RUPATADINE: 767 Adverse Event Reports & Safety Profile
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767
Total FAERS Reports
73 (9.5%)
Deaths Reported
436
Hospitalizations
767
As Primary/Secondary Suspect
145
Life-Threatening
6
Disabilities
Active Ingredient: RUPATADINE FUMARATE ·
First Report: 20130101 · Latest Report: 20241126
What Are the Most Common RUPATADINE Side Effects?
#1 Most Reported
Asthma
429 reports (55.9%)
#2 Most Reported
Dyspnoea
426 reports (55.5%)
#3 Most Reported
Wheezing
386 reports (50.3%)
All RUPATADINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Asthma | 429 | 55.9% | 44 | 328 |
| Dyspnoea | 426 | 55.5% | 44 | 327 |
| Wheezing | 386 | 50.3% | 42 | 298 |
| Full blood count abnormal | 327 | 42.6% | 44 | 268 |
| Vasculitis | 285 | 37.2% | 42 | 250 |
| Urticaria | 239 | 31.2% | 6 | 190 |
| Cough | 225 | 29.3% | 0 | 200 |
| Therapeutic product effect incomplete | 215 | 28.0% | 42 | 131 |
| Chest discomfort | 213 | 27.8% | 0 | 200 |
| Lung disorder | 204 | 26.6% | 44 | 175 |
| Breath sounds abnormal | 194 | 25.3% | 0 | 193 |
| Blood potassium decreased | 193 | 25.2% | 0 | 193 |
| Chest x-ray abnormal | 193 | 25.2% | 0 | 193 |
| Ear pruritus | 193 | 25.2% | 0 | 193 |
| Nasal polyps | 193 | 25.2% | 0 | 169 |
| Blood lactic acid increased | 192 | 25.0% | 0 | 192 |
| Nasal congestion | 184 | 24.0% | 0 | 170 |
| Rhinorrhoea | 184 | 24.0% | 0 | 169 |
| Rhinitis allergic | 181 | 23.6% | 0 | 169 |
| Lacrimation increased | 179 | 23.3% | 0 | 178 |
Who Reports RUPATADINE Side Effects? Age & Gender Data
Gender: 76.3% female, 23.7% male. Average age: 55.0 years. Most reports from: CA. View detailed demographics →
Is RUPATADINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 3 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 5 | 0 | 3 |
| 2016 | 7 | 0 | 5 |
| 2017 | 1 | 0 | 0 |
| 2018 | 12 | 1 | 7 |
| 2019 | 21 | 0 | 6 |
| 2020 | 8 | 3 | 0 |
| 2021 | 17 | 2 | 7 |
| 2022 | 10 | 0 | 2 |
| 2023 | 9 | 1 | 7 |
| 2024 | 14 | 5 | 9 |
What Is RUPATADINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 491 |
| Chronic spontaneous urticaria | 101 |
| Multiple allergies | 44 |
| Urticaria | 16 |
| Asthma | 15 |
| Pruritus | 15 |
| Hypersensitivity | 11 |
| Rhinitis allergic | 6 |
| Angioedema | 5 |
| Dermatitis atopic | 5 |
RUPATADINE vs Alternatives: Which Is Safer?
RUPATADINE vs RUXOLITINIB
RUPATADINE vs SABRIL
RUPATADINE vs SACCHAROMYCES CEREVISIAE
RUPATADINE vs SACITUZUMAB GOVITECAN
RUPATADINE vs SACITUZUMAB GOVITECAN-HZIY
RUPATADINE vs SACROSIDASE
RUPATADINE vs SACUBITRIL
RUPATADINE vs SACUBITRIL\VALSARTAN
RUPATADINE vs SAFINAMIDE
RUPATADINE vs SAIZEN
Official FDA Label for RUPATADINE
Official prescribing information from the FDA-approved drug label.