Auranofin 3 mg Capsule, 60-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Gold preparations class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- You'll need to be patient — this is not a quick-relief medicine. Most people start to notice improvement after three to four months of consistent use, and for some it can take as l...
- How long before I notice auranofin actually helping my arthritis?
- Because auranofin contains gold, and gold can cause serious problems with your blood cells and kidneys — sometimes without obvious symptoms at first. Regular lab work catches these...
- Why does my doctor keep ordering blood tests and urine tests while I'm on this?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Auranofin — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $26.25 | $1,575.01 / 60 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ridaura 3 mg 54766-0093-06 | Sebela | 60 capsules | $24.845 | — | Availability likely | — |
| Auranofin 3 mgthis 85437-0093-06 | Coral | 60 capsules | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85437-0093-06 You're viewing this | 60 CAPSULE in 1 BOTTLE (85437-093-06) | 2025-10-29 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Auranofin Capsules (auranofin) contains gold and, like other gold-containing drugs, can cause gold toxicity, signs of which include: fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Therefore, the results of recommended laboratory work (See PRECAUTIONS ) should be reviewed before writing each Auranpfin Capsules prescription. Like other gold preparations, Auranofin Capsules is only indicated for use in selected patients with active rheumatoid arthritis.
Physicians planning to use Auranofin Capsules should be experienced with chrysotherapy and should thoroughly familiarize themselves with the toxicity and benefits of Auranofin Capsules. In addition, the following precautions should be routinely employed: The possibility of adverse reactions should be explained to patients before starting therapy. Patients should be advised to report promptly any symptoms suggesting toxicity.
(See PRECAUTIONS—Information for Patients .)
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Auranofin Capsules (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. Auranofin Capsules should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, Auranofin Capsules does not produce an immediate response.
Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage.
In controlled clinical trials comparing Auranofin Capsules with injectable gold, Auranofin Capsules was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of Auranofin Capsules in patients who are candidates for chrysotherapy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Usual Adult Dosage: The usual adult dosage of Auranofin Capsules (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, Auranofin therapy should be discontinued. Safety at dosages exceeding 9 mg daily has not been studied. Transferring from Injectable Gold: In controlled clinical studies, patients on injectable gold have been transferred to Auranofin Capsules (auranofin) by discontinuing the injectable agent and starting oral therapy with Auranofin Capsules, 6 mg daily.
When patients are transferred to Auranofin Capsules, they should be informed of its adverse reaction profile, in particular the gastrointestinal reactions. (See PRECAUTIONS— Information for Patients .) At six months, control of disease activity of patients transferred to Auranofin Capsules and those maintained on the injectable agent was not different. Data beyond six months are not available.
⛔ Contraindications ▾
CONTRAINDICATIONS Auranofin Capsules (auranofin) is contraindicated in patients with a history of any of the following gold-induced disorders: anaphylactic reactions, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasia or other severe hematologic disorders.
⚠️ Warnings ▾
WARNINGS Danger signs of possible gold toxicity include fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Thrombocytopenia has occurred in 1–3% of patients (See ADVERSE REACTIONS ) treated with Auranofin Capsules (auranofin), some of whom developed bleeding. The thrombocytopenia usually appears to be peripheral in origin and is usually reversible upon withdrawal of Auranofin Capsules.
Its onset bears no relationship to the duration of Auranofin Capsules therapy and its course may be rapid. While patients' platelet counts should normally be monitored at least monthly (See PRECAUTIONS— Laboratory Tests ), the occurrence of a precipitous decline in platelets or a platelet count less than 100,000/cu mm or signs and symptoms (e.g., purpura, ecchymoses or petechiae) suggestive of thrombocytopenia indicates a need to immediately withdraw Auranofin Capsules and other therapies with the potential to cause thrombocytopenia, and to obtain additional platelet counts.
No additional Auranofin Capsules should be given unless the thrombocytopenia resolves and further studies show it was not due to gold therapy. Proteinuria has developed in 3-9% of patients (See ADVERSE REACTIONS ) treated with Auranofin Capsules. If clinically significant proteinuria or microscopic hematuria is found (See PRECAUTIONS— Laboratory Tests ), Auranofin Capsules and other therapies with the potential to cause proteinuria or microscopic hematuria should be stopped immediately.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The adverse reactions incidences listed below are based on observations of 1) 4,784 Auranofin Capsules treated patients in clinical trials (2,474 U.S., 2,310 foreign), of whom 2,729 were treated more than one year and 573 for more than three years; and 2) postmarketing experience. The highest incidence is during the first six months of treatment; however, reactions can occur after many months of therapy. With rare exceptions, all patients were on concomitant nonsteroidal anti-inflammatory therapy; some of them were also taking low dosages of corticosteroids.
Reactions occurring in more than 1% of Auranofin Capsules-treated patients Gastrointestinal: loose stools or diarrhea (47%); abdominal pain (14%); nausea with or without vomiting (10%); constipation; anorexia*; flatulence*; dyspepsia*; dysgeusia. Dermatological: rash (24%); pruritus (17%); hair loss; urticaria. Mucous Membrane: stomatitis (13%); conjunctivitis*; glossitis.
Hematological: anemia; leukopenia; thrombocytopenia; eosinophilia. Renal: proteinuria*; hematuria. Hepatic: elevated liver enzymes. *Reactions marked with an asterisk occurred in 3-9% of the patients.
The other reactions listed occurred in 1-3%. Reactions occurring in less than 1% of Auranofin Capsules-treated patients Gastrointestinal: dysphagia; gastrointestinal bleeding†; melena†; positive stool for occult blood†; ulcerative enterocolitis. Dermatological: angioedema.
Mucous Membrane: gingivitis†. Hematological: aplastic anemia; neutropenia†; agranulocytosis; pure red cell aplasia; pancytopenia. Hepatic: jaundice.
Respiratory: interstitial pneumonitis. Neurological: peripheral neuropathy. Ocular: gold deposits in the lens or cornea unassociated clinically with eye disorders or visual impairment. † Reactions marked with a dagger occurred in 0.1-1% of the patients.
The other reactions listed occurred in less than 0.1%. Reactions reported with injectable gold preparations, but not with Auranofin Capsules (auranofin) (based on clinical trials and on postmarketing experience) Cutaneous Reactions: generalized exfoliative dermatitis Incidence of Adverse Reactions for Specific Categories – 18 Comparative Trials Ridaura (445 patients) Injectable Gold (445 patients) Proteinuria 0.9% 5.4% Rash 26% 39% Diarrhea 42.5% 13% Stomatitis 13% 18% Anemia 3.1% 2.7% Leukopenia 1.3% 2.2% Thromocytopenia 0.9% 2.2% Elevated liver function tests 1.9% 1.7% Pulmonary 0.2% 0.2%
🔄 Drug Interactions ▾
Drug Interactions: In a single patient-report, there is the suggestion that concurrent administration of Auranofin Capsules and phenytoin may have increased phenytoin blood levels.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects— Pregnancy Category C. Use of Auranofin Capsules (auranofin) by pregnant women is not recommended. Furthermore, women of childbearing potential should be warned of the potential risks of Auranofin Capsules therapy during pregnancy.
(See below.) Pregnant rabbits given auranofin at doses of 0.5, 3 or 6 mg/kg/day (4.2 to 50 times the human dose) had impaired food intake, decreased maternal weights, decreased fetal weights and an increase above controls in the incidence of resorptions, abortions and congenital abnormalities, mainly abdominal defects such as gastroschisis and umbilical hernia. Pregnant rats given auranofin at a dose of 5 mg/kg/day (42 times the human dose) had an increase above controls in the incidence of resorptions and a decrease in litter size and weight linked to maternal toxicity.
No such effects were found in rats given 2.5 mg/kg/day (21 times the human dose). Pregnant mice given auranofin at a dose of 5 mg/kg/day (42 times the human dose) had no teratogenic effects. There are no adequate and well-controlled RIDAURA studies in pregnant women.
🧒 Pediatric Use ▾
Pediatric Use: Auranofin Capsules (auranofin) is not recommended for use in pediatric patients because its safety and effectiveness have not been established.
🆘 Overdosage ▾
OVERDOSAGE The acute oral LD50 for auranofin is 310 mg/kg in adult mice and 265 mg/ kg in adult rats. The minimum lethal dose in rats is 30 mg/kg. In case of acute overdosage, immediate induction of emesis or gastric lavage and appropriate supportive therapy are recommended.
Auranofin Capsules overdosage experience is limited. A 50-year-old female, previously on 6 mg Auranofin Capsules daily, took 27 mg (9 capsules) daily for 10 days and developed an encephalopathy and peripheral neuropathy. Auranofin Capules was discontinued and she eventually recovered.
There has been no experience with treating Auranofin Capsules overdosage with modalities such as chelating agents. However, they have been used with injectable gold and may be considered for Auranofin Capsules overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mechanism of action of auranofin is not understood. In patients with adult rheumatoid arthritis, Auranofin Capsules may modify disease activity as manifested by synovitis and associated symptoms, and reflected by laboratory parameters such as ESR. There is no substantial evidence, however, that gold-containing compounds induce remission of rheumatoid arthritis.
Pharmacokinetics: Pharmacokinetic studies were performed in rheumatoid arthritis patients, not in normal volunteers. Auranofin is rapidly metabolized and intact auranofin has never been detected in the blood. Thus, studies of the pharmacokinetics of auranofin have involved measurement of gold concentrations.
Approximately 25% of the gold in auranofin is absorbed. The mean terminal plasma half-life of auranofin gold at steady state was 26 days (range 21 to 31 days; n=5). The mean terminal body half-life was 80 days (range 42 to 128; n=5).
Approximately 60% of the absorbed gold (15% of the administered dose) from a single dose of auranofin is excreted in urine; the remainder is excreted in the feces. In clinical studies, steady state blood-gold concentrations are achieved in about three months. In patients on 6 mg auranofin/day, mean steady state blood-gold concentrations were 0.68 ±0.45 mcg/mL (n=63 patients).
In blood, approximately 40% of auranofin gold is associated with red cells, and 60% associated with serum proteins. In contrast, 99% of injectable gold is associated with serum proteins. Mean blood-gold concentrations are proportional to dose; however, no correlation between blood-gold concentrations and safety or efficacy has been established.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Capsules, containing 3 mg auranofin, in bottles of 60. NDC 85427-093-06 STORAGE AND HANDLING Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light-resistant container. Distributed by: Coral Way Pharma, LLC San Antonio, TX 78213 1-210-641-5334 Revised September 2025 PI 09306001
📦 Storage and Handling ▾
STORAGE AND HANDLING Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light-resistant container. Distributed by: Coral Way Pharma, LLC San Antonio, TX 78213 1-210-641-5334 Revised September 2025 PI 09306001
📋 Description ▾
DESCRIPTION Auranofin Capsules (auranofin) is available in oral form as capsules containing 3 mg auranofin. Auranofin is (2,3,4,6-tetra-O-acetyl-1-thio-ß-D-glucopyranosato-S-) (triethyl–phosphine) gold. Auranofin contains 29% gold and has the following chemical structure: Each Auranofin Cpsule, with opaque brown cap and opaque tan body, contains auranofin, 3 mg, and is imprinted with the product name RIDAURA.
Inactive ingredients consist of benzyl alcohol, cellulose, cetylpyridinium chloride, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No.
40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients. Chemical Structure
💬 Information for Patients ▾
Information for Patients: Patients should be advised of the possibility of toxicity from Auranofin Capsules and of the signs and symptoms that they should report promptly. (Patient information sheets are available.) Women of childbearing potential should be warned of the potential risks of Auranofin Capsules therapy during pregnancy (See PRECAUTIONS— Pregnancy ).