Sonidegib
Sonidegib is a targeted cancer medicine used to treat locally advanced basal cell carcinoma (a type of skin cancer) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sonidegib (Odomzo), on the market since about 2014, is a specialist drug for locally advanced basal cell carcinoma (a skin cancer) in adults when surgery or radiation has failed or is not an option; it blocks Smoothened, the on switch for Hedgehog growth signals. It is often hard going, with muscle cramps and aches in more than half of patients, plus hair loss and taste changes. Its boxed warning concerns pregnancy, since it can kill an unborn baby or cause severe birth defects, so women and men both need strict contraception during treatment and for months after. Expect regular blood checks of CK, a marker of muscle damage.
Clinical pearls
- Take it on an empty stomach, at least 1 hour before or 2 hours after food; fatty meals sharply raise levels.
- Call promptly about unexplained muscle pain or weakness, especially with less urine, a possible sign of rhabdomyolysis (muscle breakdown).
- Have any new antifungal, antibiotic or HIV medicine checked; drugs like ketoconazole or rifampin can push levels too high or low.
- Women need birth control for 20 months after the last dose; men need condoms for 8 months, even after vasectomy.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Odomzo can cause the death of an unborn baby or severe, irreversible birth defects if taken during pregnancy. This risk has been confirmed in animal studies at doses lower than the recommended human dose. Women who could become pregnant must have a pregnancy test before starting this drug and must use reliable birth control during treatment and for at least 20 months after the last dose. Men must use condoms — even after a vasectomy — during treatment and for at least 8 months after the last dose, because the drug may be present in semen and could harm a pregnant partner. Neither patients nor their male partners should donate blood or semen during treatment or for the required period afterward.
Patient information guide A plain-language walkthrough of Sonidegib, written from its FDA label.
What Sonidegib is used for
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Sonidegib is a targeted therapy approved for a specific type of skin cancer in adults. Its one supported use is through Odomzo capsules:
- Odomzo is indicated for adults with locally advanced basal cell carcinoma (BCC) — skin cancer that has come back after surgery or radiation therapy
- Odomzo is also indicated for adults with locally advanced BCC who are not able to have surgery or radiation therapy
How Sonidegib works
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Sonidegib is a Hedgehog (Hh) pathway inhibitor. The Hedgehog pathway is a set of cell signaling instructions that, when abnormally activated, can drive cancer growth. Sonidegib blocks a key protein in this pathway called Smoothened — think of Smoothened as a gateway that lets the cancer signals through. By locking that gateway shut, sonidegib cuts off the signal that tells basal cell carcinoma cells to keep growing.
Sonidegib dosage
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Odomzo is taken as an oral capsule once a day. It must be taken on an empty stomach — at least 1 hour before or 2 hours after a meal — because eating (especially a high-fat meal) can dramatically increase drug exposure. Treatment continues until the cancer progresses or side effects become too severe.
- Take at the same time each day for consistency
- If a dose is missed, skip it and resume with the next scheduled dose — never double up
- Your doctor will monitor your muscle enzymes and kidney function before and during treatment
Dosing details from the FDA-approved label
From the Sonidegib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (all patients)
- 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity
- If a dose is missed, resume dosing with the next scheduled dose
- Severe or intolerable musculoskeletal adverse reactions; first occurrence of serum CK elevation between 2.5 and 10 times ULN; recurrent serum CK elevation between 2.5 and 5 times ULN
- Interrupt ODOMZO
- Resume at 200 mg daily upon resolution of clinical signs and symptoms
- Serum CK elevation greater than 2.5 times ULN with worsening renal function; serum CK elevation greater than 10 times ULN; recurrent serum CK elevation greater than 5 times ULN; recurrent severe or intolerable musculoskeletal adverse reactions
- Permanently discontinue ODOMZO
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended dosage: 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal. ( 2.2 ) 2.1 Important Safety Information Verify the pregnancy status of females of reproductive potential prior to initiating ODOMZO [see Use in Specific Populations (8.1 , 8.3 )] . 2.2 Recommended Dosage The recommended dosage of ODOMZO is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3) ]. Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ]. If a dose of ODOMZO is missed, resume dosing with the next scheduled dose. 2.3 Dosage Modifications for Adverse Reactions Interrupt ODOMZO for Severe or intolerable musculoskeletal adverse reactions. First occurrence of serum CK elevation between 2.5 and 10 times upper limit of normal (ULN). Recurrent serum CK elevation between 2.5 and 5 times ULN. Resume ODOMZO at 200 mg daily upon resolution of clinical signs and symptoms. Permanently discontinue ODOMZO for Serum CK elevation greater than 2.5 times ULN with worsening renal function. Serum CK elevation greater than 10 times ULN. Recurrent serum CK elevation greater than 5 times ULN. Recurrent severe or intolerable musculoskeletal adverse reactions.
Read the full Dosage and Administration section on DailyMed →
Sonidegib side effects
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Side effects with Odomzo are common, but many can be managed with your care team's help. The most frequently reported ones include:
Common side effects
- Muscle spasms or cramps
- Hair loss (alopecia)
- Changes in taste (dysgeusia)
- Fatigue
- Nausea
- Muscle pain (myalgia or musculoskeletal pain)
- Diarrhea
- Decreased appetite or weight loss
- Headache, abdominal pain, vomiting, and itching (pruritus)
When to get medical help
- Call your doctor right away if you develop unexplained muscle pain, tenderness, or weakness — this can be a sign of a serious muscle condition called rhabdomyolysis
- Tell your doctor immediately if you notice decreased urination or signs of kidney problems along with muscle symptoms
- Do not take this medicine if you are pregnant — it can cause severe birth defects or fetal death
- Tell your doctor if you are a woman of childbearing age — pregnancy testing is required before starting treatment
- Men should use condoms during treatment and for at least 8 months after the last dose, even after a vasectomy
- Do not donate blood or blood products during treatment or for at least 20 months after stopping
More seriously, muscle breakdown (rhabdomyolysis) has occurred. Report any new, unexplained muscle pain, weakness, or tenderness to your doctor right away — especially if accompanied by decreased urine output.
Sonidegib warnings and precautions
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- Embryo-fetal toxicity: This is the most critical warning. Odomzo can cause fetal death or severe, permanent birth defects. Pregnancy must be ruled out before starting. Women must use effective contraception for at least 20 months after the last dose. Men must use condoms for at least 8 months after the last dose. Do not donate blood or semen during or for the required period after treatment.
- Muscle and kidney problems: Muscle spasms, pain, and elevated CK (creatine kinase — a muscle enzyme) are very common. Severe muscle breakdown (rhabdomyolysis) can damage the kidneys. Baseline and ongoing blood tests for CK and creatinine (a kidney marker) are required.
- Bone growth in children: Odomzo is not approved for pediatric patients. It has caused premature closure of bone growth plates in children, sometimes progressing even after stopping the drug.
Sonidegib interactions
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Sonidegib is primarily broken down by a liver enzyme called CYP3A. Drugs that affect this enzyme can significantly raise or lower the amount of sonidegib in your body:
- Strong CYP3A inhibitors (e.g., ketoconazole, certain antifungals) — avoid these; they more than double sonidegib exposure, raising the risk of side effects
- Moderate CYP3A inhibitors (e.g., erythromycin) — avoid if possible; if necessary, use for fewer than 14 days and monitor closely for muscle-related side effects
- Strong or moderate CYP3A inducers (e.g., rifampin, efavirenz) — avoid these; they can cut sonidegib levels by more than half, potentially making the drug less effective
- Proton pump inhibitors (e.g., esomeprazole for acid reflux) — no meaningful interaction; can be used without special precaution
Interactions listed in the FDA-approved label
From the Sonidegib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A inhibitors: Effects of other drugs on ODOMZO; concomitant administration is addressed under strong and moderate CYP3A inhibitors. Avoid concomitant administration of ODOMZO with strong CYP3A inhibitors.
- Moderate CYP3A inhibitors: Concomitant use may increase the risk of adverse reactions, particularly musculoskeletal adverse reactions. Avoid concomitant administration. If a moderate CYP3A inhibitor must be used, administer it for less than 14 days and monitor closely for adverse reactions particularly musculoskeletal adverse reactions.
- Strong and moderate CYP3A inducers: Effects of other drugs on ODOMZO; concomitant administration is addressed under strong and moderate CYP3A inducers. Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP3A inhibitors: Avoid strong CYP3A inhibitors. Avoid long-term (greater than 14 days) use of moderate CYP3A inhibitors. ( 7.1 ) CYP3A inducers: Avoid strong and moderate CYP3A inducers. ( 7.1 ) 7.1 Effects of Other Drugs on ODOMZO Strong and Moderate CYP3A Inhibitors Avoid concomitant administration of ODOMZO with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ]. Avoid concomitant administration of ODOMZO with moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer the moderate CYP3A inhibitor for less than 14 days and monitor closely for adverse reactions particularly musculoskeletal adverse reactions [see Clinical Pharmacology (12.3) ]. Strong and Moderate CYP3A Inducers Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers [see Clinical Pharmacology (12.3) ].
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sonidegib
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- Pregnancy: Must not be used during pregnancy — causes severe birth defects and fetal death. A pregnancy test is required before starting.
- Women of reproductive potential: Must use effective birth control during treatment and for at least 20 months after the last dose.
- Men: Must use condoms (even after vasectomy) during treatment and for at least 8 months after the last dose. Do not donate semen during this period.
- Breastfeeding: Do not breastfeed during treatment or for 20 months after the last dose.
- Children and teens: Not approved for pediatric use — serious bone growth problems have been reported.
- Older adults (65+): More likely to experience serious side effects, Grade 3–4 reactions, and need dose adjustments; no difference in effectiveness was seen.
- Medications: Tell your doctor about all prescription and over-the-counter drugs, especially antifungals, antibiotics, and HIV medications, as many interact with sonidegib.
- Blood donation: Do not donate blood or blood products during treatment or for at least 20 months after the last dose.
What Sonidegib does in the body
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At the approved dose level, sonidegib does not appear to affect heart rhythm — specifically, it does not prolong the QTc interval (the part of the heartbeat cycle measured on an ECG that, if prolonged, can signal an arrhythmia risk). This was evaluated at a dose higher than the recommended therapeutic dose, providing reassurance about cardiac safety at the level most patients take.
How your body processes Sonidegib
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Odomzo is absorbed from the gut, though less than 10% of each oral dose actually makes it into the bloodstream — and that amount rises dramatically (up to 7–8 times higher) if taken with a high-fat meal, which is why it must be taken on an empty stomach. The drug builds up in the body over time, reaching stable levels (steady-state) after about 4 months. Sonidegib has a very long half-life of roughly 28 days, meaning it lingers in the body for weeks after stopping. It is primarily broken down by the liver enzyme CYP3A and cleared mostly through the digestive tract (about 70% in stool, 30% in urine).
How to store Sonidegib
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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Sonidegib
138 supplements and herbal products have documented interactions with Sonidegib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 94
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Sonidegib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sonidegib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Odomzo used for?
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Does it matter when I take my capsule — like, with food or without?
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What side effects should I expect, and which ones should I call my doctor about right away?
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I heard this drug is dangerous in pregnancy — what do I need to know?
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Are there any medicines I should avoid while taking Odomzo?
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How long will I be on this medication?
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Is Sonidegib available over the counter?
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When was Sonidegib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Sonidegib on HelloPharmacist
Sonidegib forms and strengths (how it comes)
Sonidegib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sonidegib inactive ingredients by manufacturer.
Capsule
How this form is used
- Odomzo is used to treat locally advanced basal cell carcinoma (BCC) in adults whose cancer has returned after surgery or radiation therapy
- Odomzo is used for adults with locally advanced BCC who are not candidates for surgery or radiation therapy
- Odomzo capsules are taken by mouth once daily on an empty stomach — at least 1 hour before or 2 hours after a meal
- Odomzo should be taken until your doctor tells you to stop — either because the disease progresses or side effects become unacceptable
- If you miss a dose of Odomzo, skip it and take your next dose at the regularly scheduled time — do not double up
- Do not eat a high-fat meal close to your Odomzo dose — food significantly increases how much drug enters your bloodstream
Sonidegib on the U.S. market: products, makers and brands
How Sonidegib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Sonidegib product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2014. Brand names on the directory include Odomzo; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Sonidegib is used (Medicaid data)
A general measure of how commonly Sonidegib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sonidegib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sonidegib prescribed? Of the 1,601 medications we measure, Sonidegib ranks #1,468 by Medicaid prescriptions — more than 8% of them.
Utilization by Sonidegib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
sonidegib 200 MG Oral Capsule
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1659921
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sonidegib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Sonidegib NDCs with Medicaid activity.
Compare Sonidegib products
A representative set of FDA-listed product records for Sonidegib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 200 mg | Oral | Sun Pharmaceutical Industries, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Sonidegib NDCs →
Sonidegib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sonidegib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sonidegib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sonidegib FDA approval history
How Sonidegib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sonidegib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Sonidegib recalls since July 2021.
✅No Sonidegib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1659191 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 1659920In current FDA listingsClinical drug / strength (SCD) 200 MGRxCUI 1659921
Look up RxCUI 1659191 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sonidegib supply and shortage status
Whether Sonidegib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sonidegib brand names
Sonidegib is sold under one brand name in the FDA directory — Odomzo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Sonidegib: manufacturers and labelers
One company lists Sonidegib products with the FDA. By number of product records, the largest are Sun Pharmaceutical Industries, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sonidegib drug class (RxNorm)
Sonidegib belongs to the Hedgehog Pathway Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Sonidegib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →