Prescription medicine
Ceritinib Brand names: Zykadia
Ceritinib (Zykadia) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ceritinib FDA label on DailyMed (effective December 15, 2025, Novartis Pharmaceuticals Corporation); the NDA 205755 record on Drugs@FDA; every ceritinib label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)].
Forms and strengths
- 150 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 29, 2014 Zykadia, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 13, 2037 Zykadia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,378 through July 30, 2026
What is ceritinib used for?
From the label: indications and usageZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)]. ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Conditions named in the indications of ceritinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (ZYKADIA), Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set fff5d805-4ffd-4e8e-8e63-6f129697563e), via openFDA; the full label on DailyMed
What does the patient leaflet for ceritinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZYKADIA?ZYKADIA may cause serious side effects, including: Stomach and intestinal (gastrointestinal) problems. ZYKADIA may cause stomach and intestinal problems, including diarrhea, nausea, vomiting, and stomach-area pain. Follow your healthcare provider’s instructions about taking medicines to help with these symptoms. Call your healthcare provider for advice if your symptoms are severe or cannot be tolerated. Liver problems. ZYKADIA may cause liver injury. Your healthcare provider should do blood tests at least every month to check your liver during treatment with ZYKADIA. Tell your healthcare provider right away if you get any of the following: • you feel tired • you have itchy skin • your skin or the whites of your eyes turn yellow • you have nausea or vomiting • you have a decreased appetite • you have pain on the right side of your stomach-area • your urine turns dark or brown (tea color) • you bleed or bruise more easily than normal Lung problems (pneumonitis). ZYKADIA may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including: • trouble breathing or shortness of breath • cough with or without mucus • fever • chest pain Heart problems. ZYKADIA may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your heart during treatment with ZYKADIA. Tell your healthcare provider right away if you feel new chest pain or discomfort, dizziness or lightheadedness, if you faint, or have abnormal heartbeats. Tell your healthcare provider if you start to take or have any changes in heart or blood pressure medicines. […]
From the patient leaflet: What should I avoid while taking ZYKADIA?You should not drink grapefruit juice or eat grapefruit during treatment with ZYKADIA. It may make the amount of ZYKADIA in your blood increase to a harmful level. Avoid spending time in sunlight during treatment with ZYKADIA. Your skin may become more sensitive to the sun and you may burn more easily. Use sunscreen and wear protective clothing that covers your skin to help protect against sunburn.
From the patient leaflet: How should I store ZYKADIA?Store ZYKADIA at room temperature between 68°F to 77°F (20°C to 25°C). Keep ZYKADIA and all medicines out of the reach of children.
Source: FDA drug label (ZYKADIA), Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set fff5d805-4ffd-4e8e-8e63-6f129697563e), via openFDA; the full label on DailyMed
Is there a generic for ceritinib (Zykadia)?
No generic ceritinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Zykadia tablets: the compound patent runs to January 18, 2032, and the last listed entry to December 13, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ceritinib label say about other medicines?
The ceritinib label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name ceritinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clonidine | warnings and precautions | Avoid using ZYKADIA in combination with other products known to cause bradycardia (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, and digoxin) to the extent possible. Monitor heart rate and blood pressure regularly. |
| Digoxin | warnings and precautions | Avoid using ZYKADIA in combination with other products known to cause bradycardia (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, and digoxin) to the extent possible. Monitor heart rate and blood pressure regularly. |
| Ketoconazole | drug interactions | Drugs on ZYKADIA Strong CYP3A Inhibitors A strong CYP3A4/P-gp inhibitor (ketoconazole) increased the systemic exposure of ceritinib [see Clinical Pharmacology (12.3)], which may increase the incidence and severity of adverse reactions of ZYKADIA. |
| Midazolam | drug interactions | Ceritinib increased the systemic exposure of a sensitive CYP3A substrate (midazolam) [see Clinical Pharmacology (12.3)]. |
| Rifampin | drug interactions | Strong CYP3A Inducers A strong CYP3A4/P-gp inducer (rifampin) decreased the systemic exposure of ceritinib [see Clinical Pharmacology (12.3)], which may decrease the efficacy of ZYKADIA. |
| Warfarin | drug interactions | CYP2C9 Substrates Ceritinib increased the systemic exposure of a CYP2C9 substrate (warfarin) [see Clinical Pharmacology (12.3)]. |
Other labels that name ceritinib
Source: FDA drug label (ZYKADIA), Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set fff5d805-4ffd-4e8e-8e63-6f129697563e), via openFDA; the full label on DailyMed
What do FAERS reports show for ceritinib?
The FDA Adverse Event Reporting System holds 2,378 reports that list ceritinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 552 are coded as a death and 587 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ceritinib?
26 other medicines are given the same way (oral) and in the same FDA class as ceritinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ceritinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Ceritinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other