openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions
ADVERSE REACTIONS Clinical Trials The 4-month formulation of LUPRON DEPOT 30 mg was utilized in clinical trials that studied the drug in 49 nonorchiectomized prostate cancer patients for 32 weeks or longer and in 24 orchiectomized prostate cancer patients for 20 weeks. In the majority of nonorchiectomized patients, testosterone levels increased 50% or more above baseline during the first week of treatment with LUPRON DEPOT, declining thereafter to baseline levels or below by the end of the second week of treatment. Therefore, potential exacerbations of signs and symptoms during the first few weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria which, if aggravated, may lead to neurological problems such as temporary weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms. (See WARNINGS section.) In the above described clinical trials, the following adverse reactions were reported in ≥ 5% of the patients during the treatment period regardless of causality. Adverse Events Reported in ≥ 5% of Patients Regardless of Causality LUPRON DEPOT-4 Month 30 mg Nonorchiectomized, N = 49 Study 013 Orchiectomized, N = 24 Study 012 N (%) N (%) Body As a Whole Asthenia 6 (12.2) 1 (4.2) Flu Syndrome 6 (12.2) 0 (0.0) General Pain 16 (32.7) 1 (4.2) Headache 5 (10.2) 1 (4.2) Injection Site Reaction 4 (8.2) 9 (37.5) Cardiovascular System Hot flashes/Sweats * 23 (46.9) 2 (8.3) Digestive System GI Disorders 5 (10.2) 3 (12.5) Metabolic and Nutritional Disorders Dehydration 4 (8.2) 0 (0.0) Edema 4 (8.2) 5 (20.8) Musculoskeletal System Joint Disorder 8 (16.3) 1 (4.2) Myalgia 4 (8.2) 0 (0.0) Nervous System Dizziness/Vertigo 3 (6.1) 2 (8.3) Neuromuscular Disorders 3 (6.1) 1 (4.2) Paresthesia 4 (8.2) 1 (4.2) Respiratory System Respiratory Disorder 4 (8.2) 1 (4.2) Skin and Appendages Skin Reaction 6 (12.2) 0 (0.0) Urogenital System Urinary Disorders 5 (10.2) 4 (16.7) In these same studies, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT-4 Month 30 mg. Body As a Whole - Abscess, Accidental injury, Allergic reaction, Cyst, Fever, Generalized edema, Hernia, Neck pain, Neoplasm; Cardiovascular System - Atrial fibrillation, Deep thrombophlebitis, Hypertension; Digestive System - Anorexia, Eructation, Gastrointestinal hemorrhage, Gingivitis, Gum hemorrhage, Hepatomegaly, Increased appetite, Intestinal obstruction, Periodontal abscess; Hemic and Lymphatic System - Lymphadenopathy; Metabolic and Nutritional Disorders - Healing abnormal, Hypoxia, Weight loss; Musculoskeletal System - Leg cramps, Pathological fracture, Ptosis; Nervous System - Abnormal thinking, Amnesia, Confusion, Convulsion, Dementia, Depression, Insomnia/sleep disorders, Libido decreased * , Neuropathy, Paralysis; Respiratory System - Asthma, Bronchitis, Hiccup, Lung disorder, Sinusitis, Voice alteration; Skin and Appendages - Herpes zoster, Melanosis; Urogenital System - Bladder carcinoma, Epididymitis, Impotence * , Prostate disorder, Testicular atrophy * , Urinary incontinence, Urinary tract infection. * Due to the expected physiologic effects of decreased testosterone levels. Laboratory Abnormalities of certain parameters were observed, but their relationship to drug treatment is difficult to assess in this population. The following were recorded in ≥ 5% of patients: Decreased bicarbonate, Decreased hemoglobin/hematocrit/RBC, Hyperlipidemia (total cholesterol, LDL-cholesterol, triglycerides), Decreased HDL-cholesterol, Eosinophilia, Increased glucose, Increased liver function tests (ALT, AST, GGTP, LDH), Increased phosphorus. Additional laboratory abnormalities were reported: Increased BUN and PT, Leukopenia, Thrombocytopenia, Uricaciduria. Postmarketing During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse events were reported. Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Rash, urticaria, and photosensitivity reactions have also been reported. Localized reactions including induration and abscess have been reported at the site of injection. Symptoms consistent with fibromyalgia (eg, joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively. Cardiovascular System - Hypotension, Myocardial infarction, Pulmonary embolism; Hemic and Lymphatic System - Decreased WBC; Central/Peripheral Nervous System - Convulsion, Peripheral neuropathy, Spinal fracture/paralysis; Endocrine System – Diabetes; Musculoskeletal System - Tenosynovitis-like symptoms; Urogenital System - Prostate pain. Changes in Bone Density: Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with an LH-RH agonist analog. In a clinical trial, 25 men with prostate cancer, 12 of whom had been treated previously with leuprolide acetate for at least six months, underwent bone density studies as a result of pain. The leuprolide-treated group had lower bone density scores than the nontreated control group. It can be anticipated that long periods of medical castration in men will have effects on bone density. Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required. See other LUPRON DEPOT and LUPRON Injection package inserts for other events reported in women and pediatric populations.