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Lubiprostone Side Effects

The most commonly reported side effects of lubiprostone include nausea, diarrhoea, and constipation, based on 9,263 FDA adverse event reports from 2006 to 2025. 5.3% of reports found the drug to be ineffective.

Lubiprostone side effects

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

1
Nausea6.7%617
2
Diarrhoea5.5%509
3
Drug Ineffective5.3%487
4
Constipation5.2%483
5
Fatigue5.0%463
6
Headache4.4%411
7
Dyspnoea4.2%393
8
Pain4.2%390
9
Dizziness3.9%363
10
Fall3.8%356
11
Chronic Kidney Disease3.6%335
12
Vomiting3.3%310
13
Off Label Use3.3%308
14
Malaise3.1%290
15
Pyrexia2.9%273

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

Report severity

67.2%Serious6,226 reports
33.0%Hospitalizations3,059 reports
10.2%Fatal942 reports

Seriousness is determined by the reporter, not by OpenClaim.

Lubiprostone drug interactions

Other drugs that appear in adverse event reports alongside lubiprostone. 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-oxybate6.3%582
2
Esomeprazole4.0%373
3
Omeprazole3.2%294
4
Lenalidomide2.8%263
5
Pantoprazole-sodium2.2%204
6
Lansoprazole2.1%199
7
Adalimumab2.0%188
8
Linaclotide1.9%174
9
Pregabalin1.6%150
10
Dexlansoprazole1.5%136
11
Dalfampridine1.4%132
12
Dimethyl1.3%123
13
Levodopa1.3%121
14
Dupilumab1.2%113
15
Carbidopa1.2%108

Taken alongside

1
Acetaminophen19.4%1,796
2
Ergocalciferol17.5%1,624
3
Aspirin16.6%1,541
4
Levothyroxine-sodium16.1%1,495
5
Gabapentin15.1%1,399
6
Omeprazole14.3%1,322
7
Albuterol14.0%1,294
8
Furosemide13.3%1,236
9
Amlodipine11.6%1,077
10
Oxycodone11.6%1,071
11
Fluticasone11.4%1,054
12
Ondansetron10.3%951
13
Atorvastatin-calcium10.0%924
14
Duloxetine-hydrochloride9.8%912
15
Pregabalin8.9%826

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 lubiprostone side effects

65.0% of lubiprostone adverse event reports involve female patients and 27.7% involve male patients. The largest age group is adult at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female65.0%
Male27.7%
Unknown7.2%

Age group

< 2<0.1%
2–110.5%
12–170.9%
18–6451.8%
65+46.7%

What is lubiprostone used for

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

Abdominal AdhesionsAbdominal DiscomfortAbdominal DistensionAbdominal OperationAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbdominal RigidityAbnormal FaecesAdverse EventAdverse ReactionAffective DisorderAmyloidosisAnal IncontinenceAnal Sphincter Atony

Showing 15 of 163 indications

Lubiprostone brand names and reporting trend

Lubiprostone is sold under the brand name Lubiprostone.

Brand names

Lubiprostone985

Quarterly reports (20062025)

20062010201520202025

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

Taking lubiprostone with another medication?

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