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Alosetron Side Effects

The most commonly reported side effects of alosetron include constipation, abdominal pain, and diarrhoea, based on 832 FDA adverse event reports from 2004 to 2025. 9.0% of reports found the drug to be ineffective.

Alosetron side effects

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

1
Drug Ineffective9.0%75
2
Constipation7.8%65
3
Abdominal Pain7.6%63
4
Drug Ineffective6.7%56
5
Diarrhoea6.6%55
6
Diarrhoea5.9%49
7
Colitis Ischaemic5.8%48
8
Adverse Event4.0%33
9
Off Label Use3.5%29
10
Constipation3.4%28
11
Rectal Haemorrhage3.1%26
12
Nausea3.0%25
13
Nausea2.9%24
14
Vomiting2.5%21
15
Pain2.5%21

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

Report severity

47.5%Serious395 reports
23.4%Hospitalizations195 reports
5.8%Fatal48 reports

Seriousness is determined by the reporter, not by OpenClaim.

Alosetron drug interactions

Other drugs that appear in adverse event reports alongside alosetron. 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
Sodium-oxybate5.4%45
2
Adalimumab1.7%14
3
Lenalidomide1.7%14
4
Loperamide-hydrochloride1.4%12
5
Dupilumab1.4%12
6
Budesonide1.3%11
7
Paroxetine1.0%8
8
Omeprazole0.8%7
9
Eluxadoline0.8%7
10
Bupropion0.7%6
11
Ethinyl-estradiol0.7%6
12
Teduglutide0.7%6
13
Sumatriptan0.6%5
14
Lamotrigine0.6%5
15
Ondansetron0.6%5

Taken alongside

1
Acetaminophen12.5%104
2
Levothyroxine-sodium11.4%95
3
Ergocalciferol9.5%79
4
Omeprazole7.9%66
5
Atropine7.7%64
6
Diphenoxylate-hydrochloride7.0%58
7
Aspirin6.4%53
8
Hydrocodone6.3%52
9
Loperamide-hydrochloride6.1%51
10
Gabapentin6.1%51
11
Dicyclomine-hydrochloride6.0%50
12
Alprazolam5.8%48
13
Pantoprazole-sodium5.8%48
14
Albuterol5.6%47
15
Atorvastatin-calcium5.4%45

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 alosetron side effects

85.6% of alosetron adverse event reports involve female patients and 10.5% involve male patients. The largest age group is adult at 71%. These figures reflect who reports side effects, not underlying risk.

Sex

Female85.6%
Male10.5%
Unknown4.0%

Age group

< 20.2%
2–110.0%
12–171.2%
18–6471.0%
65+27.6%

What is alosetron used for

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

Abdominal PainAbdominal Pain UpperAbdominal PainChronic Fatigue SyndromeCoeliac DiseaseColitisColitis CollagenousColitis UlcerativeCrohn's DiseaseCrohn^s DiseaseColitisColitis MicroscopicDiarrheaDiarrhoeaDiarrhoea Infectious

Showing 15 of 39 indications

Alosetron brand names and reporting trend

Alosetron is sold under the brand name Alosetron Hydrochloride.

Brand names

Alosetron Hydrochloride1

Quarterly reports (20042025)

20052010201520202025

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

Taking alosetron with another medication?

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