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Cited by 110Pain Management and Opioid UseAnesthesia and Pain ManagementMusculoskeletal pain and rehabilitation

The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews

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Abdel Shaheed, Christina, Ferreira, Giovanni E, Dmitritchenko, Alissa, McLachlan, Andrew J, Day, Richard O, Saragiotto, Bruno, Lin, Christine, Langendyk, Vicki +6 more·2021·Medical Journal of Australia
DOI 10.5694/mja2.50992
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Abstract

OBJECTIVE: To evaluate the efficacy and safety of paracetamol as an analgesic medication in a range of painful conditions. STUDY DESIGN: Systematic review of systematic reviews of the analgesic effects of paracetamol in randomised, placebo-controlled trials. Conduct of systematic reviews was assessed with AMSTAR-2; confidence in effect estimates (quality of evidence) was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. DATA SOURCES: MEDLINE, EMBASE, PsycINFO, Cochrane Database of Systematic Reviews; systematic reviews published 1 January 2010 - 30 April 2020. DATA SYNTHESIS: We extracted pain and adverse events outcomes from 36 systematic reviews that assessed the efficacy of paracetamol in 44 painful conditions. Continuous pain outcomes were expressed as mean differences (MDs; standardised 0-10-point scale); dichotomous outcomes were expressed as risk ratios (RRs). There is high quality evidence that paracetamol provides modest pain relief for people with knee or hip osteoarthritis (MD, -0.3 points; 95% CI, -0.6 to -0.1 points) and after craniotomy (MD, -0.8 points; 95% CI, -1.4 to -0.2 points); there is moderate quality evidence for its efficacy in tension-type headache (pain-free at 2 hours: RR, 1.3; 95% CI, 1.1-1.4) and perineal pain soon after childbirth (patients experiencing 50% pain relief: RR, 2.4; 95% CI, 1.5-3.8). There is high quality evidence that paracetamol is not effective for relieving acute low back pain (MD, 0.2 points; 95% CI, -0.1 to 0.4 points). Evidence regarding efficacy in other conditions was of low or very low quality. Frequency of adverse events was generally similar for people receiving placebo or paracetamol, except that transient elevation of blood liver enzyme levels was more frequent during repeated administration of paracetamol to patients with spinal pain (RR, 3.8; 95% CI, 1.9-7.4). CONCLUSIONS: For most conditions, evidence regarding the effectiveness of paracetamol is insufficient for drawing firm conclusions. Evidence for its efficacy in four conditions was moderate to strong, and there is strong evidence that paracetamol is not effective for reducing acute low back pain. Investigations that evaluate more typical dosing regimens are required. PROSPERO REGISTRATION: CRD42015029282 (prospective).

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  • For short-term treatment of acute pain and fever, robust evidence continues to support both the efficacy and comparative safety of paracetamol.

    “For short-term treatment of acute pain and fever robust evidence continues to support both its efficacy and comparative safety [ 1 , 2 , 20 ].”

    From Paracetamol: A History of Assumptions, Errors, and Evidence Reversals in Pain Management (2026) · cites this paper as [1]

    The Discussion (page unavailable) reports high- or moderate-quality evidence of pain relief for only four of 44 conditions, with modest effects; the paper therefore does not support a broad claim of robust efficacy for acute pain. It reports adverse-event rates similar to placebo, but says that evidence was generally low quality. The reviewed outcomes concern pain, not fever treatment. (LLM, conf=0.88)

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Authors
Abdel Shaheed, C., Ferreira, G. E., Dmitritchenko, A., McLachlan, A. J., Day, R. O., Saragiotto, B., Lin, C., Langendyk, V., Stanaway, F., Latimer, J., Kamper, S., McLachlan, H., Ahedi, H., & Maher, C. G.
Affiliations
  • The University of Sydney Sydney NSW
  • The University of Sydney (AU)
  • Sutherland Hospital (AU)
  • UNSW Sydney (AU)
  • Universidade Cidade de São Paulo (BR)
  • Institute for Musculoskeletal Health University of Sydney Sydney
ORCID
Venue
Medical Journal of Australia
Publisher
Wiley
Published
2021-03-30
Volume
214
Issue
7
Pages
324-331
ISSN
  • 0025-729X (ISSN-L)
  • 1326-5377
DOI
10.5694/mja2.50992
OpenAlex
W3139982435
Cited by
110
References
59
Citations by year
2026: 22 · 2025: 21 · 2024: 19 · 2023: 21 · 2022: 20 · 2021: 6
FWCI
4.08
Type
journal article
Language
en
Open access
Licence
Locations
  • The Medical Journal of Australia (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Health and Medical Research Council (APP1103022, APP1113532, APP1134856, APP1171459)
Topics
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
  • Health Sciences › Medicine › Surgery › Anesthesia and Pain Management
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
Keywords
paracetamol, analgesic efficacy, analgesic safety, analgesia, osteoarthritis, tension-type headache, postpartum perineal pain, acute low back pain, elevated liver enzymes, adverse drug reactions, spinal pain, quality of evidence, GRADE, AMSTAR 2
MeSH terms
Data Management, Acetaminophen, Craniotomy, Humans, Osteoarthritis, Pain, Placebos, Prospective Studies, Safety, Case-Control Studies, Randomized Controlled Trials as Topic, Treatment Outcome, Low Back Pain, Analgesics, Non-Narcotic, Tension-Type Headache, Pain Management

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