First Approved Oral Antiviral Pill for COVID-19 Disease

• On December 22, 2021, the FDA issued a EUA (Emergency Use Authorization of an unapproved medication) for the first oral antiviral treatment, Paxlovid, to treat mild to moderate COVID-19 disease. Paxlovid is not a substitute for receiving COVID-19 vaccination and a COVID-19 booster dose.
• Get your COVID-19 vaccine and booster dose if eligible. For further details, visit the CDC website.
• The information on this page is available as a PDF download in both Spanish and English.

People who:

• Are 18 years and older and children 12 years and older (who weigh at least 88 pounds) and have mild to moderate COVID-19 disease.
• Have tested positive for SARS-CoV-2 testing, are at high risk for progression to severe COVID-19, including hospitalization or death.

The name of the drug is Paxlovid (generic Nirmatrelvir tablets and Ritonavir tablets, co-packaged for oral use). Pfizer manufactures it.

• The medicine is available by prescription only.
• The medicine is prescribed as three tablets to be taken together twice a day for 5 (five) days. Take by mouth.
• It is recommended to take Paxlovid as soon as possible after being diagnosed with COVID-19 and within the first five days of developing symptoms.
• The medicine works by stopping one of the proteins in the COVID-19 virus from replicating (making copies of itself)

Paxlovid is NOT authorized:

• For starting treatment in patients requiring hospitalization due to severe or critical COVID-19
• For pre-exposure or post-exposure prophylaxis for prevention of COVID-19 (meaning for people who have may be exposed to COVID-19 virus or have been exposed to COVID-19 virus to prevent them from getting COVID-19 disease)
• For use longer than five consecutive days

EUA Fact sheets that provide important information about using Paxlovid are available for healthcare providers and patients and caregivers for download. These fact sheets include dosing instructions, potential side effects, drug interactions and information about who is able to prescribe Paxlovid.

Possible side effects of Paxlovid can include impaired or altered sense of taste, diarrhea, increased blood pressure, and muscle aches.

• Paxlovid may also interact with certain other medications. It is best to inform your healthcare provider of any medical conditions you have and of any medicines you are taking (including herbal and over-the-counter medications) before taking Paxlovid.
• People with chronic medical conditions, including kidney or liver disease, hepatitis, HIV disease, should first check with their healthcare provider to see if they may take Paxlovid.

Paxlovid is not a substitute for receiving COVID-19 vaccination and a COVID-19 booster dose.

• Get your COVID-19 vaccine and booster dose if eligible. For further details, visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html.
• An FDA EUA is different from an FDA approval. Scientists at the FDA evaluated all of the scientific evidence available to them and carefully balanced any known or potential risks with any known or potential benefits of the product.
• Based on this thorough review, the FDA determined that it is reasonable to believe that Paxlovid may be effective for treating mild-to-moderate COVID-19 in authorized patients. Over 2000 patients were included in the clinical trial to test this new drug. None of them had received the COVID-19 vaccine, and none had COVID-19 disease before enrolling in the study. Half of the patients received the medicine, Paxlovid, and half received a placebo. They were then followed for a month to see who developed COVID-19 disease, was hospitalized with COVID-19 illness, or died from any cause. Paxlovid was found to be effective. The FDA will continue to monitor the safety and effectiveness of this medication. Details of the clinical trial of Paxlovid may be found on the FDA website.

• FDA Press Announcement: Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
• Paxlovid EUA Letter of Authorization
• Frequently Asked Questions on the Emergency Use Authorization for Paxlovid
• Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
• Coronavirus Disease (COVID-19)
• Coronavirus Treatment Acceleration Program (CTAP)