Indication

PAXLOVID is a prescription medicine used to treat mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID is not approved for use in the prevention of COVID-19.

Prescribing Information Healthcare Professionals Emergency Use Authorization

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Prescribing Information Healthcare Professionals Emergency Use Authorization

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.

PAXLOVID is now FDA approved

PAXLOVID is a prescription medicine used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID-19. There are certain medications that should not be taken with PAXLOVID.

Despite the COVID-19 Public Health Emergency (PHE) ending, PAXLOVID still remains available to patients at no charge, regardless of insurance.*

*Other administrative fees may apply. The U.S. Government has purchased PAXLOVID from Pfizer and is continuing to make it available at no charge, regardless of insurance.

Important Safety Information

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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 of 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 of 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 hormonal contraceptive (birth control).

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

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. See Prescribing Information for a complete list of ingredients of PAXLOVID. Stop taking PAXLOVID and get medical help 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
    • swelling of the mouth, lips, tongue or face
    • trouble swallowing or breathing
    • throat tightness
    • hoarseness
  • Liver problems. Tell your healthcare professional right away if you get any of the following signs and symptoms of liver problems during treatment with PAXLOVID:
    • loss of appetite
    • yellowing of your skin and the white of 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
  • vomiting
  • abdominal pain
  • nausea
  • high blood pressure
  • feeling generally unwell

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

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED WARNING.

What is PAXLOVID?

PAXLOVID is a prescription medicine used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID is not approved for use as a treatment pre-exposure or post-exposure for prevention of COVID-19.

What is PAXLOVID?

PAXLOVID is a prescription medicine used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID-19.

Please see full Prescribing Information, including BOXED WARNING.

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 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. See Prescribing Information for a complete list of ingredients in PAXLOVID. Stop taking PAXLOVID and get medical help 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
    • swelling of the mouth, lips, tongue or face
    • trouble swallowing or breathing
    • throat tightness
    • hoarseness
  • Liver problems. Tell your healthcare professional right away if you get 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
  • vomiting
  • abdominal pain
  • nausea
  • high blood pressure
  • feeling generally unwell

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

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED WARNING.

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First and only FDA-approved oral treatment for COVID-19 in adults

WHAT IS PAXLOVID?

PAXLOVID is a prescription medicine used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID-19.