Drug Safety Information for ZOFRAN ODT (Ondansetron)

Safety-related Labeling Changes for ZOFRAN PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZOFRAN ODT (ONDANSETRON) Rx Drug: FDA Link

Safety-related Labeling Changes for ZUPLENZ (ONDANSETRON) Rx Drug: FDA Link

Adverse Drug Reactions for ZOFRAN ODT* (Ondansetron)

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 ZOFRAN ODT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea2943
2Vomiting2271
3Diarrhoea1867
4Fatigue1518
5Dyspnoea1351
6Pain1289
7Pyrexia1278
8Abdominal pain1148
9Dehydration1046
10Death1000
11Headache*957
12Asthenia954
13Anaemia948
14Pneumonia940
15Febrile neutropenia886
16Hypotension862
17Decreased appetite770
18Constipation*738
19Neutropenia729
20Dizziness*718

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

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

Reason # of FDA Reports
1Nausea*17067
2Product used for unknown indication13583
3Prophylaxis of nausea and vomiting3068
4Premedication1994
5Vomiting*1662
6Prophylaxis1414
7Antiemetic supportive care1105
8Procedural nausea235
9Chemotherapy230
10Hyperemesis gravidarum*223

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


Types of Adverse Events for ZOFRAN ODT

Total Reports Filed with FDA: 129602


Number of FDA Adverse Event Reports by Patient Age for ZOFRAN ODT

Total Reports Filed with FDA: 129602*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ondansetron (Zuplenz, Zofran odt, Ondansetron)

Charts are based on 129602 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 ZOFRAN ODT Reviews and Review Summary .

Historical 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.