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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

AZTREONAM LYSINE: 11,694 Adverse Event Reports & Safety Profile

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11,694
Total FAERS Reports
1,352 (11.6%)
Deaths Reported
8,024
Hospitalizations
11,694
As Primary/Secondary Suspect
14
Life-Threatening
78
Disabilities

First Report: 1118 · Latest Report: 20250923

What Are the Most Common AZTREONAM LYSINE Side Effects?

#1 Most Reported
Cystic fibrosis
2,766 reports (23.7%)
#2 Most Reported
Off label use
1,398 reports (12.0%)
#3 Most Reported
Pneumonia
1,180 reports (10.1%)

All AZTREONAM LYSINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cystic fibrosis 2,766 23.7% 107 2,160
Off label use 1,398 12.0% 217 803
Pneumonia 1,180 10.1% 25 948
Death 1,061 9.1% 1,061 89
Infection 760 6.5% 7 621
Lung disorder 543 4.6% 24 501
Lung transplant 499 4.3% 18 271
Cystic fibrosis respiratory infection suppression 440 3.8% 1 436
Condition aggravated 431 3.7% 4 389
Dyspnoea 391 3.3% 11 324
Infective pulmonary exacerbation of cystic fibrosis 385 3.3% 16 314
Pseudomonas infection 314 2.7% 3 155
Cough 281 2.4% 1 153
Malaise 272 2.3% 8 227
Pulmonary function test decreased 252 2.2% 2 229
Influenza 251 2.2% 4 223
Haemoptysis 233 2.0% 15 201
Lung infection 198 1.7% 3 161
Intentional dose omission 148 1.3% 2 115
Covid-19 129 1.1% 3 104

Who Reports AZTREONAM LYSINE Side Effects? Age & Gender Data

Gender: 60.2% female, 39.8% male. Average age: 33.8 years. Most reports from: US. View detailed demographics →

Is AZTREONAM LYSINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2007 1 0 1
2010 7 1 4
2011 20 12 8
2012 27 15 11
2013 50 28 20
2014 152 93 47
2015 219 74 130
2016 219 60 157
2017 344 66 244
2018 733 70 592
2019 1,058 69 852
2020 509 48 346
2021 464 43 346
2022 291 37 187
2023 210 37 111
2024 170 24 102
2025 93 28 55

View full timeline →

What Is AZTREONAM LYSINE Used For?

IndicationReports
Cystic fibrosis 8,046
Pseudomonas infection 2,884
Cystic fibrosis lung 1,883
Product used for unknown indication 767
Bronchiectasis 720
Infective pulmonary exacerbation of cystic fibrosis 185
Infective exacerbation of bronchiectasis 93
Illness 92
Bacterial disease carrier 85
Bacterial infection 81

AZTREONAM LYSINE vs Alternatives: Which Is Safer?

AZTREONAM LYSINE vs BACILLUS CALMETTE-GUERIN ANTIGEN, UNSPECIFIED SUBSTRAIN AZTREONAM LYSINE vs BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN AZTREONAM LYSINE vs BACITRACIN AZTREONAM LYSINE vs BACITRACIN\NEOMYCIN\POLYMYXIN B AZTREONAM LYSINE vs BACITRACIN\POLYMYXIN B AZTREONAM LYSINE vs BACLOFEN AZTREONAM LYSINE vs BACLOFEN INTRATHECAL AZTREONAM LYSINE vs BACTRIM AZTREONAM LYSINE vs BALOXAVIR MARBOXIL AZTREONAM LYSINE vs BALSALAZIDE

Official FDA Label for AZTREONAM LYSINE

Official prescribing information from the FDA-approved drug label.