Prescribing Information for ▼PAXLOVID (nirmatrelvir / ritonavir) can be found here. Adverse event reporting information can be found at the bottom of the page.
Paxlovid has a Conditional Marketing Authorisation in the United Kingdom. A Conditional Marketing Authorisation means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed when any relevant information of significance becomes available and at least every year and the product information will be updated as necessary.
PAXLOVID Safety Profile & Tolerability
The safety profile of Paxlovid is based on data from three phase 2/3 randomized,
placebo-controlled trials in adult participants 18 years of age and older. Across the three studies, 3515 participants received a dose of Paxlovid and 2585 participants received a dose of placebo. The most common adverse reactions (≥1% incidence in the Paxlovid group and occurring at a greater frequency than in the placebo group) were dysgeusia (5.9% and 0.4%, respectively) and diarrhoea (2.9% and 1.9%, respectively).1
The safety profile of the product is based on adverse reactions reported in clinical trials or post-marketing.
| System Organ Class | Frequency category* | Adverse reactions |
|---|---|---|
| Immune system disorders | Uncommon | Hypersensitivity** |
| Rare | Anaphylaxis** | |
| Nervous system disorders | Common | Dysgeusia, headache |
| Vascular disorders | Uncommon | Hypertension** |
| Gastrointestinal disorders | Common | Diarrhoea, nausea** |
| Uncommon | Vomiting, abdominal pain** | |
| Skin and subcutaneous tissue disorders | Rare | Toxic epidermal necrolysis**, Stevens-Johnson syndrome** |
| General disorders and administration site conditions | Rare | Malaise** |
Learn more about risk reduction, viral load data and subgroup analysis from the EPIC-HR trial.
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References:
1. Pfizer Data on File excerpts from Full Clinical Study Report for EPIC-HR and Core Data Sheet, February 2024
2. PAXLOVID Summary of Product Characteristics. Pfizer Inc.
Adverse Events
Adverse Events should be reported. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-UNP-GBR-7812. January 2024.