Drug information for GELNIQUE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
GEL; TRANSDERMAL 10%(100MG/PACKET) Prescription  (Reference Drug) OXYBUTYNIN CHLORIDE oxybutynin WATSON LABS 22204
2011-02-04 Letter

2011-01-31 Label

2010-05-13 Review

2010-05-13 Summary Review

2009-02-04 Label

2009-02-03 Letter

Drug Adverse Effects information for GELNIQUE

Role code Indications Reaction # Reports
PS GASTROOESOPHAGEAL REFLUX DISEASE CHEST DISCOMFORT 1
PS GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA 1
PS GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA EXERTIONAL 1
PS GASTROOESOPHAGEAL REFLUX DISEASE IRRITABILITY 1
PS GASTROOESOPHAGEAL REFLUX DISEASE PRURITUS 1
PS GASTROOESOPHAGEAL REFLUX DISEASE URTICARIA 1
PS HYPERTONIC BLADDER HALLUCINATION 1
PS MIGRAINE CHEST DISCOMFORT 1
PS MIGRAINE DYSPNOEA 1
PS MIGRAINE DYSPNOEA EXERTIONAL 1
PS MIGRAINE IRRITABILITY 1
PS MIGRAINE PRURITUS 1
PS MIGRAINE URTICARIA 1
PS PAIN CHEST DISCOMFORT 1
PS PAIN DYSPNOEA 1
PS PAIN DYSPNOEA EXERTIONAL 1
PS PAIN IRRITABILITY 1
PS PAIN PRURITUS 1
PS PAIN URTICARIA 1
PS POLLAKIURIA CHEST DISCOMFORT 1
PS POLLAKIURIA DYSPNOEA 1
PS POLLAKIURIA DYSPNOEA EXERTIONAL 1
PS POLLAKIURIA IRRITABILITY 1
PS POLLAKIURIA PRURITUS 1
PS POLLAKIURIA URTICARIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANEURYSM 1
PS PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 10
PS PRODUCT USED FOR UNKNOWN INDICATION ATRIAL FIBRILLATION 10
PS PRODUCT USED FOR UNKNOWN INDICATION CHEST DISCOMFORT 4
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 4
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA EXERTIONAL 4
PS PRODUCT USED FOR UNKNOWN INDICATION HAEMOPTYSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION HAEMORRHAGE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE INCREASED 10
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOTENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYSTERECTOMY 1
PS PRODUCT USED FOR UNKNOWN INDICATION IRRITABILITY 4
PS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 10
PS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 4
PS PRODUCT USED FOR UNKNOWN INDICATION URINARY TRACT INFECTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION URTICARIA 4
PS PRODUCT USED FOR UNKNOWN INDICATION VOMITING 11
PS RHEUMATOID ARTHRITIS CHEST DISCOMFORT 1
PS RHEUMATOID ARTHRITIS DYSPNOEA 1
PS RHEUMATOID ARTHRITIS DYSPNOEA EXERTIONAL 1
PS RHEUMATOID ARTHRITIS IRRITABILITY 1
PS RHEUMATOID ARTHRITIS PRURITUS 1
PS RHEUMATOID ARTHRITIS URTICARIA 1
PS SEASONAL ALLERGY CHEST DISCOMFORT 1
PS SEASONAL ALLERGY DYSPNOEA 1
PS SEASONAL ALLERGY DYSPNOEA EXERTIONAL 1
PS SEASONAL ALLERGY IRRITABILITY 1
PS SEASONAL ALLERGY PRURITUS 1
PS SEASONAL ALLERGY URTICARIA 1
PS URINARY INCONTINENCE ANEURYSM 1
PS URINARY INCONTINENCE ASTHENIA 1
PS URINARY INCONTINENCE ATRIAL FIBRILLATION 1
PS URINARY INCONTINENCE HAEMOPTYSIS 1
PS URINARY INCONTINENCE HAEMORRHAGE 1
PS URINARY INCONTINENCE HEART RATE INCREASED 1
PS URINARY INCONTINENCE HYPOTENSION 1
PS URINARY INCONTINENCE NAUSEA 1
PS URINARY INCONTINENCE URINARY TRACT INFECTION 1
PS URINARY INCONTINENCE VOMITING 2
PS URINARY TRACT INFECTION CHEST DISCOMFORT 2
PS URINARY TRACT INFECTION DYSPNOEA 2
PS URINARY TRACT INFECTION DYSPNOEA EXERTIONAL 2
PS URINARY TRACT INFECTION IRRITABILITY 2
PS URINARY TRACT INFECTION PRURITUS 2
PS URINARY TRACT INFECTION URTICARIA 2
SS DRY EYE DRY EYE 2
SS DRY EYE EYELID OEDEMA 2
SS DRY EYE WRONG TECHNIQUE IN DRUG USAGE PROCESS 2
SS GASTROOESOPHAGEAL REFLUX DISEASE CHEST DISCOMFORT 3
SS GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA 3
SS GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA EXERTIONAL 2
SS GASTROOESOPHAGEAL REFLUX DISEASE IRRITABILITY 3
SS GASTROOESOPHAGEAL REFLUX DISEASE POLLAKIURIA 2
SS GASTROOESOPHAGEAL REFLUX DISEASE PRURITUS 3
SS GASTROOESOPHAGEAL REFLUX DISEASE URINARY TRACT INFECTION 2
SS GASTROOESOPHAGEAL REFLUX DISEASE URTICARIA 3
SS GROWTH OF EYELASHES DRY EYE 1
SS GROWTH OF EYELASHES EYELID OEDEMA 1
SS GROWTH OF EYELASHES WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
SS HYPERSENSITIVITY CHEST DISCOMFORT 2
SS HYPERSENSITIVITY DYSPNOEA 2
SS HYPERSENSITIVITY DYSPNOEA EXERTIONAL 1
SS HYPERSENSITIVITY IRRITABILITY 2
SS HYPERSENSITIVITY POLLAKIURIA 2
SS HYPERSENSITIVITY PRURITUS 2
SS HYPERSENSITIVITY URINARY TRACT INFECTION 2
SS HYPERSENSITIVITY URTICARIA 2
SS HYPERTENSION BLOOD PRESSURE INCREASED 2
SS HYPERTENSION DRUG INEFFECTIVE 2
SS HYPERTONIC BLADDER BLOOD PRESSURE INCREASED 1
SS HYPERTONIC BLADDER DRUG INEFFECTIVE 2
SS HYPERTONIC BLADDER POLLAKIURIA 1
SS HYPERTONIC BLADDER POOR QUALITY SLEEP 1
SS HYPERTONIC BLADDER URINARY RETENTION 1
SS HYPERTONIC BLADDER URINE FLOW DECREASED 1
SS MIGRAINE CHEST DISCOMFORT 3
SS MIGRAINE DYSPNOEA 3
SS MIGRAINE DYSPNOEA EXERTIONAL 2
SS MIGRAINE IRRITABILITY 3
SS MIGRAINE POLLAKIURIA 2
SS MIGRAINE PRURITUS 3
SS MIGRAINE URINARY TRACT INFECTION 2
SS MIGRAINE URTICARIA 3
SS PAIN CHEST DISCOMFORT 3
SS PAIN DYSPNOEA 3
SS PAIN DYSPNOEA EXERTIONAL 2
SS PAIN IRRITABILITY 3
SS PAIN POLLAKIURIA 2
SS PAIN PRURITUS 3
SS PAIN URINARY TRACT INFECTION 2
SS PAIN URTICARIA 3
SS POLLAKIURIA CHEST DISCOMFORT 1
SS POLLAKIURIA DRY MOUTH 2
SS POLLAKIURIA DYSPNOEA 1
SS POLLAKIURIA DYSPNOEA EXERTIONAL 1
SS POLLAKIURIA IRRITABILITY 1
SS POLLAKIURIA PRURITUS 1
SS POLLAKIURIA URTICARIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION CHEST DISCOMFORT 12
SS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 12
SS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA EXERTIONAL 8
SS PRODUCT USED FOR UNKNOWN INDICATION IRRITABILITY 12
SS PRODUCT USED FOR UNKNOWN INDICATION POLLAKIURIA 8
SS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 12
SS PRODUCT USED FOR UNKNOWN INDICATION URINARY TRACT INFECTION 8
SS PRODUCT USED FOR UNKNOWN INDICATION URTICARIA 12
SS RHEUMATOID ARTHRITIS CHEST DISCOMFORT 3
SS RHEUMATOID ARTHRITIS DYSPNOEA 3
SS RHEUMATOID ARTHRITIS DYSPNOEA EXERTIONAL 2
SS RHEUMATOID ARTHRITIS IRRITABILITY 3
SS RHEUMATOID ARTHRITIS POLLAKIURIA 2
SS RHEUMATOID ARTHRITIS PRURITUS 3
SS RHEUMATOID ARTHRITIS URINARY TRACT INFECTION 2
SS RHEUMATOID ARTHRITIS URTICARIA 3
SS SEASONAL ALLERGY CHEST DISCOMFORT 1
SS SEASONAL ALLERGY DYSPNOEA 1
SS SEASONAL ALLERGY DYSPNOEA EXERTIONAL 1
SS SEASONAL ALLERGY IRRITABILITY 1
SS SEASONAL ALLERGY PRURITUS 1
SS SEASONAL ALLERGY URTICARIA 1
SS THERAPEUTIC SKIN CARE TOPICAL DRY EYE 1
SS THERAPEUTIC SKIN CARE TOPICAL EYELID OEDEMA 1
SS THERAPEUTIC SKIN CARE TOPICAL WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
SS URINARY TRACT INFECTION CHEST DISCOMFORT 6
SS URINARY TRACT INFECTION DYSPNOEA 6
SS URINARY TRACT INFECTION DYSPNOEA EXERTIONAL 4
SS URINARY TRACT INFECTION IRRITABILITY 6
SS URINARY TRACT INFECTION POLLAKIURIA 4
SS URINARY TRACT INFECTION PRURITUS 6
SS URINARY TRACT INFECTION URINARY TRACT INFECTION 4
SS URINARY TRACT INFECTION URTICARIA 6
C PRODUCT USED FOR UNKNOWN INDICATION CANDIDIASIS 1
C PRODUCT USED FOR UNKNOWN INDICATION STAPHYLOCOCCAL INFECTION 1
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