REGLAN: 68 Adverse Event Reports & Safety Profile
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68
Total FAERS Reports
1 (1.5%)
Deaths Reported
17
Hospitalizations
68
As Primary/Secondary Suspect
3
Life-Threatening
12
Disabilities
First Report: 20050606 · Latest Report: 20140604
What Are the Most Common REGLAN Side Effects?
#1 Most Reported
Drug hypersensitivity
26 reports (38.2%)
#2 Most Reported
Tardive dyskinesia
16 reports (23.5%)
#3 Most Reported
Extrapyramidal disorder
16 reports (23.5%)
All REGLAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 26 | 38.2% | 0 | 2 |
| Extrapyramidal disorder | 16 | 23.5% | 0 | 7 |
| Tardive dyskinesia | 16 | 23.5% | 0 | 7 |
| Tremor | 14 | 20.6% | 0 | 3 |
| Dyskinesia | 13 | 19.1% | 0 | 9 |
| Parkinson's disease | 10 | 14.7% | 0 | 0 |
| Dysphagia | 8 | 11.8% | 0 | 7 |
| Activities of daily living impaired | 7 | 10.3% | 0 | 7 |
| Movement disorder | 7 | 10.3% | 0 | 7 |
| Nausea | 7 | 10.3% | 0 | 3 |
| Nervous system disorder | 7 | 10.3% | 0 | 7 |
| Speech disorder | 7 | 10.3% | 0 | 7 |
| Eating disorder | 6 | 8.8% | 0 | 6 |
| Vomiting | 6 | 8.8% | 0 | 3 |
Who Reports REGLAN Side Effects? Age & Gender Data
Average age: 53.5 years. Most reports from: US. View detailed demographics →
Is REGLAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2013 | 2 | 0 | 1 |
| 2014 | 10 | 1 | 7 |
What Is REGLAN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 8 |
| Gastrooesophageal reflux disease | 7 |
| Nausea | 6 |
Official FDA Label for REGLAN
Official prescribing information from the FDA-approved drug label.