fluoxetine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives 1209 54910-89-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • prozac
  • fluoxetine
  • fluoxetine hydrochloride
  • fluoxetin
  • fluoxetine HCl
The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.
  • Molecular weight: 309.33
  • Formula: C17H18F3NO
  • CLOGP: 4.57
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 21.26
  • ALOGS: -5.26
  • ROTB: 7

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 15.20 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1.25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.30 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 60 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1987 FDA ELI LILLY AND CO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 4667.19 33.15 1225 7573 19809 2329478
Toxicity to various agents 3065.31 33.15 978 7820 31776 2317511
Drug abuse 1743.17 33.15 506 8292 11520 2337767
Drug interaction 1367.96 33.15 524 8274 28639 2320648
Intentional overdose 1255.48 33.15 388 8410 10933 2338354
Serotonin syndrome 1095.75 33.15 272 8526 3268 2346019
Exposure during pregnancy 1000.00 33.15 402 8396 24817 2324470
Cardio-respiratory arrest 927.03 33.15 293 8505 8853 2340434
Suicide attempt 914.30 33.15 305 8493 10977 2338310
Cardiac arrest 905.65 33.15 325 8473 14605 2334682
Overdose 783.30 33.15 316 8482 19591 2329696
Depression 782.74 33.15 349 8449 27783 2321504
Suicidal ideation 781.20 33.15 270 8528 10817 2338470
Agitation 739.49 33.15 259 8539 10792 2338495
Electrocardiogram QT prolonged 687.42 33.15 225 8573 7589 2341698
Respiratory arrest 654.69 33.15 205 8593 5973 2343314
Foetal exposure during pregnancy 605.75 33.15 186 8612 5066 2344221
Confusional state 578.56 33.15 271 8527 24073 2325214
Poisoning 576.55 33.15 156 8642 2664 2346623
Anxiety 527.39 33.15 270 8528 29089 2320198
Hyponatraemia 517.87 33.15 210 8588 13115 2336172
Intentional self-injury 500.60 33.15 152 8646 3975 2345312
Somnolence 492.42 33.15 240 8558 23245 2326042
Death 488.43 33.15 372 8426 81096 2268191
Tremor 387.85 33.15 196 8602 20465 2328822
Drug ineffective 378.70 33.15 353 8445 101271 2248016
Coma 369.69 33.15 148 8650 8908 2340379
Drug hypersensitivity 367.59 33.15 252 8546 46391 2302896
Vomiting 353.12 33.15 292 8506 71310 2277977
Torsade de pointes 343.32 33.15 99 8699 2147 2347140
Seizure 331.95 33.15 187 8611 24279 2325008
Intentional product misuse 322.36 33.15 136 8662 9353 2339934
Product complaint 316.79 33.15 110 8688 4428 2344859
Maternal exposure during pregnancy 287.44 33.15 144 8654 14719 2334568
Condition aggravated 285.66 33.15 187 8611 31792 2317495
Hypotension 280.81 33.15 186 8612 32250 2317037
Insomnia 278.28 33.15 170 8628 25617 2323670
Coma scale abnormal 258.22 33.15 64 8734 754 2348533
Sopor 248.86 33.15 89 8709 3906 2345381
Mania 241.55 33.15 77 8721 2363 2346924
Aggression 240.41 33.15 91 8707 4695 2344592
Product substitution issue 238.89 33.15 92 8706 4977 2344310
Fall 229.18 33.15 191 8607 46908 2302379
Depressed level of consciousness 222.07 33.15 98 8700 7506 2341781
Mydriasis 219.54 33.15 70 8728 2149 2347138
Drug withdrawal syndrome 219.05 33.15 94 8704 6727 2342560
Loss of consciousness 215.89 33.15 129 8669 18638 2330649
Atrial septal defect 213.17 33.15 61 8737 1283 2348004
Hyperhidrosis 211.89 33.15 119 8679 15303 2333984
Restlessness 208.53 33.15 81 8717 4482 2344805
Headache 206.81 33.15 229 8569 79950 2269337
Unresponsive to stimuli 203.32 33.15 81 8717 4795 2344492
Tachycardia 202.36 33.15 118 8680 16291 2332996
Hypokalaemia 202.23 33.15 102 8696 10552 2338735
Respiratory depression 200.53 33.15 65 8733 2105 2347182
Irritability 197.93 33.15 86 8712 6341 2342946
Dizziness 194.95 33.15 192 8606 58473 2290814
Nausea 189.89 33.15 259 8539 111930 2237357
Weight increased 183.18 33.15 124 8674 22213 2327074
Akathisia 174.65 33.15 55 8743 1619 2347668
Pre-eclampsia 171.95 33.15 53 8745 1451 2347836
Extrapyramidal disorder 171.85 33.15 59 8739 2288 2346999
Withdrawal syndrome 169.52 33.15 64 8734 3273 2346014
Crying 169.36 33.15 69 8729 4327 2344960
Bradycardia 159.06 33.15 85 8713 9896 2339391
Depressed mood 158.21 33.15 69 8729 5129 2344158
Therapeutic response unexpected 153.56 33.15 62 8736 3797 2345490
Dystonia 152.29 33.15 53 8745 2141 2347146
Maternal exposure during breast feeding 150.38 33.15 39 8759 557 2348730
Feeling abnormal 149.65 33.15 112 8686 23469 2325818
Hypertension 147.59 33.15 118 8680 27243 2322044
Abnormal behaviour 144.26 33.15 63 8735 4697 2344590
Muscle rigidity 141.76 33.15 48 8750 1783 2347504
Ventricular fibrillation 140.66 33.15 50 8748 2151 2347136
Poisoning deliberate 140.51 33.15 43 8755 1148 2348139
Drug withdrawal syndrome neonatal 140.41 33.15 35 8763 422 2348865
Hyperprolactinaemia 138.32 33.15 38 8760 684 2348603
Malaise 138.20 33.15 156 8642 55429 2293858
Disturbance in attention 136.62 33.15 64 8734 5621 2343666
Parkinsonism 134.64 33.15 44 8754 1461 2347826
Inappropriate antidiuretic hormone secretion 134.58 33.15 49 8749 2260 2347027
Maternal drugs affecting foetus 133.45 33.15 44 8754 1503 2347784
Abortion spontaneous 133.00 33.15 84 8714 13361 2335926
Disorientation 132.66 33.15 65 8733 6307 2342980
Patent ductus arteriosus 131.56 33.15 36 8762 638 2348649
Caesarean section 130.15 33.15 56 8742 4025 2345262
Syncope 129.54 33.15 90 8708 16785 2332502
Hallucination, visual 125.92 33.15 50 8748 2929 2346358
Myocardial depression 125.31 33.15 23 8775 48 2349239
Delirium 123.04 33.15 58 8740 5165 2344122
Panic attack 121.95 33.15 53 8745 3903 2345384
Metabolic acidosis 121.33 33.15 60 8738 5938 2343349
Hyperreflexia 121.22 33.15 36 8762 865 2348422
Myoclonus 120.25 33.15 46 8752 2437 2346850
Premature baby 118.99 33.15 49 8749 3155 2346132
Miosis 118.51 33.15 38 8760 1186 2348101
Generalised tonic-clonic seizure 118.44 33.15 57 8741 5315 2343972
Sedation 116.71 33.15 49 8749 3313 2345974
Stress cardiomyopathy 115.85 33.15 39 8759 1422 2347865
Dyskinesia 115.33 33.15 54 8744 4735 2344552
Hallucination 114.85 33.15 64 8734 8084 2341203
Decorticate posture 114.84 33.15 20 8778 26 2349261
Palpitations 112.97 33.15 82 8716 16374 2332913
Premature labour 112.80 33.15 42 8756 2064 2347223
Accidental death 110.99 33.15 27 8771 292 2348995
Fatigue 109.81 33.15 173 8625 84700 2264587
Restless legs syndrome 109.71 33.15 42 8756 2229 2347058
Alcohol interaction 109.18 33.15 26 8772 255 2349032
Self-injurious ideation 108.98 33.15 30 8768 544 2348743
Hypothermia 108.36 33.15 41 8757 2107 2347180
Alanine aminotransferase increased 108.04 33.15 75 8723 13957 2335330
Acute respiratory distress syndrome 107.69 33.15 46 8752 3246 2346041
Suicidal behaviour 107.15 33.15 29 8769 492 2348795
Hypertonia neonatal 107.03 33.15 20 8778 48 2349239
Rhabdomyolysis 106.50 33.15 57 8741 6647 2342640
Drug level increased 104.77 33.15 43 8755 2744 2346543
Psychotic disorder 104.22 33.15 50 8748 4629 2344658
Gait disturbance 102.26 33.15 88 8710 22457 2326830
Muscle twitching 101.70 33.15 42 8756 2723 2346564
Interstitial lung disease 101.01 33.15 58 8740 7754 2341533
Galactorrhoea 100.33 33.15 34 8764 1265 2348022
Long QT syndrome 99.84 33.15 28 8770 545 2348742
Leukocytosis 97.62 33.15 44 8754 3532 2345755
Weight decreased 94.17 33.15 93 8705 28278 2321009
Treatment noncompliance 93.40 33.15 49 8749 5485 2343802
Abortion missed 91.88 33.15 25 8773 433 2348854
Encephalopathy 90.37 33.15 45 8753 4516 2344771
Accidental overdose 90.14 33.15 43 8755 3929 2345358
Amnesia 88.86 33.15 52 8746 7201 2342086
Sinus tachycardia 87.88 33.15 40 8758 3285 2346002
Dysarthria 87.43 33.15 49 8749 6253 2343034
Small for dates baby 86.90 33.15 26 8772 641 2348646
Exposure via ingestion 86.81 33.15 27 8771 761 2348526
Cerebral vasoconstriction 85.89 33.15 22 8776 298 2348989
Mood altered 85.31 33.15 37 8761 2709 2346578
Lethargy 84.92 33.15 54 8744 8676 2340611
Ventricular hypokinesia 84.31 33.15 25 8773 597 2348690
Decreased appetite 83.68 33.15 88 8710 28803 2320484
Talipes 83.28 33.15 21 8777 266 2349021
Pulmonary congestion 83.10 33.15 33 8765 1932 2347355
Arrhythmia 81.26 33.15 46 8752 5982 2343305
Hyperthermia 81.26 33.15 30 8768 1438 2347849
Agitation neonatal 80.22 33.15 17 8781 92 2349195
Hallucination, auditory 79.61 33.15 33 8765 2159 2347128
Mood swings 79.12 33.15 37 8761 3232 2346055
Premature rupture of membranes 79.06 33.15 26 8772 880 2348407
Hypertonia 78.79 33.15 28 8770 1202 2348085
Anger 78.60 33.15 34 8764 2473 2346814
Obsessive-compulsive disorder 78.28 33.15 24 8774 644 2348643
Electrocardiogram QRS complex prolonged 77.92 33.15 27 8771 1075 2348212
Psychomotor retardation 77.14 33.15 23 8775 560 2348727
Speech disorder 75.65 33.15 45 8753 6419 2342868
Physical assault 74.64 33.15 18 8780 187 2349100
Paranoia 74.09 33.15 31 8767 2076 2347211
Pyrexia 72.79 33.15 112 8686 53596 2295691
Gestational diabetes 71.85 33.15 27 8771 1360 2347927
Nightmare 71.83 33.15 36 8762 3661 2345626
Traumatic coma 71.35 33.15 11 8787 1 2349286
Breech presentation 71.35 33.15 19 8779 302 2348985
Personality change 70.20 33.15 24 8774 917 2348370
Psychomotor hyperactivity 70.01 33.15 29 8769 1893 2347394
Cognitive disorder 69.67 33.15 40 8758 5341 2343946
Urinary retention 69.17 33.15 35 8763 3632 2345655
Dyspnoea 68.54 33.15 135 8663 78598 2270689
Pneumonia aspiration 68.50 33.15 35 8763 3707 2345580
Anorgasmia 68.33 33.15 17 8781 203 2349084
Memory impairment 68.00 33.15 55 8743 12868 2336419
Abdominal pain 67.98 33.15 86 8712 34288 2314999
Ventricular septal defect 65.65 33.15 22 8776 790 2348497
Neonatal respiratory distress syndrome 64.84 33.15 20 8778 548 2348739
Hepatic steatosis 64.53 33.15 32 8766 3181 2346106
Clonus 63.43 33.15 20 8778 590 2348697
Drug dependence 63.16 33.15 31 8767 3014 2346273
Potentiating drug interaction 62.12 33.15 20 8778 632 2348655
Anal incontinence 62.07 33.15 26 8772 1746 2347541
Asthenia 60.96 33.15 96 8702 46830 2302457
Dissociation 60.30 33.15 18 8780 440 2348847
Sleep disorder 60.28 33.15 39 8759 6450 2342837
Off label use 60.20 33.15 123 8675 73475 2275812
Oculogyric crisis 60.13 33.15 17 8781 341 2348946
Drug use disorder 59.71 33.15 17 8781 350 2348937
Respiratory failure 59.66 33.15 52 8746 13476 2335811
Bradyphrenia 59.14 33.15 22 8776 1077 2348210
Delusion of grandeur 59.01 33.15 12 8786 51 2349236
Bezoar 58.91 33.15 15 8783 198 2349089
Tearfulness 58.74 33.15 21 8777 917 2348370
Emotional distress 58.49 33.15 33 8765 4262 2345025
Neonatal hypoxia 58.47 33.15 13 8785 91 2349196
Fear 58.37 33.15 28 8770 2588 2346699
Sinus bradycardia 57.63 33.15 26 8772 2090 2347197
Purpura senile 56.58 33.15 10 8788 15 2349272
Amenorrhoea 56.22 33.15 26 8772 2213 2347074
Coordination abnormal 55.97 33.15 25 8773 1963 2347324
Musculoskeletal stiffness 55.87 33.15 48 8750 12199 2337088
Aspiration 55.38 33.15 23 8775 1511 2347776
Hallucinations, mixed 55.31 33.15 18 8780 589 2348698
Impulsive behaviour 55.11 33.15 16 8782 354 2348933
Chest pain 54.98 33.15 70 8728 28067 2321220
Urticaria 54.90 33.15 65 8733 24196 2325091
Neuroleptic malignant syndrome 54.88 33.15 25 8773 2055 2347232
Therapeutic product effect decreased 54.82 33.15 45 8753 10744 2338543
Foetal growth restriction 54.75 33.15 21 8777 1119 2348168
Aspartate aminotransferase increased 54.65 33.15 48 8750 12564 2336723
Ventricular tachycardia 54.64 33.15 28 8770 2983 2346304
Circulatory collapse 54.52 33.15 30 8768 3690 2345597
Urinary incontinence 53.55 33.15 31 8767 4202 2345085
Neonatal asphyxia 53.25 33.15 12 8786 90 2349197
Tardive dyskinesia 53.05 33.15 23 8775 1681 2347606
Paraesthesia 53.02 33.15 61 8737 22027 2327260
Abdominal pain upper 52.99 33.15 61 8737 22039 2327248
Major depression 52.96 33.15 20 8778 1021 2348266
Persistent foetal circulation 52.68 33.15 12 8786 95 2349192
Renal failure 52.25 33.15 54 8744 17295 2331992
Placenta praevia 52.19 33.15 14 8784 229 2349058
Negative thoughts 51.91 33.15 14 8784 234 2349053
Blood pressure increased 51.39 33.15 53 8745 16933 2332354
Anterograde amnesia 51.01 33.15 12 8786 111 2349176
Nystagmus 50.94 33.15 20 8778 1135 2348152
Panic reaction 50.73 33.15 18 8780 769 2348518
Bradycardia neonatal 50.48 33.15 13 8785 180 2349107
Thinking abnormal 50.17 33.15 23 8775 1919 2347368
Reduced facial expression 50.09 33.15 13 8785 186 2349101
Orthostatic hypotension 50.01 33.15 26 8772 2853 2346434
Blood potassium decreased 49.55 33.15 32 8766 5273 2344014
Migraine 49.09 33.15 42 8756 10611 2338676
Blood prolactin increased 48.91 33.15 19 8779 1048 2348239
Dysphoria 48.65 33.15 21 8777 1518 2347769
Antipsychotic drug level increased 48.33 33.15 16 8782 553 2348734
Blood hyposmosis 48.11 33.15 8 8790 6 2349281
Medication error 47.68 33.15 33 8765 6098 2343189
Obstructive airways disorder 47.60 33.15 20 8778 1353 2347934
Hypoxic-ischaemic encephalopathy 47.28 33.15 17 8781 755 2348532
Feeling jittery 47.16 33.15 22 8776 1910 2347377
Ventricular arrhythmia 47.05 33.15 16 8782 601 2348686
Alcohol use 46.80 33.15 15 8783 467 2348820
Polydactyly 46.64 33.15 11 8787 103 2349184
Pain 46.59 33.15 100 8698 61757 2287530
Respiration abnormal 46.58 33.15 16 8782 620 2348667
Extrasystoles 46.19 33.15 18 8780 1001 2348286
Differential white blood cell count abnormal 46.15 33.15 12 8786 173 2349114
Heart rate increased 45.59 33.15 41 8757 11064 2338223
Prescribed overdose 45.23 33.15 21 8777 1803 2347484
Mental impairment 45.17 33.15 23 8775 2417 2346870
Tarsal tunnel syndrome 45.10 33.15 9 8789 34 2349253
Protein C increased 44.50 33.15 8 8790 14 2349273
Infantile apnoea 44.41 33.15 12 8786 202 2349085
Drug screen positive 44.37 33.15 17 8781 903 2348384
Mitral valve incompetence 44.21 33.15 23 8775 2527 2346760
Depression suicidal 44.09 33.15 13 8785 304 2348983
Cardiac murmur 44.05 33.15 20 8778 1631 2347656
Apnoea 43.78 33.15 19 8779 1392 2347895
Cholestasis 43.78 33.15 26 8772 3695 2345592
Bradykinesia 43.31 33.15 15 8783 596 2348691
Cogwheel rigidity 42.81 33.15 12 8786 233 2349054
Blood sodium decreased 42.70 33.15 24 8774 3076 2346211
Depersonalisation/derealisation disorder 42.43 33.15 12 8786 241 2349046
Affect lability 42.40 33.15 21 8777 2081 2347206
Pruritus 42.15 33.15 78 8720 43262 2306025
Abnormal dreams 42.13 33.15 22 8776 2436 2346851
Balance disorder 42.02 33.15 37 8761 9710 2339577
Breast enlargement 42.01 33.15 13 8785 360 2348927
Stress 41.80 33.15 32 8766 6906 2342381
Neonatal disorder 41.44 33.15 12 8786 263 2349024
Apathy 41.34 33.15 18 8780 1329 2347958
Hypomagnesaemia 41.25 33.15 22 8776 2542 2346745
Muscle spasms 41.08 33.15 53 8745 21513 2327774
Reversible cerebral vasoconstriction syndrome 41.05 33.15 12 8786 272 2349015
Eye movement disorder 41.03 33.15 17 8781 1110 2348177
Gestational hypertension 40.80 33.15 13 8785 397 2348890
Blood creatine phosphokinase increased 40.78 33.15 28 8770 5108 2344179
Social avoidant behaviour 40.69 33.15 14 8784 545 2348742
Binge eating 40.62 33.15 10 8788 114 2349173
Gastric bypass 40.49 33.15 13 8785 407 2348880
Neurological symptom 40.48 33.15 16 8782 924 2348363
Diarrhoea 40.46 33.15 114 8684 83450 2265837
Abortion induced 40.40 33.15 24 8774 3412 2345875
Pulmonary valve stenosis congenital 40.23 33.15 9 8789 65 2349222
Pulmonary oedema 40.12 33.15 32 8766 7331 2341956
Hepatotoxicity 40.11 33.15 24 8774 3457 2345830
Tic 39.81 33.15 13 8785 430 2348857
Liver function test abnormal 39.64 33.15 32 8766 7458 2341829
Drug-induced liver injury 38.76 33.15 24 8774 3675 2345612
Ecchymosis 38.55 33.15 18 8780 1565 2347722
Blood cholesterol increased 37.94 33.15 27 8771 5214 2344073
Fallot's tetralogy 37.54 33.15 9 8789 91 2349196
Feeling of despair 37.46 33.15 12 8786 373 2348914
White blood cell count abnormal 37.33 33.15 14 8784 701 2348586
Asthma 37.31 33.15 37 8761 11277 2338010
Induced abortion failed 37.04 33.15 8 8790 48 2349239
Respiratory disorder neonatal 36.97 33.15 10 8788 169 2349118
Pyloric stenosis 36.93 33.15 9 8789 98 2349189
Hypokinesia 36.80 33.15 18 8780 1736 2347551
Dysmorphism 36.74 33.15 12 8786 397 2348890
Parkinsonian gait 36.60 33.15 9 8789 102 2349185
Arnold-Chiari malformation 36.44 33.15 9 8789 104 2349183
Oppositional defiant disorder 36.32 33.15 7 8791 21 2349266
Ataxia 36.25 33.15 20 8778 2472 2346815
Intention tremor 36.21 33.15 9 8789 107 2349180
Obesity 35.97 33.15 17 8781 1519 2347768
Optic ischaemic neuropathy 35.95 33.15 11 8787 293 2348994
Hypoaesthesia 35.89 33.15 48 8750 20167 2329120
Prolonged labour 35.88 33.15 10 8788 190 2349097
Dyspepsia 35.85 33.15 34 8764 9810 2339477
Antidepressant drug level above therapeutic 35.50 33.15 8 8790 60 2349227
Muscular weakness 35.49 33.15 41 8757 14856 2334431
Cerebral atrophy 35.45 33.15 14 8784 807 2348480
Therapy non-responder 35.41 33.15 31 8767 8073 2341214
Borderline personality disorder 35.40 33.15 9 8789 118 2349169
Altered state of consciousness 35.35 33.15 23 8775 3837 2345450
Acidosis 35.21 33.15 17 8781 1593 2347694
Disease recurrence 35.17 33.15 22 8776 3429 2345858
Electrocardiogram T wave inversion 34.95 33.15 13 8785 636 2348651
Poor quality sleep 34.84 33.15 18 8780 1949 2347338
Spina bifida 34.59 33.15 9 8789 130 2349157
Bipolar I disorder 33.97 33.15 11 8787 354 2348933
Prolonged rupture of membranes 33.95 33.15 6 8792 9 2349278
Upper gastrointestinal haemorrhage 33.94 33.15 18 8780 2056 2347231
Microcephaly 33.91 33.15 9 8789 141 2349146
Pregnancy 33.91 33.15 30 8768 7919 2341368
Blood pressure decreased 33.83 33.15 32 8766 9204 2340083
General physical health deterioration 33.82 33.15 39 8759 14100 2335187
Epilepsy 33.81 33.15 24 8774 4615 2344672
Atelectasis neonatal 33.56 33.15 6 8792 10 2349277
Bladder dilatation 33.45 33.15 9 8789 149 2349138
Thyroiditis 33.45 33.15 11 8787 372 2348915
Constipation 33.37 33.15 48 8750 21581 2327706

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1531.05 38.11 470 4044 15842 1726425
Serotonin syndrome 1526.79 38.11 329 4185 2459 1739808
Toxicity to various agents 1494.36 38.11 531 3983 28610 1713657
Drug interaction 919.25 38.11 370 4144 27588 1714679
Drug abuse 741.99 38.11 262 4252 13427 1728840
Intentional overdose 734.94 38.11 226 4288 7444 1734823
Suicide attempt 579.50 38.11 187 4327 7194 1735073
Overdose 500.89 38.11 208 4306 16493 1725774
Suicidal ideation 418.24 38.11 152 4362 8366 1733901
Anxiety 400.66 38.11 174 4340 15353 1726914
Agitation 383.56 38.11 153 4361 10873 1731394
Electrocardiogram QT prolonged 283.14 38.11 102 4412 5443 1736824
Poisoning 277.33 38.11 83 4431 2449 1739818
Aggression 265.86 38.11 108 4406 8007 1734260
Death 240.34 38.11 238 4276 87205 1655062
Tremor 233.95 38.11 114 4400 13017 1729250
Akathisia 224.03 38.11 61 4453 1267 1741000
Confusional state 221.33 38.11 129 4385 21149 1721118
Rhabdomyolysis 214.80 38.11 102 4412 10988 1731279
Homicide 213.60 38.11 45 4469 287 1741980
Somnolence 213.37 38.11 116 4398 16623 1725644
Drug ineffective 209.62 38.11 192 4322 63609 1678658
Depression 208.26 38.11 114 4400 16555 1725712
Cardiac arrest 207.49 38.11 112 4402 15818 1726449
Obsessive-compulsive disorder 207.05 38.11 52 4462 776 1741491
Condition aggravated 203.60 38.11 122 4392 21028 1721239
Myoclonus 203.51 38.11 64 4450 2231 1740036
Exposure during pregnancy 198.59 38.11 66 4448 2751 1739516
Hypotension 193.80 38.11 134 4380 29520 1712747
Hyponatraemia 193.47 38.11 89 4425 8911 1733356
Intentional product misuse 190.86 38.11 83 4431 7275 1734992
Cardio-respiratory arrest 187.64 38.11 88 4426 9205 1733062
Depressed mood 186.34 38.11 64 4450 2952 1739315
Foetal exposure during pregnancy 175.62 38.11 75 4439 6284 1735983
Coma 162.87 38.11 74 4440 7188 1735079
Respiratory arrest 161.65 38.11 69 4445 5770 1736497
Hyperhidrosis 160.21 38.11 87 4427 12401 1729866
Insomnia 159.34 38.11 95 4419 16181 1726086
Abnormal behaviour 140.20 38.11 64 4450 6278 1735989
Generalised tonic-clonic seizure 139.67 38.11 56 4458 3990 1738277
Seizure 139.47 38.11 95 4419 20346 1721921
Dyskinesia 139.29 38.11 55 4459 3764 1738503
Extrapyramidal disorder 137.34 38.11 48 4466 2329 1739938
Metabolic acidosis 136.93 38.11 60 4454 5342 1736925
Drug withdrawal syndrome neonatal 131.98 38.11 35 4479 653 1741614
Premature baby 130.99 38.11 49 4465 2893 1739374
Restlessness 129.34 38.11 54 4460 4267 1738000
Bradycardia 122.96 38.11 69 4445 10465 1731802
Psychotic disorder 117.98 38.11 53 4461 5003 1737264
Intentional self-injury 117.10 38.11 44 4470 2629 1739638
Drug withdrawal syndrome 113.81 38.11 50 4464 4475 1737792
Sedation 113.45 38.11 46 4468 3371 1738896
Mania 111.52 38.11 40 4474 2093 1740174
Feeling abnormal 111.28 38.11 66 4448 11100 1731167
Vomiting 109.24 38.11 107 4407 38208 1704059
Lethargy 108.88 38.11 56 4458 7128 1735139
Shock 107.96 38.11 47 4467 4114 1738153
Weight increased 107.65 38.11 65 4449 11292 1730975
Irritability 107.25 38.11 51 4463 5481 1736786
Hyperreflexia 106.88 38.11 29 4485 592 1741675
Sleep disorder 105.76 38.11 46 4468 4017 1738250
Euphoric mood 102.43 38.11 30 4484 815 1741452
Pulmonary oedema 101.71 38.11 52 4462 6534 1735733
Pneumonia aspiration 100.41 38.11 48 4466 5218 1737049
Tachycardia 98.83 38.11 64 4450 12564 1729703
Muscle twitching 98.76 38.11 35 4479 1767 1740500
Pulmonary congestion 98.71 38.11 35 4479 1770 1740497
Apathy 97.82 38.11 32 4482 1264 1741003
Neonatal respiratory distress syndrome 94.22 38.11 28 4486 801 1741466
Maternal drugs affecting foetus 92.78 38.11 30 4484 1141 1741126
Muscle rigidity 90.40 38.11 33 4481 1815 1740452
Hallucination, auditory 89.63 38.11 34 4480 2083 1740184
Visceral congestion 88.93 38.11 18 4496 91 1742176
Fall 86.92 38.11 81 4433 27133 1715134
Tic 83.66 38.11 25 4489 729 1741538
Social avoidant behaviour 83.26 38.11 24 4490 615 1741652
Electrocardiogram QRS complex prolonged 82.98 38.11 25 4489 750 1741517
Depressed level of consciousness 81.82 38.11 45 4469 6547 1735720
Drug hypersensitivity 81.54 38.11 61 4453 15074 1727193
Product complaint 80.84 38.11 33 4481 2457 1739810
Affective disorder 80.50 38.11 24 4490 694 1741573
Disinhibition 78.03 38.11 20 4494 324 1741943
Exposure via ingestion 77.41 38.11 23 4491 657 1741610
Treatment noncompliance 77.20 38.11 40 4474 5161 1737106
Atrial septal defect 76.78 38.11 27 4487 1331 1740936
Urinary retention 75.82 38.11 40 4474 5355 1736912
Asphyxia 74.75 38.11 25 4489 1058 1741209
Paranoia 74.56 38.11 30 4484 2151 1740116
Atrioventricular block first degree 74.23 38.11 24 4490 912 1741355
Hallucination 72.85 38.11 45 4469 8125 1734142
Dizziness 72.81 38.11 82 4432 34279 1707988
Parkinsonism 72.77 38.11 26 4488 1343 1740924
Syncope 71.65 38.11 55 4459 14114 1728153
Cardiogenic shock 71.14 38.11 30 4484 2424 1739843
Mental disorder 70.11 38.11 31 4483 2812 1739455
Hypertension 70.10 38.11 62 4452 19386 1722881
Headache 69.38 38.11 80 4434 34296 1707971
Agitation neonatal 69.10 38.11 17 4497 231 1742036
Mental status changes 68.65 38.11 39 4475 6036 1736231
Delirium 66.98 38.11 39 4475 6323 1735944
Off label use 66.75 38.11 83 4431 38488 1703779
Mydriasis 66.08 38.11 24 4490 1300 1740967
Increased appetite 65.37 38.11 22 4492 949 1741318
Accidental death 64.79 38.11 18 4496 402 1741865
Blood creatine phosphokinase increased 64.63 38.11 43 4471 8813 1733454
Fatigue 64.56 38.11 94 4420 50687 1691580
Unresponsive to stimuli 64.12 38.11 34 4480 4595 1737672
Neuroleptic malignant syndrome 63.97 38.11 30 4484 3118 1739149
Antipsychotic drug level below therapeutic 63.16 38.11 15 4499 174 1742093
Loss of consciousness 62.92 38.11 52 4462 14823 1727444
Dyspnoea 62.78 38.11 94 4420 51965 1690302
Small for dates baby 62.67 38.11 19 4495 582 1741685
Homicidal ideation 61.76 38.11 19 4495 612 1741655
Drug level increased 61.21 38.11 28 4486 2749 1739518
Arteriosclerosis coronary artery 61.15 38.11 25 4489 1867 1740400
Huntington's disease 60.99 38.11 12 4502 51 1742216
Tearfulness 60.53 38.11 16 4498 294 1741973
Salivary hypersecretion 60.10 38.11 23 4491 1442 1740825
Nausea 59.67 38.11 91 4423 51105 1691162
Cholestasis 59.64 38.11 30 4484 3635 1738632
Inappropriate antidiuretic hormone secretion 59.59 38.11 24 4490 1724 1740543
Thinking abnormal 58.89 38.11 22 4492 1290 1740977
Clonus 58.26 38.11 17 4497 455 1741812
Panic attack 58.25 38.11 24 4490 1828 1740439
Therapeutic product effect variable 57.52 38.11 13 4501 119 1742148
Dystonia 56.31 38.11 24 4490 1990 1740277
Disorientation 56.17 38.11 33 4481 5436 1736831
Congenital aortic valve stenosis 56.08 38.11 10 4504 21 1742246
Anger 56.01 38.11 26 4488 2640 1739627
Cognitive disorder 54.92 38.11 30 4484 4300 1737967
Pyrexia 54.78 38.11 83 4431 46317 1695950
Oral discharge 54.59 38.11 10 4504 26 1742241
Cyanosis neonatal 54.32 38.11 12 4502 98 1742169
Bipolar disorder 54.21 38.11 18 4496 744 1741523
Depersonalisation/derealisation disorder 54.10 38.11 13 4501 159 1742108
Withdrawal syndrome 53.37 38.11 24 4490 2264 1740003
Suicidal behaviour 53.12 38.11 15 4499 356 1741911
Hypersomnia 52.83 38.11 22 4492 1721 1740546
Disturbance in attention 52.78 38.11 29 4485 4205 1738062
Testis cancer 52.67 38.11 14 4500 263 1742004
Impulsive behaviour 52.22 38.11 16 4498 508 1741759
Sexual dysfunction 51.88 38.11 22 4492 1801 1740466
Nightmare 51.86 38.11 25 4489 2762 1739505
Sinus tachycardia 51.04 38.11 24 4490 2508 1739759
Autonomic nervous system imbalance 51.03 38.11 15 4499 412 1741855
Product substitution issue 50.84 38.11 26 4488 3260 1739007
Bruxism 50.80 38.11 14 4500 303 1741964
Bradypnoea 49.95 38.11 14 4500 323 1741944
Blood prolactin increased 49.49 38.11 15 4499 459 1741808
Neonatal disorder 49.47 38.11 14 4500 335 1741932
Myalgia 48.72 38.11 46 4468 15612 1726655
Heart rate increased 48.43 38.11 32 4482 6478 1735789
Left ventricular hypertrophy 48.39 38.11 17 4497 835 1741432
Memory impairment 47.75 38.11 32 4482 6631 1735636
Hyperbilirubinaemia neonatal 47.71 38.11 11 4503 111 1742156
Nervousness 47.65 38.11 22 4492 2205 1740062
Therapeutic response unexpected 45.87 38.11 22 4492 2402 1739865
Erectile dysfunction 45.82 38.11 27 4487 4470 1737797
Hepatocellular injury 45.49 38.11 24 4490 3207 1739060
Dysuria 45.35 38.11 25 4489 3647 1738620
Poisoning deliberate 44.77 38.11 16 4498 826 1741441
Parasomnia 44.60 38.11 10 4504 88 1742179
Derealisation 44.40 38.11 11 4503 154 1742113
Haemodynamic instability 44.34 38.11 18 4496 1319 1740948
Alcohol poisoning 44.17 38.11 14 4500 498 1741769
Environmental exposure 43.74 38.11 9 4505 50 1742217
Mood swings 43.53 38.11 20 4494 1982 1740285
Tardive dyskinesia 43.39 38.11 17 4497 1135 1741132
Abdominal pain 43.24 38.11 50 4464 21440 1720827
Gait disturbance 42.84 38.11 39 4475 12631 1729636
Priapism 42.76 38.11 18 4496 1446 1740821
Acute pulmonary oedema 42.48 38.11 17 4497 1200 1741067
Vasoplegia syndrome 42.19 38.11 11 4503 191 1742076
Dysarthria 41.92 38.11 27 4487 5232 1737035
Abnormal dreams 41.46 38.11 19 4495 1872 1740395
Congenital aortic valve incompetence 41.25 38.11 8 4506 31 1742236
Amnesia 41.19 38.11 26 4488 4865 1737402
Urinary tract discomfort 40.96 38.11 7 4507 10 1742257
Movement disorder 40.48 38.11 18 4496 1652 1740615
Eye movement disorder 40.02 38.11 15 4499 887 1741380
Antipsychotic drug level increased 39.93 38.11 14 4500 683 1741584
Vascular stenosis 39.76 38.11 8 4506 39 1742228
Hypokalaemia 39.51 38.11 28 4486 6346 1735921
Choreoathetosis 38.95 38.11 10 4504 163 1742104
Dissociation 38.56 38.11 11 4503 271 1741996
Delusion 38.46 38.11 19 4495 2212 1740055
Stress 38.27 38.11 20 4494 2621 1739646
Congenital hand malformation 38.16 38.11 9 4505 101 1742166
Alcohol abuse 38.11 38.11 13 4501 584 1741683

Pharmacologic Action:

SourceCodeDescription
ATC N06AB03 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Selective serotonin reuptake inhibitors
ATC N06CA03 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOLEPTICS AND PSYCHOANALEPTICS IN COMBINATION
Antidepressants in combination with psycholeptics
FDA EPC N0000175696 Serotonin Reuptake Inhibitor
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:50949 serotonin uptake inhibitor
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35469 antidepressant
MeSH PA D000928 Antidepressive Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D002491 Central Nervous System Agents
MeSH PA D065690 Cytochrome P-450 CYP2D6 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018490 Serotonin Agents
MeSH PA D017367 Serotonin Uptake Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Depressive disorder indication 35489007
Bulimia nervosa indication 78004001
Bipolar affective disorder, current episode depression indication 191627008 DOID:3312
Obsessive-compulsive disorder indication 191736004 DOID:10933
Major depressive disorder indication 370143000
Panic disorder indication 371631005 DOID:594
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Postpartum depression off-label use 58703003 DOID:9478
Cataplexy and narcolepsy off-label use 193042000
Menopausal flushing off-label use 198436008
Fibromyalgia off-label use 203082005 DOID:631
Seasonal affective disorder off-label use 247803002
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Sinus tachycardia contraindication 11092001
Hypercholesterolemia contraindication 13644009
Bipolar disorder contraindication 13746004 DOID:3312
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Lowered convulsive threshold contraindication 19260006
Cirrhosis of liver contraindication 19943007 DOID:5082
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Dehydration contraindication 34095006
Upper gastrointestinal hemorrhage contraindication 37372002
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Bradycardia contraindication 48867003
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Paralytic ileus contraindication 55525008 DOID:8442
Hyperlipidemia contraindication 55822004 DOID:1168
Anorexia nervosa contraindication 56882008 DOID:8689
Abnormal sexual function contraindication 56925008
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Heart failure contraindication 84114007 DOID:6000
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Hyponatremia contraindication 89627008
Tardive dyskinesia contraindication 102449007
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Hypomania contraindication 231496004
Disease of liver contraindication 235856003 DOID:409
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Benign prostatic hyperplasia contraindication 266569009
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Serotonin syndrome contraindication 371089000
At risk for aspiration contraindication 371736008
Angle-closure glaucoma contraindication 392291006 DOID:13550
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.32 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 9.09 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 5.54 PDSP
Muscarinic acetylcholine receptor M2 GPCR Ki 5.57 PDSP
5-hydroxytryptamine receptor 2B GPCR ANTAGONIST Ki 5.30 IUPHAR
Alpha-2B adrenergic receptor GPCR Ki 6.16 DRUG MATRIX
Cytochrome P450 2D6 Enzyme IC50 6.15 DRUG MATRIX
Acetylcholinesterase Enzyme IC50 6.89 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor IC50 6.07 CHEMBL
Histamine H3 receptor GPCR Ki 5.14 CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 5.44 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 6 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 6.05 WOMBAT-PK
Histamine H1 receptor GPCR Ki 5.96 WOMBAT-PK
D(3) dopamine receptor GPCR Ki 5.70 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR Ki 6.40 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 6.61 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Kd 6.62 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.15 WOMBAT-PK
Beta-1 adrenergic receptor GPCR Ki 5.36 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR Ki 5.70 PDSP
Alpha-2A adrenergic receptor GPCR Ki 8.20 CHEMBL
Equilibrative nucleoside transporter 4 Transporter INHIBITOR Ki 4.64 IUPHAR
Muscarinic acetylcholine receptor M5 GPCR Ki 5.57 PDSP
Sodium-dependent serotonin transporter Transporter Ki 8.70 CHEMBL
Transporter Transporter Ki 6.80 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 7.97 CHEMBL
Transporter Transporter Ki 6.84 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 6.22 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 6.11 CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 5.72 CHEMBL
Potassium voltage-gated channel subfamily C member 1 Unclassified IC50 4.88 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR IC50 7.82 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 7.07 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 6.96 CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 6.50 IUPHAR
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 5.80 IUPHAR
G protein-activated inward rectifier potassium channel 2 Ion channel GATING INHIBITOR IC50 4.80 IUPHAR

External reference:

IDSource
D005473 MESH_DESCRIPTOR_UI
C0162373 UMLSCUI
D00326 KEGG_DRUG
01K63SUP8D UNII
3883 INN_ID
53640004 SNOMEDCT_US
4493 RXNORM
372767007 SNOMEDCT_US
17711 MMSL
4019761 VANDF
004613 NDDF
d00236 MMSL
CHEMBL41 ChEMBL_ID
DB00472 DRUGBANK_ID
56296-78-7 SECONDARY_CAS_RN
RFX PDB_CHEM_ID
CHEBI:5118 CHEBI
3386 PUBCHEM_CID
CHEMBL1201082 ChEMBL_ID
203 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3230 CAPSULE 25 mg ORAL NDA 20 sections
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3231 CAPSULE 25 mg ORAL NDA 20 sections
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3232 CAPSULE 25 mg ORAL NDA 20 sections
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3233 CAPSULE 50 mg ORAL NDA 20 sections
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3234 CAPSULE 50 mg ORAL NDA 20 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0807 TABLET, FILM COATED 20 mg ORAL ANDA 19 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5262 TABLET, FILM COATED 60 mg ORAL ANDA 20 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5503 CAPSULE 25 mg ORAL ANDA 19 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5504 CAPSULE 25 mg ORAL ANDA 19 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5505 CAPSULE 50 mg ORAL ANDA 19 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5506 CAPSULE 25 mg ORAL ANDA 19 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5507 CAPSULE 50 mg ORAL ANDA 19 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7188 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7198 CAPSULE 40 mg ORAL ANDA 20 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0121-0721 SOLUTION 20 mg ORAL ANDA 21 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0121-4721 SOLUTION 20 mg ORAL ANDA 21 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-0734 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-0735 TABLET, FILM COATED 20 mg ORAL ANDA 19 sections
SARAFEM HUMAN PRESCRIPTION DRUG LABEL 1 0430-0210 TABLET 10 mg ORAL NDA 20 sections
SARAFEM HUMAN PRESCRIPTION DRUG LABEL 1 0430-0215 TABLET 15 mg ORAL NDA 20 sections
SARAFEM HUMAN PRESCRIPTION DRUG LABEL 1 0430-0220 TABLET 20 mg ORAL NDA 20 sections
fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-1357 CAPSULE 20 mg ORAL ANDA 20 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-1384 CAPSULE 10 mg ORAL ANDA 20 sections
Fluoxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-1387 CAPSULE 40 mg ORAL ANDA 20 sections
Fluoxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-5501 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
Fluoxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-5502 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7625 CAPSULE 20 mg ORAL ANDA 21 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7638 CAPSULE 10 mg ORAL ANDA 20 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8093 CAPSULE 10 mg ORAL ANDA 21 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8183 CAPSULE 40 mg ORAL ANDA 20 sections