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Mechanism of Action DosingDosing InformationDose AdjustmentsDrug Interactions Trial Design & EfficacyTrial DesignEfficacy Safety & TolerabilityEPIC-HR Safety DataSmPC Safety DataSupport & ResourcesFrequently Asked QuestionsEducational ResourcesHCP Experience VideosNICE Guidance

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


In accordance with the ABPI Code of Practice, the information on this page is in alignment with the current GB SmPC.

PAXLOVID Safety Profile & Tolerability (SmPC Data)1

Great Britain SmPC | Adverse reactions with Paxlovid: 

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**

*Frequencies are defined as follows: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
**Adverse Drug Reaction (ADR) identified post-marketing.

Summary of the Paxlovid Safety Profile: 
 
The most commonly occurring adverse events in the Paxlovid group within the EPIC-HR trial were:
  • Dysgeusia (5.6%)
  • Diarrhoea (3.1%)
  • Vomiting (1.1%)
  • Headache (1.4%)

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 safety of Paxlovid is based on data from EPIC-HR, a Phase 2/3 randomised, placebo-controlled trial in non-hospitalised adult participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection . A total of 2,224 symptomatic adult participants 18 years of age and older who are at high risk of developing severe COVID-19 illness received at least one dose of either Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) (n=1,109) or placebo (n=1,115). Study drugs were to be taken twice daily for up to 5 days.
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Learn more about risk reduction, viral load data and subgroup analysis from the EPIC-HR trial.

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PAXLOVID can be taken orally, at home, and patients do not need to visit a doctor's surgery or clinic for administration1
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References:
1. PAXLOVID GB Summary of Product Characteristics. Pfizer Inc.

 

 


In accordance with the ABPI Code of Practice, the information on this page is in alignment with the current NI SmPC.

PAXLOVID Safety Profile & Tolerability (SmPC Data)1Northern Ireland SmPC | Adverse reactions with Paxlovid: 
 

The safety profile of the product is based on adverse reactions reported in clinical trials and spontaneous reporting. 
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

*Frequencies are defined as follows: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
** These ADRs are also manifestations of hypersensitivity reaction.

Summary of the Paxlovid Safety Profile: 
 

The most common adverse reactions reported during treatment with Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) were:

  • Dysgeusia (4.6%)
  • Diarrhoea (3.0%)
  • Vomiting (1.2%)
  • Headache (1.2%)

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.

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Explore MoreBadge EfficacyKicker

Learn more about risk reduction, viral load data and subgroup analysis from the EPIC-HR trial.

Learn more
PAXLOVID can be taken orally, at home, and patients do not need to visit a doctor's surgery or clinic for administration1
Join us! 

Set up a PfizerPro account to access further materials and resources, and receive communication about medicines and vaccines promoted by Pfizer. 

Join now
References:
1. PAXLOVID NI Summary of Product Characteristics. Pfizer Inc.
PP-C1D-GBR-0119. January 2024

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

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