SINEMET: 84 Adverse Event Reports & Safety Profile
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84
Total FAERS Reports
9 (10.7%)
Deaths Reported
32
Hospitalizations
84
As Primary/Secondary Suspect
7
Life-Threatening
8
Disabilities
First Report: 19971202 · Latest Report: 201406
What Are the Most Common SINEMET Side Effects?
#1 Most Reported
Speech disorder
10 reports (11.9%)
#2 Most Reported
Tremor
9 reports (10.7%)
#3 Most Reported
Dysphagia
9 reports (10.7%)
All SINEMET Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Speech disorder | 10 | 11.9% | 2 | 9 |
| Drug ineffective | 9 | 10.7% | 1 | 4 |
| Dysphagia | 9 | 10.7% | 1 | 7 |
| Tremor | 9 | 10.7% | 0 | 2 |
| Abasia | 8 | 9.5% | 2 | 5 |
| Dehydration | 8 | 9.5% | 0 | 7 |
| Pain | 8 | 9.5% | 1 | 4 |
| Dyskinesia | 7 | 8.3% | 0 | 7 |
| Asthenia | 6 | 7.1% | 1 | 4 |
| Drug dose omission | 6 | 7.1% | 0 | 6 |
| Fall | 6 | 7.1% | 0 | 2 |
| Loss of consciousness | 6 | 7.1% | 0 | 6 |
| Overdose | 6 | 7.1% | 0 | 4 |
| Quality of life decreased | 6 | 7.1% | 0 | 6 |
| Withdrawal syndrome | 6 | 7.1% | 0 | 6 |
| Confusional state | 5 | 6.0% | 1 | 4 |
| Wrong technique in drug usage process | 5 | 6.0% | 0 | 3 |
Who Reports SINEMET Side Effects? Age & Gender Data
Average age: 68.7 years. Most reports from: US. View detailed demographics →
Is SINEMET Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2007 | 1 | 1 | 0 |
| 2009 | 2 | 0 | 2 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 1 |
| 2012 | 7 | 0 | 1 |
| 2013 | 22 | 5 | 9 |
| 2014 | 12 | 0 | 5 |
What Is SINEMET Used For?
| Indication | Reports |
|---|---|
| Parkinson's disease | 41 |
Official FDA Label for SINEMET
Official prescribing information from the FDA-approved drug label.