The FDA has authorized the emergency use of PAXLOVID, an
investigational medicine, 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]) with a positive test for the virus that
causes COVID-19, and who are at high risk for progression to severe
COVID-19, including hospitalization or death, under an EUA.
PAXLOVID is investigational because it is still being studied. There
is limited information about the safety and effectiveness of using
PAXLOVID to treat people with mild-to-moderate COVID-19.
Important Safety Information
Before taking PAXLOVID, tell your healthcare provider if
Some medicines may interact with PAXLOVID and may cause serious
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
Tell your healthcare provider if you are taking combined hormonal
PAXLOVID may affect how your birth control pills work. Females who are
able to become pregnant should use another effective alternative form
of contraception or an additional barrier method of contraception.
Talk to your healthcare provider if you have any questions about
contraceptive methods that might be right for you.
HOW TO TAKE PAXLOVID
PAXLOVID consists of 2 medicines: nirmatrelvir and ritonavir.
The 2 medicines are taken together 2 times each day for 5
PAXLOVID is available in 2 Dose Packs. Your healthcare provider
will prescribe the PAXLOVID Dose Pack that is right for you.
If you have kidney disease, your healthcare provider may
prescribe a lower dose. Talk to your healthcare provider to make
sure you receive the correct Dose Pack.
Do not remove your PAXLOVID tablets from the blister card before
you are ready to take your dose.
Take your first dose of PAXLOVID in the Morning or Evening,
depending on when you pick up your prescription, or as recommended
by your healthcare provider.
Swallow the tablets whole. Do not chew, break, or crush the
Take PAXLOVID with or without food.
Do not stop taking PAXLOVID without talking to your healthcare
provider, even if you feel better.
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 the
dose by more than 8 hours, skip the missed dose and take the next
dose at your regular time. Do not take morning and evening doses
of PAXLOVID at the same time.
If you take too much PAXLOVID, call your healthcare provider 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 Human Immunodeficiency Virus (HIV), you
should continue to take your medicine as prescribed by your
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.
You are taking any of the following medicines:
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, 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:
trouble swallowing or breathing
swelling of the mouth, lips, or face
Liver Problems. Tell your
healthcare provider 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 eyes (jaundice), dark-colored urine,
pale-colored stools and itchy skin, or stomach area (abdominal)
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
high blood pressure
feeling generally unwell
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.
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
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.