| Document Date: 2014-05-16 09:57:41
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City Reference / / Company Sunovion Pharmaceuticals Inc. / / Country United States / Canada / / Event Product Issues / FDA Phase / Product Recall / / IndustryTerm treatment of insomnia / otitis media / food / / MedicalCondition medical illness / photophobia / vaginitis / allergic reaction / Urogenital System Urinary Tract Infection / metrorrhagia / urinary frequency / leg cramps / Viral Infection / chest pain / headache / cholelithiasis / myopathy / herpes zoster / skin and appendages rash / hyperacusis / arthritis / ulcerative stomatitis / bronchitis / urinary incontinence / hallucinations / cellulitis / bursitis / nausea / stomatitis / anaphylaxis / Whole Accidental Injury / rhinitis / neuritis / alopecia / angioedema involving / urethritis / breast pain / Known hypersensitivity / colitis / tremor / uterine hemorrhage / additive psychomotor impairment / conjunctivitis / dysosmia / gout / physical disorder / lymphadenopathy / gastritis / stomach ulcer / erythema multiforme / iritis / laryngitis / hirsutism / diarrhea / hypersensitivity / hyperlipemia / heat stroke / hepatitis / otitis media / Transient Insomnia / Chronic Insomnia / hypokinesia / back pain / flu syndrome / Gynecomastia / Respiratory System Infection / asthma / concomitant illness / incoordination / adult insomnia / abdominal pain / insomnia / epistaxis / thrombophlebitis / hypertension / accidental injury / acne / airway obstruction / cystitis / kidney calculus / dyspnea / Amnesia / furunculosis / dysphagia / hematuria / dysgeusia / vestibular disorder / Carcinogenesis / hyperesthesia / otitis externa / oliguria / eczema / next-day psychomotor impairment / vertigo / migraine / ear pain / ataxia / emotional lability / skin and appendages pruritus / fever / hernia / mydriasis / hypesthesia / viral infections / Neuralgia / melena / psychiatric disorder / pain / vomiting / stupor / maculopapular rash / mastitis / urticaria / angioedema / menorrhagia / diseases / Drug Abuse / breast neoplasm / pyelonephritis / infection / joint disorder / contact dermatitis / vesiculobullous rash / dizziness / respiratory infection / Whole Headache / hypercholesteremia / Depression / hypokalemia / rash / olfactory dysfunction / pharyngitis / paresthesia / anemia / tinnitus / lightheadedness / Digestive System Diarrhea / dehydration / / Organization DOSAGE AND ADMINISTRATION / FDA / Drug Administration / / / Position prescribing physician / / Product itraconazole / clarithromycin / Timing of Drug Administration / Olanzapine / LUNESTA / Ketoconazole / 5.5 / activities / / Technology drug metabolism / Pharmacokinetics / / URL www.fda.gov/medwatch / /
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LUNESTA® (eszopiclone) tablets