This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gemzar (Gemcitabine) 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 (598)
Death (298)
Life Threatening Events (58)
Disability (14)
Reports by Reaction Type
Death (136),
Neoplasm Progression (100),
Interstitial Lung Disease (57),
Thrombocytopenia (32),
Anaemia (31),
Renal Failure Acute (28),
White Blood Cell Count Decreased (28),
Off Label Use (26),
Pyrexia (25),
Decreased Appetite (24),
Constipation (22),
Neoplasm Malignant (22)
Below are a few examples of reports where side effects / adverse reactions may be related to Gemzar (Gemcitabine). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Italy on 2012-08-07
Patient: male
Reactions: Bone Marrow Failure, Dysplasia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gemzar
Dosage: 50 mg, weekly (1/w)
Indication: Bladder Cancer
Start date: 2009-07-01
Gemzar
Dosage: 1600 mg, other
Start date: 2009-07-13
End date: 2009-11-12
Other drugs received by patient: Prednisone TAB; Monocinque; Lansoprazole; Carboplatin; Tenormin; Zestoretic
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