Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Fluoxetine hydrochloride
Drug ID BADD_D00933
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 D00823
MeSH ID D005473
PubChem ID 62857
TTD Drug ID D0TR5X
NDC Product Code 16714-114; 50090-6066; 51655-081; 51655-274; 68180-997; 68788-9222; 70518-3554; 71205-979; 0832-0403; 17337-0517; 49452-3176; 43063-570; 43353-637; 49884-336; 50090-6065; 54838-523; 70518-1359; 70518-2134; 71205-125; 71205-974; 77771-115; 65862-194; 42543-726; 43063-993; 50090-5678; 50090-6193; 50228-114; 55111-284; 63187-218; 63187-361; 63629-2198; 65862-193; 68001-400; 70518-0417; 71335-1482; 63629-2197; 63629-2200; 68001-399; 68001-401; 68788-7817; 71335-0923; 71335-1145; 71610-683; 71610-699; 75834-148; 12780-2945; 35356-728; 43598-632; 46708-243; 49483-701; 50090-0745; 51655-314; 51655-750; 53002-3671; 63187-081; 68071-5276; 68084-605; 70518-2754; 70518-3083; 71205-393; 71335-0827; 0777-3105; 82009-102; 51927-0117; 65862-192; 16714-721; 25000-147; 0121-0721; 50090-0749; 50090-2589; 50228-422; 51672-5306; 60687-659; 60760-311; 63629-1610; 68180-998; 69367-237; 70954-600; 71205-975; 71335-1033; 82009-100; 0110-3105; 46708-855; 16714-720; 42543-727; 42708-182; 43063-712; 46708-242; 47781-600; 49483-702; 49483-703; 63629-1609; 63629-2199; 63629-8990; 69367-235; 69367-236; 70934-710; 71335-1548; 0615-8183; 0777-3107; 77771-114; 0832-6032; 82009-101; 0110-3107; 53069-0220; 62991-2866; 63415-0013; 17224-171; 25000-148; 50090-6081; 50228-113; 53002-1016; 53002-1671; 68071-5240; 68788-7909; 70518-0369; 70518-1174; 70518-3322; 72162-1495; 0777-3104; 77771-113; 0832-0402; 49706-0785; 52483-0600; 55111-007; 65862-347; 16714-722; 49884-335; 50090-6064; 50228-115; 51655-981; 53002-1796; 60687-244; 63629-8989; 71335-2020; 65691-0028; 68981-044; 25000-149; 53002-1305; 55700-866; 63187-069; 67296-1568; 68071-2275; 68180-999; 68788-7741; 70518-3483; 72189-067; 0110-3104; 17337-0020; 38779-0013; 0121-4721; 42543-725
UNII I9W7N6B1KJ
Synonyms Fluoxetine | Fluoxetin | N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine | Lilly-110140 | Lilly 110140 | Lilly110140 | Sarafem | Fluoxetine Hydrochloride | Prozac
Chemical Information
Molecular Formula C17H19ClF3NO
CAS Registry Number 56296-78-7
SMILES CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F.Cl
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)
Hypomania19.16.02.001---
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Influenza11.05.03.001; 22.07.02.001---
Insomnia17.15.03.002; 19.02.01.002--
Jaundice cholestatic09.01.01.005---
Laryngeal oedema10.01.05.003; 22.04.02.001; 23.04.01.005--
Libido decreased19.08.03.001; 21.03.02.005--
Libido increased19.08.03.002; 21.03.02.007--
Mania19.16.02.002--
Melaena07.12.02.004; 24.07.02.013---
Memory impairment17.03.02.003; 19.20.01.003--
Micturition disorder20.02.02.005---
Movement disorder17.01.02.010---
Mydriasis06.05.03.004; 17.02.11.003---
Myoclonus17.02.05.008---
Nausea07.01.07.001--
Nervousness19.06.02.003---
Oesophageal ulcer07.04.05.002--
Optic neuritis06.04.08.002; 10.02.01.097; 17.04.05.001---
Palpitations02.11.04.012--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003---
Paranoia19.05.01.005---
Peptic ulcer07.04.07.001---
Personality disorder19.05.02.002---
Petechiae01.01.03.002; 23.06.01.003; 24.07.06.004---
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
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