Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Analgesia Pregnancy: §4.6, verbatim. Pregnancy: 'A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopmental disorders in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy for the shortest possible time, at the lowest effective dose and at the lowest possible frequency.' Breastfeeding: 'Paracetamol is excreted into breast milk. No undesirable effects on nursing infants have been reported. Paracetamol 500 mg capsules, soft may be used in therapeutic dosages in breast-feeding women.' No fertility statement appears in the fetched §4.6. Note the SPC's conditional framing — 'if clinically needed', 'shortest possible time', 'lowest effective dose', 'lowest possible frequency' — which is more measured than the page's flat 'Safe at standard doses'; the SPC's own line on neurodevelopmental studies ('inconclusive results') is the sourced version of the page's clinical pearl.

Paracetamol

Brand names: Panadol, Calpol

Paracetamol is the first-line simple analgesic and antipyretic recommended across pregnancy and lactation for mild-to-moderate pain and fever in obstetric and gynaecological practice.

Adult dose

Dose: 500–1000 mg (1 to 2 × 500 mg soft capsules) per dose
Route: Oral. §4.2 Method of administration, verbatim: 'Capsule The capsules should be swallowed with enough water. The intake of paracetamol with food or drink doesn't influence the efficacy of the medicine.' SCOPE: the page also lists IV, but this bundle contains no IV product and no parenteral posology — nothing here covers IV dosing.
Frequency: Up to four times daily as required. §4.2, verbatim: 'These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.' and 'The administration interval must be at least 4 hours.'
Max: Maximum 4000 mg (8 × 500 mg soft capsules) every 24 hours
SCOPE: oral paracetamol for pain and fever — this page's primary route and indication. The 500 mg strength is pinned by the product itself ('Panadol 500 mg Soft Capsule') and the SPC states the amounts in milligrams as well as in capsules, so these are not bare capsule counts. || §4.2, verbatim: 'For adults and children aged 16 years and older, the usual dosage is 1 to 2 capsules (500-1000 mg) at a time, up to four times daily as required, with a maximum of 8 capsules (4000 mg) every 24 hours.' || DURATION, §4.2 verbatim: 'The treatment should be kept as short as possible.' / 'Depending on the recurrence of symptoms (fever and pain), repeated administration is allowed.' / 'If pain lasts for longer than 5 days or fever lasts for longer than 3 days or these symptoms become worse or if other symptoms occur, the treatment must be stopped, and a doctor must be consulted.' || LOWER CEILING IN CHRONIC ALCOHOLISM, §4.4 verbatim: 'The daily dose may not exceed 2 grams in this case.' — kept out of maxDose above, which carries the single absolute ceiling for the dose shown. || WHAT IS STILL UNSOURCED ON THIS PAGE: the IV limb and the post-caesarean 'IV 1 g TDS' regimen; the '2 g/24h in low body weight <50 kg' rule (this SPC states its 2 g limit for chronic alcoholism, NOT for body weight); the eGFR<30 renal interval; and the RCOG/NICE pregnancy claims — the SPC's own pregnancy wording is recorded verbatim in the pregnancy field and is more measured than a flat 'safe'.

Paediatric dose

Route: Oral (500 mg soft capsules). §4.2, verbatim: 'A suitable dosage form should be used.'
Frequency: Up to four times daily as required; at least 4 hours between doses and no more than four doses in any 24-hour period. §4.2, verbatim: 'These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.'
Max: Maximum daily dosage 2000 mg (4 whole capsules) in children aged 10 to 15 years
⚠️ AGE-BANDED DOSE — 500 mg (one 500 mg soft capsule) at a time applies ONLY to children aged 10 to 15 years. ⚠️ NO PER-KILOGRAM DOSE EXISTS IN THIS BUNDLE, so dosePerKg is null and the weight calculator must not fire; concentration is null because no liquid strength (mg per mL) appears anywhere in the bundle — the sourced product is a capsule. || §4.2 paediatric table, verbatim rows: '10-15 years — 1 capsule at a time, up to four times daily as required, maximum 4 whole capsules per day, maximum daily dosage 2000 mg'; '≥16 years — 1-2 capsules at a time, up to four times daily as required, maximum 8 whole capsules per day, maximum daily dosage 4000 mg' (the 16-and-over band is the adult regimen above). || AGE LIMIT, §4.2 verbatim: 'This medicine is suitable for adults and children aged 10 years and older.' and 'Children should not be given this medicine, for more than 3 days without consulting a doctor.' There is NO posology for children under 10 years in this bundle — for them the SPC says only 'A suitable dosage form should be used.' || §4.4 paediatric warning, verbatim: 'For children a treatment of 60 mg/kg/day of paracetamol combined with another antipyretic is not allowed, unless due to a lack of efficacy.' That is a PROHIBITION on combined antipyretic therapy, not a recommended daily dose. || Verify any paediatric dose against a children's formulary.

Dose adjustments

Renal

No numeric renal dose adjustment and no eGFR/CrCl threshold appears in any fetched section of this SPC. §4.4 states only, verbatim: 'Caution is required when administering paracetamol to patients with moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (incl. Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abuse, dehydration and chronic malnutrition.'

Hepatic

§4.4, verbatim: 'Caution is required when administering paracetamol to patients with moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (incl. Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abuse, dehydration and chronic malnutrition.' The ONLY numeric limit in the fetched text is for chronic alcoholism, verbatim: 'The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case. No alcohol may be used during treatment with paracetamol.' This SPC attaches its 2 g/day limit to CHRONIC ALCOHOLISM, and gives no Child-Pugh-banded maximum for hepatic impairment as such.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3, verbatim and complete — the only contraindication the SPC states: 'Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1'
  • This SPC treats hepatic disease as a §4.4 CAUTION, not a contraindication — verbatim: 'Caution is required when administering paracetamol to patients with moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (incl. Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abuse, dehydration and chronic malnutrition.'
  • Not a contraindication but a §4.2/§4.4 restriction, verbatim: 'Do not use in combination with other paracetamol-containing products.' §4.4 repeats: 'Patients must be advised not to use any other paracetamol-containing products at the same time.'
  • Not a contraindication but a §4.4 caution, verbatim: 'Caution is required in the case of asthmatic patients who are sensitive to acetylsalicylic acid as mild bronchospasms have been reported as a cross-reaction after the use of paracetamol.'
  • Not a contraindication but a §4.4 caution, verbatim: 'Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (refer also to section 4.9). Use with caution in patients with glutathione depletion due to metabolic deficiencies.'
  • Not a contraindication but a §4.4 limit in chronic alcoholism, verbatim: 'The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case. No alcohol may be used during treatment with paracetamol.'
  • Excipient warning specific to this oral soft capsule (§4.4), verbatim: 'This medicine contains 20 mg propylene glycol in each soft capsule.' and 'This medicine contains 108 mg sorbitol liquid in each soft capsule. Sorbitol is a source of fructose.' — relevant to hereditary fructose intolerance; the §4.4 sentence is cut at the source-fetch limit.

Side effects

  • §4.8 summary, verbatim: 'At therapeutic doses few undesirable effects occur. Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure.'
  • Very rare (<1/10,000) — blood and lymphatic system disorders: thrombocytopenia; agranulocytosis
  • Very rare (<1/10,000) — immune system disorders: anaphylaxis; cutaneous hypersensitivity reactions 'including, among others, skin rashes and angiodema' (sic). §4.8 adds: 'Very rare cases of serious skin reactions have been reported.'
  • Very rare (<1/10,000) — respiratory, thoracic and mediastinal disorders: bronchospasm. §4.8 footnote, verbatim: 'There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.'
  • Very rare (<1/10,000) — hepatobiliary disorders: hepatic dysfunction
  • Not known — high anion gap metabolic acidosis, verbatim: 'Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.'
  • §4.4 on overdose, verbatim: 'The taking of several daily doses at once can cause severe damage to the liver. In such cases, a loss of consciousness will not occur. However, immediate medical help must be sought even if the patient feels well because of the risk of irreversible damage to the liver (see section 4.9).'

Monitoring

  • No laboratory monitoring is specified in any fetched section of this SPC — the review instructions below are the only monitoring requirements it states. ⚠️ The page's 'hepatic function in prolonged use or overdose' and 'LFTs' items are NOT drawn from this bundle.
  • Cumulative paracetamol exposure across all preparations — §4.2/§4.4, verbatim: 'Do not use in combination with other paracetamol-containing products.' / 'Patients must be advised not to use any other paracetamol-containing products at the same time.'
  • Dose ceiling — §4.2/§4.4, verbatim: 'Do not exceed the recommended daily dose on account of the risk of severe hepatic damage (see section 4.4 and 4.9).' / 'The recommended dose should not be exceeded.'
  • §4.4, verbatim: 'In the case of a high fever, symptoms of secondary infection or the persistence of symptoms, it will be necessary to reconsider the treatment.'
  • §4.2, verbatim: 'If pain lasts for longer than 5 days or fever lasts for longer than 3 days or these symptoms become worse or if other symptoms occur, the treatment must be stopped, and a doctor must be consulted.'
  • Duration — §4.2/§4.4, verbatim: 'The treatment should be kept as short as possible.' / 'Long-term or frequent use is not advised.' / 'Long-term use can be harmful except under medical supervision.' / 'Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.'

Clinical monograph

How it works

It produces analgesia and antipyresis through poorly characterised central inhibition of prostaglandin synthesis and modulation of central pain pathways, with little peripheral anti-inflammatory effect.

Prescribing in practice

  • Hepatotoxicity in overdose is the key hazard; total intake from all combination products must be counted and the maximum daily dose not exceeded, with lower ceilings considered in low body-weight or chronic-malnutrition states.
  • It is the preferred analgesic in pregnancy and breastfeeding, with NSAIDs avoided in the third trimester and opioids reserved for severe pain.
  • Effective for many obstetric and gynaecological pains but inadequate alone for severe procedural or post-operative pain, where multimodal analgesia is needed.

Monitoring

Routine monitoring is not required at therapeutic doses, but in suspected overdose timed plasma paracetamol concentrations and liver function guide acetylcysteine treatment.

Counselling the patient

  • Do not take other products containing paracetamol at the same time, as accidental overdose can seriously damage the liver.
  • It is considered safe in pregnancy and breastfeeding when taken at the recommended dose for the shortest time needed.
  • Seek urgent help after any overdose even if you feel well, because liver injury can be delayed.

Evidence & guidelines

Paracetamol is endorsed by NICE and UK obstetric guidance as the analgesic and antipyretic of choice in pregnancy.

Reference: RCOG (2022) Obstetric Analgesics guidance; NICE CG190; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways