FDA EUA Letter
Authorized Use

The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.

Important Safety Information
Fact Sheets
Telehealth Resources Healthcare Professionals
Fact Sheet for Patients, Parents and Caregivers HOJA INFORMATIVA PARA PACIENTES, PADRES Y CUIDADORES FICHE D’INFORMATION POUR LES PATIENTS, LES PARENTS ET LES SOIGNANTS FOLHETO INFORMATIVO PARA DOENTES, PAIS E PRESTADORES DE CUIDADOS صحيفة الحقائق للمرضى واآلباء ومقدمي الرعاية FACT SHEET FOR HEALTHCARE PROVIDERS

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Important Safety Information Telehealth Resources Healthcare Professionals

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make PAXLOVID available for the treatment of COVID-19 in certain patients.

PAXLOVID

PAXLOVID is authorized for emergency use

  • PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.
  • The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
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What is mild-to-moderate COVID-19?

  • Mild-to-moderate COVID-19 has symptoms (such as fever, cough, sore throat, and more) that generally can be treated at home
  • These symptoms usually occur within the first few days of illness
  • Many people recover without needing special treatment, but in some people, COVID-19 becomes severe, often days into their symptoms. This is more likely if you have a high-risk factor
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What can happen with severe COVID-19?

If COVID-19 becomes severe, it can result in:

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Hospitalization and intensive care

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Needing a ventilator to receive enough oxygen

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Death

Don’t just “wait and see” if your COVID-19 will get worse

If you have a high-risk factor and mild-to-moderate COVID-19,
talk to your healthcare professional about PAXLOVID

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How does PAXLOVID work?

  • When you’re infected with the COVID-19 virus, it starts to multiply inside your nose and throat
  • PAXLOVID works to stop the virus from multiplying and reduces the amount of it in your body
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When taken within the first 5 days of symptoms,
PAXLOVID can help keep COVID-19 from becoming severe.

Keep reading to see how it worked in a clinical trial

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PAXLOVID
Clinical Trial Results

A total of 2113 people from around the world participated in the PAXLOVID clinical trial.

All people who participated:

  • Tested positive for COVID-19
  • Were unvaccinated*
  • Had mild-to-moderate symptoms for 5 days or fewer
  • Had certain high-risk factors for progression to severe COVID-19†
  • Were at least 18 years old

The study looked at whether PAXLOVID helped prevent hospitalization or death when compared to placebo.

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PAXLOVID reduced the risk of COVID-19–related hospitalization or death by

PAXLOVID reduced the risk of COVID-19–related hospitalization or death by

86 percent

In a clinical trial vs placebo, 9 out of 977 people who started treatment with PAXLOVID within 5 days of their first COVID-19 symptoms were hospitalized and none died.

For those who took a placebo, 64 out of 989 were hospitalized and 12 died (from any cause).

Studied with real-world people in mind

The study group included:

  • People from different races and ethnicities
  • A near equal number of male and female participants
  • People as young as 18 and as old as 88

Everyone studied had at least one risk factor for progression to severe COVID-19. The most common risk factors among study participants included†:

  • A body mass index (BMI) of more than 25
  • Current cigarette smoking
  • Hypertension (high blood pressure)

Additionally, 61% of people in the study had two or more high-risk factors.

*The authorized use of PAXLOVID isn’t limited to unvaccinated people, but all people who participated in the clinical trial were unvaccinated.

†Participants all had at least one of these high-risk factors: diabetes, overweight (BMI >25), chronic lung disease (including asthma), chronic kidney disease, current smoker, a disease or treatment that causes a weakened immune system, heart disease, high blood pressure, sickle cell disease, neurodevelopmental disorders, active cancer, medically related technological dependence, or were 60 years of age and older. Based on the latest guidance, some of this high-risk inclusion criteria may differ from the CDC’s list of high-risk factors (eg, the CDC defines high risk as 50+).

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It’s important to understand the possible risks and side effects before taking PAXLOVID.

Learn about PAXLOVID safety

It’s important to understand the possible risks and side effects before taking PAXLOVID.

Learn about PAXLOVID safety
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Important Safety Information

Expand

Significant Drug Interactions. PAXLOVID can interact with other medicines, causing severe or life-threatening side effects or death. Do not take PAXLOVID if you are taking any of the following medicines:

  • alfuzosin
  • amiodarone
  • apalutamide
  • carbamazepine
  • colchicine
  • dihydroergotamine
  • dronedarone
  • eletriptan
  • eplerenone
  • ergotamine
  • finerenone
  • flecainide
  • flibanserin
  • ivabradine
  • lomitapide
  • lovastatin
  • lumacaftor/ivacaftor
  • lurasidone
  • methylergonovine
  • midazolam (oral)
  • naloxegol
  • phenobarbital
  • phenytoin
  • pimozide
  • primidone
  • propafenone
  • quinidine
  • ranolazine
  • rifampin
  • rifapentine
  • St. John’s Wort (hypericum perforatum)
  • sildenafil (Revatio®) for pulmonary arterial hypertension
  • silodosin
  • simvastatin
  • tolvaptan
  • triazolam
  • ubrogepant
  • voclosporin

These are not the only medicines that may cause serious or life-threatening side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of other medicines. It is very important to tell your healthcare professional about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with PAXLOVID. Your healthcare professional may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines. Do not start taking a new medicine without telling your healthcare professional.

Before taking PAXLOVID, tell your healthcare professional about all your medical conditions, including if you:

  • have kidney or liver problems, including hepatitis.
  • have Human Immunodeficiency Virus 1 (HIV-1) infection. PAXLOVID may lead to some
    HIV-1 medicines not working as well in the future.
  • are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.

Tell your healthcare professional if you are taking combined hormonal contraceptive (birth control). PAXLOVID may affect how your birth control works. People who can become pregnant should use another or an alternative effective form of birth control.

PAXLOVID may cause serious side effects, including:

  • Allergic reactions, including severe allergic reactions (anaphylaxis). Do not take PAXLOVID if you are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID. Stop taking PAXLOVID and call your healthcare professional right away if you get any of the following symptoms of an allergic reaction:

    • skin rash, hives, blisters, or peeling skin
    • painful sores or ulcers in the mouth, nose, throat, or genital area
    • trouble swallowing or breathing
    • swelling of the mouth, lips, tongue, or face
    • hoarseness
    • throat tightness

  • Liver problems. Tell your healthcare professional right away if you have any of the following signs and symptoms of liver problems during treatment with PAXLOVID:

    • loss of appetite
    • yellowing of your skin and the whites of your eyes
    • dark-colored urine
    • pale-colored stools
    • itchy skin
    • stomach-area (abdominal) pain

The most common side effects of PAXLOVID include: altered sense of taste and diarrhea.

Other possible side effects include:

  • headache
  • abdominal pain
  • vomiting
  • high blood pressure
  • nausea
  • feeling generally unwell

These are not all the possible side effects of PAXLOVID. For more information, ask your
healthcare professional or pharmacist.



There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID.
For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk
from the treatment. It is recommended that you use effective barrier contraception or do not
have sexual activity while taking PAXLOVID. If you are pregnant or breastfeeding, discuss
your options and specific situation with your healthcare professional.



Take PAXLOVID exactly as your healthcare professional tells you. If you take too much PAXLOVID, call your healthcare professional or go to the nearest hospital emergency room right away. If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or HIV-1 infection, you should continue to take your medicine as prescribed.



Talk to your healthcare professional if you do not feel better or if you feel worse after 5 days.

Contact your healthcare professional if you have any side effects that bother you or do not
go away. Report side effects or problems with the appearance or packaging of PAXLOVID to
FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088, or you can report side
effects to Pfizer Inc. at www.pfizersafetyreporting.com, by fax at 1-866-635-83371-866-635-8337, or by
calling 1-800-438-19851-800-438-1985.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

AUTHORIZED USE

The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

AUTHORIZED USE

The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

Important Safety Information

Significant Drug Interactions. PAXLOVID can interact with other medicines, causing severe or life-threatening side effects or death. Do not take PAXLOVID if you are taking any of the following medicines:

  • alfuzosin
  • amiodarone
  • apalutamide
  • carbamazepine
  • colchicine
  • dihydroergotamine
  • dronedarone
  • eletriptan
  • eplerenone
  • ergotamine
  • finerenone
  • flecainide
  • flibanserin
  • ivabradine
  • lomitapide
  • lovastatin
  • lumacaftor/ivacaftor
  • lurasidone
  • methylergonovine
  • midazolam (oral)
  • naloxegol
  • phenobarbital
  • phenytoin
  • pimozide
  • primidone
  • propafenone
  • quinidine
  • ranolazine
  • rifampin
  • rifapentine
  • St. John’s Wort (hypericum perforatum)
  • sildenafil (Revatio®) for pulmonary arterial hypertension
  • silodosin
  • simvastatin
  • tolvaptan
  • triazolam
  • ubrogepant
  • voclosporin

These are not the only medicines that may cause serious or life-threatening side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of other medicines. It is very important to tell your healthcare professional about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with PAXLOVID. Your healthcare professional may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines. Do not start taking a new medicine without telling your healthcare professional.

Before taking PAXLOVID, tell your healthcare professional about all your medical conditions, including if you:

  • have kidney or liver problems, including hepatitis.
  • have Human Immunodeficiency Virus 1 (HIV-1) infection. PAXLOVID may lead to some HIV-1 medicines not working as well in the future.
  • are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.

Tell your healthcare professional if you are taking combined hormonal contraceptive (birth control). PAXLOVID may affect how your birth control works. People who can become pregnant should use another or an alternative effective form of birth control.

PAXLOVID may cause serious side effects, including:

  • Allergic reactions, including severe allergic reactions (anaphylaxis). Do not take PAXLOVID if you are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID. Stop taking PAXLOVID and call your healthcare professional right away if you get any of the following symptoms of an allergic reaction:

    • skin rash, hives, blisters, or peeling skin
    • painful sores or ulcers in the mouth, nose, throat, or genital area
    • trouble swallowing or breathing
    • swelling of the mouth, lips, tongue, or face
    • hoarseness
    • throat tightness

  • Liver problems. Tell your healthcare professional right away if you have any of the following signs and symptoms of liver problems during treatment with PAXLOVID:

    • loss of appetite
    • yellowing of your skin and the whites of your eyes
    • dark-colored urine
    • pale-colored stools
    • itchy skin
    • stomach-area (abdominal) pain

The most common side effects of PAXLOVID include: altered sense of taste and diarrhea.

Other possible side effects include:

  • headache
  • abdominal pain
  • vomiting
  • high blood pressure
  • nausea
  • feeling generally unwell

These are not all the possible side effects of PAXLOVID. For more information, ask your
healthcare professional or pharmacist.



There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID. For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk from the treatment. It is recommended that you use effective barrier contraception or do not have sexual activity while taking PAXLOVID. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare professional.



Take PAXLOVID exactly as your healthcare professional tells you. If you take too much PAXLOVID, call your healthcare professional or go to the nearest hospital emergency room right away. If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or HIV-1 infection, you should continue to take your medicine as prescribed.



Talk to your healthcare professional if you do not feel better or if you feel worse after 5 days.


Contact your healthcare professional if you have any side effects that bother you or do not go away. Report side effects or problems with the appearance or packaging of PAXLOVID to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088, or you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com, by fax at 1-866-635-83371-866-635-8337, or by calling 1-800-438-19851-800-438-1985.


Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers.

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AUTHORIZED USE

The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID use in children is still being studied. There is limited information about the safety and effectiveness of PAXLOVID to treat children with mild-to-moderate COVID-19.