Drug Safety Information for LOMOTIL (Atropine sulfate; diphenoxylate hydrochloride)

Safety-related Labeling Changes for LOMOTIL (ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for LOMOTIL* (Atropine sulfate; diphenoxylate 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 LOMOTIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea1090
2Nausea*591
3Fatigue485
4Vomiting446
5Dehydration423
6Abdominal pain361
7Drug ineffective345
8Dyspnoea345
9Asthenia337
10Pain319
11Weight decreased275
12Pyrexia264
13Dizziness*251
14Pneumonia247
15Headache241
16Decreased appetite235
17Arthralgia218
18Anaemia210
19Fall203
20Rash194

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

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

Reason # of FDA Reports
1Diarrhoea*5389
2Product used for unknown indication4116
3Crohn's disease*766
4Irritable bowel syndrome*242
5Colitis ulcerative123
6Colitis81
7Prophylaxis against diarrhoea76
8Gastroenteritis64
9Gastrointestinal disorder54
10Pain51

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


Types of Adverse Events for LOMOTIL

Total Reports Filed with FDA: 36265


Number of FDA Adverse Event Reports by Patient Age for LOMOTIL

Total Reports Filed with FDA: 36265*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Atropine sulfate; diphenoxylate hydrochloride (Low-quel, Lomanate, Logen, Di-atro, Lomotil, Lo-trol, Colonaid, Lonox)

Charts are based on 36265 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 LOMOTIL 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.