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adverse reactions
ADVERSE REACTIONS Parkinson’s Disease During the premarketing development of Ropinirole Hydrochloride Tablets, patients received Ropinirole Hydrochloride Tablets either without L-dopa (early Parkinson’s disease studies) or as concomitant therapy with L-dopa (advanced Parkinson’s disease studies). Because these 2 populations may have differential risks for various adverse events, this section will, in general, present adverse event data for these 2 populations separately. Early Parkinson’s Disease (Without L-dopa) The most commonly observed adverse events (>5%) in the double-blind, placebo-controlled early Parkinson’s disease trials associated with the use of Ropinirole Hydrochloride Tablets (n = 157) not seen at an equivalent frequency among the placebo-treated patients (n = 147) were, in order of decreasing incidence: nausea, dizziness, somnolence, headache, vomiting, syncope, fatigue, dyspepsia, viral infection, constipation, pain, increased sweating, asthenia, dependent/leg edema, orthostatic symptoms, abdominal pain, pharyngitis, confusion, hallucinations, urinary tract infections, and abnormal vision. Approximately 24% of 157 patients treated with Ropinirole Hydrochloride Tablets who participated in the double-blind, placebo-controlled early Parkinson’s disease (without L-dopa) trials discontinued treatment due to adverse events compared to 13% of 147 patients who received placebo. The adverse events most commonly causing discontinuation of treatment by patients treated with Ropinirole Hydrochloride Tablets were: nausea (6.4%), dizziness (3.8%), aggravated Parkinson’s disease (1.3%), hallucinations (1.3%), somnolence (1.3%), vomiting (1.3%), and headache (1.3%). Of these, hallucinations appear to be dose-related. While other adverse events leading to discontinuation may be dose-related, the titration design utilized in these trials precluded an adequate assessment of the dose response. For example, in the larger of the 2 trials described in CLINICAL PHARMACOLOGY: Clinical Trials , the difference in the rate of discontinuations emerged only after 10 weeks of treatment, suggesting, although not proving, that the effect could be related to dose. Adverse Event Incidence in Controlled Clinical Studies Table 2 lists treatment-emergent adverse events that occurred in ≥2% of patients with early Parkinson’s disease (without L-dopa) treated with Ropinirole Hydrochloride Tablets participating in the double-blind, placebo-controlled studies and were numerically more common in the group treated with Ropinirole Hydrochloride Tablets. In these studies, either Ropinirole Hydrochloride Tablets or placebo was used as early therapy (i.e., without L-dopa). The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied. Table 2. Treatment-Emergent Adverse Event * Incidence in Double-Blind, Placebo-Controlled Early Parkinson’s Disease (Without L-dopa) Trials (Events ≥2% of Patients Treated With Ropinirole Hydrochloride Tablets and Numerically More Frequent Than the Placebo Group) Adverse Experience Ropinirole Hydrochloride Tablets (n = 157) (%) Placebo (n = 147) (%) Autonomic nervous system Flushing 3 1 Dry mouth 5 3 Increased sweating 6 4 Body as a whole Asthenia 6 1 Chest pain 4 2 Dependent edema 6 3 Leg edema 7 1 Fatigue 11 4 Malaise 3 1 Pain 8 4 Cardiovascular general Hypertension 5 3 Hypotension 2 0 Orthostatic symptoms 6 5 Syncope 12 1 Central/peripheral nervous system Dizziness 40 22 Hyperkinesia 2 1 Hypesthesia 4 2 Vertigo 2 0 Gastrointestinal system Abdominal pain 6 3 Anorexia 4 1 Dyspepsia 10 5 Flatulence 3 1 Nausea 60 22 Vomiting 12 7 Heart rate/rhythm Extrasystoles 2 1 Atrial fibrillation 2 0 Palpitation 3 2 Tachycardia 2 0 Metabolic/nutritional Increased alkaline phosphatase 3 1 Psychiatric Amnesia 3 1 Impaired concentration 2 0 Confusion 5 1 Hallucination 5 1 Somnolence 40 6 Yawning 3 0 Reproductive male Impotence 3 1 Resistance mechanism Viral infection 11 3 Respiratory system Bronchitis 3 1 Dyspnea 3 0 Pharyngitis 6 4 Rhinitis 4 3 Sinusitis 4 3 Urinary system Urinary tract infection 5 4 Vascular extracardiac Peripheral ischemia 3 0 Vision Eye abnormality 3 1 Abnormal vision 6 3 Xerophthalmia 2 0 * Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category. Other events reported by 1% or more of early Parkinson’s disease (without L-dopa) patients treated with Ropinirole Hydrochloride Tablets, but that were equally or more frequent in the placebo group, were: headache, upper respiratory infection, insomnia, arthralgia, tremor, back pain, anxiety, dyskinesias, aggravated Parkinsonism, depression, falls, myalgia, leg cramps, paresthesias, nervousness, diarrhea, arthritis, hot flushes, weight loss, rash, cough, hyperglycemia, muscle spasm, arthrosis, abnormal dreams, dystonia, increased salivation, bradycardia, gout, basal cell carcinoma, gingivitis, hematuria, and rigors. Among the treatment-emergent adverse events in patients treated with Ropinirole Hydrochloride Tablets, hallucinations appear to be dose-related. The incidence of adverse events was not materially different between women and men. Advanced Parkinson’s Disease (With L-dopa) The most commonly observed adverse events (>5%), in the double-blind, placebo-controlled advanced Parkinson’s disease (with L-dopa) trials associated with the use of Ropinirole Hydrochloride Tablets (n = 208) as an adjunct to L-dopa not seen at an equivalent frequency among the placebo-treated patients (n = 120) were, in order of decreasing incidence: dyskinesias, nausea, dizziness, aggravated Parkinsonism, somnolence, headache, insomnia, injury, hallucinations, falls, abdominal pain, upper respiratory infection, confusion, increased sweating, vomiting, viral infection, increased drug level, arthralgia, tremor, anxiety, urinary tract infection, constipation, dry mouth, pain, hypokinesia, and paresthesia. Approximately 24% of 208 patients who received Ropinirole Hydrochloride Tablets in the double-blind, placebo-controlled advanced Parkinson’s disease (with L-dopa) trials discontinued treatment due to adverse events compared to 18% of 120 patients who received placebo. The events most commonly (≥1%) causing discontinuation of treatment by patients treated with Ropinirole Hydrochloride Tablets were: dizziness (2.9%), dyskinesias (2.4%), vomiting (2.4%), confusion (2.4%), nausea (1.9%), hallucinations (1.9%), anxiety (1.9%), and increased sweating (1.4%). Of these, hallucinations and dyskinesias appear to be dose-related. Adverse Event Incidence in Controlled Clinical Studies Table 3 lists treatment-emergent adverse events that occurred in ≥2% of patients with advanced Parkinson’s disease (with L-dopa) treated with Ropinirole Hydrochloride Tablets who participated in the double-blind, placebo-controlled studies and were numerically more common in the group treated with Ropinirole Hydrochloride Tablets. In these studies, either Ropinirole Hydrochloride Tablets or placebo was used as an adjunct to L-dopa. Adverse events were usually mild or moderate in intensity. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse events incidence rate in the population studied. Table 3. Treatment-Emergent Adverse Event* Incidence in Double-Blind, Placebo-Controlled Advanced Parkinson’s Disease (With L-dopa) Trials (Events ≥2% of Patients Treated With Ropinirole Hydrochloride Tablets and Numerically More Frequent Than the Placebo Group) Adverse Experience Ropinirole Hydrochloride Tablets (n = 208) (%) Placebo (n = 120) (%) Autonomic nervous system Dry mouth 5 1 Increased sweating 7 2 Body as a whole Increased drug level 7 3 Pain 5 3 Cardiovascular general Hypotension 2 1 Syncope 3 2 Central/peripheral nervous system Dizziness 26 16 Dyskinesia 34 13 Falls 10 7 Headache 17 12 Hypokinesia 5 4 Paresis 3 0 Paresthesia 5 3 Tremor 6 3 Gastrointestinal system Abdominal pain 9 8 Constipation 6 3 Diarrhea 5 3 Dysphagia 2 1 Flatulence 2 1 Nausea 30 18 Increased saliva 2 1 Vomiting 7 4 Metabolic/nutritional Weight decrease 2 1 Musculoskeletal system Arthralgia 7 5 Arthritis 3 1 Psychiatric Amnesia 5 1 Anxiety 6 3 Confusion 9 2 Abnormal dreaming 3 2 Hallucinations 10 4 Nervousness 5 3 Somnolence 20 8 Red blood cell Anemia 2 0 Resistance mechanism Upper respiratory tract infection 9 8 Respiratory system Dyspnea 3 2 Urinary system Pyuria 2 1 Urinary incontinence 2 1 Urinary tract infection 6 3 Vision Diplopia 2 1 * Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category. Other events reported by 1% or more of patients treated with both Ropinirole Hydrochloride Tablets and L-dopa, but equally or more frequent in the placebo/L-dopa group, were: myocardial infarction, orthostatic symptoms, virus infections, asthenia, dyspepsia, myalgia, back pain, depression, leg cramps, fatigue, rhinitis, chest pain, hematuria, vertigo, tinnitus, leg edema, hot flushes, abnormal gait, hyperkinesia, and pharyngitis. Among the treatment-emergent adverse events in patients treated with Ropinirole Hydrochloride Tablets, hallucinations and dyskinesias appear to be dose-related. Restless Legs Syndrome The most commonly observed adverse events (>5%) in the 12-week double-blind, placebo-controlled trials in the treatment of Restless Legs Syndrome with Ropinirole Hydrochloride Tablets (n = 496) and at least twice the rate for placebo-treated patients (n = 500) were, in order of decreasing incidence: nausea, somnolence, vomiting, dizziness, and fatigue (see Table 4 ). Occurrences of nausea in clinical trials were generally mild to moderate in intensity (see also DOSAGE AND ADMINISTRATION: General Dosing Considerations ). Approximately 5% of 496 patients treated with Ropinirole Hydrochloride Tablets who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse events compared to 4% of 500 patients who received placebo. The adverse events most commonly causing discontinuation of treatment by patients treated with Ropinirole Hydrochloride Tablets were: nausea (1.6%), dizziness (0.8 %), and headache (0.8%). Adverse Event Incidence in Controlled Clinical Studies Table 4 lists treatment-emergent adverse events that occurred in ≥2% of patients with RLS treated with Ropinirole Hydrochloride Tablets participating in the 12-week double-blind, placebo-controlled studies and were numerically more common in the group treated with Ropinirole Hydrochloride Tablets. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied. Table 4. Treatment-Emergent Adverse Event Incidence in Double-Blind, Placebo-Controlled RLS Trials (Events ≥2% of Patients Treated With Ropinirole Hydrochloride Tablets and Numerically More Frequent Than the Placebo Group) Adverse Experience Ropinirole Hydrochloride Tablets (n = 496) (%) Placebo (n =500) (%) Ear and labyrinth disorders Vertigo 2 1 Gastrointestinal disorders Nausea 40 8 Vomiting 11 2 Diarrhea 5 3 Dyspepsia 4 3 Dry mouth 3 2 Abdominal pain upper 3 1 General disorders and administration site conditions Fatigue 8 4 Edema peripheral 2 1 Infections and infestations Nasopharyngitis 9 8 Influenza 3 2 Musculoskeletal and connective tissue disorders Arthralgia 4 3 Muscle cramps 3 2 Pain in extremity 3 2 Nervous system disorders Somnolence 12 6 Dizziness 11 5 Paresthesia 3 1 Respiratory, thoracic, and mediastinal disorders Cough 3 2 Nasal congestion 2 1 Skin and subcutaneous tissue disorders Hyperhidrosis 3 1 Other events reported by 2% or more of patients treated with Ropinirole Hydrochloride Tablets, but equally or more frequent in the placebo group, were headache, insomnia, restless legs syndrome, upper respiratory tract infection, back pain, and sinusitis. Other Adverse Events Observed During All Phase 2/3 Clinical Trials for Parkinson’s Disease Ropinirole Hydrochloride Tablets have been administered to 1,599 individuals in clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 1,599 individuals exposed to Ropinirole Hydrochloride Tablets who experienced events of the type cited on at least 1 occasion while receiving Ropinirole Hydrochloride Tablets. All reported events that occurred at least twice (or once for serious or potentially serious events), except those already listed above, trivial events, and terms too vague to be meaningful, are included without regard to determination of a causal relationship to Ropinirole Hydrochloride Tablets, except that events very unlikely to be drug-related have been deleted. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients and infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare events are those occurring in fewer than 1/1,000 patients. Body as a Whole Infrequent : Cellulitis, peripheral edema, fever, influenza-like symptoms, enlarged abdomen, precordial chest pain, and generalized edema. Rare : Ascites. Cardiovascular Infrequent : Cardiac failure, bradycardia, tachycardia, supraventricular tachycardia, angina pectoris, bundle branch block, cardiac arrest, cardiomegaly, aneurysm, mitral insufficiency. Rare : Ventricular tachycardia. Central/Peripheral Nervous System Frequent : Neuralgia. Infrequent : Involuntary muscle contractions, hypertonia, dysphonia, abnormal coordination, extrapyramidal disorder, migraine, choreoathetosis, coma, stupor, aphasia, convulsions, hypotonia, peripheral neuropathy, paralysis. Rare : Grand mal convulsions, hemiparesis, hemiplegia. Endocrine Infrequent: Hypothyroidism, gynecomastia, hyperthyroidism. Rare: Goiter, SIADH. Gastrointestinal Infrequent : Increased hepatic enzymes, bilirubinemia, cholecystitis, cholelithiasis colitis, dysphagia, periodontitis, fecal incontinence, gastroesophageal reflux, hemorrhoids, toothache, eructation, gastritis, esophagitis, hiccups, diverticulitis, duodenal ulcer, gastric ulcer, melena, duodenitis, gastrointestinal hemorrhage, glossitis, rectal hemorrhage, pancreatitis, stomatitis and ulcerative stomatitis, tongue edema. Rare : Biliary pain, hemorrhagic gastritis, hematemesis, salivary duct obstruction. Hematologic Infrequent : Purpura, thrombocytopenia, hematoma, Vitamin B12 deficiency, hypochromic anemia, eosinophilia, leukocytosis, leukopenia, lymphocytosis, lymphopenia, lymphedema. Metabolic/Nutritional Frequent : Increased BUN. Infrequent : Hypoglycemia, increased alkaline phosphatase, increased LDH, weight increase, hyperphosphatemia, hyperuricemia, diabetes mellitus, glycosuria, hypokalemia, hypercholesterolemia, hyperkalemia, acidosis, hyponatremia, thirst, increased CPK, dehydration. Rare : Hypochloremia. Musculoskeletal Infrequent : Aggravated arthritis, tendonitis, osteoporosis, bursitis, polymyalgia rheumatica, muscle weakness, skeletal pain, torticollis. Rare : Dupuytren’s contracture requiring surgery. Neoplasm Infrequent : Malignant breast neoplasm. Rare : Bladder carcinoma, benign brain neoplasm, esophageal carcinoma, malignant laryngeal neoplasm, lipoma, rectal carcinoma, uterine neoplasm. Psychiatric Infrequent: Increased libido, agitation, apathy, impaired concentration, depersonalization, paranoid reaction, personality disorder, euphoria, delirium, dementia, delusion, emotional lability, decreased libido, manic reaction, somnambulism, aggressive reaction, neurosis. Rare : Suicide attempt. Genitourinary Infrequent : Amenorrhea, vaginal hemorrhage, penile disorder, prostatic disorder, balanoposthitis, epididymitis, perineal pain, dysuria, micturition frequency, albuminuria, nocturia, polyuria, renal calculus. Rare : Breast enlargement, mastitis, uterine hemorrhage, ejaculation disorder, Peyronie’s disease, pyelonephritis, acute renal failure, uremia. Resistance Mechanism Infrequent : Herpes zoster, otitis media, sepsis, abscess, herpes simplex, fungal infection, genital moniliasis. Respiratory Infrequent : Asthma, epistaxis, laryngitis, pleurisy, pulmonary edema. Skin/Appendage Infrequent : Pruritus, dermatitis, eczema, skin ulceration, alopecia, skin hypertrophy, skin discoloration, urticaria, fungal dermatitis, furunculosis, hyperkeratosis, photosensitivity reaction, psoriasis, maculopapular rash, psoriaform rash, seborrhea. Special Senses Infrequent : Tinnitus, earache, decreased hearing, abnormal lacrimation, conjunctivitis, blepharitis, glaucoma, abnormal accommodation, blepharospasm, eye pain, photophobia. Rare : Scotoma. Vascular Extracardiac Infrequent : Varicose veins, phlebitis, peripheral gangrene. Rare : Limb embolism, pulmonary embolism, gangrene, subarachnoid hemorrhage, deep thrombophlebitis, leg thrombophlebitis, thrombosis. Falling Asleep During Activities of Daily Living Patients treated with Ropinirole Hydrochloride Tablets have reported falling asleep while engaged in activities of daily living, including operation of a motor vehicle which sometimes resulted in accidents (see bolded WARNING ). Other Adverse Events Observed During Phase 2/3 Clinical Trials for RLS Ropinirole Hydrochloride Tablets has been administered to 911 individuals in clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using MedDRA dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 911 individuals exposed to Ropinirole Hydrochloride Tablets who experienced events of the type cited on at least one occasion while receiving Ropinirole Hydrochloride Tablets. All reported events that occurred at least twice (or once for serious or potentially serious events), except those already listed, trivial events, and terms too vague to be meaningful, are included without regard to determination of a causal relationship to Ropinirole Hydrochloride Tablets, except that events very unlikely to be drug-related have been deleted. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients and infrequent adverse events are those occurring in 1/100 to 1/1,000 patients. Blood and Lymphatic System Disorders Infrequent : Anemia, lymphadenopathy. Cardiac Disorders Frequent: Palpitations. Infrequent : Acute coronary syndrome, angina pectoris, angina unstable, bradycardia, cardiac failure, cardiovascular disorder, coronary artery disease, myocardial infarction, sick sinus syndrome, tachycardia. Congenital, Familial, and Genetic Disorders Infrequent: Pigmented nevus. Ear and Labyrinth Disorders Infrequent : Ear pain, middle ear effusion, tinnitus. Endocrine Disorders Infrequent : Goiter, hypothyroidism. Eye Disorders Infrequent : Blepharitis, conjunctival hemorrhage, conjunctivitis, eye irritation, eye pain, keratoconjunctivitis sicca, vision blurred, visual acuity reduced, visual disturbance. Gastrointestinal Disorders Frequent : Abdominal pain, constipation, gastroesophageal reflux disease, stomach discomfort, toothache. Infrequent : Abdominal adhesions, abdominal discomfort, abdominal distension, abdominal pain lower, duodenal ulcer, dysphagia, eructation, flatulence, gastric disorder, gastric hemorrhage, gastric polyps, gastric ulcer, gastritis, gastrointestinal pain, hematemesis, hemorrhoids, hiatus hernia, intestinal obstruction, irritable bowel syndrome, loose stools, mouth ulceration, pancreatitis acute, peptic ulcer, rectal hemorrhage, reflux esophagitis. General Disorders and Administration Site Conditions Frequent : Asthenia, chest pain, influenza-like illness, rigors. Infrequent : Chest discomfort, feeling cold, feeling hot, hunger, lethargy, malaise, edema, pain, pyrexia. Hepatobiliary Disorders Infrequent : Cholecystitis, cholelithiasis, ischemic hepatitis. Immune System Disorders Infrequent : Hypersensitivity. Infections and Infestations Frequent : Bronchitis, gastroenteritis, gastroenteritis viral, lower respiratory tract infection, rhinitis, tooth abscess, urinary tract infection. Infrequent : Appendicitis, bacterial infection, bladder infection, bronchitis acute, candidiasis, cellulitis, cystitis, diarrhea infectious, diverticulitis, ear infection, folliculitis, fungal infection, gastrointestinal infection, herpes simplex, infected cyst, laryngitis, localized infection, mastitis, otitis externa, otitis media, pharyngitis, pneumonia, postoperative infection, respiratory tract infection, tonsillitis, tooth infection, vaginal candidiasis, vaginal infection, vaginal mycosis, viral infection, viral upper respiratory tract infection, wound infection. Injury, Poisoning, and Procedural Complications Infrequent : Concussion, lower limb fracture, post procedural hemorrhage, road traffic accident. Investigations Infrequent : Blood cholesterol increased, blood iron decreased, blood pressure increased, blood urine present, hemoglobin decreased, heart rate increased, protein urine present, weight decreased, weight increased. Metabolism and Nutrition Disorders Infrequent : Anorexia, decreased appetite, diabetes mellitus non-insulin-dependent, fluid retention, gout, hypercholesterolemia. Musculoskeletal and Connective Tissue Disorders Frequent : Muscle spasms, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, tendonitis. Infrequent : Arthritis, aseptic necrosis bone, bone pain, bone spur, bursitis, groin pain, intervertebral disc degeneration, intervertebral disc protrusion, joint stiffness, joint swelling, localized osteoarthritis, monoarthritis, muscle contracture, muscle tightness, muscle twitching, osteoporosis, rotator cuff syndrome, sacroiliitis, synovitis. Neoplasms Benign, Malignant, and Unspecified Infrequent : Anaplastic thyroid cancer, angiomyolipoma, basal cell carcinoma, breast cancer, gastric cancer, gastrointestinal stromal tumor, malignant melanoma, prostate cancer, skin papilloma, squamous cell carcinoma, uterine leiomyoma. Nervous System Disorders Frequent : Hypoesthesia, migraine. Infrequent : Amnesia, aphasia, ataxia, balance disorder, benign intracranial hypertension, burning sensation, carpal tunnel syndrome, disturbance in attention, dizziness postural, dysgeusia, dyskinesia, head discomfort, hyperesthesia, hypersomnia, lethargy, loss of consciousness, memory impairment, migraine with aura, migraine without aura, neuralgia, sciatica, sedation, sinus headache, sleep apnea syndrome, syncope vasovagal, tension headache, transient ischemic attack, tremor. Psychiatric Disorders Frequent : Anxiety, depression, irritability, sleep disorder. Infrequent : Abnormal dreams, agitation, bruxism, confusional state, depressed mood, disorientation, early morning awakening, libido decreased, loss of libido, mood swings, nervousness, nightmare, panic attack, stress symptoms, tension. Renal and Urinary Disorders Infrequent : Dysuria, hematuria, hypertonic bladder, micturition disorder, nephrolithiasis, nocturia, pollakiuria, proteinuria, urinary retention. Reproductive System and Breast Disorders Frequent : Erectile dysfunction. Infrequent : Breast cyst, dysmenorrhea, menorrhagia, pelvic peritoneal adhesions, postmenopausal hemorrhage, premenstrual syndrome, prostatitis. Respiratory, Thoracic and Mediastinal Disorders Frequent : Asthma, pharyngolaryngeal pain. Infrequent : Dry throat, dyspnea, epistaxis, hemoptysis, hoarseness, interstitial lung disease, nasal mucosal disorder, nasal polyps, respiratory tract congestion, rhinorrhea, sinus congestion, sneezing, wheezing, yawning. Skin and Subcutaneous Tissue Disorders Frequent : Night sweats, rash. Infrequent : Acne, actinic keratosis, alopecia, cold sweat, dermatitis, dermatitis allergic, dermatitis contact, eczema, exanthem, face edema, photosensitivity reaction, pruritus, psoriasis, rash pruritic, skin lesion, urticaria. Vascular Disorders Frequent : Hot flush, hypertension, hypotension. Infrequent : Atherosclerosis, circulatory collapse, flushing, hematoma, thrombosis, varicose vein. Postmarketing Reports Psychiatric Disorders: Impulse control symptoms, pathological gambling, increased libido including hypersexuality.