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Xalkori (Crizotinib) - Side Effect Reports to FDA

 
 



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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