Flextra Side Effects

Generic name: acetaminophen / caffeine / phenyltoloxamine

Note: This document contains side effect information about acetaminophen / caffeine / phenyltoloxamine. Some dosage forms listed on this page may not apply to the brand name Flextra.

Applies to acetaminophen/caffeine/phenyltoloxamine: oral capsule.

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen/caffeine/phenyltoloxamine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

• fast or pounding heartbeat;

• easy bruising or bleeding, unusual weakness;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• trouble swallowing, increased thirst and urination;

• severe diarrhea or stomach pain;

• confusion, ringing in your ears, hearing problems;

• a light-headed feeling, like you might pass out;

• little or no urinating;

• muscle weakness, loss of coordination; or

• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Common side effects may include:

• dizziness, drowsiness, memory problems;

• nervous feeling, sleep problems (insomnia);

• blurred vision, dry mouth, nose or throat;

• upset stomach, constipation; or

• mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to acetaminophen / caffeine / phenyltoloxamine: oral capsule.

Cardiovascular

Cardiovascular side effects have included palpitations, hypotension, and cardiac stimulation.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included epigastric distress, diarrhea, intestinal cramps, nausea, xerostomia, and dryness of mouth, throat, and nose.^[Ref]

Dermatologic

Dermatologic side effects have included urticaria and rash. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).^[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reactions.^[Ref]

Hematologic

Hematologic side effects have included thrombocytopenia and agranulocytosis.^[Ref]

Musculoskeletal

Musculoskeletal side effects have included muscular weakness.^[Ref]

Genitourinary

Genitourinary side effects have included urinary retention.^[Ref]

Nervous system

Nervous system side effects have included dizziness, drowsiness, disturbed coordination, inability to concentrate, insomnia, tremors, nervousness, convulsions, irritability, and dependence.^[Ref]

Ocular

Ocular side effects have included blurred vision.^[Ref]

Renal

Renal side effects have included nephrotoxicity.^[Ref]

Metabolic

Metabolic side effects have included hyperglycemia.^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer