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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