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

Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, solution, suppository, suspension, tablet, tablet chewable, tablet disintegrating, tablet extended release. Other dosage forms:

• intravenous solution

Serious side effects of Paracetamol

Along with its needed effects, acetaminophen (the active ingredient contained in Paracetamol) 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

For Healthcare Professionals

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

General

In general, acetaminophen (the active ingredient contained in Paracetamol) 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.^[Ref]

Hepatic

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

Rare (less than 0.1%): Increased hepatic transaminases

Frequency not reported: Liver failure^[Ref]

Gastrointestinal

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^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, hypersensitivity reactions^[Ref]

Hematologic

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

Very rare (less than 0.01%): Thrombocytopenia, leucopenia, neutropenia^[Ref]

Dermatologic

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^[Ref]

Respiratory

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

Cardiovascular

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

Metabolic

Common (1% to 10%): Hypokalemia, hyperglycemia^[Ref]

Nervous system

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

Frequency not reported: Dystonia

Musculoskeletal

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

Psychiatric

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

Genitourinary

Common (1% to 10%): Oliguria

Local

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

Ocular

Common (1% to 10%): Periorbital edema

Other

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

Rare (0.01% to 0.1%): Malaise