DMARD (oral gold compound) Pregnancy: US label: Pregnancy Category C (teratogenic effects). 'Use of RIDAURA (auranofin) by pregnant women is not recommended. Furthermore, women of childbearing potential should be warned of the potential risks of RIDAURA therapy during pregnancy.' In pregnant rabbits at 4.2 to 50 times the human dose there were impaired food intake, decreased maternal and fetal weights and increased resorptions, abortions and congenital abnormalities (mainly abdominal defects such as gastroschisis and umbilical hernia); in pregnant rats at 42 times the human dose there were increased resorptions and reduced litter size and weight linked to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. (US labelling — verify against the UK SPC §4.6.)

Auranofin

Brand names: Ridaura

Auranofin is an orally administered gold compound (gold salt) historically used as a disease-modifying antirheumatic drug in rheumatoid arthritis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 6 mg daily, given either as 3 mg twice daily or as 6 mg once daily

Route: Oral

Frequency: Once or twice daily

Max: 9 mg daily (3 mg three times daily). Safety at dosages exceeding 9 mg daily has not been studied.

NO UK SPC (eMC) WAS RETRIEVED IN THIS BUNDLE — the regimen above is taken from the US FDA prescribing information for RIDAURA (Sebela Pharmaceuticals Inc.; label date 2025-11-08; https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=431445cb-3625-82d8-e063-6394a90aeaea). VERBATIM (Usual Adult Dosage): 'The usual adult dosage of RIDAURA (auranofin) is 6 mg daily, given either as 3 mg twice daily or 6 mg once daily. Initiation of therapy at dosages exceeding 6 mg daily is not recommended because it is associated with an increased incidence of diarrhea. If response is inadequate after six months, an increase to 9 mg (3 mg three times daily) may be tolerated. If response remains inadequate after a three-month trial of 9 mg daily, RIDAURA therapy should be discontinued. Safety at dosages exceeding 9 mg daily has not been studied.' TRANSFERRING FROM INJECTABLE GOLD: 'patients on injectable gold have been transferred to RIDAURA (auranofin) by discontinuing the injectable agent and starting oral therapy with RIDAURA, 6 mg daily'; patients should be informed of its adverse reaction profile, in particular the gastrointestinal reactions. At six months, control of disease activity in patients transferred to auranofin and those maintained on the injectable agent was not different; data beyond six months are not available. PAEDIATRIC: 'RIDAURA (auranofin) is not recommended for use in pediatric patients because its safety and effectiveness have not been established' — no paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. NO RENAL OR HEPATIC DOSING SECTION WAS RETRIEVED IN THIS BUNDLE (proteinuria and haematuria are listed as adverse reactions). The adverse reactions section of the fetched US label was truncated at the source-fetch limit — clinician to confirm against the full label and the UK SPC before publication.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

History of gold-induced anaphylactic reactions
History of gold-induced necrotising enterocolitis
History of gold-induced pulmonary fibrosis
History of gold-induced exfoliative dermatitis
History of gold-induced bone marrow aplasia or other severe haematologic disorders

Side effects

Loose stools or diarrhoea (47%) — the most frequent adverse reaction; abdominal pain (14%)
Rash (24%) and pruritus (17%)
Stomatitis (13%)
Nausea with or without vomiting (10%)
Haematological: anaemia, leukopenia, thrombocytopenia, eosinophilia (1–3%)
Renal: proteinuria (3–9%) and haematuria; hepatic: elevated liver enzymes

Interactions

Phenytoin — in a single patient report there is the suggestion that concurrent administration of auranofin and phenytoin may have increased phenytoin blood levels (the only drug interaction stated in this label)

Clinical monograph

How it works

Its precise mechanism is not fully defined, but gold accumulates in synovial macrophages and is thought to modulate immune and inflammatory cell function, reducing joint inflammation.

Prescribing in practice

Can cause bone marrow suppression and proteinuria, so blood counts and urinalysis must be monitored throughout treatment.
It is now rarely used, having been largely superseded by methotrexate and biologic agents.
Diarrhoea and gastrointestinal upset are common and may limit tolerability.

Monitoring

Monitor full blood count, renal function and urine for protein periodically during therapy, with the frequency guided by current prescribing references.

Counselling the patient

Report any unexplained bruising, bleeding, sore throat or rash promptly.
Loose stools are common early in treatment and should be reported if persistent.

Evidence & guidelines

Oral gold has a long-established but limited evidence base and has largely been replaced by more effective disease-modifying therapies in current practice.

Reference: SmPC Ridaura; BSR Rheumatoid Arthritis Guideline 2018; EULAR RA Management 2022; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways