In the listing as follows, the following convention is used: MedDRA system organ class/preferred term.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from available data). (See table.)
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Cases of withdrawal syndrome have occurred.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs with unknown frequency.
Post marketing: Isolated cases of cholestatic hepatitis have been reported.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system to Health Product Vigilance (HPVC), Food and Drug Administration, Thailand: Tel. 02-590-7288 or http://www.fda.moph.go.th/vigilance or adr@fda.moph.go.th.
View ADR Monitoring Form