SAPROPTERIN for Hyperphenylalaninaemia: Side Effects & Safety Data

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There are 117 adverse event reports in the FDA FAERS database where SAPROPTERIN was used for Hyperphenylalaninaemia.

Most Reported Side Effects for SAPROPTERIN

Side Effect	Reports	%	Deaths	Hosp.
Drug ineffective	356	6.4%	1	7
Therapy non-responder	348	6.3%	0	1
Headache	309	5.6%	0	5
Maternal exposure during pregnancy	277	5.0%	0	21
Vomiting	260	4.7%	0	28
Diarrhoea	238	4.3%	0	15
Amino acid level increased	194	3.5%	0	7
Nausea	189	3.4%	0	13
Abdominal pain upper	179	3.2%	0	4
Anxiety	174	3.1%	0	7
Abdominal discomfort	153	2.8%	0	3
Arthralgia	142	2.6%	0	4
Cough	138	2.5%	0	9
Nasopharyngitis	131	2.4%	0	4
Malaise	119	2.2%	0	1