PRANLUKAST: 61 Adverse Event Reports & Safety Profile
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61
Total FAERS Reports
4 (6.6%)
Deaths Reported
40
Hospitalizations
61
As Primary/Secondary Suspect
5
Life-Threatening
3
Disabilities
First Report: 20121231 · Latest Report: 20241007
What Are the Most Common PRANLUKAST Side Effects?
#1 Most Reported
Hepatic function abnormal
10 reports (16.4%)
#2 Most Reported
Drug reaction with eosinophilia and systemic symptoms
7 reports (11.5%)
#3 Most Reported
Cytomegalovirus infection
6 reports (9.8%)
All PRANLUKAST Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hepatic function abnormal | 10 | 16.4% | 1 | 6 |
| Drug reaction with eosinophilia and systemic symptoms | 7 | 11.5% | 0 | 7 |
| Cytomegalovirus infection | 6 | 9.8% | 0 | 6 |
| Asthma | 5 | 8.2% | 1 | 4 |
| Bk virus infection | 5 | 8.2% | 0 | 5 |
| Dermatitis exfoliative | 5 | 8.2% | 0 | 4 |
| Drug-induced liver injury | 5 | 8.2% | 1 | 5 |
| Pyrexia | 5 | 8.2% | 1 | 4 |
Who Reports PRANLUKAST Side Effects? Age & Gender Data
Gender: 50.0% female, 50.0% male. Average age: 40.4 years. Most reports from: JP. View detailed demographics →
Is PRANLUKAST Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2014 | 7 | 2 | 2 |
| 2015 | 9 | 1 | 7 |
| 2016 | 4 | 0 | 2 |
| 2017 | 6 | 0 | 4 |
| 2018 | 5 | 0 | 2 |
| 2019 | 3 | 0 | 2 |
| 2021 | 3 | 0 | 2 |
| 2022 | 4 | 1 | 2 |
| 2023 | 1 | 0 | 1 |
| 2024 | 1 | 0 | 1 |
What Is PRANLUKAST Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 19 |
| Asthma | 12 |
Official FDA Label for PRANLUKAST
Official prescribing information from the FDA-approved drug label.