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Diphenoxylate Side Effects

The most commonly reported side effects of diphenoxylate include diarrhoea, nausea, and fatigue, based on 14,582 FDA adverse event reports from 2004 to 2025. 7.0% of reports found the drug to be ineffective.

Diphenoxylate side effects

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

1
Diarrhoea16.2%2,361
2
Nausea9.8%1,430
3
Fatigue9.3%1,362
4
Drug Ineffective7.0%1,025
5
Weight Decreased5.6%813
6
Off Label Use5.3%771
7
Vomiting5.2%759
8
Pain4.9%715
9
Abdominal Pain4.5%653
10
Decreased Appetite4.1%593
11
Asthenia4.0%590
12
Headache4.0%582
13
Dehydration3.8%559
14
Dyspnoea3.8%552
15
Malaise3.8%552

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

Report severity

66.9%Serious9,756 reports
38.8%Hospitalizations5,662 reports
10.6%Fatal1,542 reports

Seriousness is determined by the reporter, not by OpenClaim.

Diphenoxylate drug interactions

Other drugs that appear in adverse event reports alongside diphenoxylate. 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
Adalimumab11.1%1,617
2
Lenalidomide8.6%1,251
3
Atropine6.7%978
4
Infliximab3.1%450
5
Pomalidomide2.8%408
6
Vedolizumab2.7%392
7
Capecitabine2.4%356
8
Teduglutide2.4%349
9
Cabozantinib2.3%330
10
Pantoprazole-sodium2.1%313
11
Loperamide-hydrochloride2.1%307
12
Prednisone2.1%305
13
Pregabalin2.1%304
14
Acetaminophen2.1%303
15
Treprostinil2.0%289

Taken alongside

1
Atropine93.4%13,622
2
Acetaminophen29.0%4,231
3
Ondansetron24.2%3,522
4
Ergocalciferol20.7%3,016
5
Loperamide-hydrochloride18.2%2,659
6
Aspirin17.5%2,558
7
Levothyroxine-sodium17.3%2,521
8
Omeprazole16.8%2,446
9
Gabapentin15.1%2,204
10
Furosemide13.8%2,015
11
Pantoprazole-sodium13.3%1,935
12
Oxycodone13.3%1,934
13
Hydrocodone12.3%1,800
14
Albuterol12.2%1,776
15
Metoprolol11.9%1,741

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 diphenoxylate side effects

60.5% of diphenoxylate adverse event reports involve female patients and 34.8% involve male patients. The largest age group is adult at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.5%
Male34.8%
Unknown4.7%

Age group

< 20.2%
2–110.3%
12–170.3%
18–6450.7%
65+48.6%

What is diphenoxylate used for

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

Abdominal DiscomfortAbdominal PainAbdominal Pain UpperAbnormal FaecesAccidentAccidental Drug Intake By ChildAcute Myeloid LeukaemiaAdenocarcinoma PancreasAdverse Drug ReactionAdverse EventAlopeciaAnal IncontinenceAnaphylactic ReactionAntidiarrhoeal Supportive CareAnxiety

Showing 15 of 202 indications

Diphenoxylate brand names and reporting trend

Diphenoxylate is sold under the brand name Logen.

Brand names

Logen1

Quarterly reports (20042025)

20052010201520202025

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

Taking diphenoxylate with another medication?

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