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Auranofin Side Effects

Summary

Commonly reported side effects of auranofin include: diarrhea, pruritus, skin rash, stomatitis, loose stools, nausea, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to auranofin: oral capsule

Warning

You should not use auranofin if you have ever had a severe reaction to gold therapy that affected your skin, lungs, bone marrow, blood cells, or your stomach or intestines.

Auranofin contains gold, which may be toxic and can cause symptoms such as rash, itching, mouth sores, or blood in your urine, or severe diarrhea.

Call your doctor at once if you have a severe skin rash or itching, mouth sores, severe diarrhea, pale skin, unusual tiredness, easy bruising or bleeding, blood in your urine or stools, or if you cough up blood.

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.

For Healthcare Professionals

Applies to auranofin: oral capsule

Gastrointestinal

Very common (10% or more): Diarrhea/loose stools (47%), abdominal pain (14%),

stomatitis (may be manifested by shallow ulcers on the buccal membranes, on the borders of the tongue, and on the palate or in the pharynx) (13%), nausea/vomiting (10%)

Common (1% to 10%): %), Constipation, anorexia, flatulence, dyspepsia, dysgeusia, glossitis, gingivitis

Uncommon (0.1% to 1%): GI bleeding, melena, blood in stool, ulcerative enterocolitis

Rare (less than 0.1%): Dysphagia

Frequency not reported: Metallic taste, dry mucus membrane, inflammatory bowel disease[Ref]

Dermatologic

Very common (10% or more): Rash (24%), pruritus (17%), dermatitis

Common (1% to 10%): Alopecia, urticaria

Frequency not reported: Photosensitivity, exfoliative dermatitis, chrysiasis[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Rare (less than 0.1%): Gold deposits in the lens or cornea unassociated clinically with eye disorders or visual impairment

Frequency not reported: Corneal lesion[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia, anemia, leukopenia, eosinophilia

Uncommon (0.1% to 1%): Neutropenia

Rare (less than 0.1%): Aplastic anemia, agranulocytosis, pure red cell aplasia, pancytopenia[Ref]

Renal

Common (1% to 10%): Proteinuria, hematuria

Frequency not reported: Nephrotic syndrome[Ref]

Hepatic

Common (1% to 10%): Liver enzymes elevated

Rare (less than 0.1%): Jaundice[Ref]

Respiratory

Rare (0.01% to 0.1%): Bronchitis, interstitial pneumonitis, fibrosis

Frequency not reported: Progression of preexisting pulmonary disease[Ref]

Nervous system

Rare (less than 0.1%): Peripheral neuropathy

Frequency not reported: Headache, dizziness, Bell's palsy[Ref]

Other

Frequency not reported: Ototoxicity[Ref]

References

1. "Product Information. Ridaura (auranofin)." SmithKline Beecham (2001):

2. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.