Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fluvoxamine maleate
Drug ID BADD_D00951
Description Fluvoxamine is an antidepressant which functions pharmacologically as a selective serotonin reuptake inhibitor. Though it is in the same class as other SSRI drugs, it is most often used to treat obsessive-compulsive disorder. Fluvoxamine has been in use in clinical practice since 1983 and has a clinical trial database comprised of approximately 35,000 patients. It was launched in the US in December 1994 and in Japan in June 1999. As of the end of 1995, more than 10 million patients worldwide have been treated with fluvoxamine.
Indications and Usage Indicated predominantly for the management of depression and for Obsessive Compulsive Disorder (OCD) [FDA Label]. Has also been used in the management of bulimia nervosa [A250].
Marketing Status approved; investigational
ATC Code N06AB08
DrugBank ID DB00176
KEGG ID D00824
MeSH ID D016666
PubChem ID 5384136
TTD Drug ID D0M5JI
NDC Product Code 76072-1003; 68788-7219; 70518-3153; 72789-221; 0832-1671; 69452-183; 62559-158; 0228-2849; 69452-182; 70518-1057; 0832-1672; 70966-0026; 63629-8018; 70518-1789; 71335-1974; 10370-175; 50090-5988; 60505-0166; 11722-063; 53296-0043; 0228-2848; 60505-0165; 70518-1643; 71335-2008; 60505-0164; 62559-159; 62559-160; 68788-8175; 71335-0264; 0832-1670; 59349-0009; 10370-176
UNII 5LGN83G74V
Synonyms Fluvoxamine | Fluvoxadura | Fluvoxamin AL | Fluvoxamin beta | Fluvoxamin Stada | Fluvoxamin-neuraxpharm | Fluvoxamin neuraxpharm | Fluvoxamin-ratiopharm | Fluvoxamin ratiopharm | ratio-Fluvoxamine | ratio Fluvoxamine | Fluvoxamina Geminis | Geminis, Fluvoxamina | Fluvoxamine Maleate | Fluvoxamine Maleate, (E)-Isomer | Fluvoxamine, (Z)-Isomer | Luvox | Floxyfral | Fevarin | Dumirox | Faverin | Novo-Fluvoxamine | Novo Fluvoxamine | Nu-Fluvoxamine | Nu Fluvoxamine | PMS-Fluvoxamine | PMS Fluvoxamine | Desiflu | DU-23000 | DU 23000 | DU23000
Chemical Information
Molecular Formula C19H25F3N2O6
CAS Registry Number 61718-82-9
SMILES COCCCCC(=NOCCN)C1=CC=C(C=C1)C(F)(F)F.C(=CC(=O)O)C(=O)O
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)
Pulmonary infarction24.04.09.001; 22.06.02.002--Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Retinal detachment12.01.04.004; 06.09.03.003--
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
Sinusitis22.07.03.007; 11.01.13.005--
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.01.045--
Stomatitis07.05.06.005--
Stupor19.02.05.004; 17.02.04.007--Not Available
Sudden death08.04.01.003; 02.03.04.013--
Suicide attempt19.12.01.004--
Supraventricular extrasystoles02.03.03.011--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tardive dyskinesia17.01.02.012--Not Available
Tendinous contracture15.07.01.001--Not Available
Tenosynovitis15.07.01.004--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tooth disorder07.09.05.001--Not Available
Torticollis17.01.03.003; 15.05.04.003--Not Available
Tremor17.01.06.002--
Trismus17.01.03.004; 15.05.04.004--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract infection20.08.02.001; 11.01.14.004--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vaginal infection21.14.02.002; 11.01.10.002--
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