Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fluoxetine
Drug ID BADD_D00932
Description Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI).[A181673] It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.[L7721]
Indications and Usage Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present.[L7664] Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression.[L7664]
Marketing Status approved; vet_approved
ATC Code N06AB03
DrugBank ID DB00472
KEGG ID D00326
MeSH ID D005473
PubChem ID 3386
TTD Drug ID D0TR5X
NDC Product Code 0093-0807; 43063-839; 53002-2305; 61919-869; 62332-243; 71335-0924; 0615-8093; 0093-7198; 50090-3180; 50111-647; 50228-421; 59651-308; 68645-130; 0615-7625; 72241-009; 0904-5785; 0904-7195; 49884-468; 55111-150; 59651-324; 62332-242; 65862-306; 71209-041; 61919-885; 63304-632; 72241-008; 80426-044; 63187-233; 63629-8179; 70518-3752; 71335-0565; 80425-0313; 59651-309; 13668-443; 46708-273; 68645-131; 80426-045; 23155-028; 23155-030; 42291-398; 42571-388; 62332-024; 63187-089; 71335-1048; 0904-5784; 23155-029; 42291-396; 42571-389; 62332-022; 72162-1506; 72241-007; 16714-112; 16714-113; 42291-397; 42571-387; 43598-566; 46708-272; 50228-420; 58118-0645; 70518-1619; 71209-042; 13668-473; 50111-648; 55154-1341; 61919-100; 62332-023; 63629-2201; 71205-178; 71205-188; 71209-040; 42708-025; 46708-271; 53002-5016
UNII 01K63SUP8D
Synonyms Fluoxetine | Fluoxetin | N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine | Lilly-110140 | Lilly 110140 | Lilly110140 | Sarafem | Fluoxetine Hydrochloride | Prozac
Chemical Information
Molecular Formula C17H18F3NO
CAS Registry Number 54910-89-3
SMILES CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F
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)
Brain injury17.11.01.003; 19.07.03.0070.000059%-
Intellectual disability17.03.07.001; 19.21.06.0010.000059%-
Toe walking15.03.05.032; 17.02.05.048; 19.01.02.011---
Langerhans' cell histiocytosis01.13.04.003; 09.01.08.018; 15.09.03.008; 16.21.04.003; 22.01.01.016---
Hypoxic-ischaemic encephalopathy17.13.02.006; 22.02.02.011; 24.04.06.0210.000039%-
Foetal growth restriction18.03.01.0020.000118%
Gestational hypertension18.02.03.004; 24.08.07.0040.000193%-
Microsomia08.01.03.0560.000030%-
Slow speech17.02.08.016; 19.19.02.0040.000049%-
Resting tremor17.01.06.0080.000030%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000285%-
Reversible cerebral vasoconstriction syndrome17.08.02.014; 18.06.01.004; 24.04.06.0260.000295%-
Platelet dysfunction01.08.03.0030.000059%-
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.005---
Candida infection11.03.03.021--
Foetal heart rate deceleration abnormality02.03.02.022; 18.03.02.0120.000059%-
Language disorder17.02.08.015; 19.19.01.0060.000020%-
Irregular breathing22.02.01.0260.000020%-
Intrusive thoughts19.10.03.0080.000049%-
Anal incontinence07.01.06.029; 17.05.01.0210.000020%
Depersonalisation/derealisation disorder19.14.01.0040.000030%-
Gambling disorder19.07.06.0150.000039%-
Somatic symptom disorder19.24.01.0060.000020%-
Abnormal loss of weight14.03.02.0190.000020%-
Abortion threatened18.01.04.0030.000020%-
Agitated depression17.02.05.050; 19.15.01.0070.000053%-
Alcohol interaction08.06.03.0030.000118%-
Anorexia nervosa14.03.03.002; 19.09.01.0070.000030%-
Arrested labour18.07.03.0030.000069%-
Arrhythmia neonatal02.03.02.024; 18.04.07.0050.000030%-
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ADReCS-Target
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