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GRANISETRON

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Granisetron Adverse Events Reported to the FDA Over Time

How are Granisetron adverse event reports trending over time?

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

Most Common Granisetron Adverse Events Reported to the FDA

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

Fatigue
100 (3.26%)
Nausea
90 (2.94%)
Dyspnoea
87 (2.84%)
Vomiting
84 (2.74%)
Chest Discomfort
54 (1.76%)
Diarrhoea
54 (1.76%)
Malaise
44 (1.44%)
Rash
40 (1.31%)
Drug Interaction
37 (1.21%)
Chest Pain
36 (1.17%)
Convulsion
34 (1.11%)
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Hypotension
34 (1.11%)
Abdominal Pain
32 (1.04%)
Anaphylactic Shock
32 (1.04%)
Neutrophil Count Decreased
31 (1.01%)
Pyrexia
29 (.95%)
Headache
28 (.91%)
Pulmonary Artery Thrombosis
28 (.91%)
Decreased Appetite
27 (.88%)
Aspartate Aminotransferase Increase...
26 (.85%)
Stomatitis
26 (.85%)
Tachycardia
26 (.85%)
Alopecia
25 (.82%)
Constipation
25 (.82%)
Dehydration
25 (.82%)
Febrile Neutropenia
24 (.78%)
Hypertension
24 (.78%)
Chills
22 (.72%)
Cardio-respiratory Arrest
21 (.69%)
Death
20 (.65%)
Hyperhidrosis
20 (.65%)
Shock
20 (.65%)
General Physical Health Deteriorati...
19 (.62%)
Alanine Aminotransferase Increased
18 (.59%)
Gamma-glutamyltransferase Increased
18 (.59%)
Palmar-plantar Erythrodysaesthesia ...
18 (.59%)
Pruritus
18 (.59%)
Erythema
17 (.55%)
Dyskinesia
15 (.49%)
Cyanosis
14 (.46%)
Flushing
14 (.46%)
Haematoma
14 (.46%)
Injection Site Extravasation
14 (.46%)
International Normalised Ratio Incr...
14 (.46%)
Renal Failure Acute
14 (.46%)
Bradycardia
13 (.42%)
Contusion
13 (.42%)
Depressed Level Of Consciousness
13 (.42%)
Lymphopenia
13 (.42%)
Musculoskeletal Stiffness
13 (.42%)
Respiratory Depth Decreased
13 (.42%)
Thrombocytopenia
13 (.42%)
Abdominal Pain Upper
12 (.39%)
Blood Pressure Decreased
12 (.39%)
Cardiac Arrest
12 (.39%)
Myocardial Infarction
12 (.39%)
Neutropenia
12 (.39%)
Overdose
12 (.39%)
Swelling
12 (.39%)
Weight Decreased
12 (.39%)
Dizziness
11 (.36%)
Drug Ineffective
11 (.36%)
Hypersensitivity
11 (.36%)
Hyponatraemia
11 (.36%)
Inappropriate Antidiuretic Hormone ...
11 (.36%)
Muscle Spasms
11 (.36%)
Skin Exfoliation
11 (.36%)
Asthenia
10 (.33%)
Haemoglobin Decreased
10 (.33%)
Insomnia
10 (.33%)
Pain
10 (.33%)
Photosensitivity Reaction
10 (.33%)
Platelet Count Decreased
10 (.33%)
Somnolence
10 (.33%)
White Blood Cell Count Decreased
10 (.33%)
Anorexia
9 (.29%)
Atrial Fibrillation
9 (.29%)
Confusional State
9 (.29%)
Dystonia
9 (.29%)
Ileus
9 (.29%)
Loss Of Consciousness
9 (.29%)
Paraesthesia
9 (.29%)
Pneumonia Fungal
9 (.29%)
Pulmonary Oedema
9 (.29%)
Purpura
9 (.29%)
Tremor
9 (.29%)
Acute Generalised Exanthematous Pus...
8 (.26%)
Arthralgia
8 (.26%)
Dysphagia
8 (.26%)
Hallucination
8 (.26%)
Hepatitis Cholestatic
8 (.26%)
Hiccups
8 (.26%)
Hypoaesthesia
8 (.26%)
Intestinal Obstruction
8 (.26%)
Myalgia
8 (.26%)
Pain In Extremity
8 (.26%)
Renal Impairment
8 (.26%)
Sepsis
8 (.26%)
Skin Oedema
8 (.26%)
Swollen Tongue
8 (.26%)
Syncope
8 (.26%)

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This graph shows the top adverse events submitted to the FDA for Granisetron, 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 Granisetron 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 Granisetron

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

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This graph shows the top categories of adverse events submitted to the FDA for Granisetron, 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 Granisetron 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 Granisetron According to Those Reporting Adverse Events

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

Premedication
866
Prophylaxis
531
Prophylaxis Of Nausea And Vomiting
505
Drug Use For Unknown Indication
471
Nausea
414
Antiemetic Supportive Care
305
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Product Used For Unknown Indication
189
Vomiting
163
Chemotherapy
36
Breast Cancer
28
Lymphoma
20
Pancreatic Neoplasm
13
Multiple Myeloma
12
Ovarian Cancer
10
Ill-defined Disorder
9
Gastric Cancer
6
Breast Cancer Metastatic
6
Supportive Care
6
Fatigue
6
Prophylactic Chemotherapy
5
Acute Lymphocytic Leukaemia
5
Acute Myeloid Leukaemia
4
Endocrine Pancreatic Disorder
4
Lung Neoplasm Malignant
4
Insulinoma
4
Colorectal Cancer
4
Drug Toxicity Prophylaxis
3
Bronchial Carcinoma
3
Colon Cancer
3
Intermittent Claudication
3
Non-small Cell Lung Cancer
3
Endocrine Neoplasm
3
Postoperative Analgesia
3
Neuroblastoma
3
Non-hodgkins Lymphoma
3
Post Procedural Nausea
3
Breast Cancer Recurrent
3
Colon Cancer Metastatic
3
Evidence Based Treatment
3
Lung Adenocarcinoma
3
Infection Prophylaxis
2
Urethral Cancer
2
Abdominal Pain
2
Post Procedural Vomiting
2
Anaesthesia
2
Metastases To Liver
2
Bone Marrow Conditioning Regimen
2
Ewings Sarcoma
2
Procedural Nausea
2
Gastroenteritis Radiation
2
Nasal Cavity Cancer
2

Drug Labels

LabelLabelerEffective
SancusoPhysicians Total Care, Inc.30-SEP-09
Granisetron HydrochlorideCOREPHARMA LLC.01-FEB-10
Granisetron HydrochlorideMylan Pharmaceuticals Inc.11-FEB-10
Granisetron HydrochlorideAmerigen Pharmaceuticals, Inc04-MAY-10
Granisetron HydrochlorideBedford Laboratories07-MAY-10
Granisetron HydrochlorideTaro Pharmaceuticals U.S.A., Inc.14-JUN-10
Granisetron HydrochlorideWest-ward Pharmaceutical Corp23-JUN-10
Granisetron HydrochlorideUDL Laboratories, Inc.23-JUL-10
GranisolPediatRx, Inc.19-NOV-10
Granisetron HydrochlorideAscend Laboratories, LLC21-MAR-11
Granisetron HydrochlorideAkorn Inc.12-APR-11
GranisetronSandoz Inc14-JUL-11
Granisetron HydrochlorideWOCKHARDT LIMITED29-NOV-11
Granisetron HydrochlorideWOCKHARDT USA LLC29-NOV-11
Granisetron HydrochlorideWOCKHARDT USA LLC02-DEC-11
Granisetron HydrochlorideWOCKHARDT USA LLC07-DEC-11
Granisetron HydrochlorideWOCKHARDT LIMITED07-DEC-11
Granisetron HydrochlorideWOCKHARDT LIMITED20-DEC-11
Granisetron HydrochlorideBreckenridge Pharmaceutical, Inc.08-FEB-12
SancusoProStrakan, Inc.15-FEB-12
GranisetronFresenius Kabi USA, LLC30-APR-12
Granisetron HydrochlorideTeva Parenteral Medicines, Inc19-JUL-12
Granisetron HydrochlorideTeva Parenteral Medicines, Inc19-JUL-12
Granisetron HydrochlorideTeva Parenteral Medicines, Inc19-JUL-12
Granisetron HydrochlorideTeva Pharmaceuticals USA Inc30-JUL-12
Granisetron HydrochlorideSagent Pharmaceuticals19-SEP-12
Granisetron HydrochlorideSagent Pharmaceuticals19-SEP-12
Granisetron HydrochlorideNorthstar Rx LLC15-OCT-12
Granisetron HydrochlorideNorthstar Rx LLC16-OCT-12
Granisetron HydrochlorideRoxane Laboratories, Inc01-NOV-12

Granisetron Case Reports

What Granisetron 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 Granisetron. 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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