ROFLUMILAST for Pruritus: Side Effects & Safety Data

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There are 8 adverse event reports in the FDA FAERS database where ROFLUMILAST was used for Pruritus.

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