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

Stem definition	Drug id	CAS RN
sympathomimetics	1803	42794-76-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: midodrine monohydrochloride midodrin midodrine (+/-)-Midodrine midodrine hydrochloride midodrine HCl	An ethanolamine derivative that is an adrenergic alpha-1 agonist. It is used as a vasoconstrictor agent in the treatment of HYPOTENSION. Molecular weight: 254.29 Formula: C12H18N2O4 CLOGP: -0.35 LIPINSKI: 0 HAC: 6 HDO: 3 TPSA: 93.81 ALOGS: -1.76 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

midodrine monohydrochloride
midodrin
midodrine
(+/-)-Midodrine
midodrine hydrochloride
midodrine HCl

An ethanolamine derivative that is an adrenergic alpha-1 agonist. It is used as a vasoconstrictor agent in the treatment of HYPOTENSION.

Molecular weight: 254.29
Formula: C12H18N2O4
CLOGP: -0.35
LIPINSKI: 0
HAC: 6
HDO: 3
TPSA: 93.81
ALOGS: -1.76
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.98 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	93 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.67 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	27.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.60 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	4.45 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Sept. 6, 1996	FDA

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
Hypotension	120.37	15.25	192	11200	272412	63205218
Supine hypertension	106.10	15.25	17	11375	51	63477579
Syncope	96.58	15.25	112	11280	117273	63360357
Dizziness	69.31	15.25	201	11191	429724	63047906
Hypervolaemia	67.07	15.25	49	11343	28364	63449266
Death	59.28	15.25	174	11218	374207	63103423
Blood pressure decreased	58.44	15.25	65	11327	64957	63412673
Fall	57.09	15.25	177	11215	392157	63085473
Orthostatic hypotension	50.66	15.25	46	11346	36114	63441516
Presyncope	48.33	15.25	40	11352	27745	63449885
Pulmonary arterial hypertension	38.22	15.25	32	11360	22545	63455085
Loss of consciousness	33.74	15.25	69	11323	118052	63359578
Dialysis	31.67	15.25	21	11371	10406	63467224
Human herpesvirus 6 infection reactivation	30.32	15.25	8	11384	366	63477264
Nephrogenic systemic fibrosis	29.47	15.25	15	11377	4541	63473089
Rehabilitation therapy	29.07	15.25	11	11381	1639	63475991
Contraindicated product administered	28.41	15.25	3	11389	217645	63259985
Rheumatoid arthritis	27.45	15.25	6	11386	253813	63223817
Hospitalisation	27.06	15.25	52	11340	85029	63392601
Right ventricular failure	26.31	15.25	23	11369	17165	63460465
Endocarditis	26.19	15.25	15	11377	5735	63471895
Product dose omission issue	25.43	15.25	96	11296	234217	63243413
Hallucination	24.60	15.25	39	11353	54778	63422852
Myxoedema coma	24.55	15.25	7	11385	428	63477202
BRASH syndrome	24.03	15.25	7	11385	462	63477168
Blood pressure orthostatic decreased	23.69	15.25	5	11387	85	63477545
Arthropathy	22.62	15.25	7	11385	234785	63242845
Stoma site discharge	22.31	15.25	9	11383	1589	63476041
Fluid retention	22.15	15.25	39	11353	59647	63417983
Joint swelling	22.05	15.25	16	11376	327650	63149980
Treatment failure	20.93	15.25	5	11387	199038	63278592
Postural orthostatic tachycardia syndrome	20.58	15.25	8	11384	1281	63476349
Enanthema	20.26	15.25	6	11386	420	63477210
End stage renal disease	19.17	15.25	13	11379	6680	63470950
Dyspnoea	18.81	15.25	191	11201	661122	62816508
Discomfort	18.00	15.25	4	11388	167370	63310260
Headache	17.57	15.25	182	11210	633059	62844571
Cardiac failure congestive	17.55	15.25	46	11346	92387	63385243
Acute respiratory failure	17.53	15.25	26	11366	34459	63443171
Alopecia	17.39	15.25	21	11371	337515	63140115
Product use issue	17.28	15.25	9	11383	220511	63257119
Freezing phenomenon	17.19	15.25	7	11385	1265	63476365
Atrial flutter	16.85	15.25	14	11378	9758	63467872
Arthralgia	16.59	15.25	50	11342	569660	62907970
Skin induration	16.29	15.25	9	11383	3214	63474416
Haemangioma of spleen	15.98	15.25	3	11389	27	63477603
Cerebral mass effect	15.77	15.25	6	11386	907	63476723
Blood pressure increased	15.62	15.25	64	11328	161998	63315632
Atrial fibrillation	15.40	15.25	51	11341	116585	63361045

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
Orthostatic hypotension	157.52	16.94	98	10502	25821	34920510
Fall	136.18	16.94	230	10370	202655	34743676
Hypotension	118.95	16.94	228	10372	221421	34724910
Death	99.12	16.94	304	10296	397745	34548586
Hallucination	87.06	16.94	92	10508	51406	34894925
Dizziness	72.92	16.94	186	10414	218335	34727996
Blood pressure decreased	53.79	16.94	72	10528	51443	34894888
Troponin T increased	50.60	16.94	21	10579	2350	34943981
Supine hypertension	49.29	16.94	13	10587	346	34945985
Syncope	48.69	16.94	94	10506	91357	34854974
Loss of consciousness	44.03	16.94	85	10515	82582	34863749
Confusional state	42.16	16.94	117	10483	144043	34802288
Blood pressure fluctuation	37.20	16.94	42	10558	25207	34921124
Device dislocation	33.86	16.94	22	10578	6227	34940104
Product dose omission issue	33.83	16.94	96	10504	119615	34826716
N-terminal prohormone brain natriuretic peptide increased	32.31	16.94	16	10584	2699	34943632
Multiple system atrophy	31.49	16.94	8	10592	183	34946148
Presyncope	30.31	16.94	33	10567	19026	34927305
Toxic epidermal necrolysis	30.19	16.94	35	10565	21611	34924720
Cryptococcal meningoencephalitis	28.83	16.94	7	10593	132	34946199
Orthostatic hypertension	28.26	16.94	8	10592	279	34946052
Urinary tract infection	27.31	16.94	71	10529	84010	34862321
Hospitalisation	26.08	16.94	55	10545	56847	34889484
Cerebrovascular accident	25.90	16.94	70	10530	84741	34861590
Hallucination, visual	25.20	16.94	29	10571	17762	34928569
Burkholderia test positive	25.05	16.94	10	10590	1013	34945318
Mesenteric artery thrombosis	24.73	16.94	8	10592	441	34945890
Freezing phenomenon	24.25	16.94	11	10589	1525	34944806
Cardiac pacemaker evaluation	24.19	16.94	6	10594	124	34946207
Asthenia	23.14	16.94	140	10460	245111	34701220
Hypervolaemia	22.81	16.94	29	10571	19680	34926651
Pneumonia	20.95	16.94	184	10416	362443	34583888
Toxicity to various agents	20.95	16.94	18	10582	200344	34745987
Completed suicide	19.92	16.94	3	10597	98165	34848166
Blood pressure increased	19.58	16.94	65	10535	88037	34858294
Lactobacillus infection	19.11	16.94	6	10594	300	34946031
Feeling abnormal	19.10	16.94	52	10548	63183	34883148
Wrong patient received product	18.58	16.94	11	10589	2643	34943688
Dementia	17.14	16.94	21	10579	13727	34932604
Stoma site discharge	17.01	16.94	8	10592	1205	34945126

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
Hypotension	195.58	14.77	356	17915	439961	79286156
Death	180.87	14.77	399	17872	566115	79160002
Orthostatic hypotension	150.02	14.77	115	18156	56049	79670068
Supine hypertension	130.70	14.77	28	18243	396	79725721
Fall	128.59	14.77	319	17952	487310	79238807
Syncope	107.22	14.77	166	18105	179283	79546834
Dizziness	88.49	14.77	293	17978	526148	79199969
Hypervolaemia	85.64	14.77	74	18197	42616	79683501
Hallucination	79.31	14.77	98	18173	85647	79640470
Blood pressure decreased	67.89	14.77	98	18173	99368	79626749
Presyncope	66.30	14.77	63	18208	40991	79685126
Loss of consciousness	48.45	14.77	114	18157	167829	79558288
Hospitalisation	45.16	14.77	79	18192	94157	79631960
Troponin T increased	45.02	14.77	20	18251	3502	79722615
N-terminal prohormone brain natriuretic peptide increased	42.24	14.77	21	18250	4734	79721383
Pulmonary arterial hypertension	41.05	14.77	41	18230	28325	79697792
Product dose omission issue	37.23	14.77	133	18138	247404	79478713
Dialysis	35.00	14.77	31	18240	18431	79707686
Blood pressure orthostatic decreased	32.63	14.77	9	18262	380	79725737
Rehabilitation therapy	31.75	14.77	13	18258	1864	79724253
Freezing phenomenon	31.50	14.77	13	18258	1901	79724216
Cardiac failure congestive	31.04	14.77	87	18184	142315	79583802
Arthropathy	29.80	14.77	3	18268	177108	79549009
Rheumatoid arthritis	29.37	14.77	6	18265	208464	79517653
Arthralgia	29.31	14.77	54	18217	571749	79154368
End stage renal disease	28.25	14.77	23	18248	12197	79713920
Completed suicide	27.40	14.77	11	18260	245756	79480361
Blood pressure increased	27.15	14.77	108	18163	211252	79514865
Confusional state	27.10	14.77	144	18127	317853	79408264
Blood pressure fluctuation	26.75	14.77	52	18219	67093	79659024
Stoma site discharge	26.50	14.77	12	18259	2197	79723920
Cryptococcal meningoencephalitis	26.43	14.77	7	18264	253	79725864
Hepatic enzyme increased	26.26	14.77	5	18266	182605	79543512
Contraindicated product administered	25.66	14.77	3	18268	157535	79568582
Cardiac pacemaker evaluation	25.55	14.77	6	18265	131	79725986
Asthenia	25.34	14.77	202	18069	511487	79214630
Urinary tract infection	25.25	14.77	127	18144	274385	79451732
Human herpesvirus 6 infection reactivation	24.98	14.77	8	18263	567	79725550
Burkholderia test positive	24.85	14.77	8	18263	577	79725540
Acute respiratory failure	24.81	14.77	47	18224	59494	79666623
Fluid retention	24.17	14.77	51	18220	69758	79656359
Mesenteric artery thrombosis	24.12	14.77	8	18263	634	79725483
Right ventricular failure	23.57	14.77	28	18243	23469	79702648
Dyskinesia	23.36	14.77	39	18232	44734	79681383
Cerebrovascular accident	22.95	14.77	83	18188	155209	79570908
Device dislocation	22.90	14.77	29	18242	25941	79700176
Endocarditis	22.53	14.77	19	18252	10578	79715539
Treatment failure	21.85	14.77	6	18265	170480	79555637
Joint swelling	21.10	14.77	21	18250	288625	79437492
Feeling abnormal	20.96	14.77	82	18189	159117	79567000
Pneumonia	20.88	14.77	237	18034	660009	79066108
Chronic hepatic failure	20.51	14.77	8	18263	1011	79725106
Sepsis	20.27	14.77	118	18153	269310	79456807
Toxic epidermal necrolysis	19.58	14.77	36	18235	44545	79681572
Multiple system atrophy	19.30	14.77	6	18265	386	79725731
Dyspnoea	19.29	14.77	289	17982	856736	78869381
Myxoedema coma	19.24	14.77	7	18264	730	79725387
Hallucination, visual	19.11	14.77	30	18241	32699	79693418
Tricuspid valve disease	18.73	14.77	6	18265	426	79725691
Dementia with Lewy bodies	18.30	14.77	7	18264	839	79725278
Transfusion	17.52	14.77	23	18248	21307	79704810
Nephrogenic systemic fibrosis	17.28	14.77	13	18258	6147	79719970
Dizziness postural	17.27	14.77	17	18254	11532	79714585
BRASH syndrome	17.05	14.77	7	18264	1010	79725107
Pleural effusion	16.88	14.77	72	18199	145190	79580927
Hepatic encephalopathy	16.75	14.77	24	18247	24142	79701975
Alopecia	16.71	14.77	17	18254	231338	79494779
Metabolic encephalopathy	16.62	14.77	15	18256	9132	79716985
Malnutrition	16.56	14.77	23	18248	22479	79703638
Scleroderma	16.29	14.77	12	18259	5498	79720619
Head injury	16.19	14.77	30	18241	37339	79688778
Intermittent claudication	16.11	14.77	10	18261	3461	79722656
Disseminated cryptococcosis	15.99	14.77	8	18263	1826	79724291
Seizure like phenomena	15.86	14.77	8	18263	1859	79724258
Wrong patient received product	15.82	14.77	11	18260	4607	79721510
Intentional medical device removal by patient	15.25	14.77	5	18266	382	79725735
Failure to thrive	15.11	14.77	16	18255	11828	79714289
Hospice care	15.08	14.77	15	18256	10309	79715808
Blood pressure abnormal	14.86	14.77	19	18252	17150	79708967
Orthostatic hypertension	14.80	14.77	6	18265	839	79725278

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C01CA17	CARDIOVASCULAR SYSTEM CARDIAC THERAPY CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES Adrenergic and dopaminergic agents
FDA MoA	N0000000209	Adrenergic alpha-Agonists
FDA EPC	N0000175552	alpha-Adrenergic Agonist
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058646	Adrenergic alpha-1 Receptor Agonists
MeSH PA	D000316	Adrenergic alpha-Agonists
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D013566	Sympathomimetics
MeSH PA	D014662	Vasoconstrictor Agents
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35569	alpha-adrenergic agonists
CHEBI has role	CHEBI:50266	Prodrugs

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

Disease	Relation	SNOMED_ID	DOID
Orthostatic hypotension	indication	28651003
Acute nephropathy	contraindication	58574008
Thyrotoxicosis	contraindication	90739004	DOID:7997
Retention of urine	contraindication	267064002
Pheochromocytoma	contraindication	302835009
Organic Cardiac Disease	contraindication
Severe Autonomic Insufficiency	contraindication
Supine Hypertension	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.07	acidic
pKa2	13.77	acidic
pKa3	8.39	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN	AGONIST				WOMBAT-PK	CHEMBL
Heat shock protein HSP 90-alpha	Cytosolic other	P07900	HS90A_HUMAN		IC50	7.70		WOMBAT-PK

External reference:

ID	Source
4021003	VUID
N0000179679	NUI
D01307	KEGG_DRUG
43218-56-0	SECONDARY_CAS_RN
4021003	VANDF
4024044	VANDF
C0026078	UMLSCUI
CHEBI:6933	CHEBI
CHEMBL255027	ChEMBL_ID
CHEMBL1201212	ChEMBL_ID
CHEMBL255026	ChEMBL_ID
CHEMBL1200461	ChEMBL_ID
DB00211	DRUGBANK_ID
D008879	MESH_DESCRIPTOR_UI
4195	PUBCHEM_CID
7240	IUPHAR_LIGAND_ID
3186	INN_ID
6YE7PBM15H	UNII
6963	RXNORM
47398	MMSL
5115	MMSL
d04047	MMSL
004074	NDDF
004075	NDDF
108539003	SNOMEDCT_US
108540001	SNOMEDCT_US
372504000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
MIDODRINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-4211	TABLET	2.50 mg	ORAL	ANDA	25 sections
MIDODRINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-4222	TABLET	5 mg	ORAL	ANDA	25 sections
MIDODRINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-4233	TABLET	10 mg	ORAL	ANDA	25 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0211	TABLET	2.50 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0212	TABLET	5 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0213	TABLET	10 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1901	TABLET	2.50 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1901	TABLET	2.50 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1901	TABLET	2.50 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1902	TABLET	5 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1902	TABLET	5 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1902	TABLET	5 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1903	TABLET	10 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1903	TABLET	10 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1903	TABLET	10 mg	ORAL	ANDA	24 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8291	TABLET	5 mg	ORAL	ANDA	22 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8293	TABLET	10 mg	ORAL	ANDA	22 sections
midodrine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8358	TABLET	2.50 mg	ORAL	ANDA	22 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8382	TABLET	2.50 mg	ORAL	ANDA	21 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8382	TABLET	2.50 mg	ORAL	ANDA	21 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8383	TABLET	5 mg	ORAL	ANDA	21 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8383	TABLET	5 mg	ORAL	ANDA	21 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8384	TABLET	10 mg	ORAL	ANDA	21 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8384	TABLET	10 mg	ORAL	ANDA	21 sections
MIDODRINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8443	TABLET	2.50 mg	ORAL	ANDA	20 sections
MIDODRINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8444	TABLET	5 mg	ORAL	ANDA	20 sections
MIDODRINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8445	TABLET	10 mg	ORAL	ANDA	20 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6817	TABLET	2.50 mg	ORAL	ANDA	22 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6817	TABLET	2.50 mg	ORAL	ANDA	22 sections
Midodrine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6818	TABLET	5 mg	ORAL	ANDA	22 sections