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Gemzar (Gemcitabine) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (598)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Gemzar (Gemcitabine) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 598   Next >>

Possible Gemzar side effects in female

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient: female, weighing 55.8 kg (122.8 pounds)

Reactions: Off Label Use, Dysgeusia, Vomiting, Fatigue, Nausea, Platelet Count Decreased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar

Gemzar
    Dosage: 1550 mg, other
    Indication: Gallbladder Cancer non-Resectable
    Start date: 2011-08-01
    End date: 2011-08-15

Zyprexa
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Nausea
    Start date: 2011-08-04
    End date: 2011-08-10

Other drugs received by patient: Pursennid / SCH /; Loxonin; Tramal / GFR /; Rabeprazole Sodium; Cisplatin; TS 1; Azunol; Magmitt



Possible Gemzar side effects in female

Reported by a physician from Germany on 2012-08-27

Patient: female

Reactions: Osteonecrosis

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in male

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Off Label Use, White Blood Cell Count Decreased, Neoplasm Progression, Metastases To Bone, Nephrotic Syndrome, Acute Prerenal Failure

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Alimta
    Dosage: 750 mg, every 3 weeks
    Indication: Pleural Mesothelioma Malignant
    Start date: 2009-03-12
    End date: 2009-09-24

Gemzar
    Dosage: unk
    Start date: 2010-05-28
    End date: 2010-06-04

Other drugs received by patient: Amlodipine; Vitamin B12; Panvitan; Calblock; Amlodipine; Cisplatin



Possible Gemzar side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Bedridden, Oedema Peripheral, Pleural Effusion, Asthenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in 74 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 74 year old male

Reactions: Cholangitis

Drug(s) suspected as cause:
Gemzar

Other drugs received by patient: Cisplatin



Possible Gemzar side effects in male

Reported by a physician from Japan on 2012-08-24

Patient: male

Reactions: Lung Disorder

Drug(s) suspected as cause:
Gemzar

Other drugs received by patient: Docetaxel



Possible Gemzar side effects in 56 year old male

Reported by a physician from France on 2012-08-22

Patient: 56 year old male

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: total dose:456mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-02-04
    End date: 2005-03-24

Gemzar
    Dosage: formulation-gemzar 1000 mg powder for sol for inf total dose:11.826mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-02-04
    End date: 2005-04-01

Paraplatin
    Dosage: formulation-paraplatine powder for sol for inj total dose:1.064mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-06-13
    End date: 2005-07-04

Paxene
    Dosage: paxene 6mg/ml solution for inf total dose:746mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-06-13
    End date: 2005-07-04

Other drugs received by patient: Foradil; Fluticasone Propionate / Salmeterol; Acetaminophen



Possible Gemzar side effects in female

Reported by a physician from Brazil on 2012-08-21

Patient: female, weighing 57.8 kg (127.2 pounds)

Reactions: Blood Pressure Increased, Death, Pyrexia, Tremor, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemzar
    Dosage: 1470 mg, other
    Indication: Pancreatic Carcinoma

Gemzar
    Dosage: 1580 mg, cycle

Other drugs received by patient: Glyburide; Tramadol HCL; Dipyrone TAB; Metformin HCL; Aspirin



Possible Gemzar side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male, weighing 70.7 kg (155.6 pounds)

Reactions: HIP Fracture, Joint Swelling, Neoplasm Progression, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Death, Off Label Use

Adverse event resulted in: death

Drug(s) suspected as cause:
Gemzar

Other drugs received by patient: Vinorelbine



Possible Gemzar side effects in female

Reported by a physician from France on 2012-08-16

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: General Physical Health Deterioration

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: Breast Cancer
    Start date: 2008-01-10
    End date: 2011-03-01

Gemzar
    Indication: Chemotherapy
    Start date: 2010-12-21
    End date: 2011-03-01



Possible Gemzar side effects in female

Reported by a physician from Japan on 2012-08-16

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Haemoglobin Decreased, White Blood Cell Count Decreased, Nausea, Platelet Count Decreased, Decreased Appetite

Drug(s) suspected as cause:
Gemzar
    Dosage: 1500 mg, other
    Indication: Gallbladder Cancer Stage IV
    Start date: 2011-07-25
    End date: 2011-08-29

Gemzar
    Dosage: 1300 mg, unk
    Start date: 2011-10-10
    End date: 2011-12-05

Other drugs received by patient: Cisplatin; Cisplatin



Possible Gemzar side effects in male

Reported by a physician from Germany on 2012-08-15

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Fatigue, General Physical Health Deterioration, Muscular Weakness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar
    Dosage: 1200mgm2 cyclic
    Indication: Sarcoma
    Start date: 2012-04-11

Votrient
    Dosage: 400mg per day
    Administration route: Oral
    Indication: Sarcoma
    Start date: 2012-04-11



Possible Gemzar side effects in female

Reported by a consumer/non-health professional from Hong Kong on 2012-08-15

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Thrombocytopenia, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in female

Reported by a consumer/non-health professional from France on 2012-08-15

Patient: female

Reactions: Neuropathy Peripheral

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in 46 year old female

Reported by a physician from United States on 2012-08-15

Patient: 46 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Vomiting, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar
    Dosage: 1000mgm2 per day
    Indication: Neoplasm
    Start date: 2012-07-26

Lapatinib
    Administration route: Oral
    Indication: Neoplasm
    Start date: 2012-07-12



Possible Gemzar side effects in female

Reported by a physician from Brazil on 2012-08-14

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Mucosal Inflammation, Neoplasm Progression, Neutropenia, Erythropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Gemzar
    Dosage: 1412 mg, unknown
    Start date: 2012-05-06

Gemzar
    Dosage: 1412 mg, unknown
    Indication: Neoplasm Malignant
    Start date: 2012-04-29

Other drugs received by patient: Morfina / 00036301 /; Ondansetron; Docetaxel; Sertraline Hydrochloride; Docetaxel; Bromoprida; Dexametason



Possible Gemzar side effects in 77 year old male

Reported by a consumer/non-health professional from Japan on 2012-08-13

Patient: 77 year old male

Reactions: Intestinal Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in 79 year old male

Reported by a physician from Japan on 2012-08-13

Patient: 79 year old male

Reactions: Cerebral Infarction

Drug(s) suspected as cause:
Gemzar

Other drugs received by patient: Aqupla; Serotonin (5ht3) Antagonists; Dexamethasone; Minocycline Hydrochloride; Sigmart



Possible Gemzar side effects in 73 year old male

Reported by a consumer/non-health professional from Japan on 2012-08-10

Patient: 73 year old male

Reactions: Cerebral Infarction, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Gemzar
    Dosage: 1600 mg, unk

Gemzar
    Dosage: 1000 mg, unk



Possible Gemzar side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male, weighing 92.0 kg (202.4 pounds)

Reactions: Mental Disorder, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alimta
    Dosage: 500 mg/m2, every 21 days
    Indication: Lung Cancer Metastatic
    Start date: 2011-07-20
    End date: 2011-07-27

Gemzar
    Dosage: 1000 mg/m2, unk
    Indication: Lung Cancer Metastatic



Possible Gemzar side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Hepatic Mass, Abdominal Pain, Dyshidrosis, Lymphadenopathy, Intraocular Pressure Increased, Eczema, Dermatitis, Oesophagitis, Vertebral Foraminal Stenosis, Cervical Spinal Stenosis, Vulvitis, Back Pain, Oesophageal Pain, Cerumen Impaction, Duodenal Ulcer, Pancytopenia, Cervical Dysplasia, Osteopenia, Bursitis, Keratoacanthoma, Metastases To Spine, Metastases To Central Nervous System, Seborrhoeic Keratosis, Abscess Neck, Metastases To Meninges, Osteoporosis, Skin Exfoliation, Multiple Myeloma, Strabismus, Metastases To Lymph Nodes, Hypercholesterolaemia, Anhedonia, Chest Pain, Acquired Oesophageal WEB, Depression, Ophthalmoplegia, Decreased Appetite, Renal Failure Acute, Cataract, Haemorrhagic Erosive Gastritis, Musculoskeletal Pain, Palmar-Plantar Erythrodysaesthesia Syndrome, Facet Joint Syndrome, Syncope, Impaired Healing, Arthralgia, Alopecia, Disability, Night Sweats, Paronychia, Metastases To Liver, Metaplasia, Osteomyelitis, Tooth Infection, Lumbar Spinal Stenosis, Metastases To Eye, Dyspepsia, Ingrowing Nail, Carpal Tunnel Syndrome, Intervertebral Disc Protrusion, Actinic Keratosis, Hiatus Hernia, Chest Discomfort, Hydronephrosis, Pain in Extremity, Peptic Ulcer, Anaemia, Hypoaesthesia, Wound Infection, Paraesthesia, Fungal Infection, Ear Pain, Impaired Gastric Emptying, Neuralgia, Pain, Tenosynovitis Stenosans, Bone Pain, Neoplasm Progression, Synovial Cyst, Death, Diplopia, Intervertebral Disc Degeneration, Thrombocytopenia, Gastrooesophageal Reflux Disease, Spondylolisthesis, Squamous Cell Carcinoma, Cerebral Atrophy, Cystitis, Renal Failure Chronic, Deformity, Osteoarthritis, Anxiety, Barrett's Oesophagus, Skin Papilloma, Osteonecrosis of JAW, Neoplasm Malignant, Pollakiuria, Vertigo, Spinal Osteoarthritis, Bronchitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Aredia
    Indication: Metastases To Bone

Gemzar

Mobic

Zometa
    Indication: Metastases To Bone

Other drugs received by patient: Prinivil; Ciprofloxacin HCL; Iopamidol; Cytoxan; MS Contin; Timoptic; Tobradex; Avastin; Fluorouracil; Faslodex; Topamax; Cephalexin; Dilaudid; Carboplatin; Tamoxifen Citrate; Coumadin; Oxycodone HCL; Vioxx; Pravastatin; Meloxicam; Xeloda; Prilosec; Chemotherapeutics; Taxotere; Taxol; Omeprazole; Morphine; Femara; Amoxicillin and Clavulanate Potassium; Regranex; Cymbalta; Medrol; Epirubicin



Possible Gemzar side effects in 64 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 64 year old male

Reactions: Deep Vein Thrombosis

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09

Patient: male

Reactions: Palmar-Plantar Erythrodysaesthesia Syndrome, Toxic Skin Eruption

Drug(s) suspected as cause:
Doxorubicin HCL
    Indication: Mycosis Fungoides

Gemzar
    Indication: Mycosis Fungoides



Possible Gemzar side effects in male

Reported by a physician from France on 2012-08-09

Patient: male

Reactions: Medical Device Complication, Rash Erythematous, Neoplasm Progression, Pyrexia, Erysipelas

Drug(s) suspected as cause:
Alimta
    Dosage: unk, unknown
    Start date: 2011-10-01

Alimta
    Dosage: unk, unknown
    Indication: Pleural Mesothelioma
    Start date: 2008-01-01
    End date: 2009-01-01

Alimta
    Dosage: unk, unknown
    Start date: 2010-11-01
    End date: 2011-03-01

Gemzar
    Dosage: unk unk, other
    Indication: Pleural Mesothelioma
    Start date: 2012-04-03

Other drugs received by patient: Carboplatin; Carboplatin; Carboplatin



Possible Gemzar side effects in male

Reported by a physician from United States on 2012-08-08

Patient: male, weighing 95.7 kg (210.5 pounds)

Reactions: Neoplasm Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in male

Reported by a physician from Japan on 2012-08-08

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Interstitial Lung Disease, Neoplasm Progression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Alimta
    Dosage: 500 mg/m2, q21d
    Indication: non-Small Cell Lung Cancer Stage Iiib
    Start date: 2012-07-10
    End date: 2012-07-10

Gemzar
    Dosage: unk
    Indication: non-Small Cell Lung Cancer Stage Iiib
    Start date: 2012-02-21
    End date: 2012-06-05

Other drugs received by patient: Januvia; Lyrica; Alinamin F; Carnaculin / 00088101 /; Prednisolone; Sennoside / 00571901 /; Glimepiride; Procaterol HCL; Coldrin; Vitamin B12; Vitamin B12; Mucodyne; Folic Acid; Carboplatin; Methycool



Possible Gemzar side effects in 71 year old male

Reported by a physician from Japan on 2012-08-08

Patient: 71 year old male

Reactions: Abdominal Pain, Hepatic Failure, Haemolytic Uraemic Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemzar
    Dosage: 1520 mg, qd
    Start date: 2011-12-28
    End date: 2011-12-28

Gemzar
    Dosage: 1500 mg, weekly (1/w)
    Indication: Transitional Cell Carcinoma
    Start date: 2011-12-01
    End date: 2011-12-08

Gemzar
    Dosage: 1520 mg, qd
    Start date: 2012-01-04
    End date: 2012-01-04

Other drugs received by patient: Gemcitabine Hydrochloride; Carboplatin; Carboplatin; Taxol



Possible Gemzar side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: male

Reactions: Death, Hospitalisation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemzar



Possible Gemzar side effects in male

Reported by a physician from Italy on 2012-08-07

Patient: male

Reactions: Skin Exfoliation, Neutropenia, Purpura, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar

Other drugs received by patient: Cisplatin



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