Prescribing Information for ▼PAXLOVID (nirmatrelvir / ritonavir) can be found here: Great Britain and Northern Ireland. Adverse event reporting information can be found at the bottom of the page. Please note, there are differences between the SmPC for Northern Ireland and the SmPC for Great Britain. Please refer to the appropriate SmPC depending on where you are based.
Paxlovid has a Conditional Marketing Authorisation in Great Britain. 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.
For information tailored to where you are based, please select the appropriate tab below:
Great Britain
Northern Ireland
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.
Set up a PfizerPro account to access further materials and resources, and receive communication about medicines and vaccines promoted by Pfizer.
References:
1. Pfizer Data on File excerpts from Full Clinical Study Report for EPIC-HR and Core Data Sheet, February 2024
2. PAXLOVID GB Summary of Product Characteristics. Pfizer Inc.
| System Organ Class | Frequency category* | Adverse reactions |
|---|---|---|
| Immune system disorders | Uncommon | Hypersensitivity |
| Rare | Anaphylaxis | |
| Nervous system disorders | Common | Dysgeusia, headache |
| Gastrointestinal disorders | Common | Diarrhoea, vomiting, nausea |
| Uncommon | Abdominal pain | |
| Skin and subcutaneous tissue disorders | Uncommon | Rash** |
| Rare | Toxic epidermal necrolysis, Stevens-Johnson syndrome, Pruritus** | |
| General disorders and administration site conditions |
Rare | Malaise |
| Vascular disorders | Uncommon | Hypertension |
| Musculoskeletal and connective tissue disorders | Uncommon | Myalgia |
The most common adverse reactions reported during treatment with Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) were:
Hypersensitivity reactions:
Anaphylaxis, hypersensitivity reactions and serious skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with Paxlovid (see SmPC section 4.8).
If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue Paxlovid and initiate appropriate medications and/or supportive care.
The EPIC-HR trial (one of the clincial trials contributing to the Paxlovid Safety Profile), saw Comparable rates of adverse events between Paxlovid (22.0%) and placebo groups (24.3%).
Adverse reactions in the EPIC-HR trial (affecting at least 1% of patients):
Learn more about risk reduction, viral load data and subgroup analysis from the EPIC-HR trial.
Set up a PfizerPro account to access further materials and resources, and receive communication about medicines and vaccines promoted by Pfizer.
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