Brand name · Loperamide hydrochloride and dimethicone
Imodium Multi-Symptom Relief: adverse event reports filed with FDA
5,342 reports list it as a suspect or interacting product, 2007–2026.
- 5,342
- reports as suspect product
- 0% of all reports · about 286 a year
- 181
- reports, 12 months to June 2026
- 200 in the 12 months before
- 5.3%
- marked serious by the reporter
- 57.4% across all reports
- 0.2%
- record death among outcomes, as reported
- 10 reports · not verified by FDA
Between November 2007 and June 2026, 5,342 adverse event reports received by FDA list the brand name Imodium Multi-Symptom Relief (loperamide hydrochloride and dimethicone) as a suspect or interacting product. Reports that mention it only as a concomitant medication (389) are left out of every figure here.
In the 12 months to June 2026, 181 reports listed it, close to the 200 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 286 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (24.4%), incorrect dose administered (17.2%) and dysphagia (10%). A report can list several reactions, so shares add to more than 100%; 188 different terms appear across these reports. Drug ineffective is recorded in 24.4% of these reports, against 6.3% of all reports in the database.
5.3% of the reports are marked serious by the reporter; 0.2% record death among the outcomes and 0.4% record hospitalisation, as reported. 99.4% of the reports came from consumers, and the largest patient age group is 75 and over (24.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Imodium Multi-Symptom Relief reports recording the termall reports in the database
- Drug ineffectivethe medicine did not work as expected24.4%1,302
- Incorrect dose administeredthe wrong dose was given17.2%921
- Dysphagiadifficulty swallowing10%536
- Product size issue7.7%411
- Off label useused for a purpose or in a way not on the label6.9%368
- Product packaging issuea problem with the packaging5.9%317
- Wrong technique in product usage processthe product was used in the wrong way5.8%309
- Expired product administeredthe product was used past its expiry date5.6%301
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times5.2%277
- Product use issuea problem in how the product was used4.7%251
- Wrong technique in drug usage processthe medicine was used in the wrong way4.5%238
- Chokingchoking4.4%233
- Foreign bodyan object where it should not be4.2%225
- Product difficult to swallow4%213
- Constipationconstipation3.5%187
- Product use complaint3.3%177
- Product quality issuea problem with the product itself3.2%172
- Diarrhoealoose or frequent stools2.9%153
- Intentional product use issuedeliberate use not as intended2.8%152
- Product label issuea problem with the label2.8%150
- Product use in unapproved indicationused for a purpose not on the label2.7%143
- Retching2.7%143
- Overdosea dose above the recommended amount2.5%131
- Product physical issuea physical defect in the product1.9%104
- Intentional product misusedeliberate use not as intended1.8%98
- Product coating issue1.7%92
- Abdominal pain upperupper stomach pain1.5%81
- Flatulencewind1.5%78
Top 30 of 188 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Diarrhoea | 1,886 | 35.3% |
| Irritable bowel syndrome | 181 | 3.4% |
| Flatulence | 67 | 1.3% |
| Antidiarrhoeal supportive care | 49 | 0.9% |
| Abdominal distension | 39 | 0.7% |
| Muscle spasms | 23 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 5,342 reports.
In context
| Measure | Imodium Multi-Symptom Relief | All reports |
|---|---|---|
| Reports as suspect product | 5,342 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 181 | 1,332,454 |
| Marked serious | 5.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 2 | 91 |
| Hospitalisation recorded, per 1,000 reports | 4 | 213 |
| Consumer-filed share | 99.4% | 45.8% |
| Top term, share of reports | Drug ineffective 24.4% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Imodium Multi-Symptom Relief reports
How many adverse event reports has FDA received for Imodium Multi-Symptom Relief?
5,342 reports list Imodium Multi-Symptom Relief as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 181 of them arrived in the latest 12 months. Another 389 list it only as a concomitant medication.
What reactions are recorded in Imodium Multi-Symptom Relief reports?
drug ineffective (24.4%), incorrect dose administered (17.2%), dysphagia (10%), product size issue (7.7%) and off label use (6.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Imodium Multi-Symptom Relief was responsible.
How serious are the reports?
5.3% are marked serious by the reporter. Among the outcomes recorded, 0.2% of reports include death and 0.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (99.4%), other health professional (0.4%) and physician (0.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Imodium Multi-Symptom Relief rising?
181 reports in the 12 months to June 2026, close to the 200 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Imodium Multi-Symptom Relief was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Imodium Multi-Symptom Relief?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Imodium Multi-Symptom Relief as a suspect or interacting product; reports listing it only as a concomitant medication (389) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.