Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pizotyline
Drug ID BADD_D01787
Description Pizotifen belongs to the class of antamines and is related to [cyproheptadine].[A32532] It is a potent serotonin and tryptamine antagonist that has been used for migraine prevention for many years. It exhibits weak anticholinergic, antihistamine, and antikinin actions in addition to sedative and appetite-stimulating properties [L2292]. Some patients receiving pizotifen treatment developed tolerance with the prolonged use of the drug [L2292]. Numerous studies have revealed the potential antidepressant effects of pizotifen, which are independent of its antimigraine action [A32538]. While it is suggested that pizotifen may act similarly to the classic tricyclic antidepressants [A32538], its full mechanism of antidepressant action is not fully elucidated. Pizotifen hydrochloride is an active ingredient in Sandomigran, which is used for the prophylactic management of migraines. Sandomigran is available in a number of countries but is not approved by the FDA nor EMA.
Indications and Usage Indicated for the prophylactic management of migraines [L2292].
Marketing Status approved
ATC Code N02CX01
DrugBank ID DB06153
KEGG ID D05523
MeSH ID D010918
PubChem ID 27400
TTD Drug ID D06XZR
NDC Product Code Not Available
UNII 0BY8440V3N
Synonyms Pizotyline | Pizotifen | Polomigran | Sandomigran | BC-105 | BC 105 | BC105
Chemical Information
Molecular Formula C19H21NS
CAS Registry Number 15574-96-6
SMILES CN1CCC(=C2C3=C(CCC4=CC=CC=C42)SC=C3)CC1
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Asthenia08.01.01.001---
Confusional state17.02.03.005; 19.13.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Headache17.14.01.001--
Hypotension24.06.03.002--
Increased appetite08.01.09.027; 14.03.01.003---
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nervousness19.06.02.003---
Oedema08.01.07.006; 14.05.06.010---
Somnolence17.02.04.006; 19.02.05.003--
Tension19.06.02.005---
Weight increased13.15.01.006--
Musculoskeletal discomfort15.03.04.001---
Erectile dysfunction19.08.04.001; 21.03.01.007--
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