Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 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;
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 RIDAURA (auranofin), some of whom developed bleeding.
The thrombocytopenia usually appears to be peripheral in origin and is usually reversible upon withdrawal of RIDAURA.
Its onset bears no relationship to the duration of RIDAURA 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 RIDAURA and other therapies with the potential to cause thrombocytopenia, and to obtain additional platelet counts.
Like all medications, Ridaura can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: