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Ondansetron Side Effects

The most commonly reported side effects of ondansetron include nausea, fatigue, and diarrhoea, based on 199,701 FDA adverse event reports from 2004 to 2025. 3.4% of reports found the drug to be ineffective.

Ondansetron side effects

Percentages show how often each reaction appears relative to total reports for ondansetron.

1
Nausea11.7%23,409
2
Fatigue8.3%16,608
3
Diarrhoea7.4%14,844
4
Vomiting6.8%13,589
5
Off Label Use5.6%11,115
6
Death4.8%9,560
7
Headache4.5%8,952
8
Pain4.4%8,867
9
Dyspnoea4.4%8,787
10
Pyrexia3.9%7,765
11
Constipation3.8%7,547
12
Asthenia3.7%7,469
13
Decreased Appetite3.4%6,855
14
Drug Ineffective3.4%6,755
15
Pneumonia3.2%6,412

These are voluntary reports and do not establish that ondansetron caused these reactions.

Report severity

75.9%Serious151,585 reports
42.5%Hospitalizations84,922 reports
12.5%Fatal25,038 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ondansetron drug interactions

Other drugs that appear in adverse event reports alongside ondansetron. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lenalidomide8.1%16,257
2
Carboplatin3.5%7,033
3
Cyclophosphamide3.4%6,827
4
Dexamethasone3.2%6,433
5
Paclitaxel3.1%6,147
6
Doxorubicin-hydrochloride2.5%5,009
7
Rituximab2.4%4,864
8
Oxaliplatin2.4%4,771
9
Docetaxel2.3%4,657
10
Acetaminophen2.3%4,556
11
Venetoclax2.3%4,508
12
Bevacizumab2.2%4,467
13
Pomalidomide2.2%4,332
14
Fluorouracil2.1%4,245
15
Vincristine-sulfate2.1%4,148

Taken alongside

1
Acetaminophen30.1%60,077
2
Dexamethasone19.9%39,820
3
Omeprazole15.9%31,731
4
Ergocalciferol15.5%30,861
5
Aspirin15.0%29,930
6
Pantoprazole-sodium13.9%27,711
7
Oxycodone13.8%27,650
8
Gabapentin13.1%26,177
9
Albuterol13.0%25,915
10
Acyclovir12.8%25,633
11
Levothyroxine-sodium12.6%25,166
12
Prochlorperazine11.8%23,636
13
Furosemide11.8%23,499
14
Lorazepam11.2%22,433
15
Amlodipine10.2%20,432

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ondansetron side effects

58.2% of ondansetron adverse event reports involve female patients and 33.9% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.2%
Male33.9%
Unknown7.9%

Age group

< 21.2%
2–113.2%
12–172.9%
18–6454.9%
65+37.8%

What is ondansetron used for

Conditions and purposes for which patients were taking ondansetron when the adverse event was reported.

Abdominal DiscomfortAbdominal DistensionAbdominal MigraineAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbdominal RigidityAbdominal SymptomAbdominal Wall HaematomaAbortion InducedAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To Product By ChildAccidental OverdoseAcetonaemic Vomiting

Showing 15 of 1,198 indications

Ondansetron brand names and reporting trend

Ondansetron is sold under brand names including Ondansetron, Ondansetron Hydrochloride And Dextrose In Plastic Container.

Brand names

Ondansetron153,192
Ondansetron Hydrochloride And Dextrose In Plastic Container48

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ondansetron with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.