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)
Osteomyelitis15.02.05.001; 11.01.01.001--
Osteonecrosis24.04.05.004; 15.02.04.007--
Osteoporosis15.02.03.002; 14.04.04.002--
Ovarian cyst21.11.01.002; 16.04.03.001--Not Available
Ovarian disorder21.11.02.004--Not Available
Overdose12.11.01.002--Not Available
Pain08.01.08.004--
Pain in jaw15.02.01.0030.000039%Not Available
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Palpitations02.11.04.0120.000435%
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
Panic attack19.06.04.0010.000205%Not Available
Panic disorder19.06.04.0020.000030%Not Available
Panic reaction19.06.04.0030.000059%Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Paralysis17.01.04.0040.000020%Not Available
Paranoia19.05.01.0050.000201%Not Available
Parkinsonism17.01.05.0030.000108%Not Available
Parosmia22.04.03.007; 17.04.04.002--Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Penis disorder21.12.01.0010.000030%Not Available
Peptic ulcer07.04.07.001--Not Available
Pericardial effusion02.06.01.0020.000059%
Periorbital oedema23.04.01.002; 10.01.05.010; 06.08.03.017--
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.000020%Not Available
Peripheral vascular disorder24.03.01.003--Not Available
Peroneal nerve palsy17.09.02.003--Not Available
Personality change19.05.01.006; 17.02.05.0190.000146%
Personality disorder19.05.02.0020.000020%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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