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PAXLOVID was well-tolerated in the EPIC-HR trial1

Comparable rates of adverse events were observed between PAXLOVID and placebo across a large, diverse trial in high-risk patients                   

 The most common adverse reactions reported during treatment with Paxlovid in the EPIC-HR trial were dysgeusia (4.6%), diarrhoea (3.0%), headache (1.2%) and vomiting (1.2%).1,2**Not serious adverse events and were resolved.1
PAXLOVID's safety profile in the EPIC-HR trial was comparable to that of placebo and it does not contain a boxed warning1,2


For more information about adverse reactions, see section 4.8 of the SmPC [here]
Reporting adverse events
Report suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in section 4.8 of the Summary of Product Characteristics [here] . 

Reporting suspected adverse reactions directly to [email protected] or contact Pfizer at 1800 633 363.
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Drug Interactions

Before prescribing PAXLOVID, identify any medicinal products your patient may be taking, as some may be contraindicated for concomitant use or may create potentially significant drug interactions. Then, easily search for drug interactions by active substance name or keywords. 

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References:
  1. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19. N Engl J Med. 2022;386(15):1397-1408.
  2. PAXLOVID Summary of Product Characteristics. https://www.medicines.ie/medicines/paxlovid-150-mg-100-mg-film-coated-tablets-35210/spc (Accessed October 2023).
 
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
 

Legal Category: S1A
Further information is available upon request

PP-PAX-IRL-0176. October 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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