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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.

SPIRAMYCIN: 925 Adverse Event Reports & Safety Profile

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925
Total FAERS Reports
179 (19.4%)
Deaths Reported
519
Hospitalizations
925
As Primary/Secondary Suspect
131
Life-Threatening
2
Disabilities

First Report: 20010101 · Latest Report: 20250328

What Are the Most Common SPIRAMYCIN Side Effects?

#1 Most Reported
Off label use
77 reports (8.3%)
#2 Most Reported
Cholestasis
75 reports (8.1%)
#3 Most Reported
Rash maculo-papular
70 reports (7.6%)

All SPIRAMYCIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 77 8.3% 20 44
Cholestasis 75 8.1% 0 57
Rash maculo-papular 70 7.6% 12 40
Hepatocellular injury 68 7.4% 3 46
Toxic epidermal necrolysis 65 7.0% 46 63
Eosinophilia 44 4.8% 12 28
Acute kidney injury 42 4.5% 3 36
Pyrexia 41 4.4% 16 39
Rhabdomyolysis 37 4.0% 24 16
Thrombocytopenia 37 4.0% 5 31
Acute generalised exanthematous pustulosis 34 3.7% 0 27
Drug ineffective 32 3.5% 18 23
Drug reaction with eosinophilia and systemic symptoms 32 3.5% 0 25
Maternal exposure during pregnancy 32 3.5% 4 16
Hepatic cytolysis 27 2.9% 0 22
Hypertransaminasaemia 26 2.8% 12 4
Condition aggravated 25 2.7% 10 21
Septic shock 24 2.6% 21 9
Foetal exposure during pregnancy 23 2.5% 11 1
Dyspnoea 21 2.3% 5 16

Who Reports SPIRAMYCIN Side Effects? Age & Gender Data

Gender: 40.5% female, 59.5% male. Average age: 59.7 years. Most reports from: FR. View detailed demographics →

Is SPIRAMYCIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 2
2008 2 0 2
2009 1 0 1
2010 1 0 1
2011 3 0 0
2012 1 1 1
2013 8 6 6
2014 27 1 14
2015 71 11 54
2016 37 5 25
2017 50 7 37
2018 71 2 35
2019 94 25 56
2020 174 63 108
2021 60 9 45
2022 57 4 18
2023 50 14 20
2024 37 0 20
2025 20 0 8

View full timeline →

What Is SPIRAMYCIN Used For?

IndicationReports
Product used for unknown indication 123
Pneumonia 108
Lung disorder 106
Infection 73
Toxoplasmosis 34
Bronchitis 33
Sepsis 31
Legionella infection 27
Covid-19 26
Antibiotic therapy 25

SPIRAMYCIN vs Alternatives: Which Is Safer?

SPIRAMYCIN vs SPIRIVA SPIRAMYCIN vs SPIRONOLACTONE SPIRAMYCIN vs SPRYCEL SPIRAMYCIN vs STALEVO SPIRAMYCIN vs STANNOUS FLUORIDE SPIRAMYCIN vs STANOZOLOL SPIRAMYCIN vs STAVUDINE SPIRAMYCIN vs STELARA SPIRAMYCIN vs STIRIPENTOL SPIRAMYCIN vs STIVARGA

Official FDA Label for SPIRAMYCIN

Official prescribing information from the FDA-approved drug label.