AMBENONIUM: 56 Adverse Event Reports & Safety Profile
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56
Total FAERS Reports
0
Deaths Reported
15
Hospitalizations
56
As Primary/Secondary Suspect
7
Life-Threatening
4
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Active Ingredient: AMBENONIUM CHLORIDE · FDA Application: 010155 ·
First Report: 201509 · Latest Report: 20220723
What Are the Most Common AMBENONIUM Side Effects?
#1 Most Reported
Diarrhoea
10 reports (17.9%)
#2 Most Reported
Ocular myasthenia
8 reports (14.3%)
#3 Most Reported
Drug ineffective
8 reports (14.3%)
All AMBENONIUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 10 | 17.9% | 0 | 5 |
| Drug ineffective | 8 | 14.3% | 0 | 0 |
| Ocular myasthenia | 8 | 14.3% | 0 | 0 |
| Acute kidney injury | 6 | 10.7% | 0 | 6 |
| Condition aggravated | 6 | 10.7% | 0 | 1 |
| Anaemia | 5 | 8.9% | 0 | 0 |
| Diplopia | 5 | 8.9% | 0 | 1 |
| Hyponatraemia | 5 | 8.9% | 0 | 5 |
| Thrombocytopenia | 5 | 8.9% | 0 | 0 |
Who Reports AMBENONIUM Side Effects? Age & Gender Data
Gender: 55.2% female, 44.8% male. Average age: 66.9 years. Most reports from: FR. View detailed demographics →
Is AMBENONIUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 2 | 0 | 0 |
| 2016 | 15 | 0 | 3 |
| 2017 | 3 | 0 | 1 |
| 2018 | 7 | 0 | 0 |
| 2019 | 4 | 0 | 3 |
| 2020 | 4 | 0 | 2 |
| 2022 | 5 | 0 | 5 |
What Is AMBENONIUM Used For?
| Indication | Reports |
|---|---|
| Muscular weakness | 21 |
| Myasthenia gravis | 18 |
| Ocular myasthenia | 9 |
| Product used for unknown indication | 5 |
Official FDA Label for AMBENONIUM
Official prescribing information from the FDA-approved drug label.