Drug information for PENNSAID

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION; TOPICAL 1.5% Prescription  (Reference Drug) DICLOFENAC SODIUM Diclofenac MALLINCKRODT 20947
2011-07-18 Letter

2010-05-06 Review

2010-05-06 Summary Review

2010-04-04 Label

2010-04-04 Label

2010-04-01 Other

2010-03-31 Letter

2010-03-31 Letter

2009-12-08 Other

2009-11-18 Medication Guide

2009-11-13 Letter

2009-11-12 Label

Drug Adverse Effects information for PENNSAID

Role code Indications Reaction # Reports
PS ARTHRALGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS ARTHRALGIA PRURITUS 1
PS ARTHRALGIA RASH MACULAR 1
PS ARTHRALGIA SKIN EXFOLIATION 1
PS ARTHRITIS BLOOD PRESSURE INCREASED 1
PS ARTHRITIS VISION BLURRED 1
PS BURSITIS COUGH 1
PS BURSITIS DYSPNOEA 1
PS BURSITIS SNEEZING 1
PS BURSITIS THROAT TIGHTNESS 1
PS MUSCLE TIGHTNESS INCORRECT DRUG ADMINISTRATION DURATION 1
PS MUSCLE TIGHTNESS INTENTIONAL DRUG MISUSE 1
PS MUSCLE TIGHTNESS SWELLING 1
PS OSTEOARTHRITIS APPLICATION SITE EXFOLIATION 1
PS OSTEOARTHRITIS DRY SKIN 1
PS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS PAIN PRURITUS 1
PS PAIN RASH MACULAR 1
PS PAIN SKIN EXFOLIATION 1
PS PAIN IN EXTREMITY PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION SKIN BURNING SENSATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION SKIN REACTION 1
SS ARTHRALGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS ARTHRALGIA PRURITUS 1
SS ARTHRALGIA RASH MACULAR 1
SS ARTHRALGIA SKIN EXFOLIATION 1
SS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS PAIN PRURITUS 1
SS PAIN RASH MACULAR 1
SS PAIN SKIN EXFOLIATION 1
C ANALGESIC THERAPY DIABETES MELLITUS 1
C ANALGESIC THERAPY DRUG DOSE OMISSION 1
C ANALGESIC THERAPY HYPERTENSION 1
C ANALGESIC THERAPY INSOMNIA 1
C ANALGESIC THERAPY OFF LABEL USE 1
C ANALGESIC THERAPY OSTEOPOROSIS 1
C ANALGESIC THERAPY PULSE ABSENT 1
C ANALGESIC THERAPY RESPIRATORY ARREST 1
C ANALGESIC THERAPY VERTIGO 1
C ANXIETY DIABETES MELLITUS 1
C ANXIETY DRUG DOSE OMISSION 1
C ANXIETY HYPERTENSION 1
C ANXIETY INSOMNIA 1
C ANXIETY OFF LABEL USE 1
C ANXIETY OSTEOPOROSIS 1
C ANXIETY PULSE ABSENT 1
C ANXIETY RESPIRATORY ARREST 1
C ANXIETY VERTIGO 1
C BIPOLAR DISORDER DIABETES MELLITUS 1
C BIPOLAR DISORDER DRUG DOSE OMISSION 1
C BIPOLAR DISORDER HYPERTENSION 1
C BIPOLAR DISORDER INSOMNIA 1
C BIPOLAR DISORDER OFF LABEL USE 1
C BIPOLAR DISORDER OSTEOPOROSIS 1
C BIPOLAR DISORDER PULSE ABSENT 1
C BIPOLAR DISORDER RESPIRATORY ARREST 1
C BIPOLAR DISORDER VERTIGO 1
C DEPRESSION DIABETES MELLITUS 2
C DEPRESSION DRUG DOSE OMISSION 2
C DEPRESSION HYPERTENSION 2
C DEPRESSION INSOMNIA 2
C DEPRESSION OFF LABEL USE 2
C DEPRESSION OSTEOPOROSIS 2
C DEPRESSION PULSE ABSENT 2
C DEPRESSION RESPIRATORY ARREST 2
C DEPRESSION VERTIGO 2
C DIURETIC THERAPY DIABETES MELLITUS 1
C DIURETIC THERAPY DRUG DOSE OMISSION 1
C DIURETIC THERAPY HYPERTENSION 1
C DIURETIC THERAPY INSOMNIA 1
C DIURETIC THERAPY OFF LABEL USE 1
C DIURETIC THERAPY OSTEOPOROSIS 1
C DIURETIC THERAPY PULSE ABSENT 1
C DIURETIC THERAPY RESPIRATORY ARREST 1
C DIURETIC THERAPY VERTIGO 1
C FIBROMYALGIA DIABETES MELLITUS 1
C FIBROMYALGIA DRUG DOSE OMISSION 1
C FIBROMYALGIA HYPERTENSION 1
C FIBROMYALGIA INSOMNIA 1
C FIBROMYALGIA OFF LABEL USE 1
C FIBROMYALGIA OSTEOPOROSIS 1
C FIBROMYALGIA PULSE ABSENT 1
C FIBROMYALGIA RESPIRATORY ARREST 1
C FIBROMYALGIA VERTIGO 1
C HEART DISEASE CONGENITAL DIABETES MELLITUS 1
C HEART DISEASE CONGENITAL DRUG DOSE OMISSION 1
C HEART DISEASE CONGENITAL HYPERTENSION 1
C HEART DISEASE CONGENITAL INSOMNIA 1
C HEART DISEASE CONGENITAL OFF LABEL USE 1
C HEART DISEASE CONGENITAL OSTEOPOROSIS 1
C HEART DISEASE CONGENITAL PULSE ABSENT 1
C HEART DISEASE CONGENITAL RESPIRATORY ARREST 1
C HEART DISEASE CONGENITAL VERTIGO 1
C HYPERSENSITIVITY DIABETES MELLITUS 2
C HYPERSENSITIVITY DRUG DOSE OMISSION 2
C HYPERSENSITIVITY HYPERTENSION 2
C HYPERSENSITIVITY INSOMNIA 2
C HYPERSENSITIVITY OFF LABEL USE 2
C HYPERSENSITIVITY OSTEOPOROSIS 2
C HYPERSENSITIVITY PULSE ABSENT 2
C HYPERSENSITIVITY RESPIRATORY ARREST 2
C HYPERSENSITIVITY VERTIGO 2
C MOOD SWINGS DIABETES MELLITUS 2
C MOOD SWINGS DRUG DOSE OMISSION 2
C MOOD SWINGS HYPERTENSION 2
C MOOD SWINGS INSOMNIA 2
C MOOD SWINGS OFF LABEL USE 2
C MOOD SWINGS OSTEOPOROSIS 2
C MOOD SWINGS PULSE ABSENT 2
C MOOD SWINGS RESPIRATORY ARREST 2
C MOOD SWINGS VERTIGO 2
C MUSCLE RELAXANT THERAPY DIABETES MELLITUS 1
C MUSCLE RELAXANT THERAPY DRUG DOSE OMISSION 1
C MUSCLE RELAXANT THERAPY HYPERTENSION 1
C MUSCLE RELAXANT THERAPY INSOMNIA 1
C MUSCLE RELAXANT THERAPY OFF LABEL USE 1
C MUSCLE RELAXANT THERAPY OSTEOPOROSIS 1
C MUSCLE RELAXANT THERAPY PULSE ABSENT 1
C MUSCLE RELAXANT THERAPY RESPIRATORY ARREST 1
C MUSCLE RELAXANT THERAPY VERTIGO 1
C NAUSEA DIABETES MELLITUS 1
C NAUSEA DRUG DOSE OMISSION 1
C NAUSEA HYPERTENSION 1
C NAUSEA INSOMNIA 1
C NAUSEA OFF LABEL USE 1
C NAUSEA OSTEOPOROSIS 1
C NAUSEA PULSE ABSENT 1
C NAUSEA RESPIRATORY ARREST 1
C NAUSEA VERTIGO 1
C PAIN DIABETES MELLITUS 1
C PAIN DRUG DOSE OMISSION 1
C PAIN HYPERTENSION 1
C PAIN INSOMNIA 1
C PAIN OFF LABEL USE 1
C PAIN OSTEOPOROSIS 1
C PAIN PULSE ABSENT 1
C PAIN RESPIRATORY ARREST 1
C PAIN VERTIGO 1
C PAIN MANAGEMENT DIABETES MELLITUS 5
C PAIN MANAGEMENT DRUG DOSE OMISSION 5
C PAIN MANAGEMENT HYPERTENSION 5
C PAIN MANAGEMENT INSOMNIA 5
C PAIN MANAGEMENT OFF LABEL USE 5
C PAIN MANAGEMENT OSTEOPOROSIS 5
C PAIN MANAGEMENT PULSE ABSENT 5
C PAIN MANAGEMENT RESPIRATORY ARREST 5
C PAIN MANAGEMENT VERTIGO 5
C REFLUX LARYNGITIS DIABETES MELLITUS 1
C REFLUX LARYNGITIS DRUG DOSE OMISSION 1
C REFLUX LARYNGITIS HYPERTENSION 1
C REFLUX LARYNGITIS INSOMNIA 1
C REFLUX LARYNGITIS OFF LABEL USE 1
C REFLUX LARYNGITIS OSTEOPOROSIS 1
C REFLUX LARYNGITIS PULSE ABSENT 1
C REFLUX LARYNGITIS RESPIRATORY ARREST 1
C REFLUX LARYNGITIS VERTIGO 1
C RESTLESS LEGS SYNDROME DIABETES MELLITUS 1
C RESTLESS LEGS SYNDROME DRUG DOSE OMISSION 1
C RESTLESS LEGS SYNDROME HYPERTENSION 1
C RESTLESS LEGS SYNDROME INSOMNIA 1
C RESTLESS LEGS SYNDROME OFF LABEL USE 1
C RESTLESS LEGS SYNDROME OSTEOPOROSIS 1
C RESTLESS LEGS SYNDROME PULSE ABSENT 1
C RESTLESS LEGS SYNDROME RESPIRATORY ARREST 1
C RESTLESS LEGS SYNDROME VERTIGO 1
C RHEUMATOID ARTHRITIS ARTHRALGIA 1
C RHEUMATOID ARTHRITIS BURSITIS 1
C RHEUMATOID ARTHRITIS DIABETES MELLITUS 1
C RHEUMATOID ARTHRITIS DRUG DOSE OMISSION 1
C RHEUMATOID ARTHRITIS FALL 1
C RHEUMATOID ARTHRITIS FATIGUE 1
C RHEUMATOID ARTHRITIS HYPERTENSION 1
C RHEUMATOID ARTHRITIS INSOMNIA 1
C RHEUMATOID ARTHRITIS JOINT SWELLING 1
C RHEUMATOID ARTHRITIS MUSCULAR WEAKNESS 1
C RHEUMATOID ARTHRITIS MUSCULOSKELETAL STIFFNESS 1
C RHEUMATOID ARTHRITIS NECK PAIN 1
C RHEUMATOID ARTHRITIS OEDEMA PERIPHERAL 1
C RHEUMATOID ARTHRITIS OFF LABEL USE 1
C RHEUMATOID ARTHRITIS OSTEOARTHRITIS 1
C RHEUMATOID ARTHRITIS OSTEOPOROSIS 1
C RHEUMATOID ARTHRITIS PULSE ABSENT 1
C RHEUMATOID ARTHRITIS RESPIRATORY ARREST 1
C RHEUMATOID ARTHRITIS THORACIC VERTEBRAL FRACTURE 1
C RHEUMATOID ARTHRITIS VERTIGO 1
C SLEEP DISORDER DIABETES MELLITUS 1
C SLEEP DISORDER DRUG DOSE OMISSION 1
C SLEEP DISORDER HYPERTENSION 1
C SLEEP DISORDER INSOMNIA 1
C SLEEP DISORDER OFF LABEL USE 1
C SLEEP DISORDER OSTEOPOROSIS 1
C SLEEP DISORDER PULSE ABSENT 1
C SLEEP DISORDER RESPIRATORY ARREST 1
C SLEEP DISORDER VERTIGO 1
C SYSTEMIC LUPUS ERYTHEMATOSUS DIABETES MELLITUS 1
C SYSTEMIC LUPUS ERYTHEMATOSUS DRUG DOSE OMISSION 1
C SYSTEMIC LUPUS ERYTHEMATOSUS HYPERTENSION 1
C SYSTEMIC LUPUS ERYTHEMATOSUS INSOMNIA 1
C SYSTEMIC LUPUS ERYTHEMATOSUS OFF LABEL USE 1
C SYSTEMIC LUPUS ERYTHEMATOSUS OSTEOPOROSIS 1
C SYSTEMIC LUPUS ERYTHEMATOSUS PULSE ABSENT 1
C SYSTEMIC LUPUS ERYTHEMATOSUS RESPIRATORY ARREST 1
C SYSTEMIC LUPUS ERYTHEMATOSUS VERTIGO 1
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