What the label lists and what reports show
Sonidegib side effects
Sonidegib's FDA label: “The most common adverse reactions occurring in ≥10% of patients are muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus.” FAERS holds 1,494 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is muscle spasms (195 reports).
- No generic listed
- Boxed warning
Check it at the source: the sonidegib FDA label on DailyMed (effective December 31, 2024, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of ODOMZO?ODOMZO can cause serious side effects, including: See “What is the most important information I should know about ODOMZO?” Muscle Problems. Muscle spasms and muscle pain are common with ODOMZO, but can also sometimes be symptoms of serious muscle problems. ODOMZO can increase your risk of muscle pain and, rarely a serious condition caused by injury to the muscles (rhabdomyolysis) that can lead to kidney damage. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain or tenderness, dark urine, or decreased amount of urine during treatment with ODOMZO. Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking ODOMZO, during treatment, and if you develop muscle problems. […]
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective December 31, 2024 (SPL set 028312dc-d155-4fd5-8abd-6bb9f011d3cc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions occurring in ≥10% of patients are muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Adverse Reaction All Grades a % | ODOMZO 200 mg (N=79) Grade 3 % |
|---|---|---|
| Muscle spasms | 54 | 3 |
| Musculoskeletal pain | 32 | 1 |
| Myalgia | 19 | 0 |
| Alopecia | 53 | 0 |
| Pruritus | 10 | 0 |
| Dysgeusia | 46 | 0 |
| Headache | 15 | 1 |
| Fatigue | 41 | 4 |
| Pain | 14 | 1 |
| Nausea | 39 | 1 |
| Diarrhea | 32 | 1 |
| Abdominal pain | 18 | 0 |
| Vomiting | 11 | 1 |
| Decreased weight | 30 | 3 |
| Decreased appetite | 23 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.2) ]. The most common adverse reactions occurring in ≥10% of patients are muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ODOMZO was evaluated in BOLT, a randomized, double-blind, multiple cohort trial in which 229 patients received ODOMZO at either 200 mg (n=79) or 800 mg (n=150) daily. The frequency of common adverse reactions including muscle spasms, alopecia, dysgeusia, fatigue, nausea, decreased weight, decreased appetite, myalgia, pain, and vomiting was greater in patients treated with ODOMZO 800 mg as compared to 200 mg. …
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective December 31, 2024 (SPL set 028312dc-d155-4fd5-8abd-6bb9f011d3cc), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,494 reports list sonidegib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 148 are coded as a death and 270 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sonidegib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions