ITOPRIDE: 42 Adverse Event Reports & Safety Profile
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42
Total FAERS Reports
5 (11.9%)
Deaths Reported
25
Hospitalizations
42
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 201408 · Latest Report: 20250609
What Are the Most Common ITOPRIDE Side Effects?
#1 Most Reported
Hyponatraemia
9 reports (21.4%)
#2 Most Reported
Dehydration
9 reports (21.4%)
#3 Most Reported
Constipation
9 reports (21.4%)
All ITOPRIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Constipation | 9 | 21.4% | 0 | 9 |
| Dehydration | 9 | 21.4% | 1 | 8 |
| Hyponatraemia | 9 | 21.4% | 0 | 9 |
| Anaemia of chronic disease | 8 | 19.1% | 0 | 8 |
| Anal fissure | 8 | 19.1% | 0 | 8 |
| Asthenia | 8 | 19.1% | 0 | 8 |
| Confusional state | 8 | 19.1% | 0 | 8 |
| Fall | 8 | 19.1% | 0 | 8 |
| Haematoma | 8 | 19.1% | 0 | 8 |
| Hypochloraemia | 8 | 19.1% | 0 | 8 |
| International normalised ratio increased | 8 | 19.1% | 0 | 8 |
| Intestinal haemorrhage | 8 | 19.1% | 0 | 8 |
| Oedema peripheral | 8 | 19.1% | 0 | 8 |
| Psychomotor retardation | 8 | 19.1% | 0 | 8 |
| Renal failure | 8 | 19.1% | 0 | 8 |
| Somnolence | 8 | 19.1% | 0 | 8 |
| Thrombocytosis | 8 | 19.1% | 0 | 8 |
| Urinary retention | 8 | 19.1% | 0 | 8 |
| Urinary tract infection | 8 | 19.1% | 0 | 8 |
| Drug level above therapeutic | 7 | 16.7% | 0 | 7 |
Who Reports ITOPRIDE Side Effects? Age & Gender Data
Gender: 61.4% female, 38.6% male. Average age: 67.8 years. Most reports from: JP. View detailed demographics →
Is ITOPRIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2015 | 1 | 0 | 1 |
| 2016 | 1 | 1 | 0 |
| 2017 | 3 | 1 | 1 |
| 2018 | 4 | 0 | 3 |
| 2019 | 4 | 0 | 1 |
| 2020 | 1 | 0 | 1 |
| 2021 | 2 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2024 | 3 | 0 | 2 |
| 2025 | 2 | 2 | 2 |
What Is ITOPRIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 22 |
Official FDA Label for ITOPRIDE
Official prescribing information from the FDA-approved drug label.