JOSAMYCIN: 94 Adverse Event Reports & Safety Profile
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94
Total FAERS Reports
10 (10.6%)
Deaths Reported
66
Hospitalizations
94
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities
First Report: 20110127 · Latest Report: 20240907
What Are the Most Common JOSAMYCIN Side Effects?
#1 Most Reported
Vomiting
13 reports (13.8%)
#2 Most Reported
Dyspnoea
9 reports (9.6%)
#3 Most Reported
Chest pain
8 reports (8.5%)
All JOSAMYCIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Vomiting | 13 | 13.8% | 0 | 12 |
| Dyspnoea | 9 | 9.6% | 2 | 8 |
| Chest pain | 8 | 8.5% | 2 | 8 |
| Confusional state | 7 | 7.5% | 1 | 7 |
| Gamma-glutamyltransferase increased | 7 | 7.5% | 0 | 0 |
| Hypertransaminasaemia | 7 | 7.5% | 0 | 0 |
| Dermatitis bullous | 6 | 6.4% | 0 | 6 |
| Hepatocellular injury | 6 | 6.4% | 4 | 0 |
| Hypotension | 6 | 6.4% | 0 | 6 |
| Intentional overdose | 6 | 6.4% | 0 | 6 |
| Lipase increased | 6 | 6.4% | 0 | 6 |
| Neutrophil count increased | 6 | 6.4% | 0 | 6 |
| Pulmonary oedema | 6 | 6.4% | 0 | 6 |
| Somnolence | 6 | 6.4% | 0 | 6 |
| Symmetrical drug-related intertriginous and flexural exanthema | 6 | 6.4% | 0 | 6 |
| Acute generalised exanthematous pustulosis | 5 | 5.3% | 0 | 5 |
| Headache | 5 | 5.3% | 2 | 5 |
| Hepatic cytolysis | 5 | 5.3% | 0 | 5 |
| Toxicity to various agents | 5 | 5.3% | 0 | 5 |
Who Reports JOSAMYCIN Side Effects? Age & Gender Data
Gender: 55.8% female, 44.2% male. Average age: 41.9 years. Most reports from: FR. View detailed demographics →
Is JOSAMYCIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 2 | 0 | 1 |
| 2013 | 1 | 0 | 1 |
| 2014 | 4 | 0 | 4 |
| 2015 | 10 | 8 | 3 |
| 2016 | 5 | 0 | 5 |
| 2017 | 15 | 0 | 10 |
| 2018 | 15 | 0 | 14 |
| 2019 | 13 | 0 | 12 |
| 2020 | 11 | 0 | 4 |
| 2021 | 5 | 0 | 5 |
| 2022 | 2 | 0 | 2 |
| 2024 | 1 | 0 | 0 |
What Is JOSAMYCIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 20 |
| Lung disorder | 8 |
| Bronchitis | 7 |
| Lung infection | 7 |
| Sepsis | 7 |
| Tonsillitis | 7 |
| Nasopharyngitis | 6 |
| Cough | 5 |
| Infection | 5 |
| Upper respiratory tract infection | 5 |
Official FDA Label for JOSAMYCIN
Official prescribing information from the FDA-approved drug label.