What the label lists and what reports show
Ceritinib side effects
Ceritinib's FDA label: “The most common adverse reactions (incidence of ≥ 25%) in patients treated with ZYKADIA 450 mg with food are diarrhea, nausea, abdominal pain, vomiting, and fatigue; …” FAERS holds 2,378 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 malignant neoplasm progression (427 reports).
- No generic listed
Check it at the source: the ceritinib FDA label on DailyMed (effective December 15, 2025, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZYKADIA?ZYKADIA may cause serious side effects, including: See "What is the most important information I should know about ZYKADIA?" High blood sugar (hyperglycemia). People who have diabetes or glucose intolerance or who take a corticosteroid medicine have an increased risk of high blood sugar with ZYKADIA. Your healthcare provider will check your blood sugar level before starting ZYKADIA and as needed during treatment with ZYKADIA. Call your healthcare provider right away if you have any symptoms of high blood sugar, including: • increased thirst • increased hunger • headaches • trouble thinking or concentrating • urinating often • blurred vision • tiredness • your breath smells like fruit Inflammation of the pancreas (pancreatitis). ZYKADIA can cause pancreatitis that has led to death. You may develop increased pancreatic enzyme blood levels, which may be a sign of pancreatitis. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set fff5d805-4ffd-4e8e-8e63-6f129697563e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence of ≥ 25%) in patients treated with ZYKADIA 450 mg with food are diarrhea, nausea, abdominal pain, vomiting, and fatigue; and with ZYKADIA 750 mg under fasted conditions are diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss.
Table 3: Adverse Reactions (> 10% for All Grades* or ≥ 2% for Grades 3-4) of Patients in ASCEND-4
| Reaction | All Grades % | Grade 3-4 % | All Grades % | Grade 3-4 % |
|---|---|---|---|---|
| Diarrhea | 85 | 4.8 | 11 | 1.1 |
| Nausea | 69 | 2.6 | 55 | 5 |
| Vomiting | 67 | 5 | 36 | 6 |
| Abdominal pain b | 40 | 3.7 | 13 | 0 |
| Constipation | 20 | 0 | 22 | 0 |
| Esophageal disorder c | 15 | 0.5 | 8 | 0.6 |
| Fatigue d | 45 | 7 | 49 | 6 |
| Non-cardiac chest pain | 21 | 1.1 | 10 | 0.6 |
| Back pain | 19 | 1.6 | 18 | 2.3 |
| Pyrexia | 19 | 0 | 14 | 1.1 |
| Pain in extremity | 13 | 0 | 7 | 0 |
| Musculoskeletal pain | 11 | 0.5 | 6 | 0.6 |
| Pruritus | 11 | 0.5 | 5 | 0 |
| Decreased appetite | 34 | 1.1 | 32 | 1.1 |
| Weight loss | 24 | 3.7 | 15 | 0.6 |
| Cough | 25 | 0 | 17 | 0 |
| Rash e | 21 | 1.1 | 8 | 0.6 |
| Headache | 19 | 0.5 | 13 | 1.1 |
| Dizziness | 12 | 1.1 | 10 | 0.6 |
| Prolonged QT interval | 12 | 2.6 | 1.1 | 0.6 |
| Pericarditis f | 4.2 | 1.6 | 2.3 | 1.1 |
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: Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.3)] QT Interval Prolongation [see Warnings and Precautions (5.4)] Hyperglycemia [see Warnings and Precautions (5.5)] Bradycardia [see Warnings and Precautions (5.6)] Pancreatitis [see Warnings and Precautions (5.7)] The most common adverse reactions (incidence of ≥ 25%) in patients treated with ZYKADIA 450 mg with food are diarrhea, nausea, abdominal pain, vomiting, and fatigue; and with ZYKADIA 750 mg under fasted conditions are diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 practice.
Source: FDA drug label, 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?
2,378 reports list ceritinib among the medicines taken, 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. Of the 21 reactions below, 12 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?
- Ceritinib: 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