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NSAID Analgesia Pregnancy: Contraindicated in the third trimester; avoid unless clearly necessary earlier. Verbatim §4.6: 'From the 20th week of pregnancy onward, [ibuprofen] use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, [ibuprofen] should not be given unless clearly necessary. If [ibuprofen] is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to [ibuprofen] for several days from gestational week 20 onward. [Ibuprofen] should be discontinued if oligohydramnios or ductus arteriosus constriction are found. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (with premature constriction/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction...; the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, [ibuprofen] is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3).' Lactation, verbatim: 'In limited studies, ibuprofen appears in the breast milk in very low concentrations, and is unlikely to affect the breast fed infant adversely.' (The bracketed name replaces the SPC's brand name 'Anadin Joint Pain 200mg tablets'; no other wording is altered.)

Ibuprofen

Brand names: Nurofen, Brufen

Ibuprofen, a non-steroidal anti-inflammatory drug, used for pain and inflammation; in the obstetric and gynaecological context it is commonly used postpartum and for conditions such as dysmenorrhoea, with important pregnancy-related restrictions.

Adult dose

Dose: 200–400 mg (1 or 2 x 200 mg tablets)
Route: Oral
Frequency: Up to 3 times a day as required; at least 4 hours between doses
Max: Maximum 1200 mg (6 x 200 mg tablets) in any 24-hour period — §4.2, verbatim: 'do not take more than 6 tablets in any 24 hour period'; and 'Leave at least 4 hours between doses.'
SCOPE — this page's primary use is oral NSAID analgesia in obstetrics and gynaecology (dysmenorrhoea, endometriosis-related pain, post-operative gynaecological analgesia). The fetched SPC's §4.2 is an INDICATION-AGNOSTIC adult oral analgesic posology ('as required', to 'relieve symptoms') — it is the same route and the same analgesic use as this page, but it contains NO gynaecology-specific regimen: dysmenorrhoea, endometriosis and post-operative gynaecological analgesia are named nowhere in it, and neither is a start-before-menses schedule. Publish as the general adult oral analgesic dose only. Verbatim §4.2: 'For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.' Dose, verbatim: '1 or 2 tablets to be taken, up to 3 times a day, as required. The tablets should be taken with water. When 2 tablets are taken, pain relief can last for up to 8 hours. Leave at least 4 hours between doses and do not take more than 6 tablets in any 24 hour period.' The tablet strength is pinned by the product itself — 'Anadin Joint Pain 200mg Tablets' — so 1–2 tablets = 200–400 mg and the 6-tablet ceiling = 1200 mg in 24 hours. Duration, verbatim: 'For adults aged 18 years or older the minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen or persist, the patient should consult a pharmacist or a doctor.' NOT A DOSE: §4.4 discusses 'high doses (2400mg/day)' only as a cardiovascular RISK statement — 'Clinical studies suggest that use of ibuprofen, particularly at high doses (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200mg daily) is associated with an increased risk of arterial thrombotic events.' That figure is a warning threshold, not a permitted maximum, and does NOT license a 2.4 g/day regimen from this bundle. No prescription-strength regimen (400 mg / 600 mg per dose, 1.2–2.4 g daily) appears anywhere in the fetched SPC.

Paediatric dose

Route: Oral
Frequency: Up to 3 times a day as required; at least 4 hours between doses (12 years and over only)
Max: Maximum 1200 mg (6 x 200 mg tablets) in any 24-hour period — §4.2, verbatim: 'do not take more than 6 tablets in any 24 hour period'; and 'Leave at least 4 hours between doses.'
dosePerKg is null deliberately: this SPC contains NO per-kg paediatric figure of any kind. Verbatim §4.2: 'Adults, the elderly, and children and adolescents over 12 years of age: ... 1 or 2 tablets to be taken, up to 3 times a day, as required.' and, explicitly, 'Not to be given to children under 12 years of age.' Also verbatim: 'If in children and adolescents, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.' §4.4 adds: 'Caution should be exercised when initiating treatment with ibuprofen in children with considerable dehydration. There is a risk of renal impairment in dehydrated children.' concentration is null: the bundle's product is a 200 mg TABLET and no oral suspension strength appears in it, so no volume can be calculated. Verify any dose for a child under 12 against a children's formulary — this bundle cannot support one.

Dose adjustments

Renal

No renal dose adjustment is given anywhere in this SPC. §4.3 contraindicates ibuprofen in 'Patients with severe hepatic failure, renal failure or severe heart failure (NYHA Class IV)'. §4.4 requires caution in 'Renal impairment as renal function may deteriorate' and in 'Oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur', and warns that 'Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks)'. No eGFR threshold appears in the fetched text.

Hepatic

No hepatic dose adjustment is given anywhere in this SPC. §4.3 contraindicates 'severe hepatic failure'; §4.4 lists 'Hepatic dysfunction (see section 4.3 and 4.8)' among the conditions requiring caution; §4.8 records liver disorders as a very rare adverse reaction. No graded (mild/moderate/severe) dosing rule appears in the fetched text.

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

  • Hypersensitivity to ibuprofen or to any of the constituents of the product (§4.3)
  • Previous hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other NSAIDs (§4.3)
  • Active or previous peptic ulcer — 'two or more distinct episodes of proven ulceration or bleeding' (§4.3)
  • History of upper gastrointestinal bleeding or perforation related to previous NSAID therapy (§4.3)
  • Severe hepatic failure, renal failure or severe heart failure (NYHA Class IV) (§4.3)
  • Use in the last trimester of pregnancy (§4.3, see §4.6)

Side effects

  • Gastrointestinal — common: nausea, dyspepsia, diarrhoea, vomiting; uncommon: abdominal pain, flatulence, constipation; rare: intestinal diaphragm disease; very rare: 'Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly' and exacerbation of ulcerative colitis and Crohn's disease
  • Nervous system — common: headache, drowsiness, dizziness; psychiatric — rare: nervousness
  • Renal and urinary — rare: tubulointerstitial nephritis, nephrotic syndrome, haematuria, proteinuria; very rare: 'Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema'; not known: ureteric colic, dysuria and renal tubular acidosis
  • Cardiac and vascular — rare: cardiac failure, hypertension, oedema; not known: Kounis syndrome and 'Arterial thrombotic events e.g. myocardial infarction or stroke'
  • Metabolism — not known: decreased appetite and hypokalaemia
  • Hepatobiliary — very rare: liver disorders
  • Blood — very rare: haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis); '§4.8: First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising'
  • Skin — uncommon: skin rashes; very rare: severe cutaneous adverse reactions (SCARs) including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, and DRESS; not known: photosensitivity reactions and acute generalised exanthematous pustulosis (AGEP)
  • Immune — uncommon: hypersensitivity reactions including urticaria and pruritus; aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation) in patients with existing autoimmune disorders such as SLE or mixed connective tissue disease
  • Bronchospasm — §4.4: 'Bronchospasms may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease'

Monitoring

  • This SPC has no dedicated monitoring section — the items below are the §4.4 precautions it does state. Overarching: 'Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration to control symptoms.'
  • GI symptoms and bleeding — §4.4 requires caution in 'Gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn's disease)'; §4.8 warns of peptic ulcer, perforation or haemorrhage 'sometimes fatal, particularly in the elderly'.
  • Renal function and hydration — §4.4: 'Renal impairment as renal function may deteriorate'; 'Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.'
  • Blood pressure, oedema and cardiac status — §4.4: 'Caution is required prior to starting treatment in patients with a history of hypertension and/or heart failure' and in 'Oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur'.
  • Cardiovascular risk before and during longer courses — §4.4: patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease 'should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided'.
  • Liver function — §4.4 lists 'Hepatic dysfunction' among the conditions requiring caution (and §4.3 contraindicates severe hepatic failure).
  • The elderly — §4.4: 'The elderly are at increased risk of the serious consequences of adverse reactions.'

Clinical monograph

How it works

Ibuprofen reversibly inhibits cyclo-oxygenase enzymes, reducing prostaglandin synthesis and thereby producing analgesic, anti-inflammatory and antipyretic effects.

Prescribing in practice

  • NSAIDs should be avoided in pregnancy, particularly from the second half onwards, because of the risk of premature closure of the fetal ductus arteriosus, oligohydramnios and impaired fetal renal function, with MHRA advice reinforcing avoidance from around the midpoint of pregnancy.
  • Gastrointestinal ulceration and bleeding, and renal impairment, are class risks, especially in those who are dehydrated, older or on other nephrotoxic drugs.
  • Only small amounts pass into breast milk, so it is generally considered suitable for postnatal pain in breastfeeding women.

Monitoring

Monitor for gastrointestinal and renal adverse effects, particularly with prolonged use or in those with risk factors.

Counselling the patient

  • Do not take ibuprofen in pregnancy unless specifically advised, especially in later pregnancy.
  • Take it with food and stop if you develop stomach pain, indigestion or black stools.
  • It is considered compatible with breastfeeding for short-term pain relief.

Evidence & guidelines

MHRA and NICE advice support avoiding NSAIDs such as ibuprofen in pregnancy, particularly from around the midpoint, owing to fetal cardiovascular and renal risks.

Reference: FDA Drug Safety Communication (2020) NSAIDs in pregnancy; MHRA (2013); 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.

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