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GEMCITABINE

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Gemcitabine Adverse Events Reported to the FDA Over Time

How are Gemcitabine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Gemcitabine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Gemcitabine is flagged as the suspect drug causing the adverse event.

Most Common Gemcitabine Adverse Events Reported to the FDA

What are the most common Gemcitabine adverse events reported to the FDA?

Pyrexia
1207 (1.81%)
Thrombocytopenia
1171 (1.76%)
Anaemia
1165 (1.75%)
Nausea
988 (1.48%)
Dyspnoea
949 (1.42%)
Vomiting
879 (1.32%)
Neutropenia
868 (1.3%)
Malignant Neoplasm Progression
867 (1.3%)
Dehydration
820 (1.23%)
Pneumonia
795 (1.19%)
Death
746 (1.12%)
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Platelet Count Decreased
742 (1.11%)
Diarrhoea
669 (1%)
Haemoglobin Decreased
662 (.99%)
Pulmonary Embolism
629 (.94%)
Asthenia
615 (.92%)
Fatigue
611 (.92%)
Pleural Effusion
595 (.89%)
Interstitial Lung Disease
585 (.88%)
White Blood Cell Count Decreased
585 (.88%)
Oedema Peripheral
496 (.74%)
Abdominal Pain
488 (.73%)
Disease Progression
476 (.71%)
Sepsis
471 (.71%)
General Physical Health Deteriorati...
456 (.68%)
Renal Failure Acute
435 (.65%)
Febrile Neutropenia
403 (.6%)
Deep Vein Thrombosis
391 (.59%)
Renal Failure
390 (.59%)
Pancytopenia
371 (.56%)
Decreased Appetite
347 (.52%)
Leukopenia
334 (.5%)
Ascites
323 (.48%)
Rash
321 (.48%)
Infection
317 (.48%)
Hypotension
310 (.47%)
Respiratory Failure
303 (.45%)
Neoplasm Progression
298 (.45%)
Confusional State
286 (.43%)
Constipation
283 (.42%)
Neutrophil Count Decreased
282 (.42%)
Aspartate Aminotransferase Increase...
278 (.42%)
Alanine Aminotransferase Increased
276 (.41%)
Pneumonitis
276 (.41%)
Pain
272 (.41%)
Malaise
270 (.41%)
Chills
263 (.39%)
Blood Creatinine Increased
253 (.38%)
Epistaxis
242 (.36%)
Haemolytic Uraemic Syndrome
241 (.36%)
Cholangitis
237 (.36%)
Drug Toxicity
233 (.35%)
Anorexia
229 (.34%)
Hyponatraemia
228 (.34%)
Headache
224 (.34%)
Dizziness
223 (.33%)
Disseminated Intravascular Coagulat...
220 (.33%)
Weight Decreased
220 (.33%)
Urinary Tract Infection
217 (.33%)
Cardiac Failure
206 (.31%)
Haematocrit Decreased
204 (.31%)
Hypertension
203 (.3%)
Blood Alkaline Phosphatase Increase...
202 (.3%)
Chest Pain
202 (.3%)
Hypoxia
198 (.3%)
Mucosal Inflammation
198 (.3%)
Off Label Use
196 (.29%)
Syncope
195 (.29%)
Hypokalaemia
190 (.29%)
Hepatic Failure
188 (.28%)
Pulmonary Oedema
187 (.28%)
Gastrointestinal Haemorrhage
185 (.28%)
Cough
184 (.28%)
Atrial Fibrillation
181 (.27%)
Lung Disorder
181 (.27%)
Cerebral Infarction
177 (.27%)
Erythema
174 (.26%)
Myocardial Infarction
173 (.26%)
Condition Aggravated
172 (.26%)
Back Pain
171 (.26%)
Bone Marrow Failure
171 (.26%)
Cellulitis
169 (.25%)
Blood Bilirubin Increased
166 (.25%)
Septic Shock
166 (.25%)
White Blood Cell Count Increased
166 (.25%)
Neoplasm Malignant
162 (.24%)
Tachycardia
162 (.24%)
Fall
161 (.24%)
Convulsion
157 (.24%)
Acute Respiratory Distress Syndrome
152 (.23%)
Generalised Oedema
145 (.22%)
C-reactive Protein Increased
144 (.22%)
Haemoptysis
144 (.22%)
Pain In Extremity
144 (.22%)
Jaundice
142 (.21%)
Cardiac Failure Congestive
141 (.21%)
Thrombosis
141 (.21%)
Thrombotic Microangiopathy
141 (.21%)
Oedema
139 (.21%)
Lung Infiltration
138 (.21%)
Metastases To Liver
138 (.21%)

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This graph shows the top adverse events submitted to the FDA for Gemcitabine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Gemcitabine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Gemcitabine

What are the most common Gemcitabine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Gemcitabine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Gemcitabine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Gemcitabine According to Those Reporting Adverse Events

Why are people taking Gemcitabine, according to those reporting adverse events to the FDA?

Non-small Cell Lung Cancer
3326
Pancreatic Carcinoma
2654
Breast Cancer
659
Breast Cancer Metastatic
647
Pancreatic Carcinoma Metastatic
618
Bladder Cancer
570
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Adenocarcinoma Pancreas
523
Lung Neoplasm Malignant
519
Ovarian Cancer
422
Bile Duct Cancer
370
Transitional Cell Carcinoma
275
Pancreatic Carcinoma Stage Iv
264
Chemotherapy
185
Hodgkins Disease
180
Neoplasm Malignant
172
Non-small Cell Lung Cancer Stage Iv
171
Lung Adenocarcinoma
158
Pancreatic Carcinoma Non-resectable
155
Non-hodgkins Lymphoma
151
Drug Use For Unknown Indication
145
Diffuse Large B-cell Lymphoma
97
Product Used For Unknown Indication
94
Adenocarcinoma
91
Gallbladder Cancer
90
Lung Cancer Metastatic
88
Hepatic Neoplasm Malignant
77
Ovarian Cancer Recurrent
76
Non-small Cell Lung Cancer Metastat...
74
Metastatic Renal Cell Carcinoma
67
Neoplasm
64
Renal Cell Carcinoma
62
Lymphoma
60
Mesothelioma
60
Non-small Cell Lung Cancer Stage Ii...
59
Sarcoma
57
Metastatic Neoplasm
53
Bronchial Carcinoma
53
Bladder Transitional Cell Carcinoma
51
Renal Cell Carcinoma Stage Unspecif...
49
Lung Squamous Cell Carcinoma Stage ...
47
Lung Adenocarcinoma Stage Iv
47
Adjuvant Therapy
43
Bile Duct Cancer Stage Iv
42
Metastases To Liver
38
Renal Cancer Metastatic
38
Pleural Mesothelioma Malignant
37
Squamous Cell Carcinoma
36
Small Cell Lung Cancer Stage Unspec...
36
Gallbladder Cancer Stage Iv
36
Non-small Cell Lung Cancer Recurren...
36
Leiomyosarcoma
35

Drug Labels

LabelLabelerEffective
Gemcitabine HclSandoz Inc04-FEB-11
GemcitabineSagent Pharmaceuticals09-MAR-11
Gemcitabine HydrochlorideWatson Laboratories, Inc.01-APR-11
GemcitabineHospira, Inc.01-APR-11
Gemzar Eli Lilly and Company 24-JUN-11
Gemcitabine HydrochloridePfizer Laboratories Div Pfizer Inc.13-JUL-11
GemcitabineSun Pharma Global FZE26-JUL-11
GemcitabineDr. Reddy's Laboratories Limited 30-AUG-11
Gemcitabine HydrochlorideAPP Pharmaceuticals, LLC12-SEP-11
GemcitabineHospira, Inc.07-OCT-11
GemcitabineBedford Laboratories11-DEC-11
Gemcitabine HydrochlorideAccord Healthcare, Inc.01-JAN-12
Gemcitabine HydrochlorideAPP Pharmaceuticals, LLC02-MAR-12
Gemcitabine HydrochlorideTeva Parenteral Medicines, Inc.13-AUG-12
Gemcitabine Hydrochloridehameln rds gmbh15-SEP-12
Gemcitabine HydrochlorideHeritage Pharmaceuticals Inc.13-OCT-12
GemcitabineHospira, Inc.05-JAN-13

Gemcitabine Case Reports

What Gemcitabine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Gemcitabine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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