This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xalkori (Crizotinib) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (611)
Death (168)
Life Threatening Events (4)
Reports by Reaction Type
Nausea (121),
Disease Progression (106),
Death (106),
Vomiting (93),
Diarrhoea (75),
Constipation (68),
Lung Neoplasm Malignant (56),
Fatigue (48),
Oedema Peripheral (44),
Visual Impairment (43),
Decreased Appetite (35),
Vision Blurred (34)
Below are a few examples of reports where side effects / adverse reactions may be related to Xalkori (Crizotinib). For a complete list or a specific selection of reports, please use the links above.
Possible Xalkori side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 58 year old female
Reactions: Visual Impairment, Oedema Peripheral, Paraesthesia
Drug(s) suspected as cause:
Xalkori
Dosage: 250 mg, 1x/day
Administration route: Oral
Start date: 2012-05-11
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
End date: 2012-05-02
Xalkori
Dosage: 250 mg, 2 pills one day alternating with one pill per day
Administration route: Oral
Start date: 2012-06-04
End date: 2012-06-19
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
Start date: 2012-06-19
Possible Xalkori side effects in 53 year old female
Reported by a physician from Japan on 2012-08-27
Patient: 53 year old female
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 60 year old female
Reactions: Death, Fatigue
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 46 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 46 year old male
Reactions: Nausea, Insomnia, Dizziness
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 43 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 43 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 62 year old female
Reactions: Sensation of Foreign Body
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 44 year old female
Reported by a physician from United States on 2012-08-24
Patient: 44 year old female, weighing 49.0 kg (107.8 pounds)
Reactions: Ileal Ulcer, Rectal Ulcer, Rectal Haemorrhage
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 72 year old female
Reported by a physician from Japan on 2012-08-23
Patient: 72 year old female
Reactions: Interstitial Lung Disease, Lung Neoplasm Malignant, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
Start date: 2012-07-10
End date: 2012-07-23
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2012-07-04
End date: 2012-07-07
Possible Xalkori side effects in 71 year old female
Reported by a physician from Israel on 2012-08-23
Patient: 71 year old female
Reactions: Death, Respiratory Disorder, Dyspnoea, Pneumonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xalkori
Other drugs received by patient: Crestor; Omeprazole; Dexamethasone; Normalol; Cozaar; Pramin; Paraffin, Liquid; Oxycodone HCL; Duragesic-100
Possible Xalkori side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male
Reactions: Neoplasm Malignant, Disease Progression
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 44 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 44 year old male
Reactions: Urticaria, Visual Impairment, Vision Blurred, Photopsia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xalkori
Other drugs received by patient: Percocet
Possible Xalkori side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 75 year old male
Reactions: Neuropathy Peripheral, Oedema Peripheral, Foreign Body, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 48 year old female
Reactions: Oral Mucosal Blistering, Oesophageal Pain, Stomatitis, Vomiting, Nausea, Constipation, Malaise, Oesophagitis, Dyspepsia, DRY Mouth, Influenza Like Illness
Drug(s) suspected as cause:
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
Indication: non-Small Cell Lung Cancer
Start date: 2012-01-06
Xalkori
Dosage: 250 mg, 2x/day
Start date: 2012-08-03
Other drugs received by patient: Cymbalta; Estradiol; Folic Acid; Singulair; Amiloride Hydrochloride; Medrol; Oxycontin; Trazodone; Lasix; Olopatadine Hydrochloride; Advair Diskus 100 / 50; Ondansetron Hydrochloride; Lansoprazole; Lorazepam; Lyrica; Oxycodone Hydrochloride; Calcium Carbonate; Oxycontin; Xanax
Possible Xalkori side effects in 60 year old female
Reported by a physician from Israel on 2012-08-22
Patient: 60 year old female
Reactions: Pericardial Effusion
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in female
Reported by a pharmacist from United States on 2012-08-21
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in
Reported by a physician from United States on 2012-08-20
Patient:
Reactions: Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 52 year old female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 52 year old female
Reactions: Lung Neoplasm Malignant, Disease Progression
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in
Reported by a physician from United States on 2012-08-20
Patient:
Reactions: Lung Infiltration
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 79 year old male
Reported by a physician from United States on 2012-08-20
Patient: 79 year old male
Reactions: Death, Heart Rate Decreased
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Dosage: 200 mg, 2x/day (twice daily)
Xalkori
Dosage: 250 mg, 2x/day
Indication: Lung Neoplasm Malignant
Possible Xalkori side effects in 76 year old male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 76 year old male
Reactions: Pneumonia, Diarrhoea, Constipation
Adverse event resulted in: death
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 60 year old female
Reported by a physician from Japan on 2012-08-20
Patient: 60 year old female, weighing 74.0 kg (162.8 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Interstitial Lung Disease, non-Small Cell Lung Cancer, Disease Progression
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
Indication: non-Small Cell Lung Cancer
Start date: 2012-04-29
End date: 2012-05-31
Xalkori
Dosage: 200 mg, single
Administration route: Oral
Start date: 2012-06-13
End date: 2012-06-13
Xalkori
Dosage: 200 mg, 2x/day
Administration route: Oral
Start date: 2012-07-05
End date: 2012-07-09
Other drugs received by patient: Sennoside A+B Calcium; Magnesium Oxide; Decadron Phosphate; Lansoprazole; Lasix
Possible Xalkori side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 49 year old male
Reactions: Neoplasm Malignant, Disease Progression
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 57 year old male
Reported by a physician from Japan on 2012-08-20
Patient: 57 year old male, weighing 40.9 kg (90.0 pounds)
Reactions: Cholecystitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xalkori
Other drugs received by patient: Loxonin; Alfarol; Lendormin; Rabeprazole Sodium; Prochlorperazine; Haloperidol; Decadron Phosphate; Oxycontin; Petrolatum; Primperan TAB; Magnesium Oxide; Aspara-CA
Possible Xalkori side effects in 72 year old male
Reported by a physician from United States on 2012-08-20
Patient: 72 year old male
Reactions: Lung Neoplasm Malignant, Disease Progression
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 73 year old female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 73 year old female
Reactions: Vomiting, Diarrhoea, Nausea, Chest Pain, Pain in JAW
Drug(s) suspected as cause:
Xalkori
Other drugs received by patient: Tarceva
Possible Xalkori side effects in 40 year old male
Reported by a physician from United States on 2012-08-17
Patient: 40 year old male
Reactions: Diarrhoea, Visual Impairment, Constipation
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 58 year old male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 58 year old male
Reactions: Muscle Spasms
Drug(s) suspected as cause:
Xalkori
Possible Xalkori side effects in 88 year old male
Reported by a physician from Israel on 2012-08-17
Patient: 88 year old male
Reactions: Dyspnoea, Oedema Peripheral, Pulmonary Congestion
Drug(s) suspected as cause:
Xalkori
Dosage: 250 mg, 2x/day
Indication: Anaplastic Lymphoma Kinase Gene Mutation
Xalkori
Indication: non-Small Cell Lung Cancer
Possible Xalkori side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 49 year old female
Reactions: Dizziness
Drug(s) suspected as cause:
Clarithromycin
Dosage: unk
Xalkori
Dosage: 200 mg, 1x/day
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-09-28
Possible Xalkori side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female
Reactions: Lymphadenopathy, Vomiting, Drug Ineffective, Nausea, Haemoptysis, Musculoskeletal Pain, Headache, Constipation, Product Size Issue, Neoplasm Malignant, Unevaluable Event, Decreased Appetite
Adverse event resulted in: death
Drug(s) suspected as cause:
Oxycodone HCL
Dosage: 10-20 mg q3-4 h prn
Indication: Pain
Start date: 2012-01-31
Oxycontin
Dosage: 10 mg, q12h
Indication: Pain
Start date: 2012-01-31
Xalkori
Dosage: 250 mg, bid
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2012-02-22
End date: 2012-02-29
Other drugs received by patient: MS Contin; Tylenol (Caplet); Senokot; Zofran; Roxanol; Robitussin / 00048001 /; Klonopin; Sudafed S.a.; Chloraseptic; Vitamin B6; Vitamin B12 / 00056201 /; Tussionex; Viactiv / 00751501 /; Ambien; Fosamax
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