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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.

AMPICILLIN\SULBACTAM: 1,655 Adverse Event Reports & Safety Profile

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1,655
Total FAERS Reports
308 (18.6%)
Deaths Reported
791
Hospitalizations
1,655
As Primary/Secondary Suspect
224
Life-Threatening
25
Disabilities

Active Ingredient: AMPICILLIN SODIUM\SULBACTAM SODIUM ·

First Report: 1978 · Latest Report: 20250811

What Are the Most Common AMPICILLIN\SULBACTAM Side Effects?

#1 Most Reported
Drug ineffective
258 reports (15.6%)
#2 Most Reported
Off label use
124 reports (7.5%)
#3 Most Reported
Rash
98 reports (5.9%)

All AMPICILLIN\SULBACTAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 258 15.6% 87 145
Off label use 124 7.5% 35 61
Pyrexia 98 5.9% 8 70
Rash 98 5.9% 2 47
Diarrhoea 93 5.6% 7 56
Condition aggravated 83 5.0% 33 59
Drug hypersensitivity 70 4.2% 2 19
Pneumonia 68 4.1% 24 41
Acute kidney injury 66 4.0% 9 34
Drug eruption 66 4.0% 3 38
Pruritus 54 3.3% 1 26
Renal impairment 54 3.3% 11 39
Maternal exposure during pregnancy 46 2.8% 2 21
Erythema 44 2.7% 1 29
Sepsis 43 2.6% 27 34
Drug ineffective for unapproved indication 40 2.4% 10 17
Dyspnoea 40 2.4% 3 25
Hypotension 40 2.4% 4 24
Foetal exposure during pregnancy 39 2.4% 9 2
Toxic epidermal necrolysis 38 2.3% 15 22

Who Reports AMPICILLIN\SULBACTAM Side Effects? Age & Gender Data

Gender: 45.5% female, 54.5% male. Average age: 55.5 years. Most reports from: JP. View detailed demographics →

Is AMPICILLIN\SULBACTAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2002 1 0 1
2003 3 0 3
2004 1 1 1
2006 1 0 0
2007 3 1 2
2009 3 0 1
2010 5 0 5
2011 7 3 3
2012 7 0 4
2013 20 12 10
2014 33 2 19
2015 47 3 29
2016 77 25 46
2017 87 20 50
2018 74 12 43
2019 39 12 18
2020 43 1 25
2021 32 4 10
2022 26 9 13
2023 52 3 27
2024 35 2 15
2025 15 5 7

View full timeline →

What Is AMPICILLIN\SULBACTAM Used For?

IndicationReports
Pneumonia 225
Product used for unknown indication 183
Antibiotic therapy 80
Pneumonia aspiration 63
Infection 49
Bacterial infection 41
Cellulitis 40
Osteomyelitis 37
Antibiotic prophylaxis 30
Staphylococcal infection 30

AMPICILLIN\SULBACTAM vs Alternatives: Which Is Safer?

AMPICILLIN\SULBACTAM vs AMPRENAVIR AMPICILLIN\SULBACTAM vs AMPYRA AMPICILLIN\SULBACTAM vs AMRUBICIN AMPICILLIN\SULBACTAM vs AMSACRINE AMPICILLIN\SULBACTAM vs ANAGRELIDE AMPICILLIN\SULBACTAM vs ANAKINRA AMPICILLIN\SULBACTAM vs ANAMORELIN AMPICILLIN\SULBACTAM vs ANASTROZOLE AMPICILLIN\SULBACTAM vs ANDEXANET ALFA AMPICILLIN\SULBACTAM vs ANDROGEL

Official FDA Label for AMPICILLIN\SULBACTAM

Official prescribing information from the FDA-approved drug label.