Sonidegib: basal cell carcinoma, 200 mg dosing, side effects
Last updated September 7, 2026.
**Sonidegib is a prescription oral cancer medicine, sold as Odomzo, that belongs to a class called hedgehog pathway inhibitors.** Basal cell skin cancers grow because a signaling pathway called hedgehog is stuck in the on position, and sonidegib blocks a protein in that pathway called Smoothened so the signal shuts down and the tumor stops being driven to grow. It is taken as a single capsule once a day for as long as it keeps working and you tolerate it. The most important safety point is that sonidegib causes severe birth defects or fetal death, so pregnancy must be ruled out before you start and prevented during treatment and for 20 months after your last dose.
What does it treat?
Sonidegib is approved for adults with locally advanced basal cell carcinoma that has come back after surgery or radiation, or in people who are not candidates for surgery or radiation. This is the kind of basal cell cancer that has grown deep or wide on the face, scalp, ear, or nose, where cutting it out would mean losing tissue that is hard to reconstruct, or where the same lesion keeps returning in the same spot. Typical patterns include a pearly or crusted patch that bleeds and scabs over and over for months, an ulcer that never fully heals, or a scar-like area that keeps spreading at the edges. Sonidegib is not approved for basal cell carcinoma that has spread to distant organs, and it is not used for squamous cell carcinoma or melanoma. It comes only as a single-ingredient capsule, so there are no combination products.
How do you take it?
Sonidegib comes as 200 mg capsules, and the usual adult dose is one 200 mg capsule by mouth once a day, which is also the daily ceiling. Take it on an empty stomach, at least 1 hour before or 2 hours after a meal, because food raises the amount absorbed several times over and increases side effects. Swallow the capsule whole and try to take it at about the same time each day. Avoid grapefruit and grapefruit juice. If you miss a dose, skip it and take your next dose at the regular time, and never take two capsules to catch up. If you vomit after a dose, do not repeat it. Your doctor checks blood creatine kinase and kidney function before you start and during treatment, and doses are often paused if muscle enzymes climb. Stop taking it and call your doctor the same day if you get severe or spreading muscle pain or weakness, dark or cola-colored urine, you are urinating much less than usual, or you think you may be pregnant.
Side effects to know
- Common: Most people get muscle spasms or cramps, muscle and joint pain, hair thinning or hair loss, a metallic or blunted sense of taste, fatigue, nausea, diarrhea, and weight or appetite loss, and hair and taste usually recover slowly after the drug is stopped.
- Serious: Stop the drug and get medical help right away for severe muscle pain or weakness with dark or cola-colored urine, urinating much less than usual, or confusion, which can mean rhabdomyolysis and kidney injury. Get emergency care for signs of a severe allergic reaction, including swelling of the lips, tongue, or throat, a spreading hives rash, or trouble breathing.
Who should not take it?
Do not take sonidegib if you are pregnant or could become pregnant without strict protection, because it causes severe birth defects and fetal death. If you can become pregnant, you need a negative pregnancy test within 7 days before your first dose and effective birth control during treatment and for 20 months after your last dose. Men taking sonidegib should use condoms, even after a vasectomy, during treatment and for 8 months after the last dose, and should not donate semen. Do not breastfeed during treatment or for 20 months after the last dose. Do not donate blood during treatment or for 20 months after the last dose. Tell your doctor if you have kidney or liver problems, a muscle disorder, or a history of high creatine kinase. Avoid strong and moderate CYP3A inhibitors such as ketoconazole, itraconazole, clarithromycin, and ritonavir, and avoid strong and moderate CYP3A inducers such as rifampin, carbamazepine, efavirenz, and St. John's wort, since these change sonidegib levels in either direction. Bring your full list of prescriptions, over the counter drugs, and supplements to every visit. There is no specific alcohol interaction on the label, but heavy drinking adds to nausea and dehydration and makes muscle and kidney problems harder to spot, so keep intake light or skip it.
When is it an emergency?
If you or someone else takes more sonidegib than prescribed, call Poison Control at 1-800-222-1222 right away, even if there are no symptoms yet, since extra doses mainly increase muscle and stomach side effects that build over days. Call 911 for collapse, fainting, seizure, trouble breathing, or swelling of the face, lips, tongue, or throat. Go to an emergency room for severe whole-body muscle pain or weakness with dark or cola-colored urine, very little urine, or a very fast heartbeat, and for repeated vomiting or diarrhea that leaves you unable to keep fluids down. If you find out you are pregnant while taking sonidegib, stop the drug and call your oncology team the same day.
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Common questions
What is the maximum dose of sonidegib per day?
The approved dose is one 200 mg capsule once a day, and that is also the ceiling. There is no benefit to taking more, and higher exposure mainly raises muscle pain and creatine kinase levels. Doses are not increased if the tumor responds slowly. If side effects build up, your doctor pauses the drug rather than lowering it, because 200 mg is the only strength made. Treatment often restarts at the same 200 mg dose or on an every-other-day schedule once symptoms settle.
Can I drink alcohol while taking sonidegib?
The label does not list a specific alcohol interaction, so an occasional drink is not forbidden. The practical problem is overlap: sonidegib already causes nausea, appetite loss, diarrhea, and muscle pain, and alcohol worsens all of those and dehydrates you. Dehydration matters more here because muscle breakdown and kidney strain are the serious risks with this drug. If you drink, keep it light, drink water alongside it, and skip alcohol entirely during any week when your muscles ache or your creatine kinase is up. Tell your doctor honestly how much you drink so lab results get read correctly.
Is sonidegib safe in pregnancy or while breastfeeding?
No. Sonidegib causes severe birth defects and fetal death, and this is the drug's boxed warning. If you can become pregnant, you need a negative pregnancy test within 7 days before your first dose and effective contraception during treatment and for 20 months after the last dose. Men need to use condoms during treatment and for 8 months after the last dose, including after a vasectomy, and should not donate semen. Do not breastfeed during treatment or for 20 months after your final dose. If you become pregnant on this drug, stop it and call your oncology team the same day.
Do I take sonidegib with food?
No, take it on an empty stomach, at least 1 hour before eating or 2 hours after a meal. Food, especially a high-fat meal, sharply increases how much drug your body absorbs, which raises the risk of muscle problems without helping the cancer. Many people find bedtime works well, since that is often two or more hours past dinner. Skip grapefruit and grapefruit juice completely, because they raise levels the same way. If nausea is the problem, ask about an anti-nausea medicine instead of taking the capsule with food.
What are the signs of taking too much sonidegib?
Extra doses show up as worsening muscle pain, cramps, and weakness, along with nausea, vomiting, diarrhea, and fatigue that get steadily worse over days rather than hitting all at once. The dangerous version is rhabdomyolysis: severe muscle pain or weakness with dark or cola-colored urine and reduced urination. Call Poison Control at 1-800-222-1222 right away if you take more than one capsule in a day, even if you feel fine. Call 911 for fainting, seizure, trouble breathing, or throat swelling. Bring the bottle or a photo of the label with you if you go in.
What medicines interact with sonidegib?
Sonidegib is broken down by the liver enzyme CYP3A, so drugs that block or speed up that enzyme change your levels a lot. Avoid strong and moderate CYP3A inhibitors such as ketoconazole, itraconazole, clarithromycin, ritonavir, and diltiazem, which push levels up and increase muscle side effects. Avoid strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, efavirenz, and St. John's wort, which drop levels enough to make the drug less effective. Statins deserve a specific conversation, since both can raise creatine kinase and cause muscle pain. Show your full medication and supplement list to your oncology team before starting anything new, including antibiotics and antifungals.