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Graded Oral Amoxicillin Challenge

University Hospitals Cleveland Medical Center · FDA-approved active Small molecule

Graded Oral Amoxicillin Challenge is a Small molecule drug developed by University Hospitals Cleveland Medical Center. It is currently FDA-approved for Evaluation of reported amoxicillin or penicillin allergy, Determination of safe amoxicillin tolerance in patients with penicillin sensitivity history. Also known as: Amoxicillin Challenge.

A graded oral challenge test using amoxicillin to assess tolerance and safely diagnose or rule out amoxicillin allergy in patients with reported penicillin sensitivity.

A graded oral challenge test using amoxicillin to assess tolerance and safely diagnose or rule out amoxicillin allergy in patients with reported penicillin sensitivity. Used for Evaluation of reported amoxicillin or penicillin allergy, Determination of safe amoxicillin tolerance in patients with penicillin sensitivity history.

At a glance

Generic nameGraded Oral Amoxicillin Challenge
Also known asAmoxicillin Challenge
SponsorUniversity Hospitals Cleveland Medical Center
ModalitySmall molecule
Therapeutic areaAllergy/Immunology; Infectious Disease
PhaseFDA-approved

Mechanism of action

This is a diagnostic procedure rather than a therapeutic drug. It involves administering incrementally increasing doses of amoxicillin orally under medical supervision to evaluate whether a patient has a true IgE-mediated allergic reaction or can safely tolerate the antibiotic. The graded approach allows clinicians to identify the threshold dose at which an allergic reaction occurs, if any, enabling accurate allergy classification and guiding future antibiotic selection.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

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Frequently asked questions about Graded Oral Amoxicillin Challenge

What is Graded Oral Amoxicillin Challenge?

Graded Oral Amoxicillin Challenge is a Small molecule drug developed by University Hospitals Cleveland Medical Center, indicated for Evaluation of reported amoxicillin or penicillin allergy, Determination of safe amoxicillin tolerance in patients with penicillin sensitivity history.

How does Graded Oral Amoxicillin Challenge work?

A graded oral challenge test using amoxicillin to assess tolerance and safely diagnose or rule out amoxicillin allergy in patients with reported penicillin sensitivity.

What is Graded Oral Amoxicillin Challenge used for?

Graded Oral Amoxicillin Challenge is indicated for Evaluation of reported amoxicillin or penicillin allergy, Determination of safe amoxicillin tolerance in patients with penicillin sensitivity history.

Who makes Graded Oral Amoxicillin Challenge?

Graded Oral Amoxicillin Challenge is developed and marketed by University Hospitals Cleveland Medical Center (see full University Hospitals Cleveland Medical Center pipeline at /company/university-hospitals-cleveland-medical-center).

Is Graded Oral Amoxicillin Challenge also known as anything else?

Graded Oral Amoxicillin Challenge is also known as Amoxicillin Challenge.

What development phase is Graded Oral Amoxicillin Challenge in?

Graded Oral Amoxicillin Challenge is FDA-approved (marketed).

What are the side effects of Graded Oral Amoxicillin Challenge?

Common side effects of Graded Oral Amoxicillin Challenge include Allergic reaction (urticaria, angioedema, anaphylaxis), Gastrointestinal upset.

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