NITRAZEPAM for Infantile spasms: Side Effects & Safety Data

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There are 11 adverse event reports in the FDA FAERS database where NITRAZEPAM was used for Infantile spasms.

Most Reported Side Effects for NITRAZEPAM

Side Effect	Reports	%	Deaths	Hosp.
Toxicity to various agents	228	19.6%	170	53
Suicide attempt	105	9.0%	4	44
Chest discomfort	102	8.8%	80	22
Intentional overdose	102	8.8%	14	51
Drug ineffective	101	8.7%	5	31
Fall	95	8.2%	15	73
Somnolence	93	8.0%	12	28
Drug abuse	86	7.4%	42	34
Overdose	74	6.4%	33	47
Off label use	70	6.0%	7	28
Fatigue	59	5.1%	1	26
Loss of consciousness	53	4.6%	16	36
Pulmonary oedema	50	4.3%	18	33
Weight increased	48	4.1%	0	25
Dyspnoea	47	4.0%	1	25