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Prucalopride Side Effects

The most commonly reported side effects of prucalopride include headache, nausea, and off label use, based on 2,422 FDA adverse event reports from 2010 to 2025. 11.2% of reports found the drug to be ineffective.

Prucalopride side effects

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

1
Drug Ineffective11.2%272
2
Headache10.7%260
3
Nausea9.6%233
4
Off Label Use8.7%211
5
Diarrhoea7.4%179
6
No Adverse Event7.1%172
7
Fatigue6.7%163
8
Constipation6.2%149
9
Dizziness5.5%132
10
Inability To Afford Medication5.1%123
11
Abdominal Pain4.8%116
12
Vomiting4.7%114
13
Product Use Issue4.6%111
14
Pain3.8%93
15
Insurance Issue3.8%92

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

Report severity

51.2%Serious1,240 reports
24.6%Hospitalizations597 reports
3.2%Fatal78 reports

Seriousness is determined by the reporter, not by OpenClaim.

Prucalopride drug interactions

Other drugs that appear in adverse event reports alongside prucalopride. 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
Levodopa2.5%60
2
Carbidopa2.4%58
3
Dupilumab2.2%53
4
Ondansetron2.0%48
5
Gabapentin2.0%48
6
Metoclopramide-hydrochloride1.9%46
7
Amitriptyline-hydrochloride1.7%40
8
Rituximab1.6%39
9
Cyclizine-lactate1.5%36
10
Sodium-oxybate1.5%36
11
Pregabalin1.5%36
12
Tramadol-hydrochloride1.4%34
13
Linaclotide1.4%34
14
Pantoprazole-sodium1.2%29
15
Lubiprostone1.2%29

Taken alongside

1
Acetaminophen11.6%280
2
Omeprazole11.1%268
3
Ergocalciferol10.9%263
4
Gabapentin10.2%246
5
Levothyroxine-sodium9.7%236
6
Albuterol9.6%232
7
Pantoprazole-sodium8.2%199
8
Ondansetron7.8%189
9
Linaclotide7.2%175
10
Aspirin6.3%153
11
Famotidine6.2%150
12
Atorvastatin-calcium6.2%149
13
Polyethylene-glycol-33505.7%137
14
Fluticasone5.7%137
15
Lansoprazole5.0%120

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 prucalopride side effects

65.2% of prucalopride adverse event reports involve female patients and 18.6% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female65.2%
Male18.6%
Unknown16.2%

Age group

< 20.5%
2–111.9%
12–173.2%
18–6463.7%
65+30.7%

What is prucalopride used for

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

Abdominal DiscomfortAbdominal DistensionAbdominal PainAmyloidosisAnorexia NervosaAutonomic NeuropathyAbdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain UpperAdverse EventAnal IncontinenceAnorexia NervosaAstringent TherapyAutoimmune Disorder

Showing 15 of 133 indications

Prucalopride brand names and reporting trend

Prucalopride is sold under the brand name Prucalopride Succinate.

Brand names

Prucalopride Succinate978

Quarterly reports (20102025)

20102016202020242025

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

Taking prucalopride with another medication?

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