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Amoxil (amoxicillin)
Broad-spectrum aminopenicillin that inhibits bacterial cell wall synthesis by binding penicillin-binding proteins.
At a glance
| Generic name | amoxicillin |
|---|---|
| Also known as | Amoxil, Trimox, Moxatag |
| Sponsor | Generic (originally Beecham/GSK) |
| Drug class | Aminopenicillin (Beta-lactam antibiotic) |
| Target | 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2B, 5-hydroxytryptamine receptor 2C |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1972-01-01 (United Kingdom) |
Mechanism of action
Amoxicillin is the most prescribed antibiotic worldwide, developed as an improved version of ampicillin with better oral absorption and broader spectrum. It inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, leading to cell lysis and death. It is the first-line antibiotic for many common infections including otitis media, sinusitis, and streptococcal pharyngitis.
Approved indications
- Acute bacterial sinusitis
- Acute exacerbation of chronic bronchitis
- Acute otitis media
- Bacterial pneumonia
- Bacterial urinary infection
- Duodenal Ulcer due to H. Pylori
- E. Coli Genitourinary Tract Infection
- Enterococcus Genitourinary Tract Infection
- Escherichia coli urinary tract infection
- Genitourinary Tract Infection due to Proteus
- Genitourinary Tract Infections
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Chronic Bronchitis
- Haemophilus Influenzae Pharyngitis
- Haemophilus Parainfluenzae Pneumonia
- Haemophilus influenzae pneumonia
- Infection caused by Helicobacter pylori
- Infection due to Escherichia coli
- Infection due to Staphylococcus aureus
- Infection of skin AND/OR subcutaneous tissue
Common side effects
- Diarrhea/loose stools
- Nausea
- Skin rashes and urticaria
- Vomiting
- Vaginitis
- Abdominal discomfort
- Flatulence
- Headache
Serious adverse events
- Anaphylactic/anaphylactoid reactions (including shock)
- Stevens-Johnson Syndrome (SJS)
- Toxic Epidermal Necrolysis (TEN)
- Pseudomembranous colitis
- Hepatitis and cholestatic jaundice
- Angioedema
- Serum sickness-like reactions
- Drug-induced enterocolitis syndrome (DIES)
- Hypersensitivity vasculitis
- DRESS syndrome
Key clinical trials
- Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy (N/A)
- Clinical Study on Bifidobacterium Quadruple Live Bacteria Tablets (Si Lian Kang) Reducing the Incidence Rate of Adverse Reactions in Helicobacter Pylori Quadruple Eradication Therapy and on the Effect (Phase 4)
- Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial (NA)
- Risk of Acute Liver Injury in Users of Antimicrobials in the HealthCore Integrated Research Database Population (N/A)
- A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacte (Phase 3)
- Personalized Treatment for Refractory H Pylori Infection (NA)
- Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact (NA)
- Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials (Phase 4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8299052 | 2027-05-07 | Method of Use |
| 8778924 | 2026-12-08 | Compound |
| 8357394 | 2026-12-08 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amoxil CI brief — competitive landscape report
- Amoxil updates RSS · CI watch RSS
- Generic (originally Beecham/GSK) portfolio CI