AMBROXOL\CLENBUTEROL: 38 Adverse Event Reports & Safety Profile
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38
Total FAERS Reports
2 (5.3%)
Deaths Reported
31
Hospitalizations
38
As Primary/Secondary Suspect
27
Life-Threatening
First Report: 20121220 · Latest Report: 20250609
What Are the Most Common AMBROXOL\CLENBUTEROL Side Effects?
#1 Most Reported
Sedation complication
23 reports (60.5%)
#2 Most Reported
Overdose
23 reports (60.5%)
#3 Most Reported
Off label use
23 reports (60.5%)
All AMBROXOL\CLENBUTEROL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 23 | 60.5% | 0 | 22 |
| Dyspnoea | 23 | 60.5% | 0 | 22 |
| Off label use | 23 | 60.5% | 0 | 23 |
| Overdose | 23 | 60.5% | 0 | 22 |
| Sedation complication | 23 | 60.5% | 0 | 22 |
| Balance disorder | 22 | 57.9% | 0 | 21 |
| Blood calcium decreased | 22 | 57.9% | 0 | 21 |
| Cognitive disorder | 22 | 57.9% | 0 | 21 |
| Constipation | 22 | 57.9% | 0 | 21 |
| Creatinine renal clearance decreased | 22 | 57.9% | 0 | 21 |
| Creatinine renal clearance increased | 22 | 57.9% | 0 | 21 |
| Depressed level of consciousness | 22 | 57.9% | 0 | 21 |
| Drug interaction | 22 | 57.9% | 0 | 21 |
| Fall | 22 | 57.9% | 0 | 21 |
| Hypotension | 22 | 57.9% | 0 | 21 |
| Mobility decreased | 22 | 57.9% | 0 | 21 |
| Orthostatic hypotension | 22 | 57.9% | 0 | 21 |
| Pain | 22 | 57.9% | 0 | 21 |
| Renal function test abnormal | 22 | 57.9% | 0 | 21 |
| Sedation | 22 | 57.9% | 0 | 21 |
Who Reports AMBROXOL\CLENBUTEROL Side Effects? Age & Gender Data
Gender: 78.7% female, 21.3% male. Average age: 63.0 years. Most reports from: CA. View detailed demographics →
Is AMBROXOL\CLENBUTEROL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2014 | 3 | 1 | 2 |
| 2015 | 1 | 1 | 0 |
| 2020 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2023 | 2 | 0 | 2 |
| 2024 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 1 |
What Is AMBROXOL\CLENBUTEROL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 27 |
Official FDA Label for AMBROXOL\CLENBUTEROL
Official prescribing information from the FDA-approved drug label.