Guideline for allergological diagnosis of drug hypersensitivity reactions
DGAKI · 2023 · Germany
Source and licence
- Authors
- Knut Brockow, Gerda Wurpts, Axel Trautmann et al.
- Title
- Guideline for allergological diagnosis of drug hypersensitivity reactions
- Journal
- Allergologie Select, 2023
- Licence
- CC BY 2.5
- Changes
- Verbatim excerpts; formatting adapted
Full text retrieved 2026-10-27 from Europe PMC · PMC10495942
Licence statement of the original publication
This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
This page reproduces excerpts of the original publication; the original is authoritative. It has not been reviewed by a physician, does not state a recommendation of Medelix and does not replace medical advice. The guideline may have been updated since.
Open the original publication →Full text on Europe PMC
Recommendations
Verbatim, with grade of recommendation or strength of consensus where given.
Introduction
- We recommend to clarify any suspected hypersensitivity reaction in connection with the use of medical products with the aim of identifying the trigger and, if necessary, the mechanism, assessing the risk of subsequent reactions for patients, and counseling patients in this regard (strong consensus) [2]. Failure to carry out diagnostic workup may result in a severe reaction after the drug has been taken or administered again, and may also lead to an unjustified restriction of drug therapy.
Diagnosis
- We recommend that diagnostics are put in the hands of a physician or allergology center with experience in allergology (consensus). Knowledge of drugs that frequently elicit specific hypersensitivity reactions is essential for diagnostic planning in order to be able to assess the probability with which a drug has caused a reaction. History, skin, in vitro, and provocation tests are available to identify a drug that has triggered a hypersensitivity reaction. Of utmost importance is the most accurate description and classification of the suspected clinical reaction. The diagnostic procedure must take into account the particular features of the individual case and the diagnostic possibilities.
Test procedure
- We suggest to take the reading of the test reaction after 15 – 20 minutes for the skin prick or intradermal test, and after (24 or) 48 and at least 72 hours for the patch test (consensus). In the case of exanthem, we recommend a late reading to be taken with the skin prick and intradermal test (example: clarification of an amoxicillin exanthem) (strong consensus). In case of anaphylactic symptoms and higher test risk, an open patch test with early reading after 20 – -30 minutes can be performed (example: clarification of anaphylaxis after topical application of bacitracin) (strong consensus). Note: Skin test reactions, especially with certain drugs (e.g., glucocorticoids), can also occur at a later time, sometimes even after > 1 week. Since skin test reactions can also occur after several days, we suggest to advise patients developing a positive reaction at a later time point to present again at the allergy department for an additional readingstrong consensus
Provocation tests
- We recommend to inform the test person or their legal guardian about the aim of the diagnosis, the risk, alternatives, and the test procedure including the use of placebo. Consent for provocation tests should be given in writingconsensus
- We recommend that the determination of the procedure for drug provocation testing always remains a case-by-case medical decision in which numerous factors and patient-specific characteristics (e.g., type of drug, estimated likelihood of reaction, expected severity of reaction, patient’s expectation/fear) must be consideredstrong consensus
Test procedure
- We recommend that medications and other equipment for emergency treatment is always available; staff should be familiar with treating acute emergenciesstrong consensus
Evaluation
- We recommend to evaluate the results of provocation tests using objectifiable parameters; subjective symptoms may also be included in the evaluationstrong consensus
Overall assessment
- We recommend to document the result of the overall assessment and to discuss it with the patientstrong consensus
- We suggest to indicate possible (tested) alternative substances/preparations with the maximum tolerated single and cumulative daily doseconsensus
- We recommend that allergy passports are only issued by physicians experienced in allergology (strong consensus). Medications tolerated by the patient based on medical history can be entered in the allergy passport by the physician with a corresponding note. Entries by patients themselves are not permitted.
Abstract
Not available.
Contents of the original publication
The section headings of the original.
- What’s new?
- The most important recommendations at a glance
- External appraisal and adoption
- Validity period and updating procedure
- Recommendations and consensus
- Introduction
- Definition and classification
- Diagnosis
- Medical history and clinical manifestations
- Skin tests
- Test material
- Test procedure
- Evaluation
- In vitro diagnosis
- In vitro diagnosis with drugs
- Other in vitro studies
- Provocation tests
- Test material
- Test procedure
- Evaluation
- Contraindications
- Overall assessment
- Diagnostics for special patient groups
- Children
- Pregnant women
- Elderly patients
- Chronically ill patients
- Controversies and deficits in the diagnosis of drug hypersensitivity reactions
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