cromoglicic acid ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiallergics, cromoglicic acid derivatives 741 16110-51-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sodium cromoglicate
  • cromolyn sodium
  • sodium cromolyn
  • sodium cromoglycate
  • cromoglicic acid
  • cromoglycic acid
  • cromolyn
  • cromoglycate
  • cromoglicate
  • intal
  • cromolyn disodium salt
  • cromolyn disodium
  • disodium cromoglycate
A chromone complex that acts by inhibiting the release of chemical mediators from sensitized mast cells. It is used in the prophylactic treatment of both allergic and exercise-induced asthma, but does not affect an established asthmatic attack.
  • Molecular weight: 468.37
  • Formula: C23H16O11
  • CLOGP: 1.48
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 3
  • TPSA: 165.89
  • ALOGS: -4.12
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.80 g O
40 mg N
40 mg Inhal.aerosol
80 mg Inhal.powder
80 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 210 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 28.40 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
May 28, 1982 FDA KING PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Treatment failure 248.04 21.57 149 3487 198894 63286492
Mastocytosis 82.74 21.57 16 3620 570 63484816
Perfume sensitivity 77.67 21.57 16 3620 789 63484597
Anaphylactic reaction 63.06 21.57 42 3594 66058 63419328
Mast cell activation syndrome 60.10 21.57 13 3623 812 63484574
Urticaria 36.26 21.57 46 3590 165756 63319630
Skin reaction 31.84 21.57 16 3620 14833 63470553
Scratch 29.95 21.57 12 3624 6553 63478833
Conjunctivitis allergic 27.12 21.57 7 3629 935 63484451
Food allergy 23.61 21.57 12 3624 11389 63473997
Angioedema 22.49 21.57 20 3616 47945 63437441

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Treatment failure 180.34 27.65 72 1634 46625 34908600
Mast cell activation syndrome 43.92 27.65 8 1698 242 34954983
Spleen congestion 35.88 27.65 7 1699 308 34954917
Meralgia paraesthetica 33.88 27.65 6 1700 154 34955071
Penile erythema 32.98 27.65 6 1700 180 34955045
Urticaria 32.97 27.65 26 1680 62351 34892874
Nasal inflammation 30.64 27.65 6 1700 269 34954956
Anaphylactic reaction 29.96 27.65 19 1687 32282 34922943
Hypertrichosis 28.21 27.65 6 1700 407 34954818
Mouth swelling 27.96 27.65 8 1698 1848 34953377

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Mastocytosis 79.11 20.96 15 4161 527 79739685
Perfume sensitivity 77.69 20.96 16 4160 863 79739349
Urticaria 70.65 20.96 66 4110 185135 79555077
Anaphylactic reaction 55.19 20.96 41 4135 83702 79656510
Penile erythema 33.53 20.96 6 4170 152 79740060
Nasal disorder 33.44 20.96 11 4165 3758 79736454
Spleen congestion 32.83 20.96 7 4169 447 79739765
Skin reaction 31.99 20.96 16 4160 16052 79724160
Asthma 29.75 20.96 36 4140 135059 79605153
Mast cell activation syndrome 29.61 20.96 7 4169 713 79739499
Food allergy 28.31 20.96 13 4163 10811 79729401
Scratch 28.18 20.96 12 4164 8351 79731861
Swelling face 26.35 20.96 25 4151 71187 79669025
Meralgia paraesthetica 26.33 20.96 6 4170 520 79739692
Mouth swelling 24.85 20.96 10 4166 6041 79734171
Nasal inflammation 24.40 20.96 6 4170 721 79739491
Migraine 23.77 20.96 26 4150 87467 79652745
Hypersensitivity 23.47 20.96 46 4130 262193 79478019
pH body fluid increased 23.31 20.96 4 4172 79 79740133
Angioedema 23.14 20.96 24 4152 76011 79664201
Myalgia 22.26 20.96 37 4139 185604 79554608
Cardiac valve sclerosis 21.93 20.96 4 4172 113 79740099
Gastrointestinal submucosal tumour 21.48 20.96 4 4172 127 79740085
Hypertrichosis 21.03 20.96 6 4170 1276 79738936

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EB01 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Antiallergic agents, excl. corticosteroids
ATC D11AH03 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Agents for dermatitis, excluding corticosteroids
ATC R01AC01 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Antiallergic agents, excl. corticosteroids
ATC R01AC51 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Antiallergic agents, excl. corticosteroids
ATC R03AK04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03BC01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Antiallergic agents, excl. corticosteroids
ATC S01GX01 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
ATC S01GX51 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D000082142 Mast Cell Stabilizers
MeSH PA D019141 Respiratory System Agents
FDA PE N0000175628 Decreased Histamine Release
FDA EPC N0000175630 Mast Cell Stabilizer
CHEBI has role CHEBI:38215 calcium channel blockers
CHEBI has role CHEBI:49167 anti-asthmatic drugs
CHEBI has role CHEBI:88188 allergenic drug

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

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Asthma indication 195967001 DOID:2841
Giant papillary conjunctivitis indication 231857004 DOID:2457
Vernal keratoconjunctivitis indication 317349009
Vernal conjunctivitis indication 318316003 DOID:2474
Systemic mast cell disease indication 397016004 DOID:349
Asthma management indication 406162001
Allergic conjunctivitis indication 473460002 DOID:11204
Allergic Keratoconjunctivitis indication
Bronchospasm Prevention indication
Vernal Keratitis indication
Inflammatory bowel disease off-label use 24526004 DOID:0050589
Gastrointestinal food allergy off-label use 414314005
Nasal polyp contraindication 52756005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.32 acidic
pKa2 1.92 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
G-protein coupled receptor 35 GPCR Ki 5.63 CHEMBL
Taste receptor type 2 member 20 GPCR AGONIST EC50 4.35 IUPHAR
Protein S100-P Cytosolic other SCIENTIFIC LITERATURE
G protein-coupled receptor GPR35 GPCR EC50 6.01 CHEMBL
G-protein coupled receptor 35 GPCR EC50 5.32 CHEMBL

External reference:

IDSource
4018903 VUID
N0000147197 NUI
D00526 KEGG_DRUG
15826-37-6 SECONDARY_CAS_RN
151906 RXNORM
4018903 VANDF
4019696 VANDF
C0086073 UMLSCUI
CHEBI:59773 CHEBI
CHEMBL428880 ChEMBL_ID
CHEMBL74 ChEMBL_ID
DB01003 DRUGBANK_ID
7608 IUPHAR_LIGAND_ID
2882 PUBCHEM_CID
159 MMSL
2410 MMSL
2558 MMSL
4510 MMSL
d00200 MMSL
003422 NDDF
004808 NDDF
21701005 SNOMEDCT_US
372672009 SNOMEDCT_US
387221005 SNOMEDCT_US
D004205 MESH_DESCRIPTOR_UI
2427 INN_ID
Q2WXR1I0PK UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gastrocrom HUMAN PRESCRIPTION DRUG LABEL 1 0037-0678 LIQUID 20 mg ORAL NDA 19 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0172-6406 SOLUTION 20 mg INTRABRONCHIAL ANDA 22 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0172-6406 SOLUTION 20 mg INTRABRONCHIAL ANDA 22 sections
CROMOLYN SODIUM Human Prescription Drug Label 1 16571-600 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 18 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 17478-291 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 18 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 37205-223 SPRAY, METERED 5.20 mg NASAL ANDA 14 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 42571-132 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 17 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 42571-132 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 17 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 42571-350 INHALANT 20 mg INTRABRONCHIAL ANDA 21 sections
Cromolyn Sodium Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 48102-033 SOLUTION 20 mg INTRABRONCHIAL ANDA 22 sections
Cromolyn Sodium Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 48102-033 SOLUTION 20 mg INTRABRONCHIAL ANDA 22 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-1202 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 16 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-1202 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 16 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3042 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 17 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3042 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 17 sections
cromolyn sodium HUMAN PRESCRIPTION DRUG LABEL 1 51525-0470 SOLUTION 20 mg ORAL NDA authorized generic 19 sections
cromolyn sodium HUMAN PRESCRIPTION DRUG LABEL 1 51525-0470 SOLUTION 20 mg ORAL NDA authorized generic 19 sections
NasalCrom HUMAN OTC DRUG LABEL 1 52183-199 SPRAY, METERED 5.20 mg NASAL ANDA 15 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 53002-0140 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 16 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 53002-0140 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 16 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 57782-397 SPRAY, METERED 5.20 mg NASAL ANDA 15 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 57782-397 SPRAY, METERED 5.20 mg NASAL ANDA 15 sections
Cromolyn Sodium HUMAN OTC DRUG LABEL 1 59779-075 SPRAY, METERED 5.20 mg NASAL ANDA 14 sections
Cromolyn Sodium Inhalation Solution HUMAN PRESCRIPTION DRUG LABEL 1 60940-032 SOLUTION 20 mg INTRABRONCHIAL ANDA 2 sections
Cromolyn Sodium HUMAN PRESCRIPTION DRUG LABEL 1 61314-237 SOLUTION/ DROPS 40 mg OPHTHALMIC ANDA 16 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 63629-2483 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 18 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 63629-2483 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 18 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 63629-2483 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 18 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 63629-2485 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 18 sections
CROMOLYN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 63629-2485 SOLUTION, CONCENTRATE 100 mg ORAL ANDA 18 sections