FENOTEROL HYDROBROMIDE\IPRATROPIUM: 320 Adverse Event Reports & Safety Profile

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320

Total FAERS Reports

68 (21.3%)

Deaths Reported

154

Hospitalizations

320

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: FENOTEROL HYDROBROMIDE\IPRATROPIUM BROMIDE ·

First Report: 1995 · Latest Report: 20240606

What Are the Most Common FENOTEROL HYDROBROMIDE\IPRATROPIUM Side Effects?

#1 Most Reported

Dyspnoea

77 reports (24.1%)

#2 Most Reported

Vomiting

53 reports (16.6%)

#3 Most Reported

Off label use

49 reports (15.3%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Dyspnoea	77	24.1%	30	52
Vomiting	53	16.6%	40	40
Condition aggravated	49	15.3%	37	43
Off label use	49	15.3%	36	40
Drug ineffective	48	15.0%	13	26
Nausea	48	15.0%	37	46
Multiple organ dysfunction syndrome	47	14.7%	47	36
Chronic obstructive pulmonary disease	45	14.1%	30	39
General physical health deterioration	41	12.8%	37	36
Abdominal distension	40	12.5%	40	38
Abdominal pain	40	12.5%	37	38
Ascites	39	12.2%	37	36
Constipation	39	12.2%	36	34
Hyponatraemia	39	12.2%	38	37
Blood cholesterol increased	38	11.9%	37	35
Blood uric acid increased	38	11.9%	37	35
Stress	38	11.9%	38	36
Appendicitis	37	11.6%	37	35
Appendicolith	37	11.6%	37	35
Myasthenia gravis	37	11.6%	37	35

Gender: 34.6% female, 65.4% male. Average age: 70.9 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2003	1	0	0
2005	1	0	1
2007	2	0	1
2011	6	1	3
2012	1	0	1
2014	14	0	5
2015	3	0	1
2016	13	6	6
2017	9	1	4
2018	12	0	7
2019	36	0	21
2020	12	9	8
2021	13	2	10
2022	15	0	0
2023	15	0	2
2024	15	0	5

Indication	Reports
Product used for unknown indication	107
Chronic obstructive pulmonary disease	59
Dyspnoea	49
Asthma	40
Cystic fibrosis	11
Bronchospasm	8
Emphysema	7
Cough	5
Pain	5

Official prescribing information from the FDA-approved drug label.