Odomzo Side Effects

Generic name: sonidegib

Medically reviewed by Drugs.com. Last updated on Jul 27, 2024.

Note: This document provides detailed information about Odomzo Side Effects associated with sonidegib. Some dosage forms listed on this page may not apply specifically to the brand name Odomzo.

Applies to sonidegib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits for any unwanted effects or problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use a highly effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 20 months after stopping it. 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 sexual intercourse while taking sonidegib (the active ingredient contained in Odomzo) and for 8 months after the last dose of this medicine.

Do not donate blood or blood products while taking this medicine and for 20 months after stopping it. Men should not donate semen while taking this medicine and for 8 months after the last dose.

This medicine may increase your risk of serious muscle problems called rhabdomyolysis, that can lead to kidney damage. Tell your doctor right away if you develop new or worsening muscle spams, pain, or tenderness, dark urine, or decreased amount of urine while taking sonidegib.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Serious side effects of Odomzo

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:

Other side effects of Odomzo

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:

For healthcare professionals

Applies to sonidegib: oral capsule.

Musculoskeletal adverse events

• 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]

See also:

Frequently asked questions

• What are the most common skin conditions? (with photos)
• How does Odomzo work?

Further information

Odomzo 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.

Medical Disclaimer