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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, swallowing, 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.
  • Gas.
  • 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

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

2. "Product Information. Ridaura (auranofin)." SmithKline Beecham, Philadelphia, PA.

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.

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