Drug Safety Information for KYTRIL (Granisetron hydrochloride)

Adverse Drug Reactions for KYTRIL* (Granisetron hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with KYTRIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea946
2Pyrexia821
3Diarrhoea805
4Vomiting791
5Febrile neutropenia604
6White blood cell count decreased593
7Death588
8Dyspnoea571
9Platelet count decreased564
10Fatigue542
11Neutropenia508
12Pneumonia476
13Anaemia469
14Decreased appetite465
15Neutrophil count decreased431
16Sepsis394
17Constipation*357
18Asthenia350
19Abdominal pain350
20Dehydration346

* This side effect also appears in "Top 10 Side Effects of KYTRIL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking KYTRIL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication4424
2Premedication2339
3Prophylaxis2318
4Prophylaxis of nausea and vomiting2201
5Nausea*1775
6Antiemetic supportive care766
7Vomiting602
8Chemotherapy174
9Aplastic anaemia159
10Neutropenia157

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for KYTRIL

Total Reports Filed with FDA: 50694


Number of FDA Adverse Event Reports by Patient Age for KYTRIL

Total Reports Filed with FDA: 50694*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Granisetron hydrochloride (Granisetron, Gran, Granisol, Kytril)

Charts are based on 50694 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and KYTRIL Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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