Amoxicillin - PharmaKB

Amoxicillin

Amoxicillin, Amoxicillin /, Amoxicillin / /, Amoxil, Augmentin, Larotid, Omeclamox-pak, Talicia, Voquezna (amoxicillin) is a small molecule pharmaceutical. Amoxicillin was first approved as Amoxil on 1982-01-01. It is used to treat actinomycosis, bacterial infections, bacterial skin diseases, chlamydia infections, and duodenal ulcer amongst others in the USA.

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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
urogenital diseases	D000091642
skin and connective tissue diseases	D017437
wounds and injuries	D014947

Trade Name

FDA

EMA

Amoxicillin, Amoxil (discontinued: Amoxicillin, Amoxil, Dispermox, Larotid, Moxatag, Polymox, Trimox, Utimox, Wymox)

Combinations

Amoxicillin clavulanate potassium, Augmentin, Lansoprazole, amoxicillin clarithromycin, Talicia, Voquezna dual, Voquezna triple (discontinued: Amoxicillin clavulanate potassium, Augmentin, Lansoprazole, amoxicillin clarithromycin, Omeclamox-pak, Prevpac)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Amoxicillin

Tradename	Company	Number	Date	Products
AMOXIL	USAntibiotics	N-050760 RX	1999-04-15	1 products, RLD

Show 8 discontinued

Amoxicillin

Clarithromycin

Lansoprazole

Tradename	Company	Number	Date	Products
PREVPAC (COPACKAGED)	Takeda	N-050757 DISCN	1997-12-02	1 products, RLD

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Amoxicillin

Omeprazole magnesium

Rifabutin

Tradename	Company	Number	Date	Products
TALICIA	RedHill Biopharma	N-213004 RX	2019-11-01	1 products, RLD, RS

Amoxicillin

Clarithromycin

Omeprazole

Tradename	Company	Number	Date	Products
OMECLAMOX-PAK	Cumberland Pharmaceuticals	N-050824 DISCN	2011-02-08	1 products, RLD

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Amoxicillin

Vonoprazan fumarate

Tradename	Company	Number	Date	Products
VOQUEZNA DUAL PAK	Phathom Pharmaceuticals	N-215153 RX	2022-05-03	1 products, RLD, RS

Amoxicillin

Clarithromycin

Vonoprazan fumarate

Tradename	Company	Number	Date	Products
VOQUEZNA TRIPLE PAK	Phathom Pharmaceuticals	N-215152 RX	2022-05-03	1 products, RLD, RS

Amoxicillin

Clavulanate potassium

Tradename	Company	Number	Date	Products
AUGMENTIN '125'	USAntibiotics	N-050575 RX	1984-08-06	1 products, RLD
AUGMENTIN '250'	USAntibiotics	N-050575 RX	1984-08-06	1 products, RLD, RS
AUGMENTIN '875'	USAntibiotics	N-050720 RX	1996-02-13	1 products, RLD
AUGMENTIN ES-600	USAntibiotics	N-050755 RX	2001-06-22	1 products, RLD

Show 9 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
amoclan		2009-01-07
amoxicillin	ANDA	2025-01-03
amoxicillin 500 mg	ANDA	2022-12-20
amoxicillin amoxicillin and clavulanate potassium	ANDA	2024-01-09
amoxicillin and clavulanate potassium	ANDA	2024-10-30
amoxicillin and clavulanate potassium extended release	New Drug Application	2011-04-07
amoxicillin clav/pot amoxicillin/clav pot	ANDA	2023-04-20
amoxicillin clavulanate potassium		2006-11-03
amoxicillin/clav pot oral susp	ANDA	2022-08-08
amoxil	ANDA	2023-01-12

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
urinary tract infections	EFO_0003103	D014552	N39.0
sinusitis	EFO_0007486	D012852	J32
otitis media	EFO_0004992	D010033	H66.9
bacterial infections	—	D001424	A49
bacterial skin diseases	—	D017192	—
soft tissue infections	—	D018461	—
chlamydia infections	EFO_0007205	D002690	A74.9
helicobacter infections	EFO_1000961	D016481	—
duodenal ulcer	EFO_0004607	D004381	K26
streptococcal infections	EFO_1001476	D013290	—

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Agency Specific

FDA

EMA

Expiration	Code
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM
2032-05-03	GAIN
2027-05-03	NCE
AMOXICILLIN / VONOPRAZAN FUMARATE, VOQUEZNA DUAL PAK, PHATHOM
2032-05-03	GAIN
2027-05-03	NCE
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL
2027-11-01	GAIN
2022-11-01	NP

Patent Expiration

Patent	Expires	Flag	FDA Information
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill
11878011	2042-05-27		U-3816
9050263	2034-02-12	DP	U-2660
9498445	2034-02-12	DP	U-2660
9603806	2034-02-12	DP	U-2660
10238606	2034-02-12	DP
11135172	2034-02-12	DP	U-2660
Amoxicillin / Clarithromycin / Vonoprazan Fumarate, Voquezna Triple Pak, Phathom
9186411	2030-08-11	DP
7977488	2028-08-11	DP
Amoxicillin, Moxatag, Pragma
8299052	2027-05-07		U-1304
8357394	2026-12-08	DP
8778924	2026-12-08	DS, DP	U-897

ATC Codes

A: Alimentary tract and metabolism drugs

— A02: Drugs for acid related disorders

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

— A02BD: Combinations for eradication of helicobacter pylori

— A02BD01: Omeprazole, amoxicillin and metronidazole

— A02BD03: Lansoprazole, amoxicillin and metronidazole

— A02BD04: Pantoprazole, amoxicillin and clarithromycin

— A02BD05: Omeprazole, amoxicillin and clarithromycin

— A02BD06: Esomeprazole, amoxicillin and clarithromycin

— A02BD07: Lansoprazole, amoxicillin and clarithromycin

— A02BD10: Lansoprazole, amoxicillin and levofloxacin

— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole

— A02BD12: Rabeprazole, amoxicillin and clarithromycin

— A02BD13: Rabeprazole, amoxicillin and metronidazole

— A02BD14: Vonoprazan, amoxicillin and clarithromycin

— A02BD15: Vonoprazan, amoxicillin and metronidazole

— A02BD16: Omeprazole, amoxicillin and rifabutin

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01C: Beta-lactam antibacterials, penicillins

— J01CA: Penicillins with extended spectrum

— J01CA04: Amoxicillin

— J01CR: Combinations of penicillins, incl. beta-lactamase inhibitors

— J01CR02: Amoxicillin and beta-lactamase inhibitor

HCPCS

Code	Description
G9313	Amoxicillin, with or without clavulanate, not prescribed as first line antibiotic at the time of diagnosis for documented reason
G9314	Amoxicillin, with or without clavulanate, not prescribed as first line antibiotic at the time of diagnosis, reason not given
G9315	Amoxicillin, with or without clavulanate, prescribed as a first line antibiotic at the time of diagnosis

Clinical

Clinical Trials

946 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	—	12	22	59	153	99	330
Helicobacter infections	D016481	EFO_1000961	—	7	15	22	62	46	142
Communicable diseases	D003141	—	—	3	7	27	55	38	125
Pneumonia	D011014	EFO_0003106	—	4	8	20	21	17	64
Gastritis	D005756	EFO_0000217	K29.7	3	3	12	32	8	56
Periodontitis	D010518	EFO_0000649	K05.3	1	5	6	12	17	38
Sinusitis	D012852	EFO_0007486	J32	—	1	7	14	8	30
Healthy volunteers/patients	—	—	—	14	1	1	3	7	26
Dyspepsia	D004415	EFO_0008533	K30	1	3	3	15	4	26
Ulcer	D014456	MPATH_579	—	—	3	6	5	5	18

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	—	3	2	—	5	10
Bacterial pneumonia	D018410	EFO_1001272	J15.9	—	3	5	—	—	6
Neutropenia	D009503	—	D70	—	—	4	—	2	6
Liver diseases	D008107	HP_0002910	K70-K77	—	4	1	—	—	5
Intraabdominal infections	D059413	—	—	—	—	5	—	—	5
Neoplasms	D009369	—	C80	1	1	3	—	1	5
Covid-19	D000086382	—	—	—	—	2	—	2	4
Malaria	D008288	EFO_0001068	B54	—	—	1	—	3	4
Kidney diseases	D007674	EFO_0003086	N08	—	—	1	—	3	4
Periodontal pocket	D010514	EFO_1001393	—	—	—	2	—	1	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pulmonary tuberculosis	D014397	EFO_1000049	A15	—	6	—	—	—	6
B-cell lymphoma marginal zone	D018442	—	C88.4	—	1	—	—	4	5
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	—	4	—	—	—	4
Fatty liver	D005234	EFO_0003934	—	—	4	—	—	—	4
Obesity	D009765	EFO_0001073	E66.9	1	1	—	—	3	4
Insulin resistance	D007333	HP_0000855	—	—	1	—	—	1	2
Colorectal neoplasms	D015179	—	—	—	1	—	—	1	2
Empyema	D004653	EFO_0003097	—	—	1	—	—	1	2
B-cell lymphoma	D016393	—	—	—	1	—	—	1	2
Tonsillectomy	D014068	—	—	1	1	—	—	1	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chemical and drug induced liver injury	D056486	EFO_0004228	—	1	—	—	—	2	3
Atrophy	D001284	—	—	1	—	—	—	2	3
Pregnancy rate	D018873	—	—	1	—	—	—	1	2
Drug interactions	D004347	—	—	2	—	—	—	—	2
Respiratory tract diseases	D012140	—	—	2	—	—	—	—	2
Respiration disorders	D012120	—	J00-J99	2	—	—	—	—	2
Bone regeneration	D001861	—	—	1	—	—	—	1	2
Jaw fractures	D007572	—	—	1	—	—	—	—	1
Gastrointestinal motility	D005769	—	—	1	—	—	—	—	1
Brain neoplasms	D001932	EFO_0003833	C71	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Kwashiorkor	D007732	EFO_1001009	E40	—	—	—	—	3	3
Gastrointestinal microbiome	D000069196	—	—	—	—	—	—	3	3
Hiv infections	D015658	EFO_0000764	B20	—	—	—	—	2	2
Bisphosphonate-associated osteonecrosis of the jaw	D059266	—	—	—	—	—	—	2	2
Arthritis	D001168	HP_0001369	M05-M14	—	—	—	—	2	2
Edentulous jaw	D007575	—	—	—	—	—	—	2	2
Renal insufficiency	D051437	HP_0000083	N19	—	—	—	—	2	2
Renal dialysis	D006435	EFO_0010690	Z99.2	—	—	—	—	2	2
Enterococcus	D016983	—	—	—	—	—	—	2	2
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Amoxicillin
INN	amoxicillin
Description	Amoxicillin is a penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group. It has a role as an antibacterial drug. It is a penicillin and a penicillin allergen. It is a conjugate acid of an amoxicillin(1-).
Classification	Small molecule
Drug class	penicillins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC1(C)S[C@@H]2[C@H](NC(=O)[C@H](N)c3ccc(O)cc3)C(=O)N2[C@H]1C(=O)O

Identifiers

PDB	—
CAS-ID	26787-78-0
RxCUI	—
ChEMBL ID	CHEMBL1082
ChEBI ID	2676
PubChem CID	33613
DrugBank	DB01060
UNII ID	9EM05410Q9 (ChemIDplus, GSRS)

Target

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Variants

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Financial

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Estimated US medical usage

Amoxicillin

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Amoxicillin

Lansoprazole

Clarithromycin

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Amoxicillin

Omeprazole

Clarithromycin

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Amoxicillin

Clavulanate

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Trends

PubMed Central

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Additional graphs summarizing 73,000 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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63,478 adverse events reported

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