Paracetamol

paracetamol is evaluated for the following indications with varying evidence strength: Fever (evidence tier A), Migraine (evidence tier A), Mild to moderate pain in adults (evidence tier A). See the full indication matrix with dosing and citations above on this page.

Common side effects of paracetamol (≥ 1 in 100): At recommended doses, adverse effects are rare and minimal. See the Safety section for uncommon and serious reactions.

FDA category B. Paracetamol is first-line for pain and fever in any trimester (historically FDA category B; the FDA pregnancy categories were retired in 2015). Earlier observational studies linked long-term third-trimester use to ADHD and autism, but the largest study to date — a Swedish sibling-controlled cohort (Ahlqvist VH et al. JAMA. 2024;331(14):1205–1214, n = 2.48 million children) — found no association after controlling for familial factors. Current view: standard doses for indicated use remain a safe option; unnecessary long-term high-dose use is still avoided.

Compatible with breastfeeding. Minimal concentrations in milk; one of the preferred analgesics in lactation.

paracetamol is contraindicated in: Severe hepatic impairment; Acute hepatitis; Hypersensitivity. Full list in the Safety section.

Hepatotoxicity in overdose. Daily doses above 4 g in adults (above 3 g in at-risk patients) can cause severe acute liver injury up to hepatic failure. The antidote is N-acetylcysteine.

paracetamol is a leading cause of acute liver failure worldwide. Safety critically depends on adhering to the maximum daily dose.

paracetamol lacks anti-inflammatory activity. Inflammatory conditions are best treated with NSAIDs when not contraindicated.

in children the dose is strictly 15 mg/kg per dose no more often than every 4–6 hours and no more than 4–5 times daily. Overdose in children is hepatotoxic.