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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.

ROXITHROMYCIN: 352 Adverse Event Reports & Safety Profile

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352
Total FAERS Reports
43 (12.2%)
Deaths Reported
189
Hospitalizations
352
As Primary/Secondary Suspect
24
Life-Threatening
7
Disabilities

First Report: 199504 · Latest Report: 20250619

What Are the Most Common ROXITHROMYCIN Side Effects?

#1 Most Reported
Diarrhoea
30 reports (8.5%)
#2 Most Reported
Nausea
28 reports (8.0%)
#3 Most Reported
Erythema
26 reports (7.4%)

All ROXITHROMYCIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 30 8.5% 0 13
Nausea 28 8.0% 0 12
Erythema 26 7.4% 0 14
Arthralgia 24 6.8% 0 9
Bladder transitional cell carcinoma 23 6.5% 0 23
Headache 20 5.7% 0 16
Jaundice 18 5.1% 0 16
Palpitations 18 5.1% 0 5
Abdominal pain upper 17 4.8% 0 2
Asthenia 17 4.8% 0 7
Vomiting 17 4.8% 0 14
Arrhythmia 16 4.6% 0 1
Drug reaction with eosinophilia and systemic symptoms 16 4.6% 0 16
Gait disturbance 14 4.0% 0 14
Hepatitis 14 4.0% 0 9
Myocardial infarction 14 4.0% 14 0
Toxicity to various agents 14 4.0% 5 6
Agranulocytosis 13 3.7% 0 2
Cardiovascular disorder 13 3.7% 0 0
Drug-induced liver injury 13 3.7% 0 10

Who Reports ROXITHROMYCIN Side Effects? Age & Gender Data

Gender: 57.9% female, 42.1% male. Average age: 57.9 years. Most reports from: FR. View detailed demographics →

Is ROXITHROMYCIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 10 0 10
2002 2 0 0
2004 5 4 5
2007 1 0 1
2008 1 0 1
2010 2 0 2
2012 3 0 3
2013 6 0 3
2014 10 4 4
2015 12 0 9
2016 13 0 7
2017 38 9 29
2018 26 0 21
2019 25 0 15
2020 37 5 13
2021 2 2 0
2022 3 0 2
2023 38 12 4
2024 19 0 17
2025 4 0 1

View full timeline →

What Is ROXITHROMYCIN Used For?

IndicationReports
Product used for unknown indication 139
Lung disorder 25
Bronchitis 17
Ear, nose and throat infection 13
Pneumonia 13
Rhinitis 13
Infection 11
Nasopharyngitis 8
Upper respiratory tract infection 8
Hidradenitis 6

ROXITHROMYCIN vs Alternatives: Which Is Safer?

ROXITHROMYCIN vs ROZANOLIXIZUMAB ROXITHROMYCIN vs ROZANOLIXIZUMAB-NOLI ROXITHROMYCIN vs RUBIDIUM RB-82 ROXITHROMYCIN vs RUCAPARIB ROXITHROMYCIN vs RUCAPARIB CAMSYLATE ROXITHROMYCIN vs RUFINAMIDE ROXITHROMYCIN vs RUPATADINE ROXITHROMYCIN vs RUXOLITINIB ROXITHROMYCIN vs SABRIL ROXITHROMYCIN vs SACCHAROMYCES CEREVISIAE

Official FDA Label for ROXITHROMYCIN

Official prescribing information from the FDA-approved drug label.