Ridaura

Last updated on RxList: 6/21/2017
Ridaura Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/21/2017

Ridaura (auranofin) is a gold preparation used in the management of adults with active (classical or definite) rheumatoid arthritis who have not responded to adequate trials of conventional anti-inflammatory therapy. Ridaura might also be of benefit in patients with psoriatic arthritis. Common side effects of Ridaura include diarrhea, rash, itching, abdominal pain, and inflammation or sores in the mouth.

The usual adult starting dosage of Ridaura is 6 mg per day. Ridaura may interact with phenytoin. Tell your doctor all medications and supplements you use. Ridaura is not recommended for use during pregnancy. Women are advised to avoid pregnancy during treatment with Ridaura and for at least six months after because of the slow excretion of gold and its persistence in the body tissues after discontinuation of treatment. It is unknown if Ridaura passes into breast milk. However, injectable gold passes into breast milk. Ridaura is not recommended for use while breastfeeding.

Our Ridaura (auranofin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer
Ridaura Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pale skin, easy bruising, unusual bleeding (nosebleeds, bleeding gums), purple or red spots under your skin;
  • unusual tiredness, feeling short of breath;
  • severe skin rash or itching;
  • sudden chest pain, wheezing, dry cough, feeling short of breath;
  • severe or ongoing diarrhea, nausea, vomiting, or loss of appetite;
  • black, bloody, or tarry stools; or
  • kidney problems--puffy eyes, swelling in your ankles or feet, blood in your urine, urine that looks foamy.

Auranofin may cause more side effects on the stomach than gold injections cause. If you were switched from gold injections to auranofin capsules, tell your doctor if you have concerns about these side effects. You may need to use auranofin for a few months before your symptoms improve.

Common side effects may include:

  • diarrhea, loose stools;
  • rash, itching; or
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ridaura (auranofin)

SLIDESHOW

What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow
Ridaura Professional Information

SIDE EFFECTS

The adverse reactions incidences listed below are based on observations of 1) 4,784 RIDAURA 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 RIDAURA-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 RIDAURA-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 RIDAURA (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%
Thrombocytopenia 0.9% 2.2%
Elevated liver function tests 1.9% 1.7%
Pulmonary 0.2% 0.2%

Read the entire FDA prescribing information for Ridaura (auranofin)

© Ridaura Patient Information is supplied by Cerner Multum, Inc. and Ridaura Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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