Hypersensitivity Reactions in Serious Adverse Events Reported for Paracetamol in the EudraVigilance Database, 2007–2018
Abstract
1. Introduction
2. Materials and Methods
3. Statistical analysis
4. Results
Population Characteristic, Presentation of Results
5. Discussion
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Adverse Event | n | % of Reports | Adverse Event | n | % of Reports |
---|---|---|---|---|---|
Angioedema | 1108 | 24.1% | Stevens-Johnson syndrome | 129 | 2.8% |
Rash | 847 | 18.5% | Anaphylactic shock | 115 | 2.5% |
Urticaria | 480 | 10.5% | Fixed eruption | 83 | 1.8% |
Orbital or periorbital oedema | 390 | 8.5% | Rash generalised | 76 | 1.7% |
Head, neck or respiratory tract oedema excluding orbital or periorbital area | 319 | 7.0% | Lip swelling | 75 | 1.6% |
Hypersensitivity; Drug hypersensitivity | 316 | 6.9% | Swelling face | 72 | 1.6% |
Eye swelling | 263 | 5.7% | Rash erythematous | 65 | 1.4% |
Anaphylactic reaction | 246 | 5.4% | Cough | 65 | 1.4% |
Erythema | 173 | 3.8% | Blister | 58 | 1.3% |
Face oedema | 163 | 3.6% | Maculo-papular rash | 53 | 1.2% |
Oedema in other than head or unspecified localisation | 97 | 2.1% |
Reaction Groups | Healthcare Professional | Non-Healthcare Professional | Not Specified/Missing | Total |
---|---|---|---|---|
Skin and subcutaneous tissue disorders | 2657 | 493 | 16 | 3166 |
Eye disorders | 532 | 116 | 2 | 650 |
Immune system disorders | 559 | 159 | 4 | 722 |
General disorders and administration site conditions | 230 | 0 | 0 | 230 |
Vascular disorders | 178 | 37 | 1 | 216 |
Respiratory, thoracic and mediastinal disorders | 172 | 53 | 0 | 225 |
Gastrointestinal disorders | 136 | 29 | 2 | 167 |
Reproductive system and breast disorders | 9 | 15 | 0 | 24 |
Ear and labyrinth disorders | 4 | 4 | 0 | 8 |
Investigations | 2 | 1 | 0 | 3 |
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Popiołek, I.; Piotrowicz-Wójcik, K.; Porebski, G. Hypersensitivity Reactions in Serious Adverse Events Reported for Paracetamol in the EudraVigilance Database, 2007–2018. Pharmacy 2019, 7, 12. https://doi.org/10.3390/pharmacy7010012
Popiołek I, Piotrowicz-Wójcik K, Porebski G. Hypersensitivity Reactions in Serious Adverse Events Reported for Paracetamol in the EudraVigilance Database, 2007–2018. Pharmacy. 2019; 7(1):12. https://doi.org/10.3390/pharmacy7010012
Chicago/Turabian StylePopiołek, Iwona, Katarzyna Piotrowicz-Wójcik, and Grzegorz Porebski. 2019. "Hypersensitivity Reactions in Serious Adverse Events Reported for Paracetamol in the EudraVigilance Database, 2007–2018" Pharmacy 7, no. 1: 12. https://doi.org/10.3390/pharmacy7010012
APA StylePopiołek, I., Piotrowicz-Wójcik, K., & Porebski, G. (2019). Hypersensitivity Reactions in Serious Adverse Events Reported for Paracetamol in the EudraVigilance Database, 2007–2018. Pharmacy, 7(1), 12. https://doi.org/10.3390/pharmacy7010012