Paracetamol

DRUG INFORMATION

  ADULT
    - Adult: 1 g 3 or 4 times daily (max. 4 g daily)
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - One or two tablets every 4-6 hours , if you need to. Do not take more than 8
      tablets in any 24 hours.
      Source: eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.2

  CHILD
    - Child under 1 month: 10 mg/kg 3 or 4 times daily (max. 40 mg/kg daily)
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - Child 1 month and over: 15 mg/kg 3 or 4 times daily (max. 60 mg/kg daily)
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - Reduce the dose in: children with severe acute malnutrition: 10 mg/kg up to 3
      times maximum per 24 hours
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - patients with dengue with warning sign(s): Child: 10 mg/kg 3 to 4 times daily
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - Do not give children under 10 years of age.
      Source: eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.2 - a
      restriction on THIS 500 mg tablet, not on paracetamol: MSF doses younger children
      with the 100 mg tablet and the 120 mg/5 ml suspension, below

    By age and weight:
      Age                    Weight         120 mg/5 ml susp.  100 mg tablet  500 mg tablet
      ---------------------  -------------  -----------------  -------------  -------------
      < 1 month              < 4 kg         1.5 ml x 3         -              -
      1 to < 3 months        4 to < 6 kg    2.5 ml x 3         1/2 tab x 3    -
      3 months to < 1 year   6 to < 10 kg   4 ml x 3           1 tab x 3      -
      1 to < 3 years         10 to < 15 kg  6 ml x 3           1 1/2 tab x 3  -
      3 to < 5 years         15 to < 20 kg  8 ml x 3           2 tab x 3      -
      5 to < 9 years         20 to < 30 kg  12 ml x 3          3 tab x 3      -
      9 to < 14 years        30 to < 50 kg  -                  -              1 tab x 3
      >= 14 years and adult  >= 50 kg       -                  -              2 tab x 3
      Duration: According to clinical response
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)

  RENAL IMPAIRMENT
    - No dose reduction is published for oral paracetamol in kidney impairment. Give the
      ordinary dose, and watch for the warning below in severe impairment.
      Source: Read and found silent on renal dosing: eMC 12154 sections 4.2 and 4.4; MSF
      Essential Drugs 2024 paracetamol oral. The intravenous label does state an
      interval by creatinine clearance; carrying an IV interval across to an oral dose
      is an extrapolation this project does not make without a ruling.
    - Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis
      have been reported in patients with severe illness such as severe renal impairment
      and sepsis, or in patients with malnutrition or other sources of glutathione
      deficiency (e.g. chronic alcoholism) who were treated with paracetamol at
      therapeutic dose for a prolonged period or a combination of paracetamol and
      flucloxacillin.
      Source: eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.4

  HEPATIC IMPAIRMENT
    - No reduced dose is published. Both sources say to use paracetamol with caution in
      liver disease without naming a lower figure.
      Source: Read and found silent on a reduced hepatic dose: eMC 12154 sections 4.2
      and 4.4; MSF Essential Drugs 2024 paracetamol oral
    - Administer with caution to patients with hepatic impairment.
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - Caution in liver disease. Do not combine with other analgesic drugs containing
      paracetamol (eg combination medicine). Higher doses than recommended may result in
      very severe liver damage.
      Source: eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.4

  PREGNANCY   [ SAFE ]
    Can be used - at the lowest effective dose, for the shortest time.
    - Paracetamol may be used during pregnancy if clinically motivated, but it should be
      used with the lowest effective dose for the shortest possible time and at the
      lowest possible frequency.
      Source: eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.6
    - Pregnancy : no contra-indication
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)
    - Drugs which have been taken by a large number of pregnant women and women of
      childbearing age without any proven increase in the frequency of malformations or
      other direct or indirect harmful effects on the fetus having been observed.
      Source: TGA pregnancy category A (the definition quoted here) - paracetamol is
      listed as Category A in the TGA Prescribing medicines in pregnancy database.
      Australian categorisation system for prescribing medicines in pregnancy, 'Category
      A' definition (page last updated 28 March 2025), retrieved 2026-08-29

  BREASTFEEDING   [ SAFE ]
    Can be used - it reaches the milk, but not in an amount expected to affect the baby.
    - Lactation: Paracetamol passes into breast milk but the risk of affecting the child
      seems unlikely with therapeutic doses.
      Source: eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.6
    - Breast-feeding : no contra-indication
      Source: MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated
      October 2024)