Acetaminophen

More frequently reported side effects include: fever. See below for a comprehensive list of adverse effects.

Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, acetaminophen 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 immediately if any of the following side effects occur while taking acetaminophen:

Rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• fever with or without chills (not present before treatment and not caused by the condition being treated)
• pain in the lower back and/or side (severe and/or sharp)
• pinpoint red spots on the skin
• skin rash, hives, or itching
• sore throat (not present before treatment and not caused by the condition being treated)
• sores, ulcers, or white spots on the lips or in the mouth
• sudden decrease in the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

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

Symptoms of overdose

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area

Applies to acetaminophen: compounding powder, intravenous solution, oral capsule, oral granule effervescent, oral liquid, oral powder for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, rectal suppository

In general, acetaminophen is well-tolerated when administered in therapeutic doses. The most commonly reported adverse reactions have included nausea, vomiting, constipation. Injection site pain and injection site reaction have been reported with the IV product.

Common (1% to 10%): Increased aspartate aminotransferase

Rare (less than 0.1%): Increased hepatic transaminases

Frequency not reported: Liver failure

Very common (10% or more): Nausea (up to 34%), Vomiting (up to 15%)

Common (1% to 10%): Abdominal pain, diarrhea, constipation, dyspepsia, enlarged abdomen

Frequency not reported: Dry mouth

Postmarketing reports: Anaphylaxis, hypersensitivity reactions

Common (1% to 10%): Anemia, postoperative hemorrhage

Very rare (less than 0.01%): Thrombocytopenia, leucopenia, neutropenia

Common (1% to 10%): Rash, pruritus

Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis

Very rare (less than 0.01%): Pemphigoid reaction, pustular rash, Lyell syndrome

Common (1% to 10%): Dyspnea, abnormal breath sounds, pulmonary edema, hypoxia, pleural effusion, stridor, wheezing, coughing

Common (1% to 10%): Peripheral edema, hypertension, hypotension, tachycardia, chest pain

Common (1% to 10%): Hypokalemia, hyperglycemia

Common (1% to 10%): Headache, dizziness

Frequency not reported: Dystonia

Common (1% to 10%): Muscle spasms, trismus

Common (1% to 10%): Insomnia, anxiety

Common (1% to 10%): Oliguria

Common (1% to 10%): Infusion site pain, injection site reactions

Common (1% to 10%): Periorbital edema

Common (1% to 10%): Pyrexia, fatigue

Rare (0.01% to 0.1%): Malaise