varenicline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| nicotinic acetylcholine receptor partial agonists/agonists | 2808 | 249296-44-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A benzazepine derivative that functions as an ALPHA4-BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.20 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 10, 2006 | FDA | PFIZER INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Abnormal dreams | 2635.47 | 17.35 | 714 | 35328 | 8663 | 50560419 |
| Depression | 1265.19 | 17.35 | 999 | 35043 | 164424 | 50404658 |
| Suicidal ideation | 1241.41 | 17.35 | 659 | 35383 | 54726 | 50514356 |
| Nausea | 1030.02 | 17.35 | 1805 | 34237 | 703593 | 49865489 |
| Nightmare | 822.29 | 17.35 | 339 | 35703 | 15747 | 50553335 |
| Anger | 582.97 | 17.35 | 240 | 35802 | 11093 | 50557989 |
| Feeling abnormal | 567.51 | 17.35 | 564 | 35478 | 124928 | 50444154 |
| Anxiety | 564.16 | 17.35 | 662 | 35380 | 176944 | 50392138 |
| Insomnia | 514.49 | 17.35 | 627 | 35415 | 174238 | 50394844 |
| Crying | 409.21 | 17.35 | 226 | 35816 | 20190 | 50548892 |
| Tobacco user | 408.11 | 17.35 | 97 | 35945 | 654 | 50568428 |
| Irritability | 404.41 | 17.35 | 252 | 35790 | 28174 | 50540908 |
| Aggression | 375.16 | 17.35 | 216 | 35826 | 20900 | 50548182 |
| Agitation | 371.17 | 17.35 | 306 | 35736 | 53078 | 50516004 |
| Mood swings | 282.82 | 17.35 | 163 | 35879 | 15791 | 50553291 |
| Mood altered | 276.97 | 17.35 | 149 | 35893 | 12624 | 50556458 |
| Depressed mood | 272.53 | 17.35 | 212 | 35830 | 33811 | 50535271 |
| Abnormal behaviour | 261.30 | 17.35 | 167 | 35875 | 19491 | 50549591 |
| Dysgeusia | 223.39 | 17.35 | 200 | 35842 | 38716 | 50530366 |
| Nervousness | 216.44 | 17.35 | 170 | 35872 | 27481 | 50541601 |
| Flatulence | 213.28 | 17.35 | 173 | 35869 | 29285 | 50539797 |
| Paranoia | 192.15 | 17.35 | 109 | 35933 | 10239 | 50558843 |
| Thinking abnormal | 189.12 | 17.35 | 105 | 35937 | 9462 | 50559620 |
| Panic attack | 175.76 | 17.35 | 130 | 35912 | 19212 | 50549870 |
| Homicidal ideation | 175.38 | 17.35 | 60 | 35982 | 1642 | 50567440 |
| Emotional disorder | 168.39 | 17.35 | 105 | 35937 | 11731 | 50557351 |
| Tearfulness | 155.96 | 17.35 | 68 | 35974 | 3619 | 50565463 |
| Off label use | 152.49 | 17.35 | 74 | 35968 | 474352 | 50094730 |
| Disturbance in attention | 143.85 | 17.35 | 142 | 35900 | 31044 | 50538038 |
| Sleep disorder | 143.40 | 17.35 | 190 | 35852 | 57093 | 50511989 |
| Mental disorder | 142.20 | 17.35 | 121 | 35921 | 21870 | 50547212 |
| Psychotic disorder | 130.88 | 17.35 | 115 | 35927 | 21697 | 50547385 |
| Mania | 128.56 | 17.35 | 86 | 35956 | 10830 | 50558252 |
| Drug hypersensitivity | 127.05 | 17.35 | 430 | 35612 | 250580 | 50318502 |
| Acute kidney injury | 105.12 | 17.35 | 18 | 36024 | 228040 | 50341042 |
| Suicidal behaviour | 101.83 | 17.35 | 44 | 35998 | 2290 | 50566792 |
| Death | 99.52 | 17.35 | 54 | 35988 | 325325 | 50243757 |
| Anaemia | 98.21 | 17.35 | 29 | 36013 | 252427 | 50316655 |
| Vomiting | 95.57 | 17.35 | 607 | 35435 | 460151 | 50108931 |
| Personality change | 95.56 | 17.35 | 56 | 35986 | 5589 | 50563493 |
| Amnesia | 93.38 | 17.35 | 132 | 35910 | 42128 | 50526954 |
| Rheumatoid arthritis | 89.02 | 17.35 | 18 | 36024 | 202532 | 50366550 |
| Tobacco withdrawal symptoms | 88.68 | 17.35 | 15 | 36027 | 6 | 50569076 |
| Suicide attempt | 86.57 | 17.35 | 142 | 35900 | 51590 | 50517492 |
| Weight increased | 85.10 | 17.35 | 326 | 35716 | 201565 | 50367517 |
| Bipolar disorder | 83.83 | 17.35 | 55 | 35987 | 6702 | 50562380 |
| Infusion related reaction | 83.57 | 17.35 | 11 | 36031 | 169546 | 50399536 |
| Pyrexia | 83.22 | 17.35 | 89 | 35953 | 380114 | 50188968 |
| Neutropenia | 82.33 | 17.35 | 6 | 36036 | 147959 | 50421123 |
| Dizziness | 82.31 | 17.35 | 473 | 35569 | 345896 | 50223186 |
| Hallucination | 82.06 | 17.35 | 131 | 35911 | 46526 | 50522556 |
| Self-injurious ideation | 81.11 | 17.35 | 37 | 36005 | 2192 | 50566890 |
| Malaise | 76.33 | 17.35 | 453 | 35589 | 335079 | 50234003 |
| Stress | 74.74 | 17.35 | 136 | 35906 | 53657 | 50515425 |
| Hostility | 72.56 | 17.35 | 32 | 36010 | 1750 | 50567332 |
| Systemic lupus erythematosus | 69.58 | 17.35 | 9 | 36033 | 140613 | 50428469 |
| Toxicity to various agents | 66.77 | 17.35 | 34 | 36008 | 212465 | 50356617 |
| Alopecia | 66.09 | 17.35 | 47 | 35995 | 245000 | 50324082 |
| Violence-related symptom | 65.42 | 17.35 | 20 | 36022 | 378 | 50568704 |
| Fear | 64.76 | 17.35 | 65 | 35977 | 14484 | 50554598 |
| General physical health deterioration | 61.84 | 17.35 | 13 | 36029 | 142421 | 50426661 |
| Thrombocytopenia | 61.21 | 17.35 | 9 | 36033 | 127664 | 50441418 |
| Chronic obstructive pulmonary disease | 59.45 | 17.35 | 123 | 35919 | 53312 | 50515770 |
| Impaired work ability | 58.99 | 17.35 | 60 | 35982 | 13580 | 50555502 |
| Impaired driving ability | 58.51 | 17.35 | 36 | 36006 | 3925 | 50565157 |
| Headache | 56.83 | 17.35 | 580 | 35462 | 505955 | 50063127 |
| Panic reaction | 56.73 | 17.35 | 34 | 36008 | 3535 | 50565547 |
| Arthropathy | 56.34 | 17.35 | 21 | 36021 | 157885 | 50411197 |
| Apathy | 56.01 | 17.35 | 45 | 35997 | 7503 | 50561579 |
| Memory impairment | 56.01 | 17.35 | 153 | 35889 | 79207 | 50489875 |
| Feeling jittery | 55.54 | 17.35 | 53 | 35989 | 11107 | 50557975 |
| Euphoric mood | 55.22 | 17.35 | 35 | 36007 | 4020 | 50565062 |
| Hypersomnia | 54.95 | 17.35 | 61 | 35981 | 15253 | 50553829 |
| Joint swelling | 54.05 | 17.35 | 57 | 35985 | 245229 | 50323853 |
| Infection | 53.83 | 17.35 | 28 | 36014 | 172926 | 50396156 |
| Palpitations | 52.20 | 17.35 | 167 | 35875 | 94339 | 50474743 |
| Nicotine dependence | 51.90 | 17.35 | 19 | 36023 | 636 | 50568446 |
| Somnambulism | 51.36 | 17.35 | 36 | 36006 | 4888 | 50564194 |
| Sepsis | 50.31 | 17.35 | 16 | 36026 | 132909 | 50436173 |
| Decreased interest | 49.00 | 17.35 | 29 | 36013 | 2947 | 50566135 |
| Hallucination, auditory | 47.87 | 17.35 | 48 | 35994 | 10680 | 50558402 |
| Peripheral swelling | 47.47 | 17.35 | 46 | 35996 | 205890 | 50363192 |
| Exposure during pregnancy | 45.03 | 17.35 | 15 | 36027 | 121000 | 50448082 |
| Dissociation | 44.87 | 17.35 | 25 | 36017 | 2266 | 50566816 |
| Urinary tract infection | 43.00 | 17.35 | 58 | 35984 | 223962 | 50345120 |
| Parosmia | 42.96 | 17.35 | 31 | 36011 | 4405 | 50564677 |
| Product use issue | 42.51 | 17.35 | 27 | 36015 | 149448 | 50419634 |
| Psychiatric symptom | 42.14 | 17.35 | 31 | 36011 | 4539 | 50564543 |
| Withdrawal syndrome | 41.92 | 17.35 | 57 | 35985 | 17533 | 50551549 |
| Constipation | 41.62 | 17.35 | 250 | 35792 | 185458 | 50383624 |
| Tremor | 41.51 | 17.35 | 177 | 35865 | 114726 | 50454356 |
| White blood cell count decreased | 40.83 | 17.35 | 16 | 36026 | 116706 | 50452376 |
| Therapeutic product effect incomplete | 40.44 | 17.35 | 8 | 36034 | 91507 | 50477575 |
| Social avoidant behaviour | 40.24 | 17.35 | 25 | 36017 | 2772 | 50566310 |
| Therapeutic response unexpected | 40.11 | 17.35 | 53 | 35989 | 15862 | 50553220 |
| Poor quality sleep | 39.75 | 17.35 | 54 | 35988 | 16592 | 50552490 |
| Hypotension | 39.37 | 17.35 | 67 | 35975 | 235402 | 50333680 |
| Screaming | 38.80 | 17.35 | 25 | 36017 | 2953 | 50566129 |
| Sinusitis | 38.26 | 17.35 | 39 | 36003 | 170519 | 50398563 |
| Cardiac failure | 37.28 | 17.35 | 5 | 36037 | 76035 | 50493047 |
| Disease progression | 37.24 | 17.35 | 11 | 36031 | 95855 | 50473227 |
| Product use in unapproved indication | 37.15 | 17.35 | 18 | 36024 | 115801 | 50453281 |
| Hyperphagia | 36.38 | 17.35 | 19 | 36023 | 1513 | 50567569 |
| Pleural effusion | 36.25 | 17.35 | 7 | 36035 | 81447 | 50487635 |
| Hypokalaemia | 36.24 | 17.35 | 9 | 36033 | 87983 | 50481099 |
| Somnolence | 36.23 | 17.35 | 211 | 35831 | 154774 | 50414308 |
| Hepatic enzyme increased | 36.15 | 17.35 | 27 | 36015 | 137353 | 50431729 |
| Pneumonia | 36.10 | 17.35 | 143 | 35899 | 378258 | 50190824 |
| Arthralgia | 35.69 | 17.35 | 176 | 35866 | 438526 | 50130556 |
| Haemoglobin decreased | 34.78 | 17.35 | 24 | 36018 | 127192 | 50441890 |
| Renal impairment | 34.75 | 17.35 | 6 | 36036 | 75655 | 50493427 |
| Impatience | 34.61 | 17.35 | 12 | 36030 | 342 | 50568740 |
| Impulsive behaviour | 34.39 | 17.35 | 18 | 36024 | 1440 | 50567642 |
| Pre-existing condition improved | 33.98 | 17.35 | 33 | 36009 | 7064 | 50562018 |
| Blood creatinine increased | 32.94 | 17.35 | 7 | 36035 | 76153 | 50492929 |
| Respiratory failure | 32.72 | 17.35 | 12 | 36030 | 91169 | 50477913 |
| Glossodynia | 32.68 | 17.35 | 21 | 36021 | 115548 | 50453534 |
| Affect lability | 32.55 | 17.35 | 36 | 36006 | 8962 | 50560120 |
| Energy increased | 32.07 | 17.35 | 20 | 36022 | 2232 | 50566850 |
| Hospitalisation | 32.06 | 17.35 | 5 | 36037 | 67932 | 50501150 |
| Leukopenia | 31.80 | 17.35 | 5 | 36037 | 67523 | 50501559 |
| Feelings of worthlessness | 31.67 | 17.35 | 11 | 36031 | 315 | 50568767 |
| Wound | 31.62 | 17.35 | 18 | 36024 | 105776 | 50463306 |
| Impaired healing | 31.04 | 17.35 | 6 | 36036 | 69780 | 50499302 |
| Drug withdrawal syndrome | 30.58 | 17.35 | 60 | 35982 | 25021 | 50544061 |
| Psychomotor hyperactivity | 29.90 | 17.35 | 35 | 36007 | 9266 | 50559816 |
| Nasopharyngitis | 29.47 | 17.35 | 58 | 35984 | 192869 | 50376213 |
| Renal failure | 29.30 | 17.35 | 20 | 36022 | 106613 | 50462469 |
| Platelet count decreased | 28.89 | 17.35 | 18 | 36024 | 100708 | 50468374 |
| Lower respiratory tract infection | 28.74 | 17.35 | 16 | 36026 | 95185 | 50473897 |
| Swelling | 28.48 | 17.35 | 63 | 35979 | 200809 | 50368273 |
| Affective disorder | 28.46 | 17.35 | 26 | 36016 | 5155 | 50563927 |
| Tachyphrenia | 28.31 | 17.35 | 15 | 36027 | 1230 | 50567852 |
| Bipolar I disorder | 28.20 | 17.35 | 16 | 36026 | 1502 | 50567580 |
| Abdominal pain upper | 28.08 | 17.35 | 202 | 35840 | 159107 | 50409975 |
| Abdominal distension | 27.63 | 17.35 | 114 | 35928 | 72789 | 50496293 |
| Negative thoughts | 27.25 | 17.35 | 13 | 36029 | 853 | 50568229 |
| Incorrect dose administered | 27.12 | 17.35 | 86 | 35956 | 48328 | 50520754 |
| Oedema mouth | 26.86 | 17.35 | 18 | 36024 | 2272 | 50566810 |
| Vision blurred | 26.74 | 17.35 | 119 | 35923 | 78528 | 50490554 |
| Physical assault | 26.66 | 17.35 | 13 | 36029 | 895 | 50568187 |
| Alcohol use | 26.62 | 17.35 | 17 | 36025 | 1978 | 50567104 |
| Middle insomnia | 26.49 | 17.35 | 34 | 36008 | 9887 | 50559195 |
| Feeling guilty | 26.47 | 17.35 | 11 | 36031 | 519 | 50568563 |
| Feeling of despair | 26.44 | 17.35 | 17 | 36025 | 2001 | 50567081 |
| Delusion | 26.33 | 17.35 | 35 | 36007 | 10534 | 50558548 |
| Gastrointestinal haemorrhage | 25.72 | 17.35 | 10 | 36032 | 73311 | 50495771 |
| Formication | 25.50 | 17.35 | 21 | 36021 | 3625 | 50565457 |
| Depression suicidal | 25.43 | 17.35 | 15 | 36027 | 1514 | 50567568 |
| Cardio-respiratory arrest | 25.35 | 17.35 | 4 | 36038 | 53888 | 50515194 |
| Therapeutic product effect decreased | 25.30 | 17.35 | 36 | 36006 | 136014 | 50433068 |
| Ageusia | 25.30 | 17.35 | 36 | 36006 | 11547 | 50557535 |
| Interstitial lung disease | 24.90 | 17.35 | 4 | 36038 | 53172 | 50515910 |
| Restlessness | 24.60 | 17.35 | 55 | 35987 | 25118 | 50543964 |
| Increased appetite | 24.47 | 17.35 | 30 | 36012 | 8331 | 50560751 |
| Hot flush | 24.32 | 17.35 | 78 | 35964 | 44091 | 50524991 |
| Weaning failure | 24.26 | 17.35 | 9 | 36033 | 313 | 50568769 |
| Condition aggravated | 24.21 | 17.35 | 119 | 35923 | 296939 | 50272143 |
| Pain | 24.20 | 17.35 | 280 | 35762 | 578623 | 49990459 |
| Flight of ideas | 23.73 | 17.35 | 9 | 36033 | 333 | 50568749 |
| Frustration tolerance decreased | 22.80 | 17.35 | 24 | 36018 | 5650 | 50563432 |
| Atrial fibrillation | 21.98 | 17.35 | 24 | 36018 | 101721 | 50467361 |
| Musculoskeletal stiffness | 21.97 | 17.35 | 36 | 36006 | 128445 | 50440637 |
| Tobacco abuse | 21.96 | 17.35 | 10 | 36032 | 590 | 50568492 |
| Chest pain | 21.87 | 17.35 | 207 | 35835 | 176675 | 50392407 |
| Restless legs syndrome | 21.82 | 17.35 | 40 | 36002 | 15857 | 50553225 |
| Septic shock | 21.41 | 17.35 | 7 | 36035 | 57168 | 50511914 |
| Recalled product administered | 21.11 | 17.35 | 9 | 36033 | 453 | 50568629 |
| Multiple organ dysfunction syndrome | 21.02 | 17.35 | 5 | 36037 | 50332 | 50518750 |
| COVID-19 | 20.78 | 17.35 | 4 | 36038 | 46658 | 50522424 |
| Injection site erythema | 20.66 | 17.35 | 14 | 36028 | 74922 | 50494160 |
| Drug ineffective | 20.47 | 17.35 | 437 | 35605 | 818896 | 49750186 |
| C-reactive protein increased | 20.31 | 17.35 | 11 | 36031 | 66463 | 50502619 |
| Drug interaction | 20.10 | 17.35 | 224 | 35818 | 199397 | 50369685 |
| Mental impairment | 20.05 | 17.35 | 33 | 36009 | 12011 | 50557071 |
| Injection site pain | 20.03 | 17.35 | 30 | 36012 | 110994 | 50458088 |
| Loss of employment | 19.89 | 17.35 | 13 | 36029 | 1573 | 50567509 |
| Completed suicide | 19.83 | 17.35 | 40 | 36002 | 131849 | 50437233 |
| Cellulitis | 19.82 | 17.35 | 13 | 36029 | 70785 | 50498297 |
| Laziness | 19.81 | 17.35 | 9 | 36033 | 528 | 50568554 |
| Morbid thoughts | 19.73 | 17.35 | 9 | 36033 | 533 | 50568549 |
| Hyperkalaemia | 19.64 | 17.35 | 5 | 36037 | 48084 | 50520998 |
| Flat affect | 19.63 | 17.35 | 12 | 36030 | 1293 | 50567789 |
| Depressive symptom | 19.44 | 17.35 | 17 | 36025 | 3183 | 50565899 |
| Hyponatraemia | 19.34 | 17.35 | 24 | 36018 | 96115 | 50472967 |
| Psychotic behaviour | 19.25 | 17.35 | 9 | 36033 | 564 | 50568518 |
| Hyperhidrosis | 19.12 | 17.35 | 119 | 35923 | 89307 | 50479775 |
| Cardiac arrest | 18.89 | 17.35 | 19 | 36023 | 83632 | 50485450 |
| Drug intolerance | 18.88 | 17.35 | 86 | 35956 | 219018 | 50350064 |
| Gingival bleeding | 18.75 | 17.35 | 31 | 36011 | 11322 | 50557760 |
| Osteoarthritis | 18.67 | 17.35 | 13 | 36029 | 68593 | 50500489 |
| Neuropathy peripheral | 18.59 | 17.35 | 25 | 36017 | 96732 | 50472350 |
| Alcohol interaction | 18.55 | 17.35 | 14 | 36028 | 2130 | 50566952 |
| Oxygen saturation decreased | 18.49 | 17.35 | 15 | 36027 | 73233 | 50495849 |
| Dehydration | 18.34 | 17.35 | 52 | 35990 | 152397 | 50416685 |
| Drug abuse | 18.14 | 17.35 | 10 | 36032 | 59836 | 50509246 |
| Disorientation | 18.04 | 17.35 | 61 | 35981 | 35423 | 50533659 |
| Emphysema | 18.03 | 17.35 | 27 | 36015 | 9066 | 50560016 |
| Metabolic acidosis | 18.00 | 17.35 | 3 | 36039 | 38822 | 50530260 |
| Nocturia | 17.87 | 17.35 | 23 | 36019 | 6707 | 50562375 |
| Therapy non-responder | 17.82 | 17.35 | 7 | 36035 | 51015 | 50518067 |
| Major depression | 17.46 | 17.35 | 23 | 36019 | 6861 | 50562221 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Abnormal dreams | 1928.37 | 18.41 | 528 | 21471 | 6392 | 29546136 |
| Depression | 1274.02 | 18.41 | 788 | 21211 | 84359 | 29468169 |
| Suicidal ideation | 1207.72 | 18.41 | 564 | 21435 | 34152 | 29518376 |
| Nightmare | 1037.98 | 18.41 | 370 | 21629 | 11047 | 29541481 |
| Anger | 565.68 | 18.41 | 235 | 21764 | 10655 | 29541873 |
| Irritability | 458.54 | 18.41 | 254 | 21745 | 21898 | 29530630 |
| Aggression | 454.41 | 18.41 | 299 | 21700 | 35242 | 29517286 |
| Insomnia | 448.56 | 18.41 | 432 | 21567 | 88329 | 29464199 |
| Agitation | 428.53 | 18.41 | 333 | 21666 | 50971 | 29501557 |
| Mood swings | 415.71 | 18.41 | 168 | 21831 | 7083 | 29545445 |
| Anxiety | 383.84 | 18.41 | 390 | 21609 | 84975 | 29467553 |
| Nausea | 381.86 | 18.41 | 729 | 21270 | 288526 | 29264002 |
| Feeling abnormal | 350.88 | 18.41 | 304 | 21695 | 54141 | 29498387 |
| Abnormal behaviour | 253.38 | 18.41 | 177 | 21822 | 22950 | 29529578 |
| Tobacco user | 243.00 | 18.41 | 60 | 21939 | 461 | 29552067 |
| Mood altered | 215.63 | 18.41 | 110 | 21889 | 8001 | 29544527 |
| Depressed mood | 182.70 | 18.41 | 127 | 21872 | 16321 | 29536207 |
| Paranoia | 173.88 | 18.41 | 102 | 21897 | 9775 | 29542753 |
| Personality change | 162.59 | 18.41 | 76 | 21923 | 4562 | 29547966 |
| Vomiting | 157.37 | 18.41 | 427 | 21572 | 211833 | 29340695 |
| Homicidal ideation | 156.79 | 18.41 | 62 | 21937 | 2462 | 29550066 |
| Off label use | 132.33 | 18.41 | 31 | 21968 | 300769 | 29251759 |
| Thinking abnormal | 130.46 | 18.41 | 68 | 21931 | 5168 | 29547360 |
| Hallucination | 123.39 | 18.41 | 159 | 21840 | 44553 | 29507975 |
| Nervousness | 120.17 | 18.41 | 85 | 21914 | 11221 | 29541307 |
| Amnesia | 115.35 | 18.41 | 111 | 21888 | 22532 | 29529996 |
| Acute kidney injury | 115.30 | 18.41 | 28 | 21971 | 265239 | 29287289 |
| Violence-related symptom | 114.97 | 18.41 | 33 | 21966 | 474 | 29552054 |
| Suicide attempt | 112.97 | 18.41 | 133 | 21866 | 33977 | 29518551 |
| Death | 102.95 | 18.41 | 64 | 21935 | 342020 | 29210508 |
| Drug hypersensitivity | 101.23 | 18.41 | 182 | 21817 | 68224 | 29484304 |
| Pneumonia | 100.41 | 18.41 | 57 | 21942 | 320115 | 29232413 |
| Emotional disorder | 94.95 | 18.41 | 54 | 21945 | 4877 | 29547651 |
| Pyrexia | 94.84 | 18.41 | 48 | 21951 | 287574 | 29264954 |
| Hostility | 87.60 | 18.41 | 30 | 21969 | 787 | 29551741 |
| Suicidal behaviour | 86.42 | 18.41 | 34 | 21965 | 1331 | 29551197 |
| Mania | 82.62 | 18.41 | 61 | 21938 | 8602 | 29543926 |
| Psychotic disorder | 82.14 | 18.41 | 88 | 21911 | 20266 | 29532262 |
| Toxicity to various agents | 80.05 | 18.41 | 16 | 21983 | 173645 | 29378883 |
| Sleep disorder | 77.28 | 18.41 | 93 | 21906 | 24293 | 29528235 |
| Panic attack | 73.56 | 18.41 | 56 | 21943 | 8270 | 29544258 |
| Crying | 73.06 | 18.41 | 47 | 21952 | 5304 | 29547224 |
| Sepsis | 70.41 | 18.41 | 11 | 21988 | 142671 | 29409857 |
| Alcohol use | 67.67 | 18.41 | 37 | 21962 | 3095 | 29549433 |
| Anaemia | 66.94 | 18.41 | 33 | 21966 | 200918 | 29351610 |
| Disturbance in attention | 66.73 | 18.41 | 81 | 21918 | 21343 | 29531185 |
| Neutropenia | 65.33 | 18.41 | 10 | 21989 | 131701 | 29420827 |
| Mental disorder | 65.20 | 18.41 | 63 | 21936 | 12842 | 29539686 |
| Thrombocytopenia | 65.16 | 18.41 | 11 | 21988 | 134812 | 29417716 |
| Physical assault | 65.13 | 18.41 | 26 | 21973 | 1058 | 29551470 |
| Febrile neutropenia | 64.55 | 18.41 | 5 | 21994 | 112235 | 29440293 |
| Apathy | 57.83 | 18.41 | 43 | 21956 | 6128 | 29546400 |
| Memory impairment | 57.71 | 18.41 | 100 | 21899 | 36370 | 29516158 |
| Impaired driving ability | 54.44 | 18.41 | 29 | 21970 | 2302 | 29550226 |
| Hypotension | 53.43 | 18.41 | 40 | 21959 | 194314 | 29358214 |
| Flatulence | 51.99 | 18.41 | 65 | 21934 | 17644 | 29534884 |
| Stress | 50.92 | 18.41 | 71 | 21928 | 21419 | 29531109 |
| Product use in unapproved indication | 49.58 | 18.41 | 4 | 21995 | 86871 | 29465657 |
| Impaired work ability | 47.77 | 18.41 | 37 | 21962 | 5603 | 29546925 |
| Bipolar disorder | 47.61 | 18.41 | 30 | 21969 | 3265 | 29549263 |
| Platelet count decreased | 47.44 | 18.41 | 10 | 21989 | 104662 | 29447866 |
| White blood cell count decreased | 47.12 | 18.41 | 4 | 21995 | 83358 | 29469170 |
| Self-injurious ideation | 46.99 | 18.41 | 23 | 21976 | 1528 | 29551000 |
| Pancytopenia | 46.99 | 18.41 | 4 | 21995 | 83164 | 29469364 |
| Affective disorder | 46.52 | 18.41 | 29 | 21970 | 3097 | 29549431 |
| Verbal abuse | 46.48 | 18.41 | 13 | 21986 | 169 | 29552359 |
| General physical health deterioration | 46.26 | 18.41 | 10 | 21989 | 102847 | 29449681 |
| Screaming | 45.08 | 18.41 | 21 | 21978 | 1249 | 29551279 |
| Somnambulism | 44.29 | 18.41 | 27 | 21972 | 2771 | 29549757 |
| Renal failure | 41.72 | 18.41 | 18 | 21981 | 118581 | 29433947 |
| Headache | 41.07 | 18.41 | 245 | 21754 | 173762 | 29378766 |
| Negative thoughts | 41.04 | 18.41 | 16 | 21983 | 611 | 29551917 |
| Haemoglobin decreased | 40.49 | 18.41 | 15 | 21984 | 108360 | 29444168 |
| Post-traumatic stress disorder | 40.21 | 18.41 | 21 | 21978 | 1601 | 29550927 |
| Dizziness | 39.73 | 18.41 | 259 | 21740 | 189425 | 29363103 |
| Urinary tract infection | 36.99 | 18.41 | 5 | 21994 | 72349 | 29480179 |
| Abdominal discomfort | 36.87 | 18.41 | 98 | 21901 | 47805 | 29504723 |
| Multiple organ dysfunction syndrome | 35.74 | 18.41 | 3 | 21996 | 63113 | 29489415 |
| Dysgeusia | 35.63 | 18.41 | 62 | 21937 | 22612 | 29529916 |
| Loss of personal independence in daily activities | 35.42 | 18.41 | 66 | 21933 | 25374 | 29527154 |
| Morbid thoughts | 34.97 | 18.41 | 11 | 21988 | 219 | 29552309 |
| Blood creatinine increased | 34.91 | 18.41 | 10 | 21989 | 85092 | 29467436 |
| Disease progression | 34.78 | 18.41 | 9 | 21990 | 81907 | 29470621 |
| Road traffic accident | 34.77 | 18.41 | 50 | 21949 | 15511 | 29537017 |
| Intentional self-injury | 33.83 | 18.41 | 44 | 21955 | 12417 | 29540111 |
| Social avoidant behaviour | 33.30 | 18.41 | 23 | 21976 | 2919 | 29549609 |
| Respiratory failure | 32.20 | 18.41 | 16 | 21983 | 97115 | 29455413 |
| Major depression | 32.13 | 18.41 | 25 | 21974 | 3810 | 29548718 |
| Dissociation | 32 | 18.41 | 16 | 21983 | 1113 | 29551415 |
| Palpitations | 31.75 | 18.41 | 73 | 21926 | 32531 | 29519997 |
| Tearfulness | 31.72 | 18.41 | 18 | 21981 | 1618 | 29550910 |
| Frustration tolerance decreased | 31.28 | 18.41 | 20 | 21979 | 2232 | 29550296 |
| Tobacco withdrawal symptoms | 31.02 | 18.41 | 5 | 21994 | 0 | 29552528 |
| Septic shock | 30.42 | 18.41 | 5 | 21994 | 62555 | 29489973 |
| Leukopenia | 30.25 | 18.41 | 3 | 21996 | 55200 | 29497328 |
| Withdrawal syndrome | 28.58 | 18.41 | 38 | 21961 | 10954 | 29541574 |
| Libido decreased | 27.59 | 18.41 | 24 | 21975 | 4274 | 29548254 |
| Anti-cyclic citrullinated peptide antibody positive | 27.32 | 18.41 | 13 | 21986 | 811 | 29551717 |
| Interstitial lung disease | 27.22 | 18.41 | 5 | 21994 | 57713 | 29494815 |
| Panic reaction | 26.94 | 18.41 | 15 | 21984 | 1300 | 29551228 |
| Feeling jittery | 26.84 | 18.41 | 22 | 21977 | 3611 | 29548917 |
| Drug screen false positive | 26.51 | 18.41 | 12 | 21987 | 668 | 29551860 |
| Disorientation | 26.47 | 18.41 | 64 | 21935 | 29451 | 29523077 |
| Cardiac failure | 26.37 | 18.41 | 13 | 21986 | 79274 | 29473254 |
| Renal impairment | 26.06 | 18.41 | 14 | 21985 | 81319 | 29471209 |
| Pleural effusion | 25.13 | 18.41 | 11 | 21988 | 71897 | 29480631 |
| Psychiatric symptom | 25.05 | 18.41 | 20 | 21979 | 3164 | 29549364 |
| Diarrhoea | 24.67 | 18.41 | 146 | 21853 | 332552 | 29219976 |
| Bradycardia | 24.64 | 18.41 | 9 | 21990 | 65620 | 29486908 |
| Mental impairment | 24.38 | 18.41 | 32 | 21967 | 9109 | 29543419 |
| Gun shot wound | 23.94 | 18.41 | 13 | 21986 | 1072 | 29551456 |
| Completed suicide | 23.81 | 18.41 | 131 | 21868 | 90115 | 29462413 |
| Loss of employment | 23.54 | 18.41 | 10 | 21989 | 477 | 29552051 |
| Infection | 23.46 | 18.41 | 14 | 21985 | 76737 | 29475791 |
| Fear | 23.40 | 18.41 | 32 | 21967 | 9472 | 29543056 |
| Hallucination, auditory | 23.17 | 18.41 | 32 | 21967 | 9561 | 29542967 |
| Drug withdrawal syndrome | 22.99 | 18.41 | 45 | 21954 | 17939 | 29534589 |
| Erectile dysfunction | 22.95 | 18.41 | 45 | 21954 | 17964 | 29534564 |
| Marital problem | 22.62 | 18.41 | 6 | 21993 | 63 | 29552465 |
| Sleep terror | 22.48 | 18.41 | 11 | 21988 | 730 | 29551798 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 22.46 | 18.41 | 11 | 21988 | 732 | 29551796 |
| Hypokalaemia | 22.31 | 18.41 | 5 | 21994 | 50198 | 29502330 |
| Hypomania | 22.29 | 18.41 | 16 | 21983 | 2159 | 29550369 |
| Hyperkalaemia | 22.08 | 18.41 | 9 | 21990 | 61383 | 29491145 |
| Pharyngeal oedema | 21.74 | 18.41 | 24 | 21975 | 5710 | 29546818 |
| Hospitalisation | 21.64 | 18.41 | 4 | 21995 | 45984 | 29506544 |
| Depression suicidal | 21.61 | 18.41 | 13 | 21986 | 1302 | 29551226 |
| Feeding disorder | 21.28 | 18.41 | 24 | 21975 | 5843 | 29546685 |
| Tinnitus | 21.10 | 18.41 | 40 | 21959 | 15574 | 29536954 |
| Personality disorder | 20.82 | 18.41 | 12 | 21987 | 1111 | 29551417 |
| Confusional state | 20.56 | 18.41 | 164 | 21835 | 127713 | 29424815 |
| Decreased interest | 20.26 | 18.41 | 15 | 21984 | 2123 | 29550405 |
| Imprisonment | 20.23 | 18.41 | 9 | 21990 | 481 | 29552047 |
| Dehydration | 20.12 | 18.41 | 34 | 21965 | 114714 | 29437814 |
| Drug abuse | 19.96 | 18.41 | 18 | 21981 | 79865 | 29472663 |
| Affect lability | 19.85 | 18.41 | 18 | 21981 | 3384 | 29549144 |
| Restlessness | 19.83 | 18.41 | 48 | 21951 | 22097 | 29530431 |
| Atrial fibrillation | 19.75 | 18.41 | 30 | 21969 | 105616 | 29446912 |
| Flight of ideas | 19.66 | 18.41 | 8 | 21991 | 342 | 29552186 |
| Cellulitis | 19.52 | 18.41 | 5 | 21994 | 45835 | 29506693 |
| Alcohol interaction | 19.20 | 18.41 | 16 | 21983 | 2687 | 29549841 |
| Loss of consciousness | 19.19 | 18.41 | 107 | 21892 | 73949 | 29478579 |
| Oxygen saturation decreased | 18.95 | 18.41 | 5 | 21994 | 44932 | 29507596 |
| Cardio-respiratory arrest | 18.89 | 18.41 | 7 | 21992 | 50594 | 29501934 |
| Poor quality sleep | 18.79 | 18.41 | 25 | 21974 | 7208 | 29545320 |
| Seizure | 18.73 | 18.41 | 126 | 21873 | 92997 | 29459531 |
| Adjustment disorder with mixed anxiety and depressed mood | 18.61 | 18.41 | 3 | 21996 | 0 | 29552528 |
| Ill-defined disorder | 18.43 | 18.41 | 32 | 21967 | 11646 | 29540882 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Abnormal dreams | 1847.60 | 15.64 | 504 | 29569 | 9852 | 64458807 |
| Depression | 1492.38 | 15.64 | 973 | 29100 | 182318 | 64286341 |
| Suicidal ideation | 1473.00 | 15.64 | 685 | 29388 | 65857 | 64402802 |
| Nightmare | 1148.82 | 15.64 | 414 | 29659 | 20579 | 64448080 |
| Anger | 577.39 | 15.64 | 232 | 29841 | 15509 | 64453150 |
| Nausea | 484.84 | 15.64 | 1100 | 28973 | 784700 | 63683959 |
| Anxiety | 454.03 | 15.64 | 514 | 29559 | 202135 | 64266524 |
| Irritability | 443.53 | 15.64 | 252 | 29821 | 36494 | 64432165 |
| Drug hypersensitivity | 441.68 | 15.64 | 548 | 29525 | 237267 | 64231392 |
| Aggression | 430.02 | 15.64 | 268 | 29805 | 45964 | 64422695 |
| Agitation | 428.76 | 15.64 | 344 | 29729 | 88023 | 64380636 |
| Insomnia | 376.88 | 15.64 | 462 | 29611 | 197374 | 64271285 |
| Mood swings | 364.28 | 15.64 | 173 | 29900 | 17295 | 64451364 |
| Feeling abnormal | 342.39 | 15.64 | 364 | 29709 | 133238 | 64335421 |
| Depressed mood | 339.66 | 15.64 | 221 | 29852 | 40791 | 64427868 |
| Abnormal behaviour | 320.38 | 15.64 | 198 | 29875 | 33424 | 64435235 |
| Mood altered | 269.64 | 15.64 | 137 | 29936 | 15842 | 64452817 |
| Crying | 256.43 | 15.64 | 143 | 29930 | 19947 | 64448712 |
| Paranoia | 229.68 | 15.64 | 124 | 29949 | 16228 | 64452431 |
| Tobacco user | 210.06 | 15.64 | 51 | 30022 | 608 | 64468051 |
| Tearfulness | 161.36 | 15.64 | 66 | 30007 | 4607 | 64464052 |
| Suicide attempt | 159.94 | 15.64 | 181 | 29892 | 70826 | 64397833 |
| Thinking abnormal | 157.73 | 15.64 | 86 | 29987 | 11470 | 64457189 |
| Vomiting | 150.90 | 15.64 | 580 | 29493 | 550537 | 63918122 |
| Psychotic disorder | 139.19 | 15.64 | 121 | 29952 | 34457 | 64434202 |
| Personality change | 128.62 | 15.64 | 68 | 30005 | 8525 | 64460134 |
| Homicidal ideation | 126.27 | 15.64 | 50 | 30023 | 3207 | 64465452 |
| Mania | 123.19 | 15.64 | 83 | 29990 | 16203 | 64452456 |
| Panic attack | 117.51 | 15.64 | 89 | 29984 | 20864 | 64447795 |
| Mental disorder | 111.42 | 15.64 | 95 | 29978 | 26350 | 64442309 |
| Off label use | 105.01 | 15.64 | 85 | 29988 | 632721 | 63835938 |
| Acute kidney injury | 103.72 | 15.64 | 40 | 30033 | 449200 | 64019459 |
| Emotional disorder | 101.98 | 15.64 | 67 | 30006 | 12540 | 64456119 |
| Amnesia | 101.84 | 15.64 | 119 | 29954 | 48150 | 64420509 |
| Anaemia | 99.23 | 15.64 | 27 | 30046 | 378653 | 64090006 |
| Suicidal behaviour | 86.98 | 15.64 | 37 | 30036 | 2850 | 64465809 |
| Pyrexia | 86.58 | 15.64 | 80 | 29993 | 558564 | 63910095 |
| Hallucination | 85.51 | 15.64 | 135 | 29938 | 72653 | 64396006 |
| Self-injurious ideation | 80.15 | 15.64 | 36 | 30037 | 3161 | 64465498 |
| Violence-related symptom | 79.65 | 15.64 | 24 | 30049 | 671 | 64467988 |
| Impaired work ability | 75.23 | 15.64 | 60 | 30013 | 15159 | 64453500 |
| Alcohol use | 73.38 | 15.64 | 38 | 30035 | 4564 | 64464095 |
| Neutropenia | 70.93 | 15.64 | 13 | 30060 | 239611 | 64229048 |
| Disturbance in attention | 70.06 | 15.64 | 91 | 29982 | 40983 | 64427676 |
| Toxicity to various agents | 69.17 | 15.64 | 42 | 30031 | 363471 | 64105188 |
| Hostility | 68.86 | 15.64 | 29 | 30044 | 2178 | 64466481 |
| Febrile neutropenia | 68.30 | 15.64 | 5 | 30068 | 187652 | 64281007 |
| Apathy | 68.08 | 15.64 | 50 | 30023 | 11182 | 64457477 |
| Sleep disorder | 67.72 | 15.64 | 109 | 29964 | 59600 | 64409059 |
| Nervousness | 67.61 | 15.64 | 76 | 29997 | 29480 | 64439179 |
| Thrombocytopenia | 62.36 | 15.64 | 14 | 30059 | 223787 | 64244872 |
| Negative thoughts | 60.94 | 15.64 | 23 | 30050 | 1295 | 64467364 |
| Bipolar disorder | 57.29 | 15.64 | 37 | 30036 | 6724 | 64461935 |
| Death | 56.65 | 15.64 | 86 | 29987 | 482619 | 63986040 |
| Pancytopenia | 54.58 | 15.64 | 3 | 30070 | 143306 | 64325353 |
| Stress | 53.55 | 15.64 | 99 | 29974 | 60435 | 64408224 |
| Affective disorder | 53.29 | 15.64 | 35 | 30038 | 6545 | 64462114 |
| Hypotension | 51.66 | 15.64 | 61 | 30012 | 380913 | 64087746 |
| Social avoidant behaviour | 51.56 | 15.64 | 30 | 30043 | 4527 | 64464132 |
| General physical health deterioration | 50.87 | 15.64 | 16 | 30057 | 204409 | 64264250 |
| Physical assault | 50.54 | 15.64 | 21 | 30052 | 1525 | 64467134 |
| Chronic obstructive pulmonary disease | 50.50 | 15.64 | 106 | 29967 | 70942 | 64397717 |
| Depression suicidal | 50.00 | 15.64 | 24 | 30049 | 2451 | 64466208 |
| Infusion related reaction | 48.48 | 15.64 | 9 | 30064 | 164458 | 64304201 |
| Blood creatinine increased | 48.32 | 15.64 | 4 | 30069 | 135778 | 64332881 |
| Somnambulism | 48.22 | 15.64 | 30 | 30043 | 5111 | 64463548 |
| Memory impairment | 47.70 | 15.64 | 116 | 29957 | 85566 | 64383093 |
| Sepsis | 46.07 | 15.64 | 25 | 30048 | 230316 | 64238343 |
| Delusion | 45.85 | 15.64 | 49 | 30024 | 17965 | 64450694 |
| Affect lability | 45.62 | 15.64 | 36 | 30037 | 8954 | 64459705 |
| Pre-existing condition improved | 45.20 | 15.64 | 28 | 30045 | 4734 | 64463925 |
| Withdrawal syndrome | 44.74 | 15.64 | 55 | 30018 | 23437 | 64445222 |
| Panic reaction | 44.22 | 15.64 | 26 | 30047 | 4001 | 64464658 |
| Major depression | 43.37 | 15.64 | 33 | 30040 | 7783 | 64460876 |
| Verbal abuse | 43.08 | 15.64 | 12 | 30061 | 252 | 64468407 |
| Flatulence | 43.04 | 15.64 | 67 | 30006 | 35599 | 64433060 |
| Urinary tract infection | 42.30 | 15.64 | 28 | 30045 | 231568 | 64237091 |
| Dizziness | 40.88 | 15.64 | 341 | 29732 | 429822 | 64038837 |
| Haemoglobin decreased | 40.74 | 15.64 | 20 | 30053 | 195043 | 64273616 |
| Screaming | 39.32 | 15.64 | 23 | 30050 | 3506 | 64465153 |
| Recalled product administered | 37.90 | 15.64 | 14 | 30059 | 742 | 64467917 |
| Alcohol interaction | 37.08 | 15.64 | 24 | 30049 | 4377 | 64464282 |
| Intentional self-injury | 37.07 | 15.64 | 56 | 30017 | 28988 | 64439671 |
| Road traffic accident | 36.05 | 15.64 | 57 | 30016 | 30688 | 64437971 |
| Platelet count decreased | 35.32 | 15.64 | 17 | 30056 | 167694 | 64300965 |
| Treatment failure | 35.27 | 15.64 | 6 | 30067 | 116810 | 64351849 |
| Fear | 34.87 | 15.64 | 45 | 30028 | 20126 | 64448533 |
| White blood cell count decreased | 34.79 | 15.64 | 15 | 30058 | 157822 | 64310837 |
| Dissociation | 34.54 | 15.64 | 20 | 30053 | 2991 | 64465668 |
| Therapeutic response unexpected | 34.32 | 15.64 | 41 | 30032 | 16960 | 64451699 |
| Palpitations | 34.30 | 15.64 | 117 | 29956 | 104371 | 64364288 |
| Infection | 34.23 | 15.64 | 22 | 30051 | 184858 | 64283801 |
| Loss of employment | 34.06 | 15.64 | 17 | 30056 | 1890 | 64466769 |
| Dysgeusia | 33.20 | 15.64 | 70 | 30003 | 46977 | 64421682 |
| Hallucination, auditory | 32.81 | 15.64 | 40 | 30033 | 16899 | 64451760 |
| Pneumonia | 32.76 | 15.64 | 142 | 29931 | 559434 | 63909225 |
| Product use in unapproved indication | 32.72 | 15.64 | 21 | 30052 | 176597 | 64292062 |
| Impaired driving ability | 31.14 | 15.64 | 22 | 30051 | 4632 | 64464027 |
| Leukopenia | 31.01 | 15.64 | 5 | 30068 | 101237 | 64367422 |
| Joint swelling | 30.77 | 15.64 | 33 | 30040 | 215349 | 64253310 |
| Post-traumatic stress disorder | 30.76 | 15.64 | 21 | 30052 | 4184 | 64464475 |
| Decreased interest | 29.99 | 15.64 | 19 | 30054 | 3341 | 64465318 |
| Hypokalaemia | 29.50 | 15.64 | 10 | 30063 | 121893 | 64346766 |
| Hypomania | 29.47 | 15.64 | 23 | 30050 | 5631 | 64463028 |
| Renal failure | 29.26 | 15.64 | 25 | 30048 | 181663 | 64286996 |
| Multiple organ dysfunction syndrome | 28.93 | 15.64 | 6 | 30067 | 101407 | 64367252 |
| Impulsive behaviour | 28.73 | 15.64 | 17 | 30056 | 2646 | 64466013 |
| Tachyphrenia | 28.51 | 15.64 | 15 | 30058 | 1861 | 64466798 |
| Seizure | 27.68 | 15.64 | 152 | 29921 | 166740 | 64301919 |
| Cardiac failure | 26.99 | 15.64 | 14 | 30059 | 132359 | 64336300 |
| Feeling of despair | 26.68 | 15.64 | 16 | 30057 | 2552 | 64466107 |
| Pleural effusion | 26.38 | 15.64 | 13 | 30060 | 126546 | 64342113 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 26.09 | 15.64 | 12 | 30061 | 1113 | 64467546 |
| Disease progression | 26.03 | 15.64 | 17 | 30056 | 141663 | 64326996 |
| Flat affect | 25.83 | 15.64 | 14 | 30059 | 1843 | 64466816 |
| Frustration tolerance decreased | 25.78 | 15.64 | 22 | 30051 | 6103 | 64462556 |
| Cardio-respiratory arrest | 25.74 | 15.64 | 7 | 30066 | 98386 | 64370273 |
| Tobacco withdrawal symptoms | 24.45 | 15.64 | 4 | 30069 | 3 | 64468656 |
| Flight of ideas | 24.40 | 15.64 | 10 | 30063 | 701 | 64467958 |
| Contraindicated product administered | 24.15 | 15.64 | 10 | 30063 | 107819 | 64360840 |
| Agoraphobia | 23.33 | 15.64 | 9 | 30064 | 538 | 64468121 |
| Psychiatric symptom | 23.33 | 15.64 | 21 | 30052 | 6252 | 64462407 |
| Hepatic enzyme increased | 23.32 | 15.64 | 16 | 30057 | 129927 | 64338732 |
| Headache | 23.28 | 15.64 | 361 | 29712 | 529106 | 63939553 |
| Hyperkalaemia | 23.27 | 15.64 | 9 | 30064 | 101120 | 64367539 |
| Arthropathy | 22.92 | 15.64 | 14 | 30059 | 120953 | 64347706 |
| Marital problem | 22.63 | 15.64 | 7 | 30066 | 214 | 64468445 |
| Arthralgia | 22.47 | 15.64 | 118 | 29955 | 442142 | 64026517 |
| Renal impairment | 22.45 | 15.64 | 18 | 30055 | 134999 | 64333660 |
| Disorientation | 22.40 | 15.64 | 67 | 30006 | 55761 | 64412898 |
| Weaning failure | 22.15 | 15.64 | 9 | 30064 | 617 | 64468042 |
| Interstitial lung disease | 21.99 | 15.64 | 9 | 30064 | 97723 | 64370936 |
| Alopecia | 21.91 | 15.64 | 27 | 30046 | 165663 | 64302996 |
| Bronchial hyperreactivity | 21.91 | 15.64 | 14 | 30059 | 2498 | 64466161 |
| Flashback | 21.33 | 15.64 | 7 | 30066 | 260 | 64468399 |
| Obsessive thoughts | 20.96 | 15.64 | 10 | 30063 | 1007 | 64467652 |
| Morbid thoughts | 20.86 | 15.64 | 9 | 30064 | 717 | 64467942 |
| Agitated depression | 20.55 | 15.64 | 7 | 30066 | 292 | 64468367 |
| Hospitalisation | 20.34 | 15.64 | 5 | 30068 | 75202 | 64393457 |
| Drug withdrawal syndrome | 20.29 | 15.64 | 45 | 30028 | 31246 | 64437413 |
| Septic shock | 20.26 | 15.64 | 12 | 30061 | 105425 | 64363234 |
| Pharyngeal oedema | 19.89 | 15.64 | 30 | 30043 | 15501 | 64453158 |
| Hypersomnia | 19.67 | 15.64 | 34 | 30039 | 19683 | 64448976 |
| Respiratory failure | 19.55 | 15.64 | 28 | 30045 | 161155 | 64307504 |
| Systemic lupus erythematosus | 19.42 | 15.64 | 6 | 30067 | 77606 | 64391053 |
| Alcohol poisoning | 19.39 | 15.64 | 16 | 30057 | 4239 | 64464420 |
| Malaise | 19.27 | 15.64 | 275 | 29798 | 395972 | 64072687 |
| Drug abuse | 19.21 | 15.64 | 20 | 30053 | 132354 | 64336305 |
| Formication | 19.06 | 15.64 | 16 | 30057 | 4341 | 64464318 |
| Euphoric mood | 18.69 | 15.64 | 19 | 30054 | 6572 | 64462087 |
| Rheumatoid arthritis | 18.52 | 15.64 | 30 | 30043 | 164264 | 64304395 |
| Nasopharyngitis | 18.40 | 15.64 | 40 | 30033 | 196033 | 64272626 |
| Energy increased | 18.36 | 15.64 | 13 | 30060 | 2745 | 64465914 |
| Bipolar I disorder | 18.31 | 15.64 | 11 | 30062 | 1760 | 64466899 |
| Dehydration | 18.13 | 15.64 | 47 | 30026 | 216716 | 64251943 |
| Sinusitis | 18.04 | 15.64 | 25 | 30048 | 145903 | 64322756 |
| Pneumonia aspiration | 17.98 | 15.64 | 3 | 30070 | 59268 | 64409391 |
| C-reactive protein increased | 17.96 | 15.64 | 11 | 30062 | 94898 | 64373761 |
| Schizophrenia | 17.89 | 15.64 | 24 | 30049 | 11144 | 64457515 |
| Libido decreased | 17.76 | 15.64 | 16 | 30057 | 4768 | 64463891 |
| Exposure during pregnancy | 17.73 | 15.64 | 7 | 30066 | 77668 | 64390991 |
| Atrial fibrillation | 17.68 | 15.64 | 33 | 30040 | 171056 | 64297603 |
| Cellulitis | 17.52 | 15.64 | 11 | 30062 | 93646 | 64375013 |
| Aspartate aminotransferase increased | 17.49 | 15.64 | 18 | 30055 | 119770 | 64348889 |
| Blood bilirubin increased | 17.27 | 15.64 | 3 | 30070 | 57550 | 64411109 |
| Feelings of worthlessness | 17.24 | 15.64 | 7 | 30066 | 479 | 64468180 |
| Pericarditis | 17.22 | 15.64 | 4 | 30069 | 62512 | 64406147 |
| Loss of personal independence in daily activities | 17.06 | 15.64 | 73 | 30000 | 72381 | 64396278 |
| Large intestine polyp | 16.92 | 15.64 | 23 | 30050 | 10814 | 64457845 |
| Pulmonary function test abnormal | 16.77 | 15.64 | 13 | 30060 | 3151 | 64465508 |
| Nicotine dependence | 16.77 | 15.64 | 8 | 30065 | 806 | 64467853 |
| Therapy non-responder | 16.66 | 15.64 | 5 | 30068 | 65894 | 64402765 |
| Depressive symptom | 16.62 | 15.64 | 15 | 30058 | 4481 | 64464178 |
| Sleep terror | 16.58 | 15.64 | 9 | 30064 | 1188 | 64467471 |
| Loss of consciousness | 16.44 | 15.64 | 122 | 29951 | 148243 | 64320416 |
| Impaired healing | 16.39 | 15.64 | 4 | 30069 | 60469 | 64408190 |
| Hepatic failure | 16.38 | 15.64 | 3 | 30070 | 55391 | 64413268 |
| Restlessness | 16.20 | 15.64 | 48 | 30025 | 39737 | 64428922 |
| Glossodynia | 16.19 | 15.64 | 5 | 30068 | 64691 | 64403968 |
| Economic problem | 16.18 | 15.64 | 11 | 30062 | 2176 | 64466483 |
| Panic disorder | 16.09 | 15.64 | 12 | 30061 | 2745 | 64465914 |
| Bradycardia | 15.91 | 15.64 | 19 | 30054 | 118200 | 64350459 |
| Drug reaction with eosinophilia and systemic symptoms | 15.89 | 15.64 | 3 | 30070 | 54214 | 64414445 |
| Plantar fasciitis | 15.85 | 15.64 | 12 | 30061 | 2808 | 64465851 |
| Oxygen saturation decreased | 15.77 | 15.64 | 16 | 30057 | 107160 | 64361499 |
| Neuropathy peripheral | 15.69 | 15.64 | 19 | 30054 | 117506 | 64351153 |
| Oedema mouth | 15.65 | 15.64 | 12 | 30061 | 2861 | 64465798 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07BA03 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS DRUGS USED IN ADDICTIVE DISORDERS Drugs used in nicotine dependence |
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.83 | Basic |
| pKa2 | 1.25 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.5MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | 6890927 | May 6, 2022 | AID TO SMOKING CESSATION |
| EQ 1MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | 6890927 | May 6, 2022 | AID TO SMOKING CESSATION |
| EQ 0.5MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | 7265119 | Aug. 3, 2022 | AID TO SMOKING CESSATION |
| EQ 1MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | 7265119 | Aug. 3, 2022 | AID TO SMOKING CESSATION |
| EQ 0.03MG BASE/SPRAY | TYRVAYA | OYSTER POINT PHARMA | N213978 | Oct. 15, 2021 | RX | SOLUTION | 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 | SOLUTION | 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 | SOLUTION | 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 | SOLUTION | 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 | SOLUTION | NASAL | 9597284 | Oct. 19, 2035 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 0.5MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | Feb. 22, 2022 | INFORMATION ADDED TO LABELING TO DESCRIBE A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN ADOLESCENT SMOKERS |
| EQ 1MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | Feb. 22, 2022 | INFORMATION ADDED TO LABELING TO DESCRIBE A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN ADOLESCENT SMOKERS |
| EQ 0.5MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | Aug. 22, 2022 | PEDIATRIC EXCLUSIVITY |
| EQ 1MG BASE | CHANTIX | PF PRISM CV | N021928 | May 10, 2006 | DISCN | TABLET | ORAL | Aug. 22, 2022 | PEDIATRIC EXCLUSIVITY |
| EQ 0.03MG BASE/SPRAY | TYRVAYA | OYSTER POINT PHARMA | N213978 | Oct. 15, 2021 | RX | SOLUTION | NASAL | Oct. 15, 2024 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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 |
| 8366 | INN_ID |
| 5459 | IUPHAR_LIGAND_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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |
| 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 | 49884-156 | 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 |
| Chantix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5674 | TABLET, FILM COATED | 1 mg | ORAL | NDA | 31 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 |
| Varenicline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60687-648 | TABLET, FILM COATED | 1 mg | ORAL | ANDA | 27 sections |
| CHANTIX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-4952 | TABLET, FILM COATED | 1 mg | ORAL | NDA | 31 sections |
| CHANTIX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-4953 | TABLET, FILM COATED | 0.50 mg | ORAL | NDA | 31 sections |
| CHANTIX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-0492 | TABLET, FILM COATED | 0.50 mg | ORAL | NDA | 30 sections |
| CHANTIX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71205-381 | TABLET, FILM COATED | 1 mg | ORAL | NDA | 30 sections |
| Tyrvaya | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73521-030 | SPRAY | 0.03 mg | NASAL | NDA | 24 sections |