varenicline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
nicotinic acetylcholine receptor partial agonists/agonists 2808 249296-44-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • varenicline
  • champix
  • chantix
  • varenicline tartrate
  • CP-526,555-18
A benzazepine derivative that functions as an ALPHA4-BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.
  • Molecular weight: 211.27
  • Formula: C13H13N3
  • CLOGP: 0.90
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 37.81
  • ALOGS: -3.38
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 72 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 92 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.14 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 87 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
May 10, 2006 FDA PFIZER INC

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
Abnormal dreams 2702.38 16.50 716 36454 9800 63442052
Suicidal ideation 1303.31 16.50 664 36506 61757 63390095
Depression 1294.75 16.50 1003 36167 195489 63256363
Nausea 1073.43 16.50 1834 35336 852637 62599215
Nightmare 828.58 16.50 339 36831 18855 63432997
Anger 610.04 16.50 241 36929 12215 63439637
Feeling abnormal 586.62 16.50 567 36603 147825 63304027
Anxiety 570.38 16.50 668 36502 216873 63234979
Insomnia 516.56 16.50 632 36538 214620 63237232
Crying 433.62 16.50 230 36940 23113 63428739
Irritability 427.29 16.50 253 36917 31441 63420411
Tobacco user 425.05 16.50 98 37072 712 63451140
Aggression 398.64 16.50 218 36952 23280 63428572
Agitation 397.95 16.50 308 36862 59449 63392403
Mood swings 292.18 16.50 163 37007 18085 63433767
Mood altered 287.19 16.50 150 37020 14593 63437259
Abnormal behaviour 278.19 16.50 167 37003 21259 63430593
Depressed mood 278.05 16.50 212 36958 39979 63411873
Nervousness 231.13 16.50 171 36999 30808 63421044
Dysgeusia 229.69 16.50 202 36968 46508 63405344
Flatulence 218.17 16.50 173 36997 34529 63417323
Paranoia 205.35 16.50 111 37059 11568 63440284
Thinking abnormal 197.93 16.50 105 37065 10538 63441314
Homicidal ideation 185.21 16.50 60 37110 1692 63450160
Emotional disorder 183.34 16.50 108 37062 13271 63438581
Panic attack 181.86 16.50 130 37040 22201 63429651
Off label use 180.62 16.50 85 37085 674377 62777475
Tearfulness 161.22 16.50 68 37102 4071 63447781
Mental disorder 145.54 16.50 121 37049 25798 63426054
Disturbance in attention 143.06 16.50 142 37028 38047 63413805
Mania 134.15 16.50 86 37084 12281 63439571
Psychotic disorder 134.02 16.50 115 37055 25597 63426255
Drug hypersensitivity 126.17 16.50 434 36736 310253 63141599
Sleep disorder 125.99 16.50 194 36976 81372 63370480
Suicidal behaviour 104.93 16.50 44 37126 2595 63449257
Vomiting 104.25 16.50 620 36550 558997 62892855
Infusion related reaction 102.18 16.50 12 37158 245509 63206343
Acute kidney injury 95.68 16.50 19 37151 263396 63188456
Personality change 94.76 16.50 56 37114 6917 63444935
Tobacco withdrawal symptoms 91.62 16.50 15 37155 6 63451846
Suicide attempt 91.40 16.50 143 37027 60775 63391077
Rheumatoid arthritis 88.71 16.50 20 37150 253799 63198053
Anaemia 87.98 16.50 31 37139 293399 63158453
Bipolar disorder 87.93 16.50 56 37114 7904 63443948
Systemic lupus erythematosus 87.44 16.50 10 37160 208908 63242944
Amnesia 86.92 16.50 133 37037 55452 63396400
Death 85.77 16.50 57 37113 374324 63077528
Hallucination 85.48 16.50 131 37039 54686 63397166
Self-injurious ideation 84.99 16.50 38 37132 2621 63449231
Dizziness 84.23 16.50 483 36687 429442 63022410
Pyrexia 79.76 16.50 95 37075 470383 62981469
Alopecia 79.19 16.50 50 37120 337486 63114366
Stress 77.24 16.50 140 37030 67027 63384825
Hostility 77.08 16.50 32 37138 1840 63450012
Weight increased 76.68 16.50 329 36841 260463 63191389
Arthropathy 75.33 16.50 22 37148 234770 63217082
General physical health deterioration 74.23 16.50 14 37156 201388 63250464
Fear 73.11 16.50 66 37104 15700 63436152
Malaise 72.92 16.50 454 36716 415500 63036352
Violence-related symptom 68.80 16.50 20 37150 388 63451464
Neutropenia 67.02 16.50 11 37159 174994 63276858
Chronic obstructive pulmonary disease 66.23 16.50 126 37044 62560 63389292
Joint swelling 64.70 16.50 58 37112 327608 63124244
Infection 60.90 16.50 29 37141 229144 63222708
Headache 60.81 16.50 601 36569 632640 62819212
Impaired driving ability 60.70 16.50 36 37134 4475 63447377
Apathy 59.91 16.50 46 37124 8748 63443104
Thrombocytopenia 59.01 16.50 9 37161 151148 63300704
Product use issue 58.45 16.50 28 37142 220492 63231360
Impaired work ability 58.18 16.50 61 37109 17414 63434438
Euphoric mood 58.04 16.50 36 37134 4851 63447001
Panic reaction 57.97 16.50 34 37136 4140 63447712
Toxicity to various agents 57.44 16.50 37 37133 247213 63204639
Hypersomnia 56.53 16.50 61 37109 17994 63433858
Feeling jittery 56.11 16.50 53 37117 13350 63438502
Palpitations 56.01 16.50 169 37001 112601 63339251
Product use in unapproved indication 55.23 16.50 18 37152 179062 63272790
Hallucination, auditory 54.24 16.50 51 37119 12773 63439079
Somnambulism 53.89 16.50 36 37134 5507 63446345
Nicotine dependence 53.86 16.50 19 37151 698 63451154
Memory impairment 53.44 16.50 158 37012 104100 63347752
Peripheral swelling 52.56 16.50 47 37123 265895 63185957
Decreased interest 51.88 16.50 29 37141 3225 63448627
Hepatic enzyme increased 48.75 16.50 29 37141 202299 63249553
Glossodynia 48.49 16.50 22 37148 178854 63272998
Tremor 47.75 16.50 178 36992 132061 63319791
Exposure during pregnancy 47.32 16.50 16 37154 155531 63296321
Therapeutic response unexpected 46.24 16.50 56 37114 18703 63433149
Wound 45.97 16.50 19 37151 163244 63288608
Withdrawal syndrome 44.96 16.50 57 37113 19940 63431912
Constipation 44.08 16.50 253 36917 224690 63227162
Psychiatric symptom 43.87 16.50 31 37139 5192 63446660
Dissociation 43.79 16.50 25 37145 2894 63448958
Therapeutic product effect incomplete 43.36 16.50 10 37160 125046 63326806
Social avoidant behaviour 43.25 16.50 25 37145 2963 63448889
Somnolence 43.22 16.50 213 36957 178472 63273380
Sepsis 42.82 16.50 18 37152 153105 63298747
Arthralgia 42.22 16.50 181 36989 569529 62882323
Poor quality sleep 41.96 16.50 55 37115 19880 63431972
Screaming 41.21 16.50 25 37145 3237 63448615
Impaired healing 40.25 16.50 6 37164 102536 63349316
Sinusitis 40.23 16.50 44 37126 226609 63225243
White blood cell count decreased 39.46 16.50 16 37154 139088 63312764
Pre-existing condition improved 39.18 16.50 35 37135 8209 63443643
Urinary tract infection 39.11 16.50 59 37111 264625 63187227
Parosmia 39.10 16.50 31 37139 6175 63445677
Disease progression 38.44 16.50 12 37158 122746 63329106
Hyperphagia 37.22 16.50 19 37151 1760 63450092
Swelling 36.40 16.50 66 37104 275312 63176540
Impulsive behaviour 36.33 16.50 18 37152 1565 63450287
Lower respiratory tract infection 36.28 16.50 16 37154 132291 63319561
Impatience 35.74 16.50 12 37158 379 63451473
Drug withdrawal syndrome 35.55 16.50 60 37110 27134 63424718
Cardiac failure 35.49 16.50 5 37165 89137 63362715
Therapeutic product effect decreased 34.84 16.50 37 37133 193150 63258702
Hypokalaemia 34.62 16.50 9 37161 103795 63348057
Psoriatic arthropathy 34.48 16.50 6 37164 91514 63360338
Hypotension 33.70 16.50 68 37102 272536 63179316
Feelings of worthlessness 33.21 16.50 11 37159 333 63451519
Renal impairment 32.83 16.50 6 37164 88349 63363503
Nasopharyngitis 32.66 16.50 62 37108 254195 63197657
Energy increased 32.03 16.50 20 37150 2727 63449125
Affect lability 32.01 16.50 36 37134 11115 63440737
Psychomotor hyperactivity 31.59 16.50 35 37135 10628 63441224
Condition aggravated 31.48 16.50 125 37045 402092 63049760
Pneumonia 31.46 16.50 149 37021 456618 62995234
Pleural effusion 31.24 16.50 8 37162 93202 63358650
Drug intolerance 30.97 16.50 86 37084 308575 63143277
Haemoglobin decreased 30.83 16.50 24 37146 145461 63306391
COVID-19 30.50 16.50 14 37156 113089 63338763
Blood creatinine increased 30.50 16.50 7 37163 87837 63364015
Vision blurred 30.10 16.50 120 37050 91804 63360048
Feeling of despair 29.74 16.50 18 37152 2321 63449531
Tachyphrenia 29.69 16.50 15 37155 1359 63450493
Musculoskeletal stiffness 29.40 16.50 39 37131 184579 63267273
Drug interaction 29.37 16.50 232 36938 228899 63222953
Leukopenia 29.26 16.50 5 37165 77285 63374567
Oedema mouth 29.22 16.50 18 37152 2395 63449457
Abdominal distension 29.11 16.50 114 37056 86501 63365351
Hospitalisation 29.10 16.50 7 37163 85074 63366778
Alcohol use 29.04 16.50 17 37153 2062 63449790
Affective disorder 29.02 16.50 26 37144 6120 63445732
Physical assault 28.89 16.50 13 37157 910 63450942
Negative thoughts 28.83 16.50 13 37157 914 63450938
Recalled product administered 28.66 16.50 11 37159 514 63451338
Respiratory failure 28.42 16.50 12 37158 101846 63350006
Delusion 28.20 16.50 35 37135 11982 63439870
Bipolar I disorder 27.78 16.50 16 37154 1883 63449969
Feeling guilty 27.56 16.50 11 37159 571 63451281
Incorrect dose administered 27.09 16.50 87 37083 59881 63391971
Pain 26.83 16.50 291 36879 740337 62711515
C-reactive protein increased 26.68 16.50 11 37159 94696 63357156
Hot flush 26.64 16.50 78 37092 51081 63400771
Formication 26.11 16.50 21 37149 4270 63447582
Platelet count decreased 26.10 16.50 18 37152 116104 63335748
Restlessness 26.06 16.50 55 37115 29398 63422454
Ageusia 26.03 16.50 36 37134 13692 63438160
Increased appetite 25.80 16.50 30 37140 9600 63442252
Depression suicidal 25.71 16.50 15 37155 1808 63450044
Abdominal pain upper 25.34 16.50 207 36963 206237 63245615
Middle insomnia 25.25 16.50 34 37136 12609 63439243
Renal failure 24.18 16.50 20 37150 117632 63334220
Weaning failure 23.84 16.50 9 37161 402 63451450
Interstitial lung disease 23.44 16.50 4 37166 61904 63389948
Seizure 23.27 16.50 145 37025 132489 63319363
Mobility decreased 23.21 16.50 22 37148 121137 63330715
Restless legs syndrome 23.05 16.50 40 37130 18491 63433361
Therapy non-responder 22.74 16.50 8 37162 75893 63375959
Flight of ideas 22.59 16.50 9 37161 465 63451387
Chest pain 22.57 16.50 209 36961 215750 63236102
Frustration tolerance decreased 22.56 16.50 24 37146 6964 63444888
Osteoarthritis 22.48 16.50 14 37156 95329 63356523
Cardio-respiratory arrest 22.43 16.50 4 37166 59955 63391897
Tobacco abuse 22.01 16.50 10 37160 716 63451136
Major depression 21.51 16.50 25 37145 7993 63443859
Disorientation 21.36 16.50 61 37109 39391 63412461
Drug ineffective 21.19 16.50 459 36711 1044306 62407546
Gingival bleeding 20.91 16.50 31 37139 12556 63439296
Mental impairment 20.90 16.50 33 37137 14118 63437734
Hyperhidrosis 20.89 16.50 121 37049 107715 63344137
Flat affect 20.64 16.50 12 37158 1438 63450414
Psychotic behaviour 20.54 16.50 9 37161 591 63451261
Gastrointestinal haemorrhage 20.45 16.50 11 37159 81165 63370687
Morbid thoughts 20.22 16.50 9 37161 614 63451238
Emphysema 19.72 16.50 28 37142 10910 63440942
Alcohol interaction 19.55 16.50 14 37156 2395 63449457
Inflammation 19.51 16.50 12 37158 82261 63369591
Intentional self-injury 19.37 16.50 45 37125 25642 63426210
Laziness 18.98 16.50 9 37161 710 63451142
Multiple organ dysfunction syndrome 18.77 16.50 5 37165 56747 63395105
Depressive symptom 18.68 16.50 17 37153 4085 63447767
Vertigo 18.66 16.50 77 37093 59810 63392042
Intentional product use issue 18.40 16.50 29 37141 127863 63323989
Atrial fibrillation 18.19 16.50 25 37145 116611 63335241
Loss of employment 18.11 16.50 13 37157 2231 63449621
Product dispensing error 18.02 16.50 26 37144 10279 63441573
Drug abuse 18.01 16.50 10 37160 72508 63379344
Discomfort 18.01 16.50 45 37125 167329 63284523
Nocturia 17.97 16.50 23 37147 8118 63443734
Large intestine polyp 17.94 16.50 23 37147 8134 63443718
Tobacco poisoning 17.55 16.50 5 37165 90 63451762
Knee arthroplasty 17.51 16.50 5 37165 54201 63397651
Hyperkalaemia 17.50 16.50 5 37165 54198 63397654
Obsessive thoughts 17.47 16.50 8 37162 583 63451269
Menstruation irregular 17.41 16.50 21 37149 6983 63444869
Derealisation 17.20 16.50 10 37160 1198 63450654
Liver injury 17.09 16.50 7 37163 60513 63391339
Oropharyngeal blistering 16.99 16.50 9 37161 900 63450952
Obsessive-compulsive disorder 16.89 16.50 16 37154 4044 63447808
Metabolic acidosis 16.87 16.50 3 37167 45066 63406786
Cellulitis 16.75 16.50 14 37156 81944 63369908
Dependence 16.69 16.50 12 37158 2065 63449787

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
Abnormal dreams 1955.81 18.47 529 22197 7049 34927156
Depression 1283.74 18.47 791 21935 96307 34837898
Suicidal ideation 1210.92 18.47 568 22158 39820 34894385
Nightmare 1010.30 18.47 372 22354 14019 34920186
Anger 583.25 18.47 237 22489 11647 34922558
Aggression 471.01 18.47 301 22425 38663 34895542
Irritability 467.51 18.47 255 22471 24435 34909770
Insomnia 455.14 18.47 440 22286 103467 34830738
Agitation 437.30 18.47 334 22392 57065 34877140
Mood swings 427.13 18.47 169 22557 7732 34926473
Anxiety 390.69 18.47 397 22329 99031 34835174
Nausea 371.55 18.47 732 21994 339176 34595029
Feeling abnormal 356.98 18.47 309 22417 62926 34871279
Abnormal behaviour 262.68 18.47 177 22549 24792 34909413
Tobacco user 245.15 18.47 60 22666 515 34933690
Mood altered 222.32 18.47 111 22615 8841 34925364
Depressed mood 182.02 18.47 128 22598 19189 34915016
Paranoia 170.25 18.47 103 22623 11965 34922240
Off label use 169.21 18.47 34 22692 419490 34514715
Personality change 168.05 18.47 77 22649 5062 34929143
Homicidal ideation 161.24 18.47 62 22664 2620 34931585
Vomiting 154.07 18.47 429 22297 247192 34687013
Thinking abnormal 140.38 18.47 72 22654 6065 34928140
Hallucination 127.26 18.47 162 22564 51336 34882869
Nervousness 122.15 18.47 85 22641 12521 34921684
Violence-related symptom 117.55 18.47 33 22693 503 34933702
Suicide attempt 114.39 18.47 134 22592 38982 34895223
Acute kidney injury 114.16 18.47 29 22697 304959 34629246
Amnesia 112.99 18.47 111 22615 26452 34907753
Death 102.06 18.47 67 22659 397982 34536223
Drug hypersensitivity 97.50 18.47 182 22544 80347 34853858
Pneumonia 97.12 18.47 58 22668 362569 34571636
Pyrexia 96.82 18.47 48 22678 332965 34601240
Emotional disorder 94.29 18.47 54 22672 5662 34928543
Hostility 90.47 18.47 30 22696 818 34933387
Suicidal behaviour 87.82 18.47 34 22692 1463 34932742
Panic attack 87.65 18.47 62 22664 9370 34924835
Mania 84.88 18.47 61 22665 9450 34924755
Toxicity to various agents 81.00 18.47 16 22710 200346 34733859
Psychotic disorder 80.32 18.47 89 22637 24363 34909842
Sleep disorder 75.58 18.47 98 22628 31590 34902615
Crying 74.93 18.47 47 22679 5815 34928390
Sepsis 72.34 18.47 11 22715 166550 34767655
Alcohol use 70.66 18.47 37 22689 3251 34930954
Anaemia 68.67 18.47 33 22693 233302 34700903
Physical assault 67.14 18.47 26 22700 1119 34933086
Febrile neutropenia 66.94 18.47 6 22720 136843 34797362
Neutropenia 66.62 18.47 11 22715 156767 34777438
Disturbance in attention 64.63 18.47 82 22644 25863 34908342
Mental disorder 63.62 18.47 63 22663 15146 34919059
Thrombocytopenia 62.03 18.47 13 22713 156234 34777971
Apathy 60.80 18.47 44 22682 6888 34927317
Memory impairment 60.16 18.47 104 22622 43214 34890991
Impaired driving ability 54.79 18.47 29 22697 2604 34931601
Hypotension 53.07 18.47 40 22686 221609 34712596
Product use in unapproved indication 50.44 18.47 8 22718 117491 34816714
General physical health deterioration 50.22 18.47 11 22715 128258 34805947
Flatulence 49.66 18.47 65 22661 21133 34913072
Bipolar disorder 48.36 18.47 30 22696 3639 34930566
Self-injurious ideation 48.14 18.47 23 22703 1661 34932544
Impaired work ability 47.56 18.47 38 22688 6892 34927313
Platelet count decreased 47.41 18.47 10 22716 119707 34814498
White blood cell count decreased 47.16 18.47 4 22722 95441 34838764
Verbal abuse 46.49 18.47 13 22713 195 34934010
Somnambulism 45.32 18.47 27 22699 3045 34931160
Screaming 44.66 18.47 21 22705 1463 34932742
Pancytopenia 44.36 18.47 5 22721 95152 34839053
Affective disorder 43.63 18.47 30 22696 4330 34929875
Stress 43.62 18.47 74 22652 30273 34903932
Dizziness 43.25 18.47 266 22460 218255 34715950
Headache 42.74 18.47 249 22477 200386 34733819
Negative thoughts 42.55 18.47 16 22710 635 34933570
Asthma-chronic obstructive pulmonary disease overlap syndrome 41.18 18.47 19 22707 1268 34932937
Disease progression 40.85 18.47 10 22716 108067 34826138
Post-traumatic stress disorder 39.94 18.47 21 22705 1860 34932345
Renal failure 39.06 18.47 18 22708 130539 34803666
Haemoglobin decreased 38.78 18.47 15 22711 120757 34813448
Multiple organ dysfunction syndrome 38.40 18.47 3 22723 76563 34857642
Urinary tract infection 37.76 18.47 5 22721 84076 34850129
Road traffic accident 37.04 18.47 51 22675 17399 34916806
Bronchial hyperreactivity 36.06 18.47 19 22707 1690 34932515
Morbid thoughts 36.06 18.47 11 22715 227 34933978
Dysgeusia 35.97 18.47 63 22663 26434 34907771
Intentional self-injury 35.04 18.47 44 22682 13727 34920478
Social avoidant behaviour 34.93 18.47 23 22703 3091 34931114
Abdominal discomfort 34.35 18.47 101 22625 59734 34874471
Blood creatinine increased 33.60 18.47 10 22716 94966 34839239
Major depression 33.37 18.47 26 22700 4546 34929659
Tobacco withdrawal symptoms 31.70 18.47 5 22721 0 34934205
Loss of personal independence in daily activities 31.70 18.47 68 22658 33111 34901094
Frustration tolerance decreased 31.14 18.47 20 22706 2576 34931629
Pulmonary function test abnormal 31.04 18.47 20 22706 2590 34931615
Palpitations 30.52 18.47 75 22651 39911 34894294
Withdrawal syndrome 30.43 18.47 39 22687 12416 34921789
Leukopenia 30.06 18.47 3 22723 62853 34871352
Panic reaction 30.00 18.47 16 22710 1459 34932746
Respiratory failure 29.45 18.47 17 22709 108555 34825650
Libido decreased 28.55 18.47 24 22702 4672 34929533
Septic shock 28.43 18.47 6 22720 71828 34862377
Dissociation 28.24 18.47 16 22710 1642 34932563
COVID-19 27.73 18.47 8 22718 77542 34856663
Feeling jittery 27.57 18.47 22 22704 3981 34930224
Disorientation 27.20 18.47 64 22662 33124 34901081
Completed suicide 27.13 18.47 131 22595 98037 34836168
Drug screen false positive 27.10 18.47 12 22714 727 34933478
Renal impairment 26.79 18.47 14 22712 94499 34839706
Cardiac failure 26.64 18.47 13 22713 91235 34842970
Fear 25.90 18.47 33 22693 10443 34923762
Tearfulness 25.86 18.47 18 22708 2649 34931556
Psychiatric symptom 25.69 18.47 20 22706 3493 34930712
Gun shot wound 25.11 18.47 13 22713 1115 34933090
Diarrhoea 25.02 18.47 150 22576 389762 34544443
Bradycardia 24.81 18.47 9 22717 75409 34858796
C-reactive protein increased 24.81 18.47 3 22723 54095 34880110
Pleural effusion 24.75 18.47 11 22715 81535 34852670
Mental impairment 24.71 18.47 32 22694 10290 34923915
Loss of employment 24.31 18.47 10 22716 505 34933700
Infusion related reaction 24.19 18.47 3 22723 53054 34881151
Drug withdrawal syndrome 24.16 18.47 45 22681 19789 34914416
Hospitalisation 24.12 18.47 4 22722 56898 34877307
Erectile dysfunction 24.12 18.47 46 22680 20591 34913614
Product availability issue 23.79 18.47 15 22711 1872 34932333
Marital problem 23.42 18.47 6 22720 63 34934142
Pharyngeal oedema 23.36 18.47 24 22702 6023 34928182
Hypomania 23.06 18.47 16 22710 2343 34931862
Interstitial lung disease 22.85 18.47 7 22719 65275 34868930
Affect lability 22.76 18.47 19 22707 3664 34930541
Hypokalaemia 22.75 18.47 5 22721 58209 34875996
Confusional state 22.73 18.47 166 22560 143994 34790211
Tinnitus 22.48 18.47 44 22682 20074 34914131
Drug abuse 22.27 18.47 19 22707 99077 34835128
Infection 22.24 18.47 16 22710 90899 34843306
Personality disorder 21.89 18.47 12 22714 1156 34933049
Restlessness 21.82 18.47 50 22676 25432 34908773
Adjustment disorder with mixed anxiety and depressed mood 21.70 18.47 4 22722 6 34934199
Hyperkalaemia 21.63 18.47 9 22717 69380 34864825
Seizure 21.53 18.47 129 22597 104728 34829477
Loss of consciousness 21.18 18.47 108 22618 82559 34851646
Hallucination, auditory 21.15 18.47 32 22694 11885 34922320
Imprisonment 20.86 18.47 9 22717 512 34933693
Decreased interest 20.74 18.47 15 22711 2345 34931860
Drug intolerance 20.59 18.47 85 22641 59485 34874720
Feeding disorder 20.44 18.47 24 22702 6986 34927219
Ascites 20.36 18.47 3 22723 46568 34887637
Flight of ideas 20.13 18.47 8 22718 369 34933836
Alcohol interaction 20.04 18.47 16 22710 2897 34931308
Cellulitis 19.80 18.47 5 22721 52946 34881259
Dehydration 19.60 18.47 34 22692 129935 34804270
Peripheral swelling 19.34 18.47 13 22713 76528 34857677
Anti-cyclic citrullinated peptide antibody positive 19.20 18.47 13 22713 1830 34932375
Poor quality sleep 18.84 18.47 25 22701 8231 34925974

FDA Adverse Event Reporting System (Geriatric)

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
Abnormal dreams 1892.42 15.33 506 30918 10906 79702058
Suicidal ideation 1511.82 15.33 691 30733 75649 79637315
Depression 1502.00 15.33 977 30447 215813 79497151
Nightmare 1136.13 15.33 415 31009 25446 79687518
Anger 602.85 15.33 234 31190 16928 79696036
Nausea 491.77 15.33 1126 30298 956070 78756894
Irritability 459.24 15.33 253 31171 40891 79672073
Anxiety 457.41 15.33 525 30899 247987 79464977
Aggression 455.33 15.33 271 31153 50687 79662277
Agitation 447.48 15.33 346 31078 99369 79613595
Drug hypersensitivity 423.02 15.33 553 30871 298363 79414601
Insomnia 374.00 15.33 471 30953 244699 79468265
Mood swings 370.68 15.33 173 31251 19707 79693257
Feeling abnormal 350.85 15.33 370 31054 158829 79554135
Depressed mood 339.82 15.33 221 31203 48259 79664705
Abnormal behaviour 336.52 15.33 198 31226 36223 79676741
Mood altered 280.09 15.33 138 31286 17709 79695255
Crying 268.89 15.33 146 31278 22897 79690067
Paranoia 234.76 15.33 126 31298 19306 79693658
Tobacco user 211.42 15.33 51 31373 708 79712256
Thinking abnormal 172.14 15.33 90 31334 13071 79699893
Suicide attempt 165.30 15.33 183 31241 82749 79630215
Tearfulness 155.68 15.33 66 31358 5979 79706985
Vomiting 153.85 15.33 592 30832 665236 79047728
Psychotic disorder 139.95 15.33 122 31302 41280 79671684
Off label use 136.38 15.33 96 31328 907119 78805845
Panic attack 132.98 15.33 95 31329 24121 79688843
Homicidal ideation 131.54 15.33 50 31374 3407 79709557
Personality change 128.60 15.33 68 31356 10102 79702862
Mania 127.25 15.33 83 31341 18177 79694787
Mental disorder 111.38 15.33 95 31329 31207 79681757
Emotional disorder 109.17 15.33 69 31355 14318 79698646
Acute kidney injury 98.18 15.33 41 31383 519363 79193601
Anaemia 94.52 15.33 29 31395 444986 79267978
Amnesia 93.96 15.33 120 31304 62937 79650027
Suicidal behaviour 88.78 15.33 37 31387 3210 79709754
Hallucination 85.95 15.33 135 31289 85610 79627354
Pyrexia 85.55 15.33 85 31339 678624 79034340
Self-injurious ideation 84.73 15.33 37 31387 3601 79709363
Violence-related symptom 82.44 15.33 24 31400 707 79712257
Alcohol use 77.69 15.33 38 31386 4793 79708171
Impaired work ability 74.68 15.33 62 31362 19619 79693345
Hostility 72.30 15.33 29 31395 2281 79710683
Apathy 71.44 15.33 51 31373 12926 79700038
Nervousness 70.46 15.33 76 31348 33339 79679625
Febrile neutropenia 68.83 15.33 6 31418 230993 79481971
Disturbance in attention 68.41 15.33 92 31332 50709 79662255
Toxicity to various agents 63.90 15.33 44 31380 421496 79291468
Negative thoughts 63.37 15.33 23 31401 1376 79711588
Thrombocytopenia 62.51 15.33 14 31410 265245 79447719
Bipolar disorder 61.07 15.33 38 31386 7669 79705295
Neutropenia 60.58 15.33 19 31405 287691 79425273
General physical health deterioration 60.09 15.33 17 31407 275221 79437743
Sleep disorder 59.81 15.33 115 31309 85562 79627402
Product availability issue 57.41 15.33 29 31395 3918 79709046
Infusion related reaction 56.62 15.33 11 31413 230226 79482738
Social avoidant behaviour 54.74 15.33 30 31394 4784 79708180
Recalled product administered 54.12 15.33 18 31406 829 79712135
Affective disorder 53.56 15.33 36 31388 8283 79704681
Stress 53.30 15.33 105 31319 79507 79633457
Physical assault 53.12 15.33 21 31403 1590 79711374
Chronic obstructive pulmonary disease 52.83 15.33 109 31315 85310 79627654
Death 52.68 15.33 89 31335 566425 79146539
Major depression 51.07 15.33 36 31388 8944 79704020
Pancytopenia 50.20 15.33 4 31420 165741 79547223
Somnambulism 49.92 15.33 30 31394 5691 79707273
Hypotension 47.91 15.33 62 31362 440255 79272709
Delusion 47.59 15.33 49 31375 20374 79692590
Memory impairment 47.49 15.33 123 31301 111611 79601353
Treatment failure 46.75 15.33 6 31418 170480 79542484
Withdrawal syndrome 46.26 15.33 55 31369 26799 79686165
Blood creatinine increased 46.25 15.33 4 31420 155053 79557911
Affect lability 45.93 15.33 37 31387 11222 79701742
Pre-existing condition improved 45.53 15.33 28 31396 5535 79707429
Panic reaction 44.73 15.33 26 31398 4639 79708325
Verbal abuse 44.13 15.33 12 31412 274 79712690
Depression suicidal 43.84 15.33 24 31400 3818 79709146
Dizziness 43.52 15.33 355 31069 526086 79186878
Bronchial hyperreactivity 43.23 15.33 22 31402 3018 79709946
Flatulence 42.42 15.33 67 31357 42657 79670307
Sepsis 42.30 15.33 27 31397 269401 79443563
Malignant neoplasm progression 41.98 15.33 3 31421 135987 79576977
Urinary tract infection 41.10 15.33 29 31395 274483 79438481
Screaming 40.60 15.33 23 31401 3910 79709054
Intentional self-injury 39.57 15.33 56 31368 32363 79680601
Product use in unapproved indication 39.42 15.33 25 31399 250334 79462630
Joint swelling 38.79 15.33 34 31390 288612 79424352
Alcohol interaction 38.54 15.33 24 31400 4850 79708114
Infection 38.25 15.33 24 31400 241688 79471276
Haemoglobin decreased 38.08 15.33 20 31404 222099 79490865
Therapeutic response unexpected 37.96 15.33 43 31381 19903 79693061
Fear 37.82 15.33 45 31379 21941 79691023
Asthma-chronic obstructive pulmonary disease overlap syndrome 36.42 15.33 20 31404 3201 79709763
Dysgeusia 35.39 15.33 73 31351 57104 79655860
White blood cell count decreased 35.27 15.33 15 31409 188273 79524691
Hallucination, auditory 35.02 15.33 42 31382 20651 79692313
Seizure 34.74 15.33 157 31267 188677 79524287
Pulmonary function test abnormal 34.28 15.33 21 31403 4123 79708841
Platelet count decreased 34.15 15.33 17 31407 194647 79518317
Contraindicated product administered 33.86 15.33 10 31414 157528 79555436
Palpitations 33.54 15.33 118 31306 126492 79586472
Arthropathy 33.35 15.33 14 31410 177097 79535867
Dissociation 32.30 15.33 20 31404 4001 79708963
Loss of employment 31.86 15.33 17 31407 2570 79710394
Impaired driving ability 31.47 15.33 22 31402 5393 79707571
Decreased interest 31.26 15.33 19 31405 3678 79709286
Post-traumatic stress disorder 31.13 15.33 21 31403 4860 79708104
Impulsive behaviour 30.04 15.33 17 31407 2883 79710081
Leukopenia 29.85 15.33 5 31419 116508 79596456
Road traffic accident 29.71 15.33 58 31366 43606 79669358
Hypokalaemia 29.43 15.33 10 31414 144030 79568934
Tachyphrenia 29.43 15.33 15 31409 2065 79710899
Hepatic enzyme increased 29.06 15.33 18 31406 182592 79530372
Alopecia 29.01 15.33 29 31395 231326 79481638
Multiple organ dysfunction syndrome 29.01 15.33 6 31418 120240 79592724
Arthralgia 28.65 15.33 122 31302 571681 79141283
Pneumonia 28.32 15.33 149 31275 660097 79052867
Disease progression 28.21 15.33 19 31405 184343 79528621
Feeling of despair 27.78 15.33 16 31408 2805 79710159
Pericarditis 27.78 15.33 4 31420 104232 79608732
Systemic lupus erythematosus 27.33 15.33 7 31417 121142 79591822
Hypomania 27.04 15.33 23 31401 7521 79705443
Flat affect 26.80 15.33 14 31410 2027 79710937
Cardiac failure 26.44 15.33 14 31410 154828 79558136
Renal failure 25.42 15.33 25 31399 200943 79512021
Tobacco withdrawal symptoms 25.12 15.33 4 31420 3 79712961
Frustration tolerance decreased 25.12 15.33 22 31402 7480 79705484
Ischaemic cardiomyopathy 24.64 15.33 22 31402 7673 79705291
Disorientation 24.52 15.33 67 31357 62709 79650255
Headache 24.39 15.33 377 31047 653395 79059569
Agoraphobia 24.32 15.33 9 31415 569 79712395
Psychiatric symptom 24.30 15.33 21 31403 7014 79705950
Flight of ideas 24.17 15.33 10 31414 852 79712112
Marital problem 23.70 15.33 7 31417 217 79712747
Pleural effusion 23.56 15.33 14 31410 145248 79567716
Glossodynia 23.25 15.33 6 31418 103331 79609633
Pharyngeal oedema 22.71 15.33 30 31394 16242 79696722
Nasopharyngitis 22.53 15.33 41 31383 253840 79459124
Weaning failure 22.46 15.33 9 31415 706 79712258
Drug withdrawal syndrome 22.28 15.33 45 31379 34673 79678291
Hospitalisation 22.13 15.33 5 31419 94231 79618733
Rheumatoid arthritis 21.97 15.33 30 31394 208440 79504524
Impaired healing 21.93 15.33 4 31420 87651 79625313
Renal impairment 21.89 15.33 18 31406 157765 79555199
Hyperkalaemia 21.60 15.33 9 31415 114389 79598575
Flashback 21.60 15.33 7 31417 297 79712667
Obsessive thoughts 21.55 15.33 10 31414 1122 79711842
C-reactive protein increased 21.54 15.33 12 31412 129015 79583949
Morbid thoughts 21.46 15.33 9 31415 793 79712171
Cardio-respiratory arrest 21.37 15.33 8 31416 108502 79604462
Hypersomnia 21.27 15.33 35 31389 23051 79689913
Drug abuse 20.84 15.33 20 31404 162671 79550293
Loss of consciousness 20.73 15.33 125 31299 167818 79545146
Euphoric mood 20.70 15.33 20 31404 7706 79705258
Exposure during pregnancy 20.69 15.33 7 31417 101125 79611839
COVID-19 20.65 15.33 19 31405 157655 79555309
Alcohol poisoning 20.00 15.33 16 31408 4805 79708159
Formication 19.42 15.33 16 31408 5007 79707957
Agitated depression 19.20 15.33 7 31417 424 79712540
Libido decreased 18.62 15.33 16 31408 5305 79707659
Energy increased 18.30 15.33 13 31411 3269 79709695
Bipolar I disorder 18.15 15.33 11 31413 2118 79710846
Interstitial lung disease 18.05 15.33 11 31413 112589 79600375
Peripheral swelling 17.86 15.33 51 31373 269566 79443398
Sinusitis 17.85 15.33 31 31393 195470 79517494
Malaise 17.67 15.33 281 31143 489588 79223376
Musculoskeletal stiffness 17.63 15.33 26 31398 174982 79537982
Restlessness 17.54 15.33 49 31375 46443 79666521
Feelings of worthlessness 17.52 15.33 7 31417 545 79712419
Economic problem 17.50 15.33 11 31413 2259 79710705
Large intestine polyp 17.08 15.33 23 31401 12685 79700279
Panic disorder 17.02 15.33 12 31412 2980 79709984
Pneumonia aspiration 16.88 15.33 3 31421 66964 79646000
Dependence 16.85 15.33 11 31413 2411 79710553
Nicotine dependence 16.83 15.33 8 31416 947 79712017
Oedema mouth 16.81 15.33 12 31412 3039 79709925
Blood bilirubin increased 16.62 15.33 3 31421 66229 79646735
Schizophrenia 16.42 15.33 25 31399 15415 79697549
Dehydration 16.40 15.33 47 31377 248140 79464824
Therapeutic product effect incomplete 16.36 15.33 19 31405 141626 79571338
Cardiac disorder 16.31 15.33 60 31364 65697 79647267
Therapy non-responder 16.27 15.33 8 31416 92297 79620667
Respiratory failure 16.23 15.33 29 31395 180882 79532082
Dysphoria 16.09 15.33 14 31410 4720 79708244
Drug reaction with eosinophilia and systemic symptoms 15.93 15.33 3 31421 64241 79648723
Cellulitis 15.68 15.33 12 31412 109048 79603916
Aspartate aminotransferase increased 15.59 15.33 19 31405 138622 79574342
Needle track marks 15.56 15.33 4 31420 73 79712891
Plantar fasciitis 15.46 15.33 12 31412 3448 79709516

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N07BA03 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in nicotine dependence
ATC S01XA28 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
FDA MoA N0000175369 Cholinergic Agonists
MeSH PA D018678 Cholinergic Agents
MeSH PA D018679 Cholinergic Agonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018722 Nicotinic Agonists
MeSH PA D000077444 Smoking Cessation Agents
FDA MoA N0000175702 Partial Cholinergic Nicotinic Agonists
FDA EPC N0000175705 Partial Cholinergic Nicotinic Agonist
FDA EPC N0000175884 Cholinergic Receptor Agonist
CHEBI has role CHEBI:35941 serotonin agonists
CHEBI has role CHEBI:47958 muscarinic agonists

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Smoking cessation assistance indication 384742004
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Bipolar disorder contraindication 13746004 DOID:3312
Mood swings contraindication 18963009
Feeling agitated contraindication 24199005
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Schizophrenia contraindication 58214004 DOID:5419
Acute nephropathy contraindication 58574008
Aggressive behavior contraindication 61372001
Aortocoronary artery bypass graft contraindication 67166004
Hostile behavior contraindication 79351003
Angina pectoris contraindication 194828000
Acute coronary syndrome contraindication 394659003
Cardiovascular event risk contraindication 395112001
Peripheral vascular disease contraindication 400047006
Nausea contraindication 422587007




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.83 Basic
pKa2 1.25 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.03MG BASE/SPRAY TYRVAYA OYSTER POINT PHARMA N213978 Oct. 15, 2021 RX SPRAY NASAL 10456396 Oct. 19, 2035 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
EQ 0.03MG BASE/SPRAY TYRVAYA OYSTER POINT PHARMA N213978 Oct. 15, 2021 RX SPRAY NASAL 11224598 Oct. 19, 2035 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
EQ 0.03MG BASE/SPRAY TYRVAYA OYSTER POINT PHARMA N213978 Oct. 15, 2021 RX SPRAY NASAL 9504644 Oct. 19, 2035 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
EQ 0.03MG BASE/SPRAY TYRVAYA OYSTER POINT PHARMA N213978 Oct. 15, 2021 RX SPRAY NASAL 9532944 Oct. 19, 2035 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
EQ 0.03MG BASE/SPRAY TYRVAYA OYSTER POINT PHARMA N213978 Oct. 15, 2021 RX SPRAY NASAL 9597284 Oct. 19, 2035 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.03MG BASE/SPRAY TYRVAYA OYSTER POINT PHARMA N213978 Oct. 15, 2021 RX SPRAY NASAL Oct. 15, 2024 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel AGONIST Ki 9.40 WOMBAT-PK CHEMBL
Neuronal acetylcholine receptor; alpha3/beta4 Ion channel Ki 7.07 WOMBAT-PK
Neuronal acetylcholine receptor; alpha4/beta4 Ion channel Ki 6.96 CHEMBL
Acetylcholine receptor; alpha1/beta1/delta/gamma Ion channel Ki 5.09 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel Ki 6.90 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel Ki 7.49 CHEMBL
Neuronal acetylcholine receptor; alpha2/beta2 Ion channel Ki 9.66 CHEMBL
Neuronal acetylcholine receptor; alpha3/beta2 Ion channel Ki 8.72 CHEMBL
Neuronal acetylcholine receptor; alpha3/beta4 Ion channel Ki 7.07 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel Ki 10.30 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta4 Ion channel Ki 7.82 CHEMBL
Neuronal acetylcholine receptor; alpha2/beta4 Ion channel Ki 7.15 CHEMBL
Acetylcholine receptor Ion channel Ki 5.45 CHEMBL

External reference:

IDSource
4025278 VUID
N0000179790 NUI
D06282 KEGG_DRUG
375815-87-5 SECONDARY_CAS_RN
4025278 VANDF
4025594 VANDF
C1569608 UMLSCUI
CHEBI:84500 CHEBI
QMR PDB_CHEM_ID
CHEMBL1396 ChEMBL_ID
DB01273 DRUGBANK_ID
CHEMBL2062259 ChEMBL_ID
D000068580 MESH_DESCRIPTOR_UI
170361 PUBCHEM_CID
5459 IUPHAR_LIGAND_ID
8366 INN_ID
W6HS99O8ZO UNII
591622 RXNORM
21404 MMSL
348368 MMSL
82173 MMSL
d05807 MMSL
011508 NDDF
011509 NDDF
420507002 SNOMEDCT_US
421772003 SNOMEDCT_US
428382005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 0069-0468 TABLET, FILM COATED 0.50 mg ORAL NDA 30 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 0069-0469 TABLET, FILM COATED 1 mg ORAL NDA 30 sections
Chantix HUMAN PRESCRIPTION DRUG LABEL 1 21695-633 TABLET, FILM COATED 0.50 mg ORAL NDA 31 sections
Chantix HUMAN PRESCRIPTION DRUG LABEL 1 21695-946 TABLET, FILM COATED 1 mg ORAL NDA 31 sections
Varenicline tartrate HUMAN PRESCRIPTION DRUG LABEL 1 42934-104 TABLET, FILM COATED 0.50 mg ORAL ANDA 28 sections
Varenicline tartrate HUMAN PRESCRIPTION DRUG LABEL 1 42934-105 TABLET, FILM COATED 1 mg ORAL ANDA 28 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 43353-899 TABLET, FILM COATED 1 mg ORAL NDA 30 sections
Varenicline HUMAN PRESCRIPTION DRUG LABEL 1 49884-155 TABLET, FILM COATED 0.50 mg ORAL ANDA 27 sections
Varenicline HUMAN PRESCRIPTION DRUG LABEL 1 49884-155 TABLET, FILM COATED 0.50 mg ORAL ANDA 27 sections
Varenicline HUMAN PRESCRIPTION DRUG LABEL 1 49884-156 TABLET, FILM COATED 1 mg ORAL ANDA 27 sections
Varenicline HUMAN PRESCRIPTION DRUG LABEL 1 49884-156 TABLET, FILM COATED 1 mg ORAL ANDA 27 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 50090-0995 TABLET, FILM COATED 1 mg ORAL NDA 29 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 50090-0995 TABLET, FILM COATED 1 mg ORAL NDA 29 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 50090-4481 TABLET, FILM COATED 0.50 mg ORAL NDA 30 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 50090-4482 TABLET, FILM COATED 1 mg ORAL NDA 30 sections
VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 50090-6446 TABLET, FILM COATED 1 mg ORAL ANDA 28 sections
VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 50090-6447 TABLET, FILM COATED 0.50 mg ORAL ANDA 28 sections
VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 51407-755 TABLET, FILM COATED 0.50 mg ORAL ANDA 28 sections
VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 51407-756 TABLET, FILM COATED 1 mg ORAL ANDA 28 sections
Chantix HUMAN PRESCRIPTION DRUG LABEL 1 54868-5674 TABLET, FILM COATED 1 mg ORAL NDA 31 sections
VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 60505-3613 TABLET, FILM COATED 0.50 mg ORAL ANDA 28 sections
VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 60505-3614 TABLET, FILM COATED 1 mg ORAL ANDA 28 sections
APO-VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 60505-4765 TABLET, FILM COATED 0.50 mg ORAL Unapproved drug for use in drug shortage 7 sections
APO-VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 60505-4765 TABLET, FILM COATED 0.50 mg ORAL Unapproved drug for use in drug shortage 7 sections
APO-VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 60505-4766 TABLET, FILM COATED 1 mg ORAL Unapproved drug for use in drug shortage 7 sections
APO-VARENICLINE HUMAN PRESCRIPTION DRUG LABEL 1 60505-4766 TABLET, FILM COATED 1 mg ORAL Unapproved drug for use in drug shortage 7 sections
Varenicline HUMAN PRESCRIPTION DRUG LABEL 1 60687-648 TABLET, FILM COATED 1 mg ORAL ANDA 27 sections
varenicline Human Prescription Drug Label 1 67877-743 TABLET, FILM COATED 0.50 mg ORAL ANDA 26 sections
varenicline Human Prescription Drug Label 1 67877-744 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections
CHANTIX HUMAN PRESCRIPTION DRUG LABEL 1 68151-4952 TABLET, FILM COATED 1 mg ORAL NDA 31 sections