Drug Safety Information for IMODIUM (Loperamide hydrochloride)

Safety-related Labeling Changes for IMODIUM (LOPERAMIDE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for IMODIUM A-D EZ CHEWS (LOPERAMIDE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE; SIMETHICONE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for IMODIUM* (Loperamide hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with IMODIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*3029
2Nausea*1405
3Vomiting*1241
4Fatigue1091
5Drug ineffective1038
6Dehydration986
7Pyrexia900
8Dyspnoea827
9Abdominal pain750
10Asthenia747
11Death636
12Anaemia604
13Decreased appetite603
14Weight decreased576
15Pain*573
16Pneumonia525
17Hypotension501
18Rash495
19Dizziness491
20Headache465

* This side effect also appears in "Top 10 Side Effects of IMODIUM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking IMODIUM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Diarrhoea*15127
2Product used for unknown indication11124
3Crohn's disease1044
4Irritable bowel syndrome*764
5Prophylaxis against diarrhoea284
6Colitis ulcerative177
7Prophylaxis170
8Gastroenteritis166
9Antidiarrhoeal supportive care132
10Nausea116

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for IMODIUM

Total Reports Filed with FDA: 86137


Number of FDA Adverse Event Reports by Patient Age for IMODIUM

Total Reports Filed with FDA: 86137*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Loperamide hydrochloride (Imodium a-d ez chews, A d, Medique diamode, Antidiarrheal relief, Anti-diarrheal, Vaprino a-d, Imodium a-d, Leader loperamide, Anti diarrheal, Imodium ad, Loperamide hcl, Loperamida, Loperamide, Imodium)

Charts are based on 86137 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and IMODIUM Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.