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

Stem definitionDrug idCAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives 2611 60-54-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • achromycin
  • tetracycline phosphate complex
  • tetracycline metaphosphate
  • tetracycline
  • tetracycline hydrochloride
  • tetracycline HCl
  • tetracycline phosphate
A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.
  • Molecular weight: 444.44
  • Formula: C22H24N2O8
  • CLOGP: -1.33
  • LIPINSKI: 1
  • HAC: 10
  • HDO: 6
  • TPSA: 181.62
  • ALOGS: -2.52
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 g O
1 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1.70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 58 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 74.92 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 77 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.78 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 19, 1953 FDA

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
Drug hypersensitivity 3150.64 27.71 1012 2937 309675 63175398
Urticaria 61.68 27.71 63 3886 165739 63319334
Eyelid exfoliation 58.31 27.71 10 3939 164 63484909
Skin odour abnormal 49.94 27.71 13 3936 1653 63483420
Rash 43.99 27.71 103 3846 560768 62924305
Dysphemia 43.85 27.71 13 3936 2662 63482411
Muscle tension dysphonia 43.21 27.71 8 3941 206 63484867
Wound secretion 36.88 27.71 13 3936 4601 63480472
Tuberculin test positive 36.31 27.71 12 3937 3499 63481574
Cystitis interstitial 36.16 27.71 10 3939 1598 63483475
Vaccination complication 34.39 27.71 9 3940 1168 63483905
Food intolerance 32.93 27.71 11 3938 3314 63481759
Oral pruritus 32.67 27.71 10 3939 2281 63482792
Scar 31.71 27.71 16 3933 13766 63471307
Tooth discolouration 31.18 27.71 8 3941 960 63484113
Immunisation reaction 29.34 27.71 7 3942 623 63484450
Anaphylactic reaction 27.99 27.71 27 3922 66073 63419000

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
Drug hypersensitivity 436.57 30.12 134 768 80395 34875634
Somnambulism 38.51 30.12 10 892 3062 34952967

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
Drug hypersensitivity 2337.99 25.87 766 3233 298150 79442239
Eyelid exfoliation 61.81 25.87 10 3989 142 79740247
Urticaria 57.83 25.87 58 3941 185143 79555246
Skin odour abnormal 44.72 25.87 12 3987 2129 79738260
Drug intolerance 42.65 25.87 59 3940 264060 79476329
Cystitis interstitial 39.79 25.87 10 3989 1373 79739016
Rash 38.00 25.87 87 3912 578271 79162118
Drug resistance 36.45 25.87 24 3975 42189 79698200
Tuberculin test positive 35.00 25.87 11 3988 3397 79736992
Muscle tension dysphonia 33.21 25.87 6 3993 168 79740221
Administration site bruise 32.35 25.87 6 3993 195 79740194
Wound secretion 32.19 25.87 12 3987 6176 79734213
Dysphemia 30.66 25.87 10 3989 3474 79736915
Vaccination complication 28.57 25.87 7 3992 866 79739523
Scar 27.54 25.87 14 3985 15182 79725207
Immunisation reaction 26.87 25.87 6 3993 496 79739893
Administration site swelling 26.72 25.87 6 3993 509 79739880

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AB13 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC A02BD02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD08 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC D06AA04 DERMATOLOGICALS
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
ANTIBIOTICS FOR TOPICAL USE
Tetracycline and derivatives
ATC J01AA07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
TETRACYCLINES
Tetracyclines
ATC J01RA08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AA09 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
ATC S02AA08 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA02 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
FDA CS M0021223 Tetracyclines
FDA EPC N0000175505 Tetracycline-class Antimicrobial
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011500 Protein Synthesis Inhibitors
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:35441 antiinfective agents
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:48001 protein synthesis inhibitors
CHEBI has role CHEBI:76891 alanine aminopeptidase inhibitor
CHEBI has role CHEBI:76893 carboxytripeptidase inhibitor
CHEBI has role CHEBI:35820 antiprotozoal drugs
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:76971 Escherichia coli metabolites

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

DiseaseRelationSNOMED_IDDOID
Trachoma indication 2576002 DOID:11265
Actinomycotic infection indication 11817007 DOID:8478
Gonorrhea indication 15628003 DOID:7551
Infection of skin AND/OR subcutaneous tissue indication 19824006
Gingivostomatitis indication 20607006
Acute gonococcal cervicitis indication 20943002 DOID:10615
Granuloma inguinale indication 28867007 DOID:9113
Acute gonococcal urethritis indication 29864006
Acute gonococcal epididymo-orchitis indication 30168008 DOID:10802
Bronchitis indication 32398004 DOID:6132
Neonatal conjunctivitis indication 34298002 DOID:9699
Sinusitis indication 36971009
Gonorrhea of rectum indication 42746002
Acute gonococcal endometritis indication 65295003 DOID:7527
Urinary tract infectious disease indication 68566005
Yaws indication 70647001 DOID:10371
Gonorrhea of pharynx indication 74372003
Rickettsialpox indication 75096007 DOID:11103
Ornithosis indication 75116005 DOID:11262
Brucellosis indication 75702008 DOID:11077
Syphilis indication 76272004
Acne vulgaris indication 88616000
Bacterial conjunctivitis indication 128350005 DOID:9700
Rocky Mountain spotted fever indication 186772009
Q fever indication 186788009 DOID:11100
Lymphogranuloma venereum indication 186946009 DOID:13819
Pneumonia indication 233604007 DOID:552
Inclusion conjunctivitis indication 266109000
Infective otitis media indication 312218008
Bacterial keratitis indication 314557000
Pharyngitis indication 405737000 DOID:2275
Anthrax indication 409498004 DOID:7427
Relapsing fever indication 420079008 DOID:13034
Chlamydia trachomatis infection of genital structure indication 428015005
Typhus Infections indication
Sexually Transmitted Epididymo-Orchitis indication
Female Urethral Syndrome indication
Rectal Chlamydia Trachomatis Infection indication
Inflammatory Disease of Female Pelvic Organs indication
Superficial Ocular Infection indication
Minor Bacterial Skin Infections indication
Duodenal Ulcer due to H. Pylori indication
Tularemia off-label use 19265001
Enterocolitis off-label use 43752006
Pneumonia due to Mycoplasma pneumoniae off-label use 46970008
Tropical sprue off-label use 47384003 DOID:10607
Plague off-label use 58750007 DOID:3482
Malaria off-label use 61462000 DOID:12365
Blepharoconjunctivitis off-label use 68659002 DOID:2456
Cholangitis off-label use 82403002 DOID:9446
Chlamydial infection off-label use 105629000
Infectious disease of abdomen off-label use 128070006
Ocular rosacea off-label use 200933006
Meibomianitis off-label use 309779001
Infective blepharitis off-label use 312219000
Rosacea off-label use 398909004 DOID:8881
Helicobacter pylori-associated gastritis off-label use 708164002
Chloroquine Resistant Plasmodium Falciparum Malaria off-label use
Alcoholism contraindication 7200002
Lowered convulsive threshold contraindication 19260006
Alcohol intoxication contraindication 25702006
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypovolemia contraindication 28560003
Glomerulonephritis contraindication 36171008 DOID:2921
Acute hepatitis contraindication 37871000
Hypokalemia contraindication 43339004
Uremia contraindication 44730006 DOID:4676
Stokes-Adams syndrome contraindication 46935006
Chronic heart failure contraindication 48447003
Atrial fibrillation contraindication 49436004 DOID:0060224
Sinus bradycardia contraindication 49710005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Wolff-Parkinson-White pattern contraindication 74390002 DOID:384
Decreased respiratory function contraindication 80954004
Disorder of brain contraindication 81308009 DOID:936
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Seizure disorder contraindication 128613002
Hypomagnesemia contraindication 190855004
Partial atrioventricular block contraindication 195039008
Non-infective meningitis contraindication 230155003
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Hypoxia contraindication 389086002
Pseudomembranous enterocolitis contraindication 397683000
Breastfeeding (mother) contraindication 413712001
Lidocaine Toxicity contraindication
Reduced Hepatic Blood Flow contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cattle Bacterial pneumonia Indication
Cattle Bacterial enteritis caused by Escherichia coli Indication
Cattle Bacterial enteritis caused by Salmonella spp Indication
Cats Bacterial gastroenteritis caused by Escherichia coli Indication
Cats Urinary tract infections caused by Staphylococcus species Indication
Cats Urinary Tract Infections caused by Escherichia coli Indication
Chickens Synovitis caused by Mycoplasma synoviae Indication
Chickens Air sacculitis (air-sac disease chronic respiratory disease) caused by Mycoplasma gallisepticum Indication
Chickens Chronic respiratory disease (CRD or airsac disease) caused by Escherichia coli Indication
Dogs Bacterial gastroenteritis caused by Escherichia coli Indication
Dogs Urinary tract infections caused by Staphylococcus species Indication
Dogs Urinary Tract Infections caused by Escherichia coli Indication
Swine Bacterial enteritis caused by Escherichia coli Indication
Swine Bacterial pneumonia associated with Pasteurella species Indication
Swine Bacterial pneumonia associated with Actinobacillus pleuropneumoniae Indication
Swine Bacterial pneumonia associated with Klebsiella species Indication
Turkeys Control of complicating bacterial organisms associated with bluecomb Indication
Turkeys Infectious synovitis caused by Mycoplasma synoviae Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Panmycin Tablets Zoetis Inc. 1
Albaplex 3x Tablets, Albaplex Tablets Zoetis Inc. 2
Panmycin 500 Bolus, Panmycin Hydrochloride Zoetis Inc. 1
Panmycin Aquadrops Liquid Zoetis Inc. 1
Tetrachel-Vet Drops, Tetrachel-Vet Syrup Zoetis Inc. 1
Tetrachel-Vet Tablets 100 Zoetis Inc. 1
Tetrachel-Vet Capsules 500 Zoetis Inc. 1
Delta Albaplex 3x Tablets, Delta Albaplex Tablets Zoetis Inc. 3
Albaplex Capsules Zoetis Inc. 2
Tetracycline-Vet Capsules 250 Zoetis Inc. 1
Tetracyn Ointment Zoetis Inc. 1
Tetracycline Soluble Powder Zoetis Inc. 1
Tetracycline Zoetis Inc. 1
Tet-Sol 10, Tet-Sol 324 Huvepharma EOOD 1
Polyotic Huvepharma EOOD 1
Polyotic Oblets Zoetis Inc. 1
Panmycin Capsules Zoetis Inc. 1
Tetra-Sal Zoetis Inc. 1
Polyotic Soluble Powder Concentrate Zoetis Inc. 1
TetraSure 324 Phibro Animal Health Corp. 1
SOLU-TET Zoetis Inc. 1
Tetra-Bac 324 Huvepharma EOOD 1
Tetracycline HCL Powder, Tetracycline Hydrochloride Soluble Powder-324 Quo Vademus LLC 1
Tetrasol Soluble Powder Med-Pharmex Inc. 1
TetraMed 324 HCA Bimeda Animal Health Limited 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.26 acidic
pKa2 7.44 acidic
pKa3 8.06 acidic
pKa4 11.92 acidic
pKa5 12.84 acidic
pKa6 13.45 acidic
pKa7 9.49 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
140MG;125MG;125MG BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE RICONPHARMA LLC A217511 July 3, 2023 RX CAPSULE ORAL Dec. 29, 2023 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Alpha-synuclein Transporter IC50 5.22 CHEMBL
30S ribosomal protein S4 Ribosomal protein WOMBAT-PK
30S ribosomal protein S9 Ribosomal protein WOMBAT-PK

External reference:

IDSource
4017625 VUID
N0000146005 NUI
D00201 KEGG_DRUG
1336-20-5 SECONDARY_CAS_RN
64-75-5 SECONDARY_CAS_RN
4017625 VANDF
4017626 VANDF
C0039644 UMLSCUI
CHEBI:27902 CHEBI
TAC PDB_CHEM_ID
CHEMBL1440 ChEMBL_ID
CHEMBL1201071 ChEMBL_ID
CHEMBL454950 ChEMBL_ID
D013752 MESH_DESCRIPTOR_UI
DB00759 DRUGBANK_ID
10927 IUPHAR_LIGAND_ID
298 INN_ID
F8VB5M810T UNII
54675776 PUBCHEM_CID
DB09550 DRUGBANK_ID
10395 RXNORM
2048 MMSL
5561 MMSL
6463 MMSL
d00041 MMSL
002738 NDDF
002739 NDDF
002740 NDDF
16355005 SNOMEDCT_US
372809001 SNOMEDCT_US
66261008 SNOMEDCT_US
96075004 SNOMEDCT_US
13930-32-0 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-8505 CAPSULE 250 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-2474 CAPSULE 250 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-2474 CAPSULE 250 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-2475 CAPSULE 500 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-2475 CAPSULE 500 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-590 CAPSULE 500 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16590-216 CAPSULE 250 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16590-217 CAPSULE 500 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-302 CAPSULE 250 mg ORAL ANDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-640 CAPSULE 500 mg ORAL ANDA 23 sections
tetracycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-017 CAPSULE 250 mg ORAL NDA 21 sections
tetracycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-018 CAPSULE 500 mg ORAL NDA 21 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-766 CAPSULE 250 mg ORAL ANDA 13 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-766 CAPSULE 250 mg ORAL ANDA 13 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-767 CAPSULE 500 mg ORAL ANDA 13 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-767 CAPSULE 500 mg ORAL ANDA 13 sections
Diabecline HUMAN OTC DRUG LABEL 1 24471-200 OINTMENT 30 mg TOPICAL OTC monograph final 13 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42291-798 CAPSULE 250 mg ORAL NDA 23 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42291-799 CAPSULE 500 mg ORAL NDA 23 sections
TETRA-ABC HUMAN OTC DRUG LABEL 1 43074-103 OINTMENT 0.03 mg TOPICAL OTC monograph final 24 sections
Dyabetex HUMAN OTC DRUG LABEL 1 43074-108 OINTMENT 0.03 mg TOPICAL OTC monograph final 24 sections
Diabecline HUMAN OTC DRUG LABEL 1 43074-112 OINTMENT 30 mg TOPICAL OTC monograph final 13 sections
Tetracycline-ABC HUMAN OTC DRUG LABEL 1 43074-115 OINTMENT 0.03 mg TOPICAL OTC monograph final 12 sections
Acnecycline HUMAN OTC DRUG LABEL 1 43074-116 OINTMENT 0.03 mg TOPICAL OTC monograph final 12 sections
TetraStem HUMAN OTC DRUG LABEL 1 43074-301 OINTMENT 30 mg TOPICAL OTC monograph final 13 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 47781-508 CAPSULE 250 mg ORAL ANDA 26 sections
Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 47781-509 CAPSULE 500 mg ORAL ANDA 26 sections
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 3 49884-151 CAPSULE 125 mg ORAL ANDA 27 sections
SUMYCIN HUMAN PRESCRIPTION DRUG LABEL 1 49884-732 TABLET, FILM COATED 250 mg ORAL ANDA 23 sections
SUMYCIN HUMAN PRESCRIPTION DRUG LABEL 1 49884-733 TABLET, FILM COATED 500 mg ORAL ANDA 23 sections