Drug information for OMNARIS

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SPRAY, METERED; NASAL 0.05MG/INH Prescription  (Reference Drug) CICLESONIDE ciclesonide NYCOMED US 22004
2010-05-17 Label
2010-05-12 Letter
2010-05-12 Letter
2007-11-26 Letter
2007-11-26 Label
2006-12-22 Review
2006-10-26 Letter
2006-10-23 Label
SPRAY; NASAL 50MCG Prescription   CICLESONIDE ciclesonide NYCOMED US INC 22124
2009-11-12 Review
2009-11-12 Summary Review
2007-11-26 Label
2007-11-26 Letter

Drug Adverse Effects information for OMNARIS

Role code Indications Reaction # Reports
PS SINUSITIS ANOSMIA 1
PS SINUSITIS OFF LABEL USE 1
PS SINUSITIS OLFACTORY NERVE DISORDER 1
SS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 2
SS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 2
SS PRODUCT USED FOR UNKNOWN INDICATION NASAL DISCOMFORT 2
C ARTHROPATHY VISUAL IMPAIRMENT 1
C ASTHMA ABDOMINAL DISCOMFORT 1
C ASTHMA ASTHMA 5
C ASTHMA BLOOD PRESSURE DECREASED 1
C ASTHMA BRONCHIECTASIS 1
C ASTHMA COUGH 4
C ASTHMA DEPRESSION 3
C ASTHMA DIZZINESS 3
C ASTHMA DRUG INTOLERANCE 3
C ASTHMA DYSPHONIA 3
C ASTHMA FATIGUE 3
C ASTHMA HEADACHE 4
C ASTHMA INFLUENZA 3
C ASTHMA LARYNGITIS 1
C ASTHMA MIDDLE EAR EFFUSION 1
C ASTHMA MYALGIA 3
C ASTHMA NASAL CONGESTION 3
C ASTHMA NASOPHARYNGITIS 3
C ASTHMA NAUSEA 1
C ASTHMA OROPHARYNGEAL PAIN 3
C ASTHMA PHARYNGEAL OEDEMA 1
C ASTHMA PNEUMONIA 1
C ASTHMA SLEEP APNOEA SYNDROME 3
C ASTHMA THROAT IRRITATION 1
C ASTHMA VOMITING 1
C ASTHMA WHEEZING 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER ASTHMA 1
C BLADDER DISORDER ASTHMA 1
C BLADDER DISORDER DRUG INTOLERANCE 1
C BLADDER DISORDER HEADACHE 1
C BLADDER DISORDER MYALGIA 1
C BLADDER DISORDER SLEEP APNOEA SYNDROME 1
C BRONCHIECTASIS ASTHMA 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE ASTHMA 4
C DIABETES MELLITUS BALANCE DISORDER 2
C DIABETES MELLITUS COUGH 2
C DIABETES MELLITUS DEPRESSION 2
C DIABETES MELLITUS DRY THROAT 2
C DIABETES MELLITUS DYSPHAGIA 2
C DIABETES MELLITUS HEADACHE 2
C DIABETES MELLITUS INJECTION SITE ERYTHEMA 2
C DIABETES MELLITUS PAIN 2
C DIABETES MELLITUS THROAT IRRITATION 2
C DIABETES MELLITUS TREMOR 2
C DRY EYE ASTHMA 1
C DRY EYE DRUG INTOLERANCE 1
C DRY EYE HEADACHE 1
C DRY EYE MYALGIA 1
C DRY EYE SLEEP APNOEA SYNDROME 1
C DYSPEPSIA ANXIETY 1
C DYSPEPSIA ARTHRITIS 1
C DYSPEPSIA ASTHENIA 1
C DYSPEPSIA BALANCE DISORDER 1
C DYSPEPSIA CLUMSINESS 1
C DYSPEPSIA COGNITIVE DISORDER 1
C DYSPEPSIA COMPRESSION FRACTURE 1
C DYSPEPSIA CONFUSIONAL STATE 1
C DYSPEPSIA DIARRHOEA 1
C DYSPEPSIA DRY MOUTH 1
C DYSPEPSIA DYSKINESIA 1
C DYSPEPSIA DYSPEPSIA 1
C DYSPEPSIA DYSPHAGIA 1
C DYSPEPSIA ECONOMIC PROBLEM 1
C DYSPEPSIA EDENTULOUS 1
C DYSPEPSIA EMOTIONAL DISORDER 1
C DYSPEPSIA ERYTHEMA 1
C DYSPEPSIA EXTRAPYRAMIDAL DISORDER 1
C DYSPEPSIA FALL 1
C DYSPEPSIA GASTROOESOPHAGEAL REFLUX DISEASE 1
C DYSPEPSIA HYPOTHYROIDISM 1
C DYSPEPSIA INCONTINENCE 1
C DYSPEPSIA INCORRECT DRUG ADMINISTRATION DURATION 1
C DYSPEPSIA MENTAL STATUS CHANGES 1
C DYSPEPSIA MULTIPLE ALLERGIES 1
C DYSPEPSIA MUSCULOSKELETAL PAIN 1
C DYSPEPSIA NAUSEA 1
C DYSPEPSIA PARAESTHESIA 1
C DYSPEPSIA PARKINSONISM 1
C DYSPEPSIA RHINORRHOEA 1
C DYSPEPSIA SINUS HEADACHE 1
C DYSPEPSIA STRESS 1
C DYSPEPSIA SWOLLEN TONGUE 1
C DYSPEPSIA TARDIVE DYSKINESIA 1
C DYSPEPSIA TRANSIENT ISCHAEMIC ATTACK 1
C DYSPEPSIA TREMOR 1
C DYSPEPSIA UNEVALUABLE EVENT 1
C DYSPEPSIA URINARY TRACT INFECTION 1
C DYSPEPSIA VISION BLURRED 1
C DYSPEPSIA VOMITING 1
C DYSPEPSIA WALKING AID USER 1
C DYSPEPSIA WHEELCHAIR USER 1
C GASTROOESOPHAGEAL REFLUX DISEASE ANXIETY 1
C GASTROOESOPHAGEAL REFLUX DISEASE ARTHRITIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE ASTHENIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE BALANCE DISORDER 1
C GASTROOESOPHAGEAL REFLUX DISEASE CLUMSINESS 1
C GASTROOESOPHAGEAL REFLUX DISEASE COGNITIVE DISORDER 1
C GASTROOESOPHAGEAL REFLUX DISEASE COMPRESSION FRACTURE 1
C GASTROOESOPHAGEAL REFLUX DISEASE CONFUSIONAL STATE 1
C GASTROOESOPHAGEAL REFLUX DISEASE DIARRHOEA 1
C GASTROOESOPHAGEAL REFLUX DISEASE DRY MOUTH 1
C GASTROOESOPHAGEAL REFLUX DISEASE DYSKINESIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE DYSPEPSIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE DYSPHAGIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE ECONOMIC PROBLEM 1
C GASTROOESOPHAGEAL REFLUX DISEASE EDENTULOUS 1
C GASTROOESOPHAGEAL REFLUX DISEASE EMOTIONAL DISORDER 1
C GASTROOESOPHAGEAL REFLUX DISEASE ERYTHEMA 1
C GASTROOESOPHAGEAL REFLUX DISEASE EXTRAPYRAMIDAL DISORDER 1
C GASTROOESOPHAGEAL REFLUX DISEASE FALL 1
C GASTROOESOPHAGEAL REFLUX DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 1
C GASTROOESOPHAGEAL REFLUX DISEASE HYPOTHYROIDISM 1
C GASTROOESOPHAGEAL REFLUX DISEASE INCONTINENCE 1
C GASTROOESOPHAGEAL REFLUX DISEASE INCORRECT DRUG ADMINISTRATION DURATION 1
C GASTROOESOPHAGEAL REFLUX DISEASE MENTAL STATUS CHANGES 1
C GASTROOESOPHAGEAL REFLUX DISEASE MULTIPLE ALLERGIES 1
C GASTROOESOPHAGEAL REFLUX DISEASE MUSCULOSKELETAL PAIN 1
C GASTROOESOPHAGEAL REFLUX DISEASE NAUSEA 1
C GASTROOESOPHAGEAL REFLUX DISEASE PARAESTHESIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE PARKINSONISM 1
C GASTROOESOPHAGEAL REFLUX DISEASE RHINORRHOEA 1
C GASTROOESOPHAGEAL REFLUX DISEASE SINUS HEADACHE 1
C GASTROOESOPHAGEAL REFLUX DISEASE STRESS 1
C GASTROOESOPHAGEAL REFLUX DISEASE SWOLLEN TONGUE 1
C GASTROOESOPHAGEAL REFLUX DISEASE TARDIVE DYSKINESIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE TRANSIENT ISCHAEMIC ATTACK 1
C GASTROOESOPHAGEAL REFLUX DISEASE TREMOR 1
C GASTROOESOPHAGEAL REFLUX DISEASE UNEVALUABLE EVENT 1
C GASTROOESOPHAGEAL REFLUX DISEASE URINARY TRACT INFECTION 1
C GASTROOESOPHAGEAL REFLUX DISEASE VISION BLURRED 1
C GASTROOESOPHAGEAL REFLUX DISEASE VOMITING 1
C GASTROOESOPHAGEAL REFLUX DISEASE WALKING AID USER 1
C GASTROOESOPHAGEAL REFLUX DISEASE WHEELCHAIR USER 1
C HYPERCHLORAEMIA ASTHMA 1
C HYPERCHLORAEMIA DRUG INTOLERANCE 1
C HYPERCHLORAEMIA HEADACHE 1
C HYPERCHLORAEMIA MYALGIA 1
C HYPERCHLORAEMIA SLEEP APNOEA SYNDROME 1
C HYPERSENSITIVITY ASTHMA 2
C HYPERSENSITIVITY DRUG INTOLERANCE 2
C HYPERSENSITIVITY HEADACHE 2
C HYPERSENSITIVITY MYALGIA 2
C HYPERSENSITIVITY SLEEP APNOEA SYNDROME 2
C HYPERTENSION ASTHENIA 1
C HYPERTENSION ASTHMA 2
C HYPERTENSION BALANCE DISORDER 1
C HYPERTENSION DEHYDRATION 1
C HYPERTENSION DIVERTICULUM 1
C HYPERTENSION FALL 1
C HYPERTENSION GASTROENTERITIS 1
C HYPERTENSION HEADACHE 1
C HYPERTENSION HYPERTENSION 1
C HYPERTENSION HYPOAESTHESIA 1
C HYPERTENSION INJECTION SITE ERYTHEMA 1
C HYPERTENSION JOINT SWELLING 1
C HYPERTENSION PARAESTHESIA 1
C HYPERTENSION RENAL FAILURE ACUTE 1
C HYPERTENSION RENAL TUBULAR NECROSIS 1
C MULTIPLE SCLEROSIS ASTHENIA 1
C MULTIPLE SCLEROSIS BALANCE DISORDER 2
C MULTIPLE SCLEROSIS COUGH 1
C MULTIPLE SCLEROSIS DEHYDRATION 1
C MULTIPLE SCLEROSIS DEPRESSION 1
C MULTIPLE SCLEROSIS DIVERTICULUM 1
C MULTIPLE SCLEROSIS DRY THROAT 1
C MULTIPLE SCLEROSIS DYSPHAGIA 1
C MULTIPLE SCLEROSIS FALL 1
C MULTIPLE SCLEROSIS GASTROENTERITIS 1
C MULTIPLE SCLEROSIS HEADACHE 2
C MULTIPLE SCLEROSIS HYPERTENSION 1
C MULTIPLE SCLEROSIS HYPOAESTHESIA 1
C MULTIPLE SCLEROSIS INJECTION SITE ERYTHEMA 2
C MULTIPLE SCLEROSIS JOINT SWELLING 1
C MULTIPLE SCLEROSIS PAIN 1
C MULTIPLE SCLEROSIS PARAESTHESIA 1
C MULTIPLE SCLEROSIS RENAL FAILURE ACUTE 1
C MULTIPLE SCLEROSIS RENAL TUBULAR NECROSIS 1
C MULTIPLE SCLEROSIS THROAT IRRITATION 1
C MULTIPLE SCLEROSIS TREMOR 1
C NASAL CONGESTION ASTHMA 1
C NASAL DISORDER ASTHMA 1
C NASAL DISORDER DRUG INTOLERANCE 1
C NASAL DISORDER HEADACHE 1
C NASAL DISORDER MYALGIA 1
C NASAL DISORDER SLEEP APNOEA SYNDROME 1
C OSTEOPOROSIS ARTHRALGIA 2
C OSTEOPOROSIS FEMUR FRACTURE 2
C OSTEOPOROSIS PAIN 1
C OSTEOPOROSIS PAIN IN EXTREMITY 2
C PREMEDICATION ASTHENIA 1
C PREMEDICATION BALANCE DISORDER 1
C PREMEDICATION DEHYDRATION 1
C PREMEDICATION DIVERTICULUM 1
C PREMEDICATION FALL 1
C PREMEDICATION GASTROENTERITIS 1
C PREMEDICATION HEADACHE 1
C PREMEDICATION HYPERTENSION 1
C PREMEDICATION HYPOAESTHESIA 1
C PREMEDICATION INJECTION SITE ERYTHEMA 1
C PREMEDICATION JOINT SWELLING 1
C PREMEDICATION PARAESTHESIA 1
C PREMEDICATION RENAL FAILURE ACUTE 1
C PREMEDICATION RENAL TUBULAR NECROSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION ASTHMA 5
C PRODUCT USED FOR UNKNOWN INDICATION BRONCHIECTASIS 5
C PRODUCT USED FOR UNKNOWN INDICATION PHARYNGEAL OEDEMA 5
C PRODUCT USED FOR UNKNOWN INDICATION THROAT IRRITATION 5
C PRODUCT USED FOR UNKNOWN INDICATION WHEEZING 5
C PROPHYLAXIS ASTHMA 1
C PROPHYLAXIS CHEMICAL BURN OF SKIN 1
C PROPHYLAXIS ERYTHEMA 1
C PROPHYLAXIS EYELID OEDEMA 1
C PROPHYLAXIS OCULAR HYPERAEMIA 1
C PROPHYLAXIS SKIN SWELLING 1
C RESPIRATORY TRACT CONGESTION ASTHMA 1
C RHEUMATOID ARTHRITIS ARTHRALGIA 1
C RHEUMATOID ARTHRITIS COUGH 1
C RHEUMATOID ARTHRITIS DIZZINESS 1
C RHEUMATOID ARTHRITIS FATIGUE 1
C RHEUMATOID ARTHRITIS HEADACHE 1
C RHEUMATOID ARTHRITIS HYPERGLYCAEMIA 1
C RHEUMATOID ARTHRITIS HYPOGLYCAEMIA 1
C RHEUMATOID ARTHRITIS LATENT TUBERCULOSIS 1
C RHEUMATOID ARTHRITIS LETHARGY 1
C RHEUMATOID ARTHRITIS MUSCULAR WEAKNESS 1
C RHEUMATOID ARTHRITIS OEDEMA PERIPHERAL 1
C RHEUMATOID ARTHRITIS PAIN IN EXTREMITY 1
C RHEUMATOID ARTHRITIS RASH 1
C RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS 1
C RHEUMATOID ARTHRITIS THROAT IRRITATION 1
C RHEUMATOID ARTHRITIS TREMOR 1
C RHEUMATOID ARTHRITIS VISION BLURRED 1
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