AGOMELATINE for Off label use: Side Effects & Safety Data

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There are 9 adverse event reports in the FDA FAERS database where AGOMELATINE was used for Off label use.

Most Reported Side Effects for AGOMELATINE

Side Effect	Reports	%	Deaths	Hosp.
Fall	229	25.1%	206	32
Insomnia	215	23.6%	181	8
Coma	207	22.7%	187	15
Tachycardia	206	22.6%	183	10
Arthralgia	204	22.3%	182	4
Diarrhoea	204	22.3%	190	4
Dizziness	204	22.3%	183	5
Fatigue	204	22.3%	163	19
Pruritus	203	22.2%	189	1
Dyspnoea	202	22.1%	184	3
Somnolence	202	22.1%	164	16
Head discomfort	199	21.8%	188	0
Altered state of consciousness	197	21.6%	192	3
Chills	197	21.6%	188	0
Cardio-respiratory arrest	195	21.4%	194	0