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 Labeled indication include: major depressive disorder (MDD), moderate to severe bulimia nervosa, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), panic disorder with or without agoraphobia, and combination treatment with olanzapine for treatment-resistant or bipolar I depression. Unlabeled indications include: selective mutism, mild dementia-associated agitation in nonpsychotic patients, post-traumatic stress disorder (PTSD), social anxiety disorder, chronic neuropathic pain, fibromyalgia, and Raynaud's phenomenon.
Marketing Status Prescription; Discontinued
ATC Code N06AB03
DrugBank ID DB00472
KEGG ID D00326
MeSH ID D005473
PubChem ID 3386
TTD Drug ID D0TR5X
NDC Product Code 0093-7188; 50090-3332; 50228-420; 67296-1198; 63304-632; 70934-712; 63187-233; 50111-647; 61919-253; 0904-5785; 50228-421; 59651-324; 61919-885; 58118-0645; 59651-308; 53002-2305; 42708-025; 16714-112; 68071-4033; 42291-397; 16714-113; 23155-030; 71209-041; 42291-398; 0093-7198; 63629-2201; 59651-309; 61919-745; 46708-272; 53002-5016; 16714-353; 23155-029; 68001-129; 0093-0807; 62332-242; 46708-273; 71335-0924; 61919-869; 62332-022; 65862-306; 68071-4606; 46708-271; 72241-007; 43063-839; 55111-150; 50090-2776; 0615-8093; 49884-468; 16714-351; 23155-028; 71610-464; 0093-5262; 0904-5784; 68645-130; 43598-566; 60760-259; 55154-1341; 16714-352; 13668-473; 71205-178; 13668-443; 61919-100; 55700-089; 0615-7625; 50090-0744; 42291-396; 62332-243; 63187-089; 72241-008; 71335-1048; 50111-648; 71209-040; 72241-009; 71205-188; 61919-490; 71335-0565; 62332-024; 68645-131; 63629-8179; 62332-023; 71209-042
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.001498%
Abnormal dreams17.15.02.001; 19.02.03.0010.000408%Not Available
Abnormal faeces07.01.03.0010.000136%Not Available
Abnormal weight gain14.03.02.0100.000136%Not Available
Abortion18.01.01.0010.000091%Not Available
Abortion missed18.01.01.0020.000136%Not Available
Abortion spontaneous18.01.04.0010.002360%Not Available
Accommodation disorder06.02.04.001--Not Available
Acne23.02.01.001--Not Available
Acrochordon16.26.01.005; 23.10.01.0050.000091%Not Available
Acute abdomen07.01.06.015--Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Acute respiratory distress syndrome22.01.03.001--
Adrenal insufficiency05.01.02.001; 14.11.01.0040.000318%
Affective disorder19.04.04.0010.000363%Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Aggression19.05.01.0010.001951%Not Available
Agitation17.02.05.012; 19.06.02.0010.002813%
Agitation neonatal17.02.05.028; 18.04.04.002; 19.06.02.0070.000227%Not Available
Agoraphobia19.06.03.0040.000091%Not Available
Agranulocytosis01.02.03.001--Not Available
Akathisia17.01.02.002; 19.06.02.0060.001407%
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Alcohol abuse19.07.02.0070.000227%Not Available
Alcohol intolerance14.02.01.0010.000182%
Alcoholism19.07.02.0010.000771%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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