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.

Safety,
Side Effects,
& Drug Interactions

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.

Important topics to cover with your healthcare professional


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Talk to your healthcare professional about your medical conditions and review your recent medical records together

This will help your healthcare professional determine if PAXLOVID is right for you, if you need a different dose of PAXLOVID, or if you need to stop or change the dose of any other medicines you take.

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You can help prepare for this discussion by knowing if you:

  • Are allergic to nirmatrelvir, ritonavir, or any of the other ingredients in PAXLOVID
  • Have liver or kidney problems, including hepatitis (bring your latest lab results, if possible)
  • 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, are breastfeeding, or plan to breastfeed. It is not known if PAXLOVID is safe to take during pregnancy or while breastfeeding, so be sure to discuss this with your healthcare professional
  • Take a hormonal birth control medicine. PAXLOVID can affect how some birth controls work, so be sure to ask your healthcare professional if you need to use a different or an additional form of contraception
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It is very important to come with a list of all the medicines you take, including over-the-counter and prescription medicines, vitamins, and herbal supplements

  • Your healthcare professional can tell you if it's safe to take PAXLOVID with other medicines
  • You can ask your healthcare professional or pharmacist for a list of medicines that interact with PAXLOVID
  • Don't start taking a new medicine without telling your healthcare professional
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Some medications cannot be taken with PAXLOVID

  • Taking certain medicines with PAXLOVID can cause severe or life-threatening side effects or death
  • It is very important to tell your healthcare professional about all of the medicines you are taking 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
  • The table below is not a complete list of all medicines that cannot be taken with PAXLOVID. PAXLOVID may increase or decrease the levels of other medicines

Medicine name

Common brand name(s)

Common conditions treated*

alfuzosin

Uroxatral®

Enlarged prostate

amiodarone

Pacerone®, Cordarone®

Irregular heartbeat (arrhythmia)

apalutamide

Erleada®

Prostate cancer

carbamaz­epine

Tegretol XR®, Tegretol®, Carbatrol®

Epilepsy/​seizures, nerve pain, bipolar disorder

colchicine

Mitigare®, Colcrys®

Gout attacks

dihydroer­gotamine

Migraine and cluster headaches

dronedarone

Multaq®

Irregular heartbeat (arrhythmia)

eletriptan

Relpax®

Migraine

eplerenone

Inspra®

High blood pressure

ergotamine

Cafergot®

Migraine

finerenone

Kerendia®

Chronic kidney disease

flecainide

Tambocor®

Irregular heartbeat (arrhythmia)

flibanserin

Addyi®

Low sexual desire in females

ivabradine

Corlanor®

Heart failure

lomitapide

Juxtapid®

High cholesterol

lovastatin

Altoprev®

High cholesterol

lumacaftor/​ivacaftor

Orkambi®

Cystic fibrosis

lurasidone

Latuda®

Schizo­phrenia

methylergo­novine

Mether­gine®

Severe bleeding after childbirth or an abortion

midazolam (oral)

midazolam (oral)

Versed®

Anxiety before a medical procedure

naloxegol

Movantik®

Constipation from prolonged treatment with opiate pain medications

phenobar­bital

Luminal®

Seizures, anxiety, withdrawal from another barbiturate medication

phenytoin

Phenytek®, Dilantin®

Seizures

pimozide

Orap®

Tourette syndrome

primidone

Mysoline®

Seizures

propafenone

Rythmol SR®

Irregular heartbeat (arrhythmia)

quinidine

Irregular heartbeat (arrhythmia)

ranolazine

Ranexa®

Chronic chest pain (angina)

rifampin

Rifadin®

Tuberculosis

rifapentine

Priftin®

Tuberculosis

St. John’s Wort

A wide range of uses such as depression and wounds

sildenafil

Revatio®

Pulmonary arterial hypertension

silodosin

Rapaflo®

Enlarged prostate

simvastatin

Zocor®, FloLipid®

High cholesterol and triglyceride levels

tolvaptan

Samsca®

Low blood sodium

triazolam

Halcion®

Insomnia (sleep disorder)

ubrogepant

Ubrelvy®

Migraine

voclosporin

Lupkynis®

Lupus nephritis

*Some medicines may be taken off-label. Brand names are registered trademarks of their respective owners.

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Get the most out of your conversation with your healthcare professional
by coming prepared. Download the COVID-19 Preparedness Plan

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Get the most out of your
conversation with your healthcare
professional by coming prepared.
Download the COVID-19
Preparedness Plan

Get the most out of your conversation with your healthcare professional by coming prepared.

Download the COVID-19 Preparedness Plan
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Get the most out of your conversation with your healthcare professional by coming prepared.

Download the COVID-19 Preparedness Plan
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Possible Side Effects

PAXLOVID may cause side effects, some of which may be serious, such as allergic reactions or liver problems.
The list below doesn't include all of the possible side effects of PAXLOVID. For more information, ask your healthcare professional or pharmacist.

Some side effects of PAXLOVID are:

Allergic Reactions

Stop taking PAXLOVID and call your healthcare professional right away if you get any of the following symptoms of an allergic reaction:

  • Hives, skin rash, 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
  • Throat tightness
  • Hoarseness of voice

Liver Problems

Tell your healthcare professional right away if you have any of these signs and symptoms of liver problems:

  • Loss of appetite
  • Yellowing of your skin and the whites of your eyes (jaundice)
  • Dark-colored urine
  • Pale-colored stools
  • Itchy skin
  • Stomach area (abdominal) pain

Most Common Side Effects

  • Change in sense of taste
  • Diarrhea

Other Possible Side Effects

  • Headache
  • Vomiting
  • Stomach-area (abdominal) pain
  • Nausea
  • High blood pressure
  • Feeling generally unwell

Contact your healthcare professional if you have any side effects that bother you or do not go away.

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/medwatch† or call 1-800-FDA-1088.

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

†By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.

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PAXLOVID can help treat mild-to-moderate COVID-19 in people with certain high-risk factors.

Learn who can take PAXLOVID
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PAXLOVID can help treat mild-to-moderate COVID-19 in people with certain high-risk factors.

Learn who can take PAXLOVID
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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.