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; 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% |
|