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Updated: Dec 12, 2025

Basophil Activation Test for Investigation of IgE-Mediated Mechanisms in Drug Hypersensitivity
Published on: September 16, 2011
Behind the scene: Paracetamol hypersensitivity in children
Sevgi Sipahi Cimen1, Esra Yucel1, Deniz Ozceker2
1Istanbul Faculty of Medicine, Department of Pediatrics, Division of Pediatric Allergy and Immunology, Istanbul University, Istanbul, Turkey.
Insights
Oral challenge tests (OCTs) are the gold standard for diagnosing paracetamol hypersensitivity in children. This method effectively identifies hypersensitivity, reaction types, and safe alternative medications when needed.
Area of Science:
- Pediatric Allergy and Immunology
- Pharmacology
- Drug Hypersensitivity
Background:
- Paracetamol is a widely used non-steroidal anti-inflammatory drug for fever and pain.
- Evaluating children with suspected paracetamol hypersensitivity is crucial due to its common use.
- Accurate diagnosis is essential for managing potential adverse reactions.
Purpose of the Study:
- To evaluate children with suspected paracetamol hypersensitivity.
- To confirm diagnoses using objective testing methods.
- To classify reaction types and identify safe alternative medications.
Main Methods:
- Sixty children with suspected paracetamol hypersensitivity underwent evaluation.
- Reactions were classified using established allergy network guidelines.
- Diagnosis was confirmed via skin tests and oral challenge tests (OCTs).
- OCTs with COX-1 and COX-2 inhibitors were used to classify intolerance and find alternatives.
Main Results:
- Hypersensitivity to paracetamol was confirmed in 8 out of 60 children.
- Four children were selective responders, and 3 were cross-intolerant to COX-1 inhibitors.
- Skin tests showed low positivity; OCTs were definitive.
- Safe alternative non-steroidal anti-inflammatory drugs were identified for cross-intolerant patients.
Conclusions:
- Oral challenge testing (OCT) is the gold standard for diagnosing paracetamol-induced hypersensitivity.
- OCTs are vital for classifying reaction types (selective vs. cross-intolerance).
- OCTs successfully identify safe alternative drugs for hypersensitive children.
Background:
Paracetamol, a non-steroidal anti-inflammatory drug, is commonly being used for fever and pain relief worldwide. The aim of this study was to evaluate children with a suspected history of paracetamol hypersensitivity.
Methods:
Sixty patients who were referred to our clinic in between January 2015 and December 2018 with a suspected history of paracetamol hypersensitivity were included. Reactions were classified according to the European Network for Drug Allergy (ENDA)/Global Allergy and Asthma European Network classification and European Academy of Allergy and Clinical Immunology (EAACI)/ENDA Position Paper. Diagnoses were confirmed by skin tests and oral challenge tests (OCTs). In those with verified paracetamol hypersensitivity, an OCT with a strong COX-1 inhibitor was performed to classify the type of the reaction to refer as either selective or cross-intolerance hypersensitivity. A subsequent OCT with a selective COX-2 inhibitor was performed in those cross-intolerant patients to find out a safe alternative drug.
Results:
Sixty OCTs with paracetamol were performed to patients with a median age of 8.5 years, and hypersensitivity to paracetamol was verified in 8 patients. Four children were classified as selective responders, and 3 were classified as cross-intolerant after OCT with a COX-1 inhibitor. Overall, skin test positivity for paracetamol was detected in only one patient, in whom OCT with paracetamol was negative. In all 3 cross-intolerant patients, a safe alternative non-steroidal anti-inflammatory drug was identified after an OCT with a selective COX-2 inhibitor.
Conclusion:
OCT stands as the gold-standard procedure in verifying the diagnosis of patients with paracetamol-induced drug hypersensitivity, as well as, in defining the type of reactions and finding out safe alternative drugs.
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