Ridaura Side Effects
Generic Name: auranofin
Note: This document contains side effect information about auranofin. Some of the dosage forms listed on this page may not apply to the brand name Ridaura.
For the Consumer
Applies to auranofin: oral capsule
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Very bad belly pain.
- Skin irritation.
- Change in eyesight, eye pain, or very bad eye irritation.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Belly pain.
- Loose stools (diarrhea).
- Not hungry.
- Upset stomach or throwing up.
- Stomach cramps.
- Mouth irritation or mouth sores.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to auranofin: oral capsule
In one study evaluating the incidence of diarrhea during auranofin (the active ingredient contained in Ridaura) therapy, diarrhea occurred in 74% of patients during the first month of treatment. The diarrhea was categorized as mild in 64% of cases, moderate in 28% of cases, and severe in 8% of cases. These symptoms may be reduced by the use of antidiarrheals or bulk-forming agents. Approximately 11% of patients required discontinuation of therapy.
Diarrhea is often dose-related as it increases in incidence with higher doses (for example, 9 mg per day). Initiating therapy at lower doses, or reducing the dose if diarrhea develops, may help to prevent or alleviate symptoms.
While diarrhea is generally mild and self-limiting, the possibility of more serious gastrointestinal pathology should be kept in mind. Enterocolitis and toxic megacolon have been reported. Diarrhea may be accompanied by nausea and/or vomiting, abdominal pain, and fever as well as bloody stools in cases of auranofin-induced enterocolitis.[Ref]
Gastrointestinal side effects are among the most common complaints in patients treated with auranofin. Diarrhea or loose stools may occur in 50% to 74% of patients. Abdominal pain (14%), nausea/vomiting (10%), anorexia (3% to 9%), flatulence (3% to 9%), dyspepsia (3% to 9%), stomatitis, constipation, and dysgeusia have also been reported. More serious gastrointestinal effects include gastrointestinal bleeding (0.1% to 1%), enterocolitis and toxic megacolon, as well as aphthous ulcerations of the gastric and intestinal mucosa.[Ref]
Pruritus and rash may be early warning signs of gold toxicity. Any eruption during auranofin (the active ingredient contained in Ridaura) therapy should be considered a drug-related side effect until proven otherwise. Serious dermatologic toxicity, including exfoliative dermatitis, has been associated with parenteral gold.
Skin pigmentation--known as chrysiasis--characterized by a gray or blue discoloration of sun-exposed skin, has been reported following the use of parenteral gold salts.[Ref]
Dermatologic reactions are relatively common and include rash (24%) and pruritus (17%). Pityriasis rosea and discoid eczema as well as skin pigmentation, known as chrysiasis, have also been reported. While not associated with auranofin, per se, exfoliative dermatitis has been associated with parenteral gold therapy. Topical use of 0.1% to 0.6% products may produce contact dermatitis.[Ref]
Ocular side effects include gold deposits in the cornea and, occasionally, the lens. Vision is not usually affected. Conjunctivitis is also reported.[Ref]
Gold deposits in either the lens or cornea are not usually associated with visual disturbances. Deposits typically disappear within months following discontinuation of gold therapy.[Ref]
Hematologic abnormalities associated with auranofin (the active ingredient contained in Ridaura) include thrombocytopenia (>1%), eosinophilia (>1%), leukopenia (>1%), neutropenia (0.1% to 1%), agranulocytosis, aplastic anemia, pure red cell aplasia, and pancytopenia.[Ref]
Decreases in hemoglobin as well as leukopenia, granulocytopenia, and thrombocytopenia may be warning signs of gold toxicity. Any rapid decline in platelet counts or a platelet count of less than 100,000/mm3 necessitates discontinuation of auranofin. Gold therapy should not be reinstituted unless the thrombocytopenia is shown to be unrelated to gold.
Auranofin-induced thrombocytopenia appears to be due to an immune-mediated peripheral destruction of platelets. Bone marrow aspirates in cases of auranofin thrombocytopenia revealed an increased number of megakaryocytes. In addition, platelet reactive antibodies were detectable only in the presence of gold. In one case report, increased uptake of platelets by the spleen with subsequent platelet destruction was demonstrated.[Ref]
Renal side effects include hematuria, proteinuria, and nephropathy. Parenteral gold salts are associated with glomerulonephritis as well as nephrotic syndrome.[Ref]
Proteinuria occurs in 3% to 9% of patients treated with auranofin. Clinically significant proteinuria and/or hematuria may require cessation of auranofin therapy. Renal toxicity is usually reversible if recognized early and auranofin is discontinued.[Ref]
Hepatic side effects include elevations in liver function tests (>1%) and jaundice. These effects are usually reversible and may be more common in patients with preexisting liver disease. Cholestatic jaundice has been associated with the use of parenteral gold salts.[Ref]
Cardiovascular side effects are limited to a case report of a vasomotor or nitritoid reaction. While not usually seen with auranofin (the active ingredient contained in Ridaura) or aurothioglucose therapy, this reaction is not uncommon in patients treated with gold sodium thiomalate.[Ref]
Vasomotor, or nitritoid, symptoms typically include faintness, palpitations, and flushing and occur most often following injection of gold sodium thiomalate. In the elderly, this may result in myocardial infarction or central nervous system injury.
A 37-year-old female with a history of a nitritoid reaction to gold sodium thiomalate, developed similar symptoms during oral therapy with auranofin. Onset of symptoms (i.e. nausea, palpitations, and presyncope) occurred after 18 months of auranofin (6 mg/day) therapy.
Several case reports suggest that concomitant therapy with angiotensin converting enzyme inhibitors may increase the risk of nitritoid reactions in some patients.[Ref]
Irreversible bronchiolitis developed in a 44-year-old female with seropositive rheumatoid arthritis treated with auranofin (the active ingredient contained in Ridaura) (6 mg/day) for five months. A lung biopsy revealed a dense, cellular infiltrate around the bronchioles, with mucous plugging and macrophage infiltration of the bronchiole lumens. The extent to which auranofin versus rheumatoid arthritis contributed to the pathology is uncertain.[Ref]
Respiratory side effects are uncommon although rare cases of bronchiolitis and interstitial pneumonitis have been reported.[Ref]
Nervous system side effects are rare. Peripheral neuropathy after long-term use has been reported. Serious nervous system toxicity, including Guillain Barre-type syndrome and acute disseminated encephalomyelitis, has been associated with parenteral gold salts.[Ref]
Endocrine side effects are limited to a single case report of gynecomastia.[Ref]
1. Michet CJ Jr, Rakela J, Luthra HS "Auranofin-associated colitis and eosinophilia." Mayo Clin Proc 62 (1987): 142-4
2. Cohen MA "Adverse reactions to gold compounds." Adverse Drug React Acute Poisoning Rev 7 (1988): 163-78
3. Langer HE, Hartmann G, Heinemann G, Richter K "Gold colitis induced by auranofin treatment of rheumatoid arthritis: case report and review of the literature." Ann Rheum Dis 46 (1987): 787-92
4. "Product Information. Ridaura (auranofin)." SmithKline Beecham, Philadelphia, PA.
5. Benfield GF, Asquith P, Felix-Davies DD "Widespread gastric ulceration during auranofin therapy." J Rheumatol 13 (1986): 228-9
6. Jarner D, Nielsen AM "Auranofin (SK + F 39162) induced enterocolitis in rheumatoid arthritis. A case report." Scand J Rheumatol 12 (1983): 254-6
7. Wallin BA, McCafferty JP, Fox MJ, Cooper DR, Goldschmidt MS "Incidence and management of diarrhea during longterm auranofin therapy." J Rheumatol 15 (1988): 1755-8
8. Helm KF, Marks JG, Leyden JJ, Guzzo C, Krueger GG, Griffiths TW, Griffiths CEM "Topical auranofin ointment for the treatment of plaque psoriasis." J Am Acad Dermatol 33 (1995): 517-9
9. Wilkinson SM, Smith AG, Davis MJ, Mattey D, Dawes PT "Pityriasis rosea and discoid eczema: dose related reactions to treatment with gold." Ann Rheum Dis 51 (1992): 881-4
10. Weidle EG "Lenticular chrysiasis in oral chrysotherapy." Am J Ophthalmol 103 (1987): 240-1
11. Sykes HR, Griffiths ID "Severe thrombocytopenia associated with auranofin: evidence for immunological mechanism with peripheral destruction in the spleen." Br J Rheumatol 30 (1991): 75-6
12. Kosty MP, Hench PK, Tani P, McMillan R "Thrombocytopenia associated with auranofin therapy: evidence for a gold-dependent immunologic mechanism." Am J Hematol 30 (1989): 236-9
13. Cicuttini FM, Wiley JS, Fraser KJ "Immune thrombocytopenia in association with oral gold treatment." Arthritis Rheum 31 (1988): 299-300
14. Hakala M, Timonen TT, Rossi O, et al "Agranulocytosis in a patient with psoriatic arthritis receiving auranofin and ibuprofen." Scand J Rheumatol 16 (1987): 375-6
15. Wilson AP, Prouse PJ, Gumpel JM "Gold nephropathy due to auranofin obscured by tolmetin pseudoproteinuria." Ann Rheum Dis 43 (1984): 511-2
16. Healey LA, Backes MB "Nitritoid reactions and angiotensin-converting-enzyme inhibitors." N Engl J Med 321 (1989): 763
17. Proudman SM, Cleland LG "Auranofin-induced vasomotor reaction." Arthritis Rheum 35 (1992): 1452-4
18. O'Duffy JD, Luthra HS, Unni KK, Hyatt RE "Bronchiolitis in a rheumatoid arthritis patient receiving auranofin." Arthritis Rheum 29 (1986): 556-9
19. Williams HJ "Gynecomastia as a complication of auranofin therapy." J Rheumatol 15 (1988): 1863-4
Some side effects of Ridaura may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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