Allergo Journal International

, Volume 24, Issue 3, pp 94–105 | Cite as

Guideline for the diagnosis of drug hypersensitivity reactions

S2K-Guideline of the German Society for Allergology and Clinical Immunology (DGAKI) and the German Dermatological Society (DDG) in collaboration with the Association of German Allergologists (AeDA), the German Society for Pediatric Allergology and Environmental Medicine (GPA), the German Contact Dermatitis Research Group (DKG), the Swiss Society for Allergy and Immunology (SGAI), the Austrian Society for Allergology and Immunology (ÖGAI), the German Academy of Allergology and Environmental Medicine (DAAU), the German Center for Documentation of Severe Skin Reactions and the German Federal Institute for Drugs and Medical Products (BfArM)
  • Knut Brockow
  • Bernhard Przybilla
  • Werner Aberer
  • Andreas J. Bircher
  • Randolf Brehler
  • Heinrich Dickel
  • Thomas Fuchs
  • Thilo Jakob
  • Lars Lange
  • Wolfgang Pfützner
  • Maja Mockenhaupt
  • Hagen Ott
  • Oliver Pfaar
  • Johannes Ring
  • Bernhardt Sachs
  • Helmut Sitter
  • Axel Trautmann
  • Regina Treudler
  • Bettina Wedi
  • Margitta Worm
  • Gerda Wurpts
  • Torsten Zuberbier
  • Hans F. Merk


Drug hypersensitivity reactions are unpredictable adverse drug reactions. They manifest either within 1–6 h following drug intake (immediate reactions) with mild to life-threatening symptoms of anaphylaxis, or several hours to days later (delayed reactions), primarily as exanthematous eruptions. It is not always possible to detect involvement of the immune system (allergy). Waiving diagnostic tests can result in severe reactions on renewed exposure on the one hand, and to unjustified treatment restrictions on the other. With this guideline, experts from various specialist societies and institutions have formulated recommendations and an algorithm for the diagnosis of allergies. The key principles of diagnosing allergic/hypersensitivity drug reactions are presented. Where possible, the objective is to perform allergy diagnostics within 4 weeks–6 months following the reaction. A clinical classification of symptoms based on the morphology and time course of the reaction is required in order to plan a diagnostic work-up. In the case of typical symptoms of a drug hypersensitivity reaction and unequivocal findings from validated skin and/or laboratory tests, a reaction can be attributed to a trigger with sufficient confidence. However, skin and laboratory tests are often negative or insufficiently reliable. In such cases, controlled provocation testing is required to clarify drug reactions. This method is reliable and safe when attention is paid to indications and contraindications and performed under appropriate medical supervision. The results of the overall assessment are discussed with the patient and documented in an „allergy passport“ in order to ensure targeted avoidance in the future and allow the use of alternative drugs where possible.

Key words

drug hypersensitivity diagnosis skin test in vitro test provocation test 



Adrenocorticotropic hormone


Acute generalized exanthematous pustulosis


Cellular antigen stimulation test


Drug reaction with eosinophilia and systemic symptoms


Epstein-Barr virus


Enzyme-Linked ImmunoSpot


European Network on Drug Allergy


Human immunodeficiency virus


Human leukocyte antigen




Not applicable or no concentration recommended


Non-steroidal anti-inflammatory drug


Specific immunoglobulin E


Stevens-Johnson syndrome


Toxic epidermal necrolysis


Adverse drug reactions


Ultraviolet radiation


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Copyright information

© Urban & Vogel 2015

Authors and Affiliations

  • Knut Brockow
    • 1
  • Bernhard Przybilla
    • 2
  • Werner Aberer
    • 3
  • Andreas J. Bircher
    • 4
  • Randolf Brehler
    • 5
  • Heinrich Dickel
    • 6
  • Thomas Fuchs
    • 7
  • Thilo Jakob
    • 8
  • Lars Lange
    • 9
  • Wolfgang Pfützner
    • 10
  • Maja Mockenhaupt
    • 11
  • Hagen Ott
    • 12
  • Oliver Pfaar
    • 13
  • Johannes Ring
    • 1
  • Bernhardt Sachs
    • 14
  • Helmut Sitter
    • 15
  • Axel Trautmann
    • 16
  • Regina Treudler
    • 17
  • Bettina Wedi
    • 18
  • Margitta Worm
    • 19
  • Gerda Wurpts
    • 20
  • Torsten Zuberbier
    • 19
  • Hans F. Merk
    • 20
  1. 1.Department of Dermatology and Allergology BiedersteinTechnical University of MunichMunichGermany
  2. 2.Department of Dermatology and Allergology, Allergy CenterLudwig Maximilian University of MunichMunichGermany
  3. 3.Department of DermatologyMedical University of GrazGrazAustria
  4. 4.Department of AllergologyUniversity Hospital BasleBasleSwitzerland
  5. 5.Department of DermatologyMünster University HospitalMünsterGermany
  6. 6.Department of Dermatology, Venereology and Allergology, St. Josef HospitalRuhr University BochumBochumGermany
  7. 7.Department of Dermatology, Venereology and AllergologyGöttingen University HospitalGöttingenGermany
  8. 8.Department of Dermatology and VenereologyFreiburg University HospitalFreiburgGermany
  9. 9.Department of PediatricsMarien Hospital BonnBonnGermany
  10. 10.Department of Dermatology and AllergologyGießen and Marburg University HospitalMarburgGermany
  11. 11.German Center for the Documentation of Severe Skin Reactions, Department of Dermatology and VenereologyFreiburg University HospitalFreiburgGermany
  12. 12.Children’s and Adolescents’ Hospital „Auf der Bult,“HannoverGermany
  13. 13.ENT at Mannheim University Hospital, Center for Rhinology and AllergologyWiesbadenGermany
  14. 14.Federal Institute for Drugs and Medicinal ProductsBonnGermany
  15. 15.Institute of Theoretical SurgeryPhilipps UniversityMarburgGermany
  16. 16.Department of Dermatology and Allergology, Mainfranken AllergyWürzburg University HospitalWürzburgGermany
  17. 17.Department of Dermatology, Venereology and AllergologyLeipzig UniversityLeipzigGermany
  18. 18.Department of Dermatology, Venereology and AllergologyHannover Medical UniversityHannoverGermany
  19. 19.Department of Dermatology, Venereology and AllergologyCharité University HospitalBerlinGermany
  20. 20.Department of Dermatology and AllergologyRTWH AachenAachenGermany

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