LOMOTIL FDA MedWatch Direct Reports Summary
These tables and charts are created from 791 voluntary U.S. reports for LOMOTIL (ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS LOMOTIL Report.
Top Adverse Effects Associated with LOMOTIL (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 DIARRHEA 117 2 DISEASE PROGRESSION 68 3 DEATH 60 4 NAUSEA 57 5 FATIGUE 46 6 VOMITING 39 7 THERAPY INTERRUPTED 35 8 LACK OF STRENGTH AND ENERGY (ASTHENIA) 27 9 DEHYDRATION 26 10 SHORTNESS OF BREATH 25 11 THERAPY CESSATION 24 12 HOSPICE CARE 23 13 HOSPITALIZATION 23 14 DRUG INEFFECTIVE 21 15 PAIN 21 16 DIZZINESS 20 17 ABDOMINAL PAIN 17 18 DECREASED APPETITE 17 19 CONDITION AGGRAVATED 16 20 PLATELET COUNT DECREASED 16 21 PNEUMONIA 16 22 FALL 15 23 HAND-FOOT SYNDROME 14 24 RASH 14 25 CONFUSIONAL STATE 13
LOMOTIL Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 303 | 466 | 22 | 791 |
| Medwatch Reporter Type | Count |
| Consumer | 205 |
| Physician | 54 |
| Pharmacist | 163 |
| Other Health Professional | 183 |
| Top Indications | |
| DIARRHEA | |
Type of Outcome Reported
Serious: 522
Not Serious: 269
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 791
Concomitant Drugs: 759
Note: A single MedWatch report can list more than one drug. This summary includes LOMOTIL identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
LOMOTIL (ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes
Have experience (good or bad) with LOMOTIL? Rate LOMOTIL at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.