ROFLUMILAST for Chronic obstructive pulmonary disease: Side Effects & Safety Data
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There are 945 adverse event reports in the FDA FAERS database where ROFLUMILAST was used for Chronic obstructive pulmonary disease.
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
Product used for unknown indication (369)
Psoriasis (149)
Seborrhoeic dermatitis (61)
Emphysema (40)
Asthma (27)
Pseudomonas infection (27)
Dermatitis atopic (26)
Dyspnoea (22)
Eczema (15)
Bronchitis chronic (14)
Other Drugs Used for Chronic obstructive pulmonary disease
TIOTROPIUM (20,175)
FLUTICASONE\SALMETEROL (8,896)
FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE (8,730)
ALBUTEROL (8,572)
BUDESONIDE\FORMOTEROL (6,539)
FLUTICASONE FUROATE\VILANTEROL TRIFENATATE (4,580)
UMECLIDINIUM\VILANTEROL TRIFENATATE (4,512)
DUPILUMAB (3,526)
ALBUTEROL\IPRATROPIUM (3,289)
ACLIDINIUM (2,321)