cromoglicic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiallergics, cromoglicic acid derivatives | 741 | 16110-51-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.80 | g | O |
| 40 | mg | N |
| 40 | mg | Inhal.aerosol |
| 80 | mg | Inhal.powder |
| 80 | mg | Inhal.solution |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 28, 1982 | FDA | KING PHARMS |
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 |
|---|---|---|---|---|---|---|
| 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 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 |
|---|---|---|---|---|---|---|
| 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 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 |
|---|---|---|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |