Cuprimine Side Effects

Generic Name: penicillamine

Please note - some side effects for Cuprimine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cuprimine - for the Consumer

Cuprimine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cuprimine:

Diarrhea; loss of appetite; mild stomach pain; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding or bruising; blood in the urine; burning, itching, peeling, or redness of skin; changes in taste; chills; cough; dark urine; difficult urination; fever; general feeling of discomfort; joint pain; muscle weakness; severe stomach pain; shortness of breath; skin lesions; sore throat; swelling of the feet or legs; vision problems; weight gain; wheezing.

Cuprimine Side Effects - for the Professional

Cuprimine

Penicillamine is a drug with a high incidence of untoward reactions, some of which are potentially fatal. Therefore, it is mandatory that patients receiving penicillamine therapy remain under close medical supervision throughout the period of drug administration.

Reported incidences (%) for the most commonly occurring adverse reactions in rheumatoid arthritis patients are noted, based on 17 representative clinical trials reported in the literature (1270 patients).

Allergic

Generalized pruritus, early and late rashes (5%), pemphigus, and drug eruptions which may be accompanied by fever, arthralgia, or lymphadenopathy have occurred. Some patients may show a lupus erythematosus-like syndrome similar to drug-induced lupus produced by other pharmacological agents.

Urticaria and exfoliative dermatitis have occurred.

Thyroiditis has been reported; hypoglycemia in association with anti-insulin antibodies has been reported. These reactions are extremely rare.

Some patients may develop a migratory polyarthralgia, often with objective synovitis.

Gastrointestinal

Anorexia, epigastric pain, nausea, vomiting, or occasional diarrhea may occur (17%).

Isolated cases of reactivated peptic ulcer have occurred, as have hepatic dysfunction including hepatic failure, and pancreatitis. Intrahepatic cholestasis and toxic hepatitis have been reported rarely. There have been a few reports of increased serum alkaline phosphatase, lactic dehydrogenase, and positive cephalin flocculation and thymol turbidity tests.

Some patients may report a blunting, diminution, or total loss of taste perception (12%); or may develop oral ulcerations. Although rare, cheilosis, glossitis, and gingivostomatitis have been reported.

Gastrointestinal side effects are usually reversible following cessation of therapy.

Hematological

Penicillamine can cause bone marrow depression. Leukopenia (2%) and thrombocytopenia (4%) have occurred. Fatalities have been reported as a result of thrombocytopenia, agranulocytosis, aplastic anemia, and sideroblastic anemia.

Thrombotic thrombocytopenic purpura, hemolytic anemia, red cell aplasia, monocytosis, leukocytosis, eosinophilia, and thrombocytosis have also been reported.

Renal

Patients on penicillamine therapy may develop proteinuria (6%) and/or hematuria which, in some, may progress to the development of the nephrotic syndrome as a result of an immune complex membranous glomerulopathy. Renal failure has been reported.

Central Nervous System

Tinnitus, optic neuritis and peripheral sensory and motor neuropathies (including polyradiculoneuropathy, i.e., Guillain-Barré syndrome) have been reported. Muscular weakness may or may not occur with the peripheral neuropathies. Visual and psychic disturbances; mental disorders; and agitation and anxiety have been reported.

Neuromuscular

Myasthenia gravis; dystonia.

Other

Adverse reactions that have been reported rarely include thrombophlebitis; hyperpyrexia; falling hair or alopecia; lichen planus; polymyositis; dermatomyositis; mammary hyperplasia; elastosis perforans serpiginosa; toxic epidermal necrolysis; anetoderma (cutaneous macular atrophy); and Goodpasture's syndrome, a severe and ultimately fatal glomerulonephritis associated with intra-alveolar hemorrhage. Vasculitis, including fatal renal vasculitis, has also been reported. Allergic alveolitis, obliterative bronchiolitis, interstitial pneumonitis and pulmonary fibrosis have been reported in patients with severe rheumatoid arthritis, some of whom were receiving penicillamine. Bronchial asthma also has been reported.

Increased skin friability, excessive wrinkling of skin, and development of small white papules at venipuncture and surgical sites have been reported; yellow nail syndrome.

The chelating action of the drug may cause increased excretion of other heavy metals such as zinc, mercury and lead.

There have been reports associating penicillamine with leukemia. However, circumstances involved in these reports are such that a cause and effect relationship to the drug has not been established.

Side Effects by Body System

Nervous system

Nervous system side effects have included tinnitus, myasthenia gravis, polyradiculopathy (rare), peripheral sensory and motor neuropathies (including polyradiculoneuropathy). Muscular weakness may or may not occur with the peripheral neuropathies.

Ocular

Ocular side effects have included reversible optic neuritis with racemic penicillamine (may be related to pyridoxine deficiency).

Gastrointestinal

Gastrointestinal side effects have included anorexia, epigastric pain, nausea, vomiting, and occasional diarrhea (17%). Some patients may report a blunting, diminution, or total loss of taste perception (12%); or may develop oral ulcerations. Although rare, cheilosis, glossitis, and gingivostomatitis have been reported.

Hematologic

Hematologic side effects have included thrombocytopenia (4%), leukopenia (2%), and bone marrow depression. Fatalities have been reported as a result of thrombocytopenia, agranulocytosis, aplastic anemia, and sideroblastic anemia.

Renal

Renal side effects have included proteinuria (6%) and/or hematuria which, in some, may progress to the development of the nephrotic syndrome as a result of an immune complex membranous glomerulopathy. Renal failure and a severe and ultimately fatal renal vasculitis have also been reported.

Musculoskeletal

Musculoskeletal side effects have included myasthenia gravis and dystonia.

Dermatologic

Dermatologic side effects have included skin friability, excessive wrinkling of skin, toxic epidermal necrolysis, anetoderma, development of small white papules at venipuncture and surgical sites, lichen planus, and bullous pemphigoid.

Respiratory

Respiratory side effects have included allergic alveolitis, obliterative bronchiolitis, interstitial pneumonitis, pulmonary fibrosis, and bronchial asthma.

Other

Other side effects have included hyperpyrexia, alopecia, and Goodpasture's syndrome.

Other

The chelating action of the drug may cause increased excretion of other heavy metals such as zinc, mercury, and lead.

Local

Local side effects have included thrombophlebitis.

Genitourinary

Genitourinary side effects have included mammary atrophy.

Immunologic

Immunologic side effects have included polymyositis and dermatomyositis.

Oncologic

There have been reports associating penicillamine with leukemia. However, circumstances involved in these reports are such that a cause and effect relationship to penicillamine has not been established.

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