SIMPONI for Crohn's disease: Side Effects & Safety Data

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There are 12 adverse event reports in the FDA FAERS database where SIMPONI was used for Crohn's disease.

Most Reported Side Effects for SIMPONI

Side Effect	Reports	%	Deaths	Hosp.
Pneumonia	50	7.1%	3	28
Drug ineffective	36	5.1%	0	5
Device malfunction	29	4.1%	0	8
Drug dose omission	26	3.7%	0	9
Pain	24	3.4%	1	10
Diarrhoea	21	3.0%	0	5
Rheumatoid arthritis	20	2.8%	2	3
Vomiting	20	2.8%	0	5
Fall	18	2.6%	0	11
Malaise	18	2.6%	0	6
Off label use	18	2.6%	0	9
Abdominal pain	17	2.4%	0	3
Arthralgia	16	2.3%	1	4
Dyspnoea	16	2.3%	0	8
Nausea	16	2.3%	0	4