OpenClaim

Crofelemer Side Effects

The most commonly reported side effects of crofelemer include off label use, diarrhoea, and product dose omission issue, based on 210 FDA adverse event reports from 2013 to 2025. 21.4% of reports found the drug to be ineffective.

Crofelemer side effects

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

1
Off Label Use25.2%53
2
Drug Ineffective21.4%45
3
Diarrhoea10.0%21
4
Product Dose Omission Issue9.5%20
5
Death9.0%19
6
Pain8.1%17
7
Anxiety6.7%14
8
Emotional Distress6.7%14
9
Anhedonia5.7%12
10
Chronic Kidney Disease4.8%10
11
Fatigue4.8%10
12
Constipation4.3%9
13
Dizziness3.8%8
14
Osteoporosis3.8%8
15
Depression3.8%8

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

Report severity

35.2%Serious74 reports
13.8%Hospitalizations29 reports
11.4%Fatal24 reports

Seriousness is determined by the reporter, not by OpenClaim.

Crofelemer drug interactions

Other drugs that appear in adverse event reports alongside crofelemer. 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
Tenofovir8.6%18
2
Emtricitabine7.6%16
3
Tesamorelin-acetate3.3%7
4
Efavirenz2.4%5
5
Cobicistat1.9%4
6
Elvitegravir1.9%4
7
Dolutegravir1.4%3
8
Bictegravir1.4%3
9
Pertuzumab1.0%2
10
Trastuzumab1.0%2
11
Docetaxel1.0%2
12
Lisinopril1.0%2
13
Loperamide-hydrochloride1.0%2
14
Rilpivirine1.0%2
15
Lamivudine1.0%2

Taken alongside

1
Emtricitabine25.7%54
2
Tenofovir25.7%54
3
Dolutegravir19.0%40
4
Bictegravir15.2%32
5
Acyclovir11.4%24
6
Gabapentin10.0%21
7
Atorvastatin-calcium10.0%21
8
Lamivudine10.0%21
9
Darunavir9.5%20
10
Omeprazole9.5%20
11
Testosterone9.0%19
12
Ergocalciferol8.6%18
13
Bupropion8.1%17
14
Aspirin8.1%17
15
Pantoprazole-sodium7.6%16

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 crofelemer side effects

8.6% of crofelemer adverse event reports involve female patients and 40.0% involve male patients. The largest age group is adult at 72%. These figures reflect who reports side effects, not underlying risk.

Sex

Female8.6%
Male40.0%
Unknown51.4%

Age group

< 20.0%
2–110.0%
12–171.9%
18–6472.2%
65+25.9%

What is crofelemer used for

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

ColitisColitis UlcerativeColon CancerCrohn^s DiseaseDiarrhoeaDyspnoeaDermatitisDiarrhoeaFunctional Gastrointestinal DisorderGastrointestinal Bacterial OvergrowthGastroenteritisGastrointestinal InflammationGastrointestinal Stoma ComplicationHer-2 Positive Breast CancerHiv Enteropathy

Showing 15 of 24 indications

Crofelemer brand names and reporting trend

Crofelemer is sold under the brand name Mytesi.

Brand names

Mytesi16

Quarterly reports (20132025)

201320242025

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

Taking crofelemer with another medication?

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