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

Stem definition	Drug id	CAS RN
	1231	59-30-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: folic acid acifolic aspol cytofol folacid pteroylglutamic acid folate sodium	A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia. Molecular weight: 441.40 Formula: C19H19N7O6 CLOGP: -1.43 LIPINSKI: 2 HAC: 13 HDO: 6 TPSA: 207.93 ALOGS: -3.74 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

folic acid
acifolic
aspol
cytofol
folacid
pteroylglutamic acid
folate sodium

A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.

Molecular weight: 441.40
Formula: C19H19N7O6
CLOGP: -1.43
LIPINSKI: 2
HAC: 13
HDO: 6
TPSA: 207.93
ALOGS: -3.74
ROTB: 9

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.40	mg	O
10	mg	P

ADMET properties:

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Property	Value	Reference
Vd (Volume of distribution)	9.70 L/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	75 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	52 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.60 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	11.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Aug. 13, 1946	FDA	LEDERLE

FDA Adverse Event Reporting System (Female)

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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
Pemphigus	1658.51	10.07	4414	551218	179312	62754078
Systemic lupus erythematosus	1565.69	10.07	4692	550940	204226	62729164
Glossodynia	1374.54	10.07	4054	551578	174822	62758568
Hand deformity	1117.78	10.07	3500	552132	155957	62777433
Arthropathy	1026.17	10.07	4421	551211	230371	62703019
Completed suicide	1003.04	10.07	70	555562	145603	62787787
Maternal exposure during pregnancy	945.64	10.07	4123	551509	215939	62717451
Alopecia	942.15	10.07	5600	550032	331936	62601454
Abdominal discomfort	934.53	10.07	5384	550248	315501	62617889
Wound	924.78	10.07	3336	552296	159927	62773463

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FDA Adverse Event Reporting System (Male)

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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
Foetal exposure during pregnancy	681.09	10.28	968	202634	37133	34716196
Rheumatoid arthritis	518.86	10.28	855	202747	37383	34715946
Drug abuse	410.49	10.28	48	203554	99048	34654281
Toxicity to various agents	353.22	10.28	388	203214	199974	34553355
Completed suicide	314.09	10.28	91	203511	98077	34655252
Arthralgia	199.37	10.28	1680	201922	168361	34584968
Dysmorphism	193.90	10.28	155	203447	3001	34750328
Sickle cell anaemia with crisis	179.49	10.28	165	203437	3888	34749441
Psoriatic arthropathy	178.01	10.28	371	203231	19427	34733902
Atrial septal defect	173.89	10.28	215	203387	7177	34746152

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FDA Adverse Event Reporting System (Geriatric)

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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
Completed suicide	1251.38	9.71	157	579998	245610	78918623
Rheumatoid arthritis	1165.65	9.71	3750	576405	204720	78959513
Toxicity to various agents	1051.56	9.71	913	579242	420627	78743606
Arthropathy	870.10	9.71	3051	577104	174060	78990173
Pemphigus	861.02	9.71	2100	578055	97482	79066751
Systemic lupus erythematosus	858.59	9.71	2371	577784	118778	79045455
Hand deformity	833.91	9.71	2130	578025	101789	79062444
Joint swelling	821.37	9.71	4209	575946	284437	78879796
Synovitis	802.87	9.71	2668	577487	148066	79016167
Drug abuse	783.09	9.71	123	580032	162568	79001665

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FDA Adverse Event Reporting System (Pediatric)

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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
Small for dates baby	17.38	16.49	150	2722	2659	84261

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Pharmacologic Action:

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Source	Code	Description
ATC	B03AD01	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in combination with folic acid
ATC	B03AD02	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in combination with folic acid
ATC	B03AD03	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in combination with folic acid
ATC	B03AD04	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in combination with folic acid
ATC	B03AD05	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in combination with folic acid
ATC	B03AE01	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in other combinations
ATC	B03AE02	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in other combinations
ATC	B03BB01	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS VITAMIN B12 AND FOLIC ACID Folic acid and derivatives
ATC	B03BB51	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS VITAMIN B12 AND FOLIC ACID Folic acid and derivatives
ATC	V04CX02	VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Other diagnostic agents

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

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Disease	Relation	SNOMED_ID	DOID
Megaloblastic anemia due to folate deficiency	indication	85649008	DOID:14026
Vitamin deficiency	indication	85670002
Iron deficiency anemia	indication	87522002
Mineral deficiency	indication	111379007
Folic acid deficiency	indication	190633005
Pregnancy, function	indication	289908002
Breastfeeding (mother)	indication	413712001
Vitamin Deficiency Prevention	indication
Mineral Deficiency Prevention	indication
Prevention of Vitamin B12 Deficiency	indication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.46	acidic
pKa2	5.15	acidic
pKa3	12.96	acidic
pKa4	4.55	Basic
pKa5	4.15	Basic
pKa6	2.28	Basic
pKa7	1.73	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN	Ki	4.40	CHEMBL
Aldose reductase	Enzyme	P15121	ALDR_HUMAN	IC50	4.28	CHEMBL
Dihydrofolate reductase	Enzyme		DYR_ECOLI	Kd	6.09	CHEMBL
Dihydrofolate reductase	Enzyme		B0BL08_ECOLX	Kd	6.09	CHEMBL

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External reference:

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ID	Source
FA	PDB_CHEM_ID
001049	NDDF
126224002	SNOMEDCT_US
1300473	RXNORM
135398658	PUBCHEM_CID
264	MMSL
4017507	VUID
4017507	VANDF
4563	IUPHAR_LIGAND_ID
4759	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CitraNatal 90 DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0178-0821	TABLET	1 mg	ORAL	unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0178-0821	TABLET	1 mg	ORAL	unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN OTC DRUG LABEL	14	0178-0829	TABLET	1 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	1.40 mg	ORAL	unapproved drug other	15 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	1.40 mg	ORAL	unapproved drug other	15 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	1.40 mg	ORAL	unapproved drug other	15 sections
CitraNatal DHA	HUMAN OTC DRUG LABEL	14	0178-0898	TABLET	1 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0798	CAPSULE, GELATIN COATED	1 mg	ORAL	UNAPPROVED DRUG OTHER	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0799	CAPSULE, GELATIN COATED	1 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0812	CAPSULE, GELATIN COATED	1 mg	ORAL	Unapproved drug other	11 sections

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