Frequently Asked
Questions About
PAXLOVID

PAXLOVID has not been approved, but has been authorized for emergency use by the FDA under an Emergency Use Authorization (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.

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.

According to the FDA, an EUA is a mechanism to facilitate the availability and use of medical countermeasures during public health emergencies, such as the current COVID-19 pandemic. Under an emergency use authorization, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products, in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

PAXLOVID was studied in a clinical trial that included 2246 people from around the world. All participants were unvaccinated adults, at risk for progression to severe COVID-19, had mild-to-moderate symptoms for 5 days or fewer, and tested positive for COVID-19.

The primary goal of the clinical trial was to see how well PAXLOVID worked to reduce the risk of COVID-19–related hospitalization or death when compared with placebo.

Learn more about how PAXLOVID was studied and see the results.

Viruses spread in the body by making copies of themselves. If there are enough copies of the virus in your body, it may be hard for your immune system to fight the infection off. PAXLOVID works to stop the virus from multiplying and reduces the amount of it in your body.

PAXLOVID is available at no charge for the drug and is currently available regardless of insurance coverage. Other administrative fees may apply.

The U.S. Government has purchased PAXLOVID from Pfizer and is making it available to patients at no charge. Specific insurers may develop coverage policies for PAXLOVID in the future after Government purchase supply is no longer available.

You can take any available FDA-authorized COVID-19 viral test (eg, RT-PCR, rapid antigen) to determine if you have COVID-19. Per the Centers for Disease Control and Prevention (CDC), a viral test checks specimens from the nose or mouth and can be performed in a laboratory, at a testing site, at home, or anywhere else. This page can help you find a testing provider.

If you suspect you have COVID-19 and have a high-risk factor, speak to a healthcare professional as soon as possible.

For more information on COVID-19 testing, see the CDC’s COVID-19 Testing: What You Need To Know.*

*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.

You can get PAXLOVID with a prescription from a physician, advanced practice registered nurse, or physician assistant. As of July 6, 2022, state-licensed pharmacists have also been authorized to prescribe PAXLOVID.

If you have COVID-19 symptoms or test positive and want to determine if you’re eligible for a PAXLOVID prescription from a pharmacist, bring the following information:

• Electronic or printed health records less than 12 months old, including recent laboratory blood work, for the pharmacist to review for kidney or liver problems. Pharmacists can also receive this information through your healthcare professional
• A list of all medications you are taking, including over-the-counter medications, so the pharmacist can screen for drugs with potentially serious interactions with PAXLOVID

Learn more about how to get PAXLOVID.

PAXLOVID should be started within 5 days of your first symptoms, so talk to your healthcare professional as soon as you have symptoms or test positive.

The Test to Treat initiative* can help you get tested for COVID-19 and, if appropriate, receive treatment all in the same location. Find a location near you here or call 1-800-232-0233.^*

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

PAXLOVID consists of 2 medicines: nirmatrelvir and ritonavir.

• If you are prescribed the standard dose pack (300 mg nirmatrelvir; 100 mg ritonavir): Take 2 pink tablets of nirmatrelvir with 1 white to off-white tablet of ritonavir by mouth 2 times each day (in the morning and in the evening) for 5 days. For each dose, take all 3 tablets at the same time
• If you have kidney disease, talk to your healthcare professional. You may need a different dose
• If you are prescribed the reduced dose pack (150 mg nirmatrelvir; 100 mg ritonavir): Take 1 pink tablet of nirmatrelvir with 1 white to off-white tablet of ritonavir by mouth 2 times each day (in the morning and in the evening) for 5 days. For each dose, take both tablets at the same time

• Swallow the tablets whole. Do not chew, break, or crush the tablets
• Take PAXLOVID with or without food
• Do not stop taking PAXLOVID without talking to your healthcare professional, even if you feel better
• If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or human immunodeficiency virus (HIV), you should continue to take your medicine as prescribed by your healthcare professional
• Talk to your healthcare professional if you do not feel better or if you feel worse after 5 days

Learn more about how to take PAXLOVID.

If you miss a dose of PAXLOVID within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PAXLOVID at the same time.

If you take too much PAXLOVID, call your healthcare professional or go to the nearest hospital emergency room right away.

Do not stop taking PAXLOVID without talking to your healthcare professional, even if you feel better.

Possible side effects include: altered sense of taste, diarrhea, high blood pressure, muscle aches, abdominal pain, nausea, and malaise.

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 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

Other possible side effects of PAXLOVID include liver problems and resistance to HIV medicines.

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, or stomach area (abdominal) pain.

If you have untreated or undiagnosed 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, and muscle aches.

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

Report side effects to FDA MedWatch at www.fda.gov/medwatch* or call 1-800-FDA-1088 or you can report side effects to Pfizer Inc. at the contact information provided below.

On January 18, 2023, the FDA authorized a shelf-life extension to 24 months for certain lots of PAXLOVID. For more information and to look up adjusted product expiration dates by original printed expiry date or batch number, please refer to the following update from the Administration for Strategic Preparedness & Response: Shelf-Life Extension for Specific Lots of Paxlovid | HHS/ASPR.*

*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.