Tetracycline

Achromycin, Helidac, Pylera, Tetracyn, Tetrex (tetracycline) is a small molecule pharmaceutical. Tetracycline was first approved as Achromycin on 1982-01-01. It is used to treat acne vulgaris, bacterial eye infections, bacterial infections, bartonella infections, and borrelia infections amongst others in the USA.

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
respiratory tract diseases	D012140
eye diseases	D005128
urogenital diseases	D000091642
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Achromycin (generic drugs available since 1982-01-01, discontinued: Actisite, Bristacycline, Cyclopar, Panmycin, Retet, Robitet, Sumycin, Tetrachel, Tetracyn, Tetramed, Tetrex, Topicycline)

Combinations

Pylera (generic drugs available since 1982-01-01, discontinued: Achromycin, Helidac, Tetracyn)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Bismuth subcitrate potassium

Metronidazole

Tetracycline hydrochloride

Tradename	Company	Number	Date	Products
PYLERA	AbbVie	N-050786 RX	2006-09-28	1 products, RLD, RS

Bismuth subsalicylate

Metronidazole

Tetracycline hydrochloride

Tradename	Company	Number	Date	Products
HELIDAC	Casper Pharma	N-050719 DISCN	1996-08-15	1 products, RLD

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Hydrocortisone

Tetracycline hydrochloride

Tradename	Company	Number	Date	Products
ACHROMYCIN	Lederle Laboratories	N-050272 DISCN	1982-01-01	1 products

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Procaine hydrochloride

Tetracycline hydrochloride

Tradename	Company	Number	Date	Products
ACHROMYCIN	Lederle Laboratories	N-050276 DISCN	1982-01-01	2 products

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Tetracycline hydrochloride

Tradename	Company	Number	Date	Products
ACHROMYCIN V	Avet Lifesciences	N-050278 RX	1982-01-01	2 products, RLD

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Tetracycline phosphate complex

Tradename	Company	Number	Date	Products
TETREX	Bristol Myers Squibb	N-050212 DISCN	1982-01-01	2 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
helidac therapy	ANDA	2020-06-17
pylera	New Drug Application	2021-12-15
tetracycline hydrochloride	ANDA	2023-05-25

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acne vulgaris	EFO_0003894	D000152	L70
bacterial eye infections	—	D015818	—
bacterial infections	—	D001424	A49
bartonella infections	EFO_0007166	D001474	A44
borrelia infections	EFO_1000842	D001899	—
bronchitis	—	D001991	J40
campylobacter infections	EFO_0007190	D002169	—
chancroid	—	D002602	A57
chlamydia infections	EFO_0007205	D002690	A74.9
cholera	—	D002771	A00

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Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

A: Alimentary tract and metabolism drugs

— A01: Stomatological preparations

— A01A: Stomatological preparations

— A01AB: Antiinfectives and antiseptics for local oral treatment

— A01AB13: Tetracycline

— A02: Drugs for acid related disorders

— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

— A02BD: Combinations for eradication of helicobacter pylori

— A02BD02: Lansoprazole, tetracycline and metronidazole

— A02BD08: Bismuth subcitrate, tetracycline and metronidazole

D: Dermatologicals

— D06: Antibiotics and chemotherapeutics for dermatological use

— D06A: Antibiotics for topical use

— D06AA: Tetracycline and derivatives, topical antibiotics

— D06AA04: Tetracycline

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01A: Tetracycline antibiotics

— J01AA: Tetracyclines

— J01AA07: Tetracycline

— J01R: Combinations of antibacterials

— J01RA: Combinations of antibacterials

— J01RA08: Tetracycline and oleandomycin

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01A: Antiinfective ophthalmologics

— S01AA: Antibiotics, ophthalmologic

— S01AA09: Tetracycline

— S02: Otologicals

— S02A: Antiinfective drugs, otologic

— S02AA: Antiinfectives

— S02AA08: Tetracycline

— S03: Ophthalmological and otological preparations

— S03A: Antiinfectives, ophthalmologic and otologic

— S03AA: Antiinfectives

— S03AA02: Tetracycline

HCPCS

Code	Description
J0120	Injection, tetracycline, up to 250 mg
J2460	Injection, oxytetracycline hcl, up to 50 mg

Clinical

Clinical Trials

84 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544		1	—	1	25	5	32
Gastritis	D005756	EFO_0000217	K29.7	1	—	—	2	1	4
Helicobacter infections	D016481	EFO_1000961		—	—	1	2	1	4
Stomach neoplasms	D013274	EFO_0003897	C16	1	—	—	2	—	3
Osteoporosis	D010024	EFO_0003882	M81.0	—	—	—	2	—	2
Helicobacter pylori	D016480	NCBITaxon_210	B96.81	—	—	—	1	1	2
Trichiasis	D058457	HP_0001128		—	—	—	1	—	1
Peptic ulcer	D010437	HP_0004398	K27	—	—	—	1	—	1
Dyspepsia	D004415	EFO_0008533	K30	—	—	—	1	—	1
Dysbiosis	D064806			—	—	—	1	—	1

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bacterial vaginosis	D016585	EFO_0003932		—	—	2	—	—	2
Trachoma	D014141		A71	—	—	1	—	—	1
Vulvovaginal candidiasis	D002181	EFO_0007543	B37.3	—	—	1	—	—	1
Candidiasis	D002177		B37	—	—	1	—	—	1
Burns	D002056		T30.0	—	1	1	—	—	1
Periodontitis	D010518	EFO_0000649	K05.3	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223		C85.9	—	2	—	—	—	2
Lung neoplasms	D008175		C34.90	—	1	—	—	—	1
Exanthema	D005076		R21	—	1	—	—	—	1
Non-hodgkin lymphoma	D008228		C85.9	—	1	—	—	—	1
Chronic periodontitis	D055113	EFO_0006343	K05.3	—	1	—	—	—	1
Hiv infections	D015658	EFO_0000764	B20	—	1	—	—	—	1
Post-lyme disease syndrome	D000077342			—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Malignant pleural effusion	D016066		J91.0	1	—	—	—	—	1
Healthy volunteers/patients	—			1	—	—	—	—	1
Chalazion	D017043	EFO_0007363	H00.1	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gingival recession	D005889		K06.0	—	—	—	—	2	2
Neoplasms	D009369		C80	—	—	—	—	1	1
Head and neck neoplasms	D006258			—	—	—	—	1	1
Dry eye syndromes	D015352		H04.12	—	—	—	—	1	1
Paronychia	D010304	EFO_0007421	L03.0	—	—	—	—	1	1
Breast neoplasms	D001943	EFO_0003869	C50	—	—	—	—	1	1
Covid-19	D000086382		U07.1	—	—	—	—	1	1
Pneumothorax	D011030		J93.11	—	—	—	—	1	1
Wound infection	D014946			—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	TETRACYCLINE
INN	tetracycline
Description	Tetracycline is a broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria. It has a role as an antimicrobial agent, an antibacterial drug, an antiprotozoal drug, a protein synthesis inhibitor and an Escherichia coli metabolite. It is a tertiary alpha-hydroxy ketone and a member of tetracyclines. It is a conjugate acid of a tetracycline(1-) and a tetracycline zwitterion.
Classification	Small molecule
Drug class	antibiotics (tetracycline derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN(C)[C@@H]1C(O)=C(C(N)=O)C(=O)[C@@]2(O)C(O)=C3C(=O)c4c(O)cccc4[C@@](C)(O)[C@H]3C[C@@H]12

Identifiers

PDB	—
CAS-ID	60-54-8
RxCUI	10395
ChEMBL ID	CHEMBL1440
ChEBI ID	27902
PubChem CID	54675776
DrugBank	DB00759
UNII ID	F8VB5M810T (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

No data

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Helidac therapy, Pylera

Adverse Events

Top Adverse Reactions

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35,815 adverse events reported

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