What are the possible side effects of D-Penil?
If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:
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an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
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fever or chills;
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a sore throat;
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unusual bleeding or bruising;
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blood in the urine;
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unexplained shortness of breath, coughing, or wheezing;
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abdominal pain;
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yellow skin or eyes;
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muscle weakness; or
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double vision.
Other, less serious side effects may be more likely to occur. Continue to take D-Penil and notify your doctor if you experience
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itching or a rash;
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nausea, vomiting, diarrhea, or decreased appetite;
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ringing in the ears;
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decreased taste;
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sores in the mouth;
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poor wound healing; or
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increased wrinkling of the skin.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of D-Penil in details
D-Penil is a drug with a high incidence of untoward reactions, some of which are potentially fatal. Therefore, it is mandatory that patients receiving D-Penil 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
D-Penil 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 D-Penil 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 D-Penil. 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 D-Penil with leukemia. However, circumstances involved in these reports are such that a cause and effect relationship to the drug has not been established.
What is the most important information I should know about D-Penil?
- Your doctor may prescribe a vitamin B supplement called pyridoxine while you are taking D-Penil. Follow your doctor's instructions for taking this supplement.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using D-Penil.
- LAB TESTS, including complete blood cell counts, platelet counts, liver and kidney function tests, urinalysis, and body temperature, may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use D-Penil with caution in the ELDERLY because they may be more sensitive to its effects.
- D-Penil is not recommended for use in CHILDREN with juvenile rheumatoid arthritis. Safety and effectiveness have not been confirmed.
- PREGNANCY and BREAST-FEEDING: D-Penil has been shown to cause harm to the fetus. If you become, discuss with your doctor the benefits and risks of using D-Penil during pregnancy. It is unknown if D-Penil is excreted in breast milk. Do not breast-feed while taking D-Penil.
D-Penil contraindications
Except for the treatment of Wilson’s disease or certain patients with cystinuria, use of D-Penil during pregnancy is contraindicated.
Although breast milk studies have not been reported in animals or humans, mothers on therapy with D-Penil should not nurse their infants.
Patients with a history of D-Penil-related aplastic anemia or agranulocytosis should not be restarted on D-Penil.
Because of its potential for causing renal damage, D-Penil should not be administered to rheumatoid arthritis patients with a history or other evidence of renal insufficiency.
Reviews
The results of a survey conducted on ndrugs.com for D-Penil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking D-Penil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology