ROFLUMILAST for Dyspnoea: Side Effects & Safety Data
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There are 22 adverse event reports in the FDA FAERS database where ROFLUMILAST was used for Dyspnoea.
Most Reported Side Effects for ROFLUMILAST
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 569 | 21.1% | 568 | 8 |
| Dyspnoea | 433 | 16.0% | 7 | 191 |
| Chronic obstructive pulmonary disease | 292 | 10.8% | 26 | 158 |
| Diarrhoea | 265 | 9.8% | 6 | 82 |
| Off label use | 242 | 9.0% | 7 | 65 |
| Weight decreased | 224 | 8.3% | 8 | 74 |
| Nausea | 191 | 7.1% | 5 | 36 |
| Pneumonia | 176 | 6.5% | 7 | 123 |
| Headache | 166 | 6.2% | 2 | 26 |
| Malaise | 164 | 6.1% | 6 | 48 |
| Asthma | 158 | 5.9% | 0 | 76 |
| Drug ineffective | 156 | 5.8% | 1 | 30 |
| Decreased appetite | 151 | 5.6% | 6 | 44 |
| Insomnia | 151 | 5.6% | 2 | 29 |
| Cough | 140 | 5.2% | 0 | 40 |
Other Indications for ROFLUMILAST
Chronic obstructive pulmonary disease (945)
Product used for unknown indication (369)
Psoriasis (149)
Seborrhoeic dermatitis (61)
Emphysema (40)
Asthma (27)
Pseudomonas infection (27)
Dermatitis atopic (26)
Eczema (15)
Bronchitis chronic (14)
Other Drugs Used for Dyspnoea
ALBUTEROL (4,007)
FLUTICASONE\SALMETEROL (1,359)
BUDESONIDE\FORMOTEROL (876)
FLUTICASONE FUROATE\VILANTEROL TRIFENATATE (672)
IPRATROPIUM (538)
TIOTROPIUM (527)
UMECLIDINIUM\VILANTEROL TRIFENATATE (467)
PREDNISONE (366)
UMECLIDINIUM (320)
FLUTICASONE (299)