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Sonidegib Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 13, 2020.

In Summary

Commonly reported side effects of sonidegib include: muscle spasm, musculoskeletal pain, and myalgia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sonidegib: oral capsule

Warning

Oral route (Capsule)

Use of sonidegib during pregnancy can cause embryofetal death or severe birth defects. Verify pregnancy status prior to initiating treatment and advise females of reproductive potential to use adequate contraception during treatment and for at least 20 months after discontinuation. Male patients with a female partner of reproductive potential must be advised to use adequate contraception during treatment for at least 8 months after discontinuation.

Side effects requiring immediate medical attention

Along with its needed effects, sonidegib 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 sonidegib:

More common

  • Difficulty with moving
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • muscle spasms
  • swollen joints

Rare

  • Dark-colored urine
  • fever
  • muscle stiffness
  • unusual tiredness or weakness

Side effects not requiring immediate medical attention

Some side effects of sonidegib 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

For Healthcare Professionals

Applies to sonidegib: oral capsule

Musculoskeletal

Very common (10% or more): Increased serum creatinine (92%), increased serum creatinine kinase (61%), muscle spasms (54%), musculoskeletal pain (32%), myalgia (19%)

Uncommon (0.1% to 1%): Rhabdomyolysis[Ref]

75% of patients with increased serum creatinine had levels that remained within normal range.[Ref]

Dermatologic

Very common (10% or more): Alopecia (53%), pruritus (10%)

Common (1% to 10%): Rash, abnormal hair growth[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (51%), dysgeusia (46%), decreased weight (30%), decreased appetite (23%)

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

Nervous system

Very common (10% or more): Dysgeusia (46%), headache (15%)[Ref]

Gastrointestinal

Very common (10% or more): Increased lipase (43%), nausea (39%), diarrhea (32%), abdominal pain (18%), increased amylase (16%), vomiting (11%)

Common (1% to 10%): Dyspepsia, constipation, GI reflux[Ref]

Other

Very common (10% or more): Fatigue (41%), pain (14%)[Ref]

Hematologic

Very common (10% or more): Anemia (32%), lymphopenia (28%)[Ref]

Hepatic

Very common (10% or more): Increased ALT (19%), increased AST (19%)[Ref]

Endocrine

Frequency not reported: Amenorrhea[Ref]

References

1. "Product Information. Odomzo (sonidegib)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

Frequently asked questions

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.