PROMETHAZINE for Restlessness: Side Effects & Safety Data

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There are 50 adverse event reports in the FDA FAERS database where PROMETHAZINE was used for Restlessness.

Most Reported Side Effects for PROMETHAZINE

Side Effect	Reports	%	Deaths	Hosp.
Intentional overdose	3,193	41.0%	39	3,111
Intentional self-injury	2,869	36.8%	7	2,822
Toxicity to various agents	742	9.5%	522	206
Tachycardia	653	8.4%	13	632
Drug hypersensitivity	627	8.0%	2	31
Fatigue	617	7.9%	5	544
Depressed level of consciousness	522	6.7%	40	484
Somnolence	510	6.5%	26	393
Drug abuse	359	4.6%	278	57
Akathisia	343	4.4%	12	338
Nausea	314	4.0%	13	157
Vomiting	309	4.0%	13	203
Anxiety	295	3.8%	14	220
Hallucination	251	3.2%	7	210
Completed suicide	238	3.1%	236	53