Stem definition | Drug id | CAS RN |
---|---|---|
4191 | 286930-02-7 |
Dose | Unit | Route |
---|---|---|
4 | mg | O |
3.50 | mg | O |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
S (Water solubility) | 256 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.33 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Date | Agency | Company | Orphan |
---|---|---|---|
Oct. 31, 2008 | FDA | PFIZER |
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 |
---|---|---|---|---|---|---|
Dry mouth | 244.88 | 17.14 | 131 | 6852 | 64074 | 56221010 |
Urinary retention | 239.89 | 17.14 | 100 | 6883 | 27974 | 56257110 |
Brain injury | 98.63 | 17.14 | 35 | 6948 | 6320 | 56278764 |
Fall | 98.53 | 17.14 | 166 | 6817 | 357344 | 55927740 |
Urinary incontinence | 87.04 | 17.14 | 51 | 6932 | 29534 | 56255550 |
Multiple fractures | 79.33 | 17.14 | 31 | 6952 | 7310 | 56277774 |
Pulseless electrical activity | 70.08 | 17.14 | 28 | 6955 | 6996 | 56278088 |
Hypertonic bladder | 58.62 | 17.14 | 20 | 6963 | 3212 | 56281872 |
Electrocardiogram QRS complex prolonged | 55.26 | 17.14 | 22 | 6961 | 5445 | 56279639 |
Dysuria | 50.98 | 17.14 | 37 | 6946 | 30692 | 56254392 |
Gait disturbance | 44.96 | 17.14 | 76 | 6907 | 163245 | 56121839 |
Constipation | 41.72 | 17.14 | 83 | 6900 | 201860 | 56083224 |
Bradycardia | 35.81 | 17.14 | 43 | 6940 | 67461 | 56217623 |
Nocturia | 34.21 | 17.14 | 17 | 6966 | 7089 | 56277995 |
Micturition urgency | 33.60 | 17.14 | 18 | 6965 | 8763 | 56276321 |
Pollakiuria | 30.14 | 17.14 | 25 | 6958 | 25177 | 56259907 |
Dry throat | 27.68 | 17.14 | 14 | 6969 | 6060 | 56279024 |
Rheumatoid arthritis | 27.18 | 17.14 | 7 | 6976 | 382597 | 55902487 |
Loss of consciousness | 26.31 | 17.14 | 48 | 6935 | 109301 | 56175783 |
Therapeutic product effect incomplete | 26.09 | 17.14 | 47 | 6936 | 105984 | 56179100 |
Bladder spasm | 25.76 | 17.14 | 9 | 6974 | 1550 | 56283534 |
Feeling abnormal | 22.98 | 17.14 | 51 | 6932 | 133551 | 56151533 |
Overdose | 22.41 | 17.14 | 44 | 6939 | 105786 | 56179298 |
Product blister packaging issue | 22.19 | 17.14 | 5 | 6978 | 171 | 56284913 |
Vision blurred | 20.69 | 17.14 | 37 | 6946 | 82906 | 56202178 |
Multiple sclerosis relapse | 19.66 | 17.14 | 26 | 6957 | 44877 | 56240207 |
Balance disorder | 18.92 | 17.14 | 34 | 6949 | 76486 | 56208598 |
Dry eye | 17.71 | 17.14 | 22 | 6961 | 35694 | 56249390 |
Body height decreased | 17.40 | 17.14 | 12 | 6971 | 9173 | 56275911 |
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 |
---|---|---|---|---|---|---|
Urinary retention | 440.83 | 22.00 | 148 | 2578 | 33577 | 31661041 |
Dry mouth | 117.36 | 22.00 | 52 | 2674 | 24406 | 31670212 |
Dysuria | 57.58 | 22.00 | 32 | 2694 | 24262 | 31670356 |
Fall | 51.35 | 22.00 | 71 | 2655 | 186018 | 31508600 |
Hypertonic bladder | 49.81 | 22.00 | 14 | 2712 | 1716 | 31692902 |
Dementia | 36.91 | 22.00 | 19 | 2707 | 12341 | 31682277 |
Benign prostatic hyperplasia | 33.03 | 22.00 | 18 | 2708 | 13107 | 31681511 |
Cystitis interstitial | 30.09 | 22.00 | 6 | 2720 | 165 | 31694453 |
Constipation | 27.82 | 22.00 | 43 | 2683 | 123948 | 31570670 |
Pollakiuria | 25.41 | 22.00 | 17 | 2709 | 17885 | 31676733 |
Product substitution issue | 23.90 | 22.00 | 13 | 2713 | 9419 | 31685199 |
Urine flow decreased | 23.03 | 22.00 | 7 | 2719 | 1126 | 31693492 |
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 |
---|---|---|---|---|---|---|
Urinary retention | 305.19 | 16.41 | 139 | 7949 | 52381 | 70867975 |
Dry mouth | 218.72 | 16.41 | 122 | 7966 | 70335 | 70850021 |
Fall | 133.78 | 16.41 | 205 | 7883 | 443891 | 70476465 |
Hypertonic bladder | 93.52 | 16.41 | 29 | 8059 | 3754 | 70916602 |
Multiple fractures | 84.33 | 16.41 | 31 | 8057 | 6734 | 70913622 |
Brain injury | 84.03 | 16.41 | 35 | 8053 | 10582 | 70909774 |
Urinary incontinence | 67.28 | 16.41 | 46 | 8042 | 37796 | 70882560 |
Pulseless electrical activity | 61.29 | 16.41 | 30 | 8058 | 13185 | 70907171 |
Dysuria | 59.41 | 16.41 | 46 | 8042 | 45748 | 70874608 |
Gait disturbance | 49.26 | 16.41 | 81 | 8007 | 185025 | 70735331 |
Electrocardiogram QRS complex prolonged | 41.73 | 16.41 | 21 | 8067 | 9785 | 70910571 |
Micturition urgency | 33.41 | 16.41 | 19 | 8069 | 11295 | 70909061 |
Constipation | 31.76 | 16.41 | 81 | 8007 | 252357 | 70667999 |
Therapeutic product effect incomplete | 31.24 | 16.41 | 52 | 8036 | 119830 | 70800526 |
Urinary tract infection | 30.44 | 16.41 | 79 | 8009 | 248690 | 70671666 |
Nocturia | 29.49 | 16.41 | 18 | 8070 | 12186 | 70908170 |
Cystitis interstitial | 28.75 | 16.41 | 9 | 8079 | 1200 | 70919156 |
Dementia | 27.98 | 16.41 | 22 | 8066 | 22343 | 70898013 |
Benign prostatic hyperplasia | 26.77 | 16.41 | 16 | 8072 | 10427 | 70909929 |
Loss of consciousness | 25.03 | 16.41 | 55 | 8033 | 155661 | 70764695 |
Body height decreased | 22.79 | 16.41 | 13 | 8075 | 7770 | 70912586 |
Product blister packaging issue | 22.42 | 16.41 | 5 | 8083 | 178 | 70920178 |
Bradycardia | 22.31 | 16.41 | 46 | 8042 | 124569 | 70795787 |
Pollakiuria | 22.16 | 16.41 | 23 | 8065 | 33438 | 70886918 |
Urine flow decreased | 21.58 | 16.41 | 7 | 8081 | 1047 | 70919309 |
Cystitis | 20.47 | 16.41 | 26 | 8062 | 46915 | 70873441 |
Bladder spasm | 20.27 | 16.41 | 8 | 8080 | 2105 | 70918251 |
Bladder disorder | 19.45 | 16.41 | 12 | 8076 | 8277 | 70912079 |
Balance disorder | 19.45 | 16.41 | 36 | 8052 | 90092 | 70830264 |
Dizziness | 19.34 | 16.41 | 104 | 7984 | 464037 | 70456319 |
Product prescribing error | 19.29 | 16.41 | 23 | 8065 | 38929 | 70881427 |
Drug ineffective | 18.78 | 16.41 | 176 | 7912 | 939576 | 69980780 |
Colitis ischaemic | 17.88 | 16.41 | 14 | 8074 | 14123 | 70906233 |
Mental impairment | 17.45 | 16.41 | 15 | 8073 | 17240 | 70903116 |
Fine motor delay | 16.90 | 16.41 | 4 | 8084 | 186 | 70920170 |
Completed suicide | 16.47 | 16.41 | 3 | 8085 | 227132 | 70693224 |
None
Source | Code | Description |
---|---|---|
ATC | G04BD11 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence |
ATC | G04BD13 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence |
MeSH PA | D018678 | Cholinergic Agents |
MeSH PA | D018680 | Cholinergic Antagonists |
MeSH PA | D018727 | Muscarinic Antagonists |
MeSH PA | D018377 | Neurotransmitter Agents |
MeSH PA | D064804 | Urological Agents |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Urgent desire to urinate | indication | 75088002 | |
Urge incontinence of urine | indication | 87557004 | |
Bladder muscle dysfunction - overactive | indication | 236633002 | |
Increased Urinary Frequency | indication | ||
Acute nephropathy | contraindication | 58574008 | |
Hepatic failure | contraindication | 59927004 | |
Myasthenia gravis | contraindication | 91637004 | DOID:437 |
Acute constipation | contraindication | 197119006 | |
Bladder outflow obstruction | contraindication | 236645006 | |
Retention of urine | contraindication | 267064002 | |
Gastric retention | contraindication | 307227006 | |
Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
Gastrointestinal hypomotility | contraindication | 421807004 | |
Poor metabolizer due to cytochrome p450 CYP2D6 variant | contraindication | 423629005 | |
Aggravated Glaucoma | contraindication |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 9.64 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
4MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | 6858650 | July 3, 2022 | TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY |
8MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | 6858650 | July 3, 2022 | TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY |
4MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | 7807715 | June 7, 2027 | TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY |
4MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | 8088398 | June 7, 2027 | TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY |
8MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | 7807715 | June 7, 2027 | TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY |
8MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | 8088398 | June 7, 2027 | TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
4MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | June 17, 2024 | TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG |
8MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | June 17, 2024 | TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG |
4MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | Dec. 17, 2024 | PEDIATRIC EXCLUSIVITY |
8MG | TOVIAZ | PFIZER | N022030 | Oct. 31, 2008 | RX | TABLET, EXTENDED RELEASE | ORAL | Dec. 17, 2024 | PEDIATRIC EXCLUSIVITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Muscarinic acetylcholine receptor M2 | GPCR | ANTAGONIST | Ki | 6.40 | WOMBAT-PK | CHEMBL | |||
Muscarinic acetylcholine receptor M3 | GPCR | ANTAGONIST | Ki | 6.27 | WOMBAT-PK | CHEMBL | |||
Muscarinic acetylcholine receptor M1 | GPCR | Ki | 6.39 | WOMBAT-PK | |||||
Muscarinic acetylcholine receptor M4 | GPCR | Ki | 6.19 | WOMBAT-PK | |||||
Muscarinic acetylcholine receptor M5 | GPCR | Ki | 5.98 | WOMBAT-PK |
ID | Source |
---|---|
4028101 | VUID |
N0000179802 | NUI |
D07226 | KEGG_DRUG |
286930-03-8 | SECONDARY_CAS_RN |
4028101 | VANDF |
4028102 | VANDF |
C2343853 | UMLSCUI |
CHEBI:135920 | CHEBI |
CHEMBL1201764 | ChEMBL_ID |
CHEMBL1201765 | ChEMBL_ID |
DB06702 | DRUGBANK_ID |
C526675 | MESH_SUPPLEMENTAL_RECORD_UI |
7473 | IUPHAR_LIGAND_ID |
8068 | INN_ID |
621G617227 | UNII |
6918558 | PUBCHEM_CID |
DB15578 | DRUGBANK_ID |
797195 | RXNORM |
137285 | MMSL |
25992 | MMSL |
358891 | MMSL |
d07162 | MMSL |
012671 | NDDF |
012672 | NDDF |
432254002 | SNOMEDCT_US |
432255001 | SNOMEDCT_US |
441469003 | SNOMEDCT_US |
C4301611 | UMLSCUI |
CHEMBL3348932 | ChEMBL_ID |
10020 | INN_ID |
207679-81-0 | SECONDARY_CAS_RN |
9819382 | PUBCHEM_CID |
YU871O78GR | UNII |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0242 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0242 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0242 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0244 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0244 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0244 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 32 sections |
Fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-247 | TABLET, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 26 sections |
Fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-248 | TABLET, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 26 sections |
Fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-661 | TABLET, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 26 sections |
Fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-662 | TABLET, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 26 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6156 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 29 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6175 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 29 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-183 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-183 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-242 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 32 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-242 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 32 sections |
FESOTERODINE FUMARATE | Human Prescription Drug Label | 1 | 65862-766 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 27 sections |
FESOTERODINE FUMARATE | Human Prescription Drug Label | 1 | 65862-767 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 27 sections |
Fesoterodine Fumarate | Human Prescription Drug Label | 1 | 67877-064 | TABLET, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 26 sections |
Fesoterodine Fumarate | Human Prescription Drug Label | 1 | 67877-068 | TABLET, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 26 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68382-479 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 26 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68382-479 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 26 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68382-479 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 26 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68382-480 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 26 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68382-480 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 26 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68382-480 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 26 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-0242 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | NDA | 28 sections |
Toviaz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-0244 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | NDA | 28 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1168 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 1 sections |
fesoterodine fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1168 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 1 sections |