FDA EUA Letter
Authorized Use

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

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.

Important Safety Information
Fact Sheets
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 has issued an Emergency Use Authorization (EUA) to make PAXLOVID available during the COVID-19 pandemic. PAXLOVID is not an FDA-approved medicine in the United States.

Safety,
Side Effects, & Drug Interactions

PAXLOVID is authorized for emergency use

  • PAXLOVID has not been approved, but has been authorized for emergency use by the FDA under an EUA, for adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death; and
  • 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


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.

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

  • Have any allergies (do not take PAXLOVID if you are allergic to nirmatrelvir, ritonavir, or any of the other ingredients in PAXLOVID)
  • Have liver or kidney disease (bring your latest lab results, if possible)
  • Are pregnant, plan to become pregnant, or are breastfeeding. 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
  • Have any serious illnesses
  • 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

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

  • PAXLOVID may strengthen or weaken multiple other medicines. Taking PAXLOVID with certain medicines may cause serious life-threatening side effects or affect how PAXLOVID works. It is critical to tell your healthcare professional about all of the medicines you are taking, including herbal supplements, because taking certain laboratory tests or changing the dose of your other medicines or supplements may be necessary
  • Don’t start any new medications without discussing with your healthcare professional

Some medications cannot be taken with PAXLOVID

The table below is not a complete list of all medicines that cannot be taken with PAXLOVID. There are other medicines that may need to be stopped temporarily. Speak to your healthcare professional about all medicines you are taking, not just those listed below. Taking certain medicines with PAXLOVID may result in serious, life-threatening reactions.

Medicine name

Common brand name(s)

Common conditions treated*

Alfuzosin

Uroxatral®

Enlarged prostate

Ranolazine

Ranexa®

Chronic chest pain (angina)

Amiodarone

Pacerone®, Cordarone®

Irregular heartbeat (arrhythmia)

Droneda­rone

Multaq®

Irregular heartbeat (arrhythmia)

Flecainide

Tambocor®

Irregular heartbeat (arrhythmia)

Propafe­none

Rythmol SR®

Irregular heartbeat (arrhythmia)

Quinidine

Irregular heartbeat (arrhythmia)

Colchicine

Mitigare®, Colcrys®

Gout attacks

Lurasidone

Latuda®

Schizophre­nia

Pimozide

Orap®

Tourette syndrome

Dihydroer­gotamine

Migraine and cluster headaches

Ergotamine

Cafergot®

Migraine

Methylergo­novine

Mether­gine®

Severe bleeding after childbirth or an abortion

Lovastatin

Altoprev®

High cholesterol

Simvastatin

Zocor®, FloLipid®

High cholesterol and triglyceride levels

Sildenafil

Revatio®

Pulmonary arterial hypertension

Triazolam

Halcion®

Insomnia (sleep disorder)

Oral midazolam

Versed®

Anxiety before a medical procedure

Apaluta­mide

Erleada®

Prostate cancer

Carbamaze
-pine

Carbamaze­pine

Tegretol XR®, Tegretol®, Carbatrol®

Epilepsy/​seizures, nerve pain, bipolar disorder

Phenobar­bital

Luminal®

Seizures, anxiety, withdrawal from another barbiturate medication

Phenytoin

Phenytek®, Dilantin®

Seizures

Rifampin

Rifadin®

Tuberculosis

St. John’s wort

A wide range of uses such as depression and wounds

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

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

Possible Side Effects

PAXLOVID may cause side effects, some of which may be severe. Some medicines may interact with PAXLOVID and may cause serious side effects. Tell your healthcare professional about all the medicines you take, and tell them if you experience any side effects while taking PAXLOVID.

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
  • Trouble swallowing or breathing
  • Swelling of the mouth, lips, 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 and itchy skin
  • Stomach area (abdominal) pain

Resistance to HIV Medicines

  • If you have untreated human immunodeficiency virus (HIV) infection, PAXLOVID may lead to some HIV medicines not working as well in the future

Other Possible Side Effects

  • Change in sense of taste
  • Diarrhea
  • High blood pressure
  • Muscle aches
  • Stomach area (abdominal) pain
  • Nausea
  • Generally feeling unwell (malaise)

These are not all the possible side effects of PAXLOVID. Ask your healthcare professional to go over the possible side effects with you. 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.

For more information, 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 of this site or service.

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

Learn who can take PAXLOVID

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

Learn who can take PAXLOVID

Important Safety Information

Expand

Before taking PAXLOVID, tell your healthcare provider if you:

  • Have any allergies, liver or kidney disease, or any serious illness;
  • Are pregnant or plan to become pregnant, or are breastfeeding a child

Some medicines may interact with PAXLOVID and may cause serious side effects.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Your healthcare provider can tell you if it is safe to take PAXLOVID with other medicines.
  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with PAXLOVID.
  • Do not start taking a new medicine without telling your healthcare provider.

Tell your healthcare provider if you are taking combined hormonal contraceptive.

PAXLOVID may affect how your birth control pills work. People who are able to become pregnant should use another or an alternative effective form of contraception.

Take PAXLOVID exactly as your HCP tells you.

If you take too much PAXLOVID, call your HCP or go to the nearest hospital emergency room right away. If you are taking a ritonavir – or cobicistat-containing medicine for hepatitis C or Human Immunodeficiency Virus (HIV) continue to take your medicine as prescribed.

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

Do not take PAXLOVID if:

  • You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID or 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
    • St. John’s Wort (hypericum perforatum)
    • sildenafil (Revatio®) for pulmonary arterial hypertension
    • silodosin
    • simvastatin
    • tolvaptan
    • triazolam
    • ubrogepant
    • voclosporin

Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works. These are not the only medicines that may cause serious side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary while you are taking PAXLOVID. Your healthcare provider 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.

Possible side effects of PAXLOVID are:

  • Allergic Reactions. Allergic reactions, including severe allergic reactions (known as ‘anaphylaxis’), can happen in people taking PAXLOVID, even after only 1 dose. Stop taking PAXLOVID and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction:
    • hives
    • trouble swallowing or breathing
    • swelling of the mouth, lips, or face
    • hoarseness
    • throat tightness
    • skin rash
  • Liver Problems. Tell your healthcare provider right away if you have any symptoms of liver problems (loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach area (abdominal) pain.)
  • Resistance to HIV Medicines. If you have untreated HIV infection, PAXLOVID may lead to some HIV medicines not working as well in the future.
  • Other possible side effects include:
    • altered sense of taste
    • diarrhea
    • high blood pressure
    • muscle aches
    • abdominal pain
    • nausea
    • feeling generally unwell

These are not all the possible side effects of PAXLOVID. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all risks are not known at this time.

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 provider.

Contact your healthcare provider 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 adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.

AUTHORIZED USE

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

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.

Important Safety Information

Before taking PAXLOVID, tell your healthcare provider if you:

  • Have any allergies, liver or kidney disease, or any serious illness;
  • Are pregnant or plan to become pregnant, or are breastfeeding a child

Some medicines may interact with PAXLOVID and may cause serious side effects.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Your healthcare provider can tell you if it is safe to take PAXLOVID with other medicines.
  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with PAXLOVID.
  • Do not start taking a new medicine without telling your healthcare provider.

Tell your healthcare provider if you are taking combined hormonal contraceptive.

PAXLOVID may affect how your birth control pills work. People who are able to become pregnant should use another or an alternative effective form of contraception.

Take PAXLOVID exactly as your HCP tells you.

If you take too much PAXLOVID, call your HCP or go to the nearest hospital emergency room right away. If you are taking a ritonavir – or cobicistat-containing medicine for hepatitis C or Human Immunodeficiency Virus (HIV) continue to take your medicine as prescribed.

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

Do not take PAXLOVID if:

  • You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID or 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
    • St. John’s Wort (hypericum perforatum)
    • sildenafil (Revatio®) for pulmonary arterial hypertension
    • silodosin
    • simvastatin
    • tolvaptan
    • triazolam
    • ubrogepant
    • voclosporin

Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works. These are not the only medicines that may cause serious side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary while you are taking PAXLOVID. Your healthcare provider 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.

Possible side effects of PAXLOVID are:

  • Allergic Reactions. Allergic reactions, including severe allergic reactions (known as ‘anaphylaxis’), can happen in people taking PAXLOVID, even after only 1 dose. Stop taking PAXLOVID and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction:
    • hives
    • trouble swallowing or breathing
    • swelling of the mouth, lips, or face
    • hoarseness
    • throat tightness
    • skin rash
  • Liver Problems. Tell your healthcare provider right away if you have any symptoms of liver problems (loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach area (abdominal) pain.)
  • Resistance to HIV Medicines. If you have untreated HIV infection, PAXLOVID may lead to some HIV medicines not working as well in the future.
  • Other possible side effects include:
    • altered sense of taste
    • diarrhea
    • high blood pressure
    • muscle aches
    • abdominal pain
    • nausea
    • feeling generally unwell

These are not all the possible side effects of PAXLOVID. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all risks are not known at this time.

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 provider.

Contact your healthcare provider 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.

CLOSE

AUTHORIZED USE

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

PAXLOVID is still being studied. There is limited information about the safety and effectiveness of PAXLOVID.