Drug Safety Information for ZOFRAN (Ondansetron hydrochloride)

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

Adverse Drug Reactions for ZOFRAN* (Ondansetron 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 ZOFRAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea2604
2Vomiting2025
3Diarrhoea1462
4Fatigue1300
5Dyspnoea1197
6Pyrexia1118
7Dehydration1107
8Pain*1097
9Death1059
10Abdominal pain992
11Asthenia968
12Headache*853
13Anaemia808
14Pneumonia774
15Hypotension747
16Decreased appetite694
17Constipation*680
18Dizziness*677
19Anxiety*620
20Weight decreased616

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

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

Reason # of FDA Reports
1Nausea*12800
2Product used for unknown indication11555
3Prophylaxis of nausea and vomiting1664
4Premedication1516
5Vomiting*976
6Prophylaxis590
7Antiemetic supportive care333
8Hyperemesis gravidarum*190
9Vomiting in pregnancy*179
10Chemotherapy110

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


Types of Adverse Events for ZOFRAN

Total Reports Filed with FDA: 110176


Number of FDA Adverse Event Reports by Patient Age for ZOFRAN

Total Reports Filed with FDA: 110176*


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

Charts are based on 110176 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 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.

Visit   DrugInformer.com more on ZOFRAN's side effects.