Important Safety Information
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Before taking PAXLOVID, tell your healthcare provider if
you:
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Have any allergies, liver or kidney disease, or any serious illness;
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Are pregnant or plan to become pregnant, or are breastfeeding a child
Some medicines may interact with PAXLOVID and may cause serious
side effects.
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Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
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Your healthcare provider can tell you if it is safe to take
PAXLOVID with other medicines.
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You can ask your healthcare provider or pharmacist for a list of
medicines that interact with PAXLOVID.
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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:
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:
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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:
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hives
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trouble swallowing or breathing
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swelling of the mouth, lips, or face
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hoarseness
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throat tightness
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skin rash
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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).
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Resistance to HIV Medicines.
If you have untreated HIV infection, PAXLOVID may lead to some
HIV medicines not working as well in the future.
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Other possible side effects include:
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altered sense of taste
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diarrhea
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high blood pressure
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muscle aches
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abdominal pain
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nausea
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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
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.
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.
and a reduced dose pack
