FDA Update
ACETAMINOPHEN is a pain reliever. It is used to treat pain and fever. Compare acetaminophens.

Ofirmev Side Effects

What should I watch for?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not take other medicines that contain acetaminophen with this medicine. Too much acetaminophen can be very dangerous and cause an overdose. Always read labels carefully.

Report any possible overdose to your doctor right away, even if there are no symptoms. The effects of extra doses may not be seen for many days.


Interactions with Medications

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common-Adults

Abnormal breath sounds

bloating or swelling of the face, arms, hands, lower legs, or feet

difficult or labored breathing

difficulty opening the mouth

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

irregular heartbeat


loss of appetite

muscle pain or cramps

muscle spasm, especially of the neck and back

nausea or vomiting


numbness or tingling in the hands, feet, or lips

pain at the injection site

slow or fast heartbeat


tightness in the chest

unusual tiredness or weakness

Less common-Children

Difficult, fast, or noisy breathing, sometimes with wheezing

fast, slow, pounding, or irregular heartbeat or pulse

decreased urination


lower back, side, or stomach pain

muscle spasms (tetany) or twitching

noisy breathing

pain in the arms or legs

swelling around the eyes

swelling of the feet, ankles, or lower legs

Incidence not known

Abdominal or stomach pain or tenderness

clay colored stools

dark urine

decreased appetite

difficulty with swallowing

flu-like symptoms

loss of appetite

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

right upper stomach tenderness

skin rash, itching, or hives

tightness in the chest

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Black, tarry stools

bleeding gums

bloating of the abdomen or stomach

blood in the urine or stools


difficult or painful urination

general feeling of discomfort or illness

light-colored stools

pinpoint red spots on the skin

sudden decrease in the amount of urine

unpleasant breath odor

vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Trouble sleeping

Less common-Adults


Less common-Children


difficulty having a bowel movement (stool)



Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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