What the label lists and what reports show
Crizotinib side effects
Crizotinib's FDA label: “The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.” FAERS holds 12,638 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 nausea (1,118 reports).
- No generic listed
Check it at the source: the crizotinib FDA label on DailyMed (effective July 22, 2025, Pfizer Laboratories Div Pfizer Inc); 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 XALKORI?XALKORI may cause serious side effects, including: • See " What is the most important information I should know about XALKORI? " The most common side effects of XALKORI in adults with NSCLC include: • vision problems • nausea, diarrhea, or vomiting • swelling of your hands, feet, face, or eyes • constipation • increased liver function blood tests • tiredness • decreased appetite • upper respiratory infection • dizziness • feeling of numbness or tingling in your arms or legs The most common side effects of XALKORI in people with ALCL include: • diarrhea, vomiting, or nausea • vision problems • headache • muscle and joint pain • mouth sores • tiredness • decreased appetite • fever • stomach-area (abdominal) pain • cough • itchy skin • low blood counts The most common side effects of XALKORI in adults with IMT include: • vision problems • nausea • swelling of your hands, feet, face, or […]
Source: FDA drug label, NDA217581 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective July 22, 2025 (SPL set 2a51b0de-47d6-455e-a94c-d2c737b04ff7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.
Table 13. Adverse Reactions in ≥20% of Patients with Systemic ALCL in Study ADVL0912
| Reaction | Adverse Reaction All Grades (%) | XALKORI N=26 Grade 3–4 (%) |
|---|---|---|
| Neutropenia Includes neutrophil count decreased. | 100 | 77 |
| Lymphopenia Includes lymphocyte count decreased. | 58 | 38 |
| Anemia | 54 | 3.8 |
| Thrombocytopenia Includes platelet count decreased. | 38 | 19 |
| Diarrhea | 92 | 12 |
| Vomiting | 92 | 3.8 |
| Nausea | 77 | 3.8 |
| Abdominal Pain | 50 | 0 |
| Stomatitis Includes oral pain, oropharyngeal pain, stomatitis. | 46 | 8 |
| Constipation | 31 | 0 |
| Blood creatinine increased | 100 | 0 |
| ALT increased | 81 | 3.8 |
| AST increased | 65 | 3.8 |
| Hypocalcemia | 62 | 3.8 |
| Hypoalbuminemia | 54 | 0 |
| Hyperglycemia | 46 | 0 |
| Hypomagnesemia | 46 | 0 |
| Hypoglycemia | 35 | 0 |
| Hypokalemia | 31 | 3.8 |
| Hypermagnesemia | 27 | 0 |
| Hyperkalemia | 23 | 0 |
| Headache | 58 | 3.8 |
| Dysgeusia | 23 | 0 |
| Dizziness | 23 | 0 |
| Vision disorders Includes blurred vision, visual impairment, photophobia, photopsia,… | 65 | 0 |
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: • Hepatotoxicity [see Warnings and Precautions (5.1) ] • Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] • QT Interval Prolongation [see Warnings and Precautions (5.3) ] • Bradycardia [see Warnings and Precautions (5.4) ] • Severe Visual Loss [see Warnings and Precautions (5.5) ] • Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. ( 6.1 ) The most common adverse reactions (≥35%) in patients with ALCL are diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3–4 laboratory abnormalities (≥15%) are neutropenia, lymphopenia, and thrombocytopenia. ( 6.1 ) The most common adverse reactions (≥35%) in adult patients with IMT are vision disorders, nausea, and edema. …
Source: FDA drug label, NDA217581 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective July 22, 2025 (SPL set 2a51b0de-47d6-455e-a94c-d2c737b04ff7), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,638 reports list crizotinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,792 are coded as a death and 3,067 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 20 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?
- Crizotinib: 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