecia (65%), dysgeusia (57%), weight loss (49%), fatigue (45%), and nausea (35%).[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]
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]
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]
See also:
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References
1. (2012) "Product Information. Erivedge (vismodegib)." Genentech
Frequently asked questions
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- Drug class: hedgehog pathway inhibitors
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Further information
Vismodegib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.