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NSAID (oxicam) Pregnancy: CONTRAINDICATED IN THE THIRD TRIMESTER (§4.3: 'During the last trimester of pregnancy'). eMC §4.6, verbatim extracts — Fertility: 'the use of NSAIDs, including piroxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including piroxicam, should be considered.' Pregnancy: 'the safety of piroxicam during pregnancy or during lactation has not yet been established'; 'In view of the known effects of NSAIDs on the foetal CV system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child'; 'Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy'; 'From the 20th week of pregnancy onward, piroxicam use may cause oligohydramnios resulting from foetal renal dysfunction... there have been reports of ductus arteriosus constriction following treatment in the second trimester'; 'Therefore, during the first and second trimester of pregnancy, piroxicam should not be given unless clearly necessary. If piroxicam 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 piroxicam for several days from gestational week 20 onward. Piroxicam should be discontinued if oligohydramnios or ductus arteriosus constriction are found.' US §8.1: 'Use of NSAIDs, including piroxicam capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of piroxicam capsules in pregnant women.' ⚠️ Both pregnancy sections are cut at the source-fetch limit; the eMC text breaks mid-list at 'inhibition of uterine […]', and no breast-feeding paragraph was retrieved.

Piroxicam

Brand names: Feldene

Piroxicam is a long-acting non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, used for inflammatory and degenerative joint disease where other options are unsuitable.

Adult dose

Dose: 20 mg once daily as a single dose (recommended starting dose in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis); the majority of patients are maintained on 20 mg daily, and a relatively small group of patients may be maintained on 10 mg daily
Route: Oral, 'to be taken preferably with or after food' (§4.2). SCOPE: the fetched sources cover ORAL capsules only — the topical 3% gel also carried on this page is not covered by any fetched source, and no topical figure is drafted here.
Frequency: Once daily. §4.2: 'The recommended starting dose is 20mg given as a single daily dose.' The US label adds: 'If desired, the daily dose may be divided.'
Max: 20 mg daily. §4.2, verbatim: 'The maximum recommended daily dose is 20mg.'
SCOPE — this draft covers the page's primary route and indications: oral piroxicam for rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, which is exactly what both fetched labels dose. The page's topical 3% gel is unsourced in this bundle and is deliberately left undrafted. ⚠️ INTERNAL TENSION IN §4.2, BOTH SENTENCES VERBATIM AND BOTH IN THE SAME SECTION: 'The maximum recommended daily dose is 20mg' and, three sentences later, 'Some patients may require up to 30mg daily given in single or divided doses. Long-term administration of doses 30mg or higher carries an increased risk of gastro-intestinal side effects.' The stated MAXIMUM is 20 mg and that is what the maxDose field carries; §4.4 reinforces it — 'Administration of doses of greater than 20 mg per day carries an increased risk of GI side effects' — as does §4.8: 'Administration of doses exceeding 20mg daily (of more than several days duration) carries an increased risk of gastrointestinal side effects, but they may also occur with lower doses'. Do not promote the 30 mg sentence into the maximum. PRESCRIBER RESTRICTION, verbatim §4.2: 'The prescription of Piroxicam should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases.' DURATION, verbatim §4.2: 'Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review.' GASTROPROTECTION, verbatim §4.2: 'Given that Piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.' ELDERLY, verbatim §4.2: 'The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.' §4.4 adds: 'The risk for developing serious GI complications increased with age. Age over 70 years is associated with high risk of complications. The administration to patients older than 80 years old should be avoided.' CYP2C9, verbatim §4.4: 'Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance' — a caution, with no numeric dose reduction given. ONSET, US label: 'Because of the long half-life of piroxicam capsules, steady-state blood levels are not reached for 7 to 12 days... the effect of therapy should not be assessed for two weeks.' STRENGTHS, US §3: 'Piroxicam Capsules, USP are available containing 10 mg or 20 mg of piroxicam, USP.'

Dose adjustments

Renal

No numeric dose adjustment is stated in either label. §4.2 (Elderly) gives a caution only: 'As with other NSAIDs caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.' The US label states use restrictions rather than a dose change — §5.6, verbatim: 'Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of piroxicam capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.' Note that eMC §4.4 and US §5 are both cut at the source-fetch limit, so any further renal wording was not retrieved. Do not infer a numeric adjustment.

Hepatic

No numeric dose adjustment is stated in either label. §4.2 (Elderly) gives the same caution about patients 'more likely to be suffering from impaired renal, hepatic or cardiac function'. The US label, §5.3, verbatim: 'Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.' §5.6 additionally directs monitoring of renal function in hepatic impairment. eMC §4.4 and US §5 are cut at the source-fetch limit. Do not infer a numeric adjustment.

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

  • History of gastro-intestinal ulceration, bleeding or perforation (§4.3)
  • Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis (§4.3)
  • Active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding (§4.3)
  • Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses (§4.3)
  • Concomitant use with anticoagulants (§4.3)
  • History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (§4.3)
  • Hypersensitivity to the active substance or any of the excipients, and previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications (§4.3)
  • Previous hypersensitivity reactions (e.g. asthma, nasal polyps, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (§4.3)
  • The last trimester of pregnancy (§4.3, see §4.6)
  • Severe heart failure (§4.3)
  • US label adds: 'In the setting of CABG surgery'

Side effects

  • ⚠️ FREQUENCY CATEGORIES COULD NOT BE ATTRIBUTED — the §4.8 table has six frequency columns (very common / common / uncommon / rare / very rare / not known) but arrives flattened in this bundle, so each reaction below is listed under its system organ class only. Do not read any of them as carrying a stated frequency.
  • Blood and lymphatic system: anaemia, eosinophilia, leucopenia, thrombocytopenia, aplastic anaemia, haemolytic anaemia
  • Immune system: anaphylaxis, serum sickness
  • Metabolism and nutrition: anorexia, hyperglycaemia, hypoglycaemia, fluid retention
  • Psychiatric: depression, dream abnormalities, hallucinations, insomnia, mental confusion, mood alterations, nervousness
  • Nervous system: dizziness, headache, somnolence, vertigo, paraesthesia
  • Eye: blurred vision, eye irritations, swollen eyes
  • Ear and labyrinth: tinnitus, hearing impairment
  • Cardiac: palpitations, cardiac failure, arterial thrombotic events
  • Vascular: vasculitis, hypertension
  • Respiratory, thoracic and mediastinal: bronchospasm, dyspnoea, epistaxis
  • Gastrointestinal: abdominal discomfort, abdominal pain, constipation, diarrhoea, epigastric distress, flatulence, nausea, vomiting, indigestion, stomatitis, gastritis, gastrointestinal bleeding (including haematemesis and melaena), pancreatitis, perforation, ulceration
  • Hepatobiliary: fatal hepatitis, jaundice
  • Renal and urinary: interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, glomerulonephritis
  • Skin and subcutaneous tissue: pruritus, skin rash, severe cutaneous adverse reactions (SCARs) — Stevens-Johnson syndrome and toxic epidermal necrolysis — alopecia, angioedema, dermatitis exfoliative, erythema multiforme, non-thrombocytopenic purpura (Henoch-Schoenlein), onycholysis, photoallergic reactions, urticaria, vesiculo-bullous reactions, fixed drug eruption
  • Reproductive system and breast: female fertility decreased
  • General: oedema (mainly of the ankle), malaise
  • Investigations: increased serum transaminase levels, weight increase, positive ANA, weight decrease, decreases in haemoglobin and haematocrit unassociated with obvious gastro-intestinal bleeding
  • US label, most common adverse reactions (incidence >2% from clinical trials): nausea, constipation, flatulence, abdominal pain, diarrhea, headache, dizziness, edema, rash
  • ⚠️ eMC §4.8 and US §6 are both cut at the source-fetch limit — the eMC text breaks mid-sentence at 'Oedema, hypertension, and cardiac failure, […]', so this list is incomplete

Monitoring

  • Formal review of benefit and tolerability within 14 days — §4.2: 'The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review.' §4.4 adds: 'The clinical benefit and tolerability should be re-evaluated periodically'
  • Regular monitoring for GI bleeding during NSAID therapy, specifically named for elderly patients (§4.2); §4.4: 'Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during Piroxicam treatment. Patients should be asked to report any new or unusual abdominal symptom during treatment'
  • Immediate discontinuation at the first appearance of cutaneous reactions or relevant gastrointestinal events (§4.4); the US label likewise: 'Discontinue piroxicam capsules at first appearance of skin rash or other signs of hypersensitivity'
  • Blood pressure — US §5.4: 'Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure'
  • Renal function — US §5.6: 'Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia'
  • Liver tests — US §5.3: 'Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop'
  • If a gastrointestinal complication is suspected during treatment, piroxicam 'should be discontinued immediately and additional clinical evaluation and treatment should be considered' (§4.4)
  • Do not assess therapeutic effect too early — US label: 'the effect of therapy should not be assessed for two weeks'

Clinical monograph

How it works

It inhibits cyclo-oxygenase, reducing prostaglandin synthesis and thereby producing anti-inflammatory and analgesic effects.

Prescribing in practice

  • Because of a higher risk of serious gastrointestinal and skin reactions, MHRA advice restricts piroxicam to second-line use in rheumatic disease, initiated only by specialists, and not for acute pain.
  • It carries the usual NSAID cardiovascular, renal, and bleeding risks and should be used at the lowest effective dose for the shortest time.
  • Gastroprotection should be considered, particularly in older patients or those with risk factors for ulceration.

Monitoring

Monitor renal function, blood pressure, and for gastrointestinal symptoms or signs of bleeding, especially in at-risk patients.

Counselling the patient

  • Take with or after food and report any indigestion, black stools, or signs of stomach bleeding.
  • Stop and seek urgent advice if any skin rash, blistering, or mouth ulceration develops.
  • Avoid other anti-inflammatory painkillers unless advised by your clinician.

Evidence & guidelines

MHRA review of piroxicam led to restricted indications and prescribing safeguards because of its gastrointestinal and dermatological risk profile.

Reference: MHRA; NICE; 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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