Drug information for ADVIL PM
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE; ORAL
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Over The Counter
(Reference Drug)
DIPHENHYDRAMINE HYDROCHLORIDE
;
IBUPROFEN
Diphenhydramine
WYETH CONS
21393
2011-04-21 Letter
2009-05-27 Letter
2008-06-16 Letter
2006-09-07 Review
2006-01-19 Letter
2006-01-05 Label
TABLET; ORAL
38MG;200MG
Over The Counter
(Reference Drug)
DIPHENHYDRAMINE CITRATE
;
IBUPROFEN
Diphenhydramine
PFIZER CONS HLTHCARE
21394
2011-04-28 Letter
2010-09-07 Letter
2009-05-27 Letter
2008-06-13 Letter
2006-09-07 Review
2006-01-19 Letter
2006-01-05 Label
Drug Adverse Effects information for ADVIL PM
Role code
Indications
Reaction
# Reports
PS
AFFECTIVE DISORDER
DRUG INEFFECTIVE
2
PS
AFFECTIVE DISORDER
HOT FLUSH
2
PS
AFFECTIVE DISORDER
RASH
2
PS
AFFECTIVE DISORDER
SLEEP DISORDER
2
PS
ARTHRALGIA
AGITATION
1
PS
ARTHRALGIA
DRUG INEFFECTIVE
3
PS
ARTHRALGIA
INSOMNIA
2
PS
ARTHRALGIA
RESTLESSNESS
1
PS
ARTHROPATHY
CONVULSION
2
PS
BACK PAIN
DRUG INEFFECTIVE
2
PS
BACK PAIN
HYPOAESTHESIA
2
PS
BACK PAIN
MIDDLE INSOMNIA
2
PS
BACK PAIN
SINUS HEADACHE
1
PS
BLOOD CHOLESTEROL ABNORMAL
DRUG INEFFECTIVE
1
PS
BLOOD CHOLESTEROL ABNORMAL
OSTEOARTHRITIS
1
PS
BLOOD CHOLESTEROL ABNORMAL
WEIGHT DECREASED
1
PS
BLOOD CHOLESTEROL INCREASED
ENERGY INCREASED
2
PS
BLOOD CHOLESTEROL INCREASED
HEART RATE INCREASED
2
PS
BLOOD CHOLESTEROL INCREASED
INSOMNIA
4
PS
BLOOD PRESSURE ABNORMAL
OSTEOARTHRITIS
1
PS
BLOOD PRESSURE ABNORMAL
WEIGHT DECREASED
1
PS
BONE DISORDER
OSTEOARTHRITIS
1
PS
BONE DISORDER
WEIGHT DECREASED
1
PS
CARDIAC DISORDER
CONVULSION
2
PS
CARDIAC DISORDER
OSTEOARTHRITIS
1
PS
CARDIAC DISORDER
WEIGHT DECREASED
1
PS
CARDIAC MURMUR
OSTEOARTHRITIS
1
PS
CARDIAC MURMUR
WEIGHT DECREASED
1
PS
CONSTIPATION
WEIGHT DECREASED
1
PS
DEPRESSION
DRUG INEFFECTIVE
2
PS
DEPRESSION
HOT FLUSH
2
PS
DEPRESSION
RASH
2
PS
DEPRESSION
SLEEP DISORDER
2
PS
DIABETES MELLITUS
BLOOD GLUCOSE INCREASED
1
PS
DIABETES MELLITUS
TINNITUS
1
PS
EYE DISORDER
INSOMNIA
4
PS
EYE DISORDER
OSTEOARTHRITIS
1
PS
EYE DISORDER
WEIGHT DECREASED
1
PS
HEADACHE
DRUG INEFFECTIVE
2
PS
HEADACHE
HEADACHE
2
PS
HEADACHE
HOT FLUSH
1
PS
HEADACHE
INSOMNIA
2
PS
HEADACHE
RASH
1
PS
HEADACHE
SLEEP DISORDER
1
PS
HYPERTENSION
AGITATION
1
PS
HYPERTENSION
DRUG INEFFECTIVE
1
PS
HYPERTENSION
INSOMNIA
1
PS
HYPERTENSION
RESTLESSNESS
1
PS
HYPERTENSION
SINUS HEADACHE
2
PS
INSOMNIA
AGITATION
1
PS
INSOMNIA
ANXIETY
1
PS
INSOMNIA
BLOOD GLUCOSE INCREASED
1
PS
INSOMNIA
CONVULSION
2
PS
INSOMNIA
DIZZINESS
1
PS
INSOMNIA
DRUG INEFFECTIVE
4
PS
INSOMNIA
FEELING DRUNK
1
PS
INSOMNIA
GAIT DISTURBANCE
1
PS
INSOMNIA
HYPOAESTHESIA
3
PS
INSOMNIA
INSOMNIA
2
PS
INSOMNIA
MIDDLE INSOMNIA
2
PS
INSOMNIA
SINUS HEADACHE
1
PS
INSOMNIA
SOMNOLENCE
1
PS
INSOMNIA
TINNITUS
1
PS
INSOMNIA
URINE ODOUR ABNORMAL
1
PS
JOINT INJURY
DIZZINESS
2
PS
JOINT INJURY
FATIGUE
2
PS
JOINT INJURY
SOMNOLENCE
2
PS
JOINT INJURY
WRONG DRUG ADMINISTERED
2
PS
MIGRAINE
DRUG INEFFECTIVE
1
PS
MIGRAINE
HOT FLUSH
1
PS
MIGRAINE
RASH
1
PS
MIGRAINE
SLEEP DISORDER
1
PS
MUSCLE SPASMS
FATIGUE
1
PS
MUSCLE SPASMS
HYPERSOMNIA
1
PS
MUSCLE SPASMS
OVERDOSE
1
PS
MUSCLE SPASMS
SOMNOLENCE
1
PS
MUSCULOSKELETAL CHEST PAIN
SINUS HEADACHE
1
PS
MYALGIA
CONVULSION
2
PS
NECK PAIN
SINUS HEADACHE
1
PS
OSTEOARTHRITIS
OSTEOARTHRITIS
1
PS
OSTEOARTHRITIS
WEIGHT DECREASED
1
PS
OSTEOPOROSIS
INSOMNIA
2
PS
PAIN
DIZZINESS
1
PS
PAIN
DRUG INEFFECTIVE
2
PS
PAIN
FATIGUE
1
PS
PAIN
FEELING ABNORMAL
1
PS
PAIN
HEART RATE ABNORMAL
1
PS
PAIN
HYPERSENSITIVITY
1
PS
PAIN
HYPERSOMNIA
1
PS
PAIN
HYPOAESTHESIA
2
PS
PAIN
MIDDLE INSOMNIA
2
PS
PAIN
MUSCLE SPASMS
1
PS
PAIN
OVERDOSE
1
PS
PAIN
SOMNOLENCE
1
PS
SERUM SEROTONIN DECREASED
ANXIETY
1
PS
SERUM SEROTONIN DECREASED
HYPOAESTHESIA
1
PS
SERUM SEROTONIN DECREASED
INSOMNIA
1
PS
SERUM SEROTONIN DECREASED
SOMNOLENCE
1
PS
SLEEP DISORDER
AGITATION
1
PS
SLEEP DISORDER
DRUG INEFFECTIVE
4
PS
SLEEP DISORDER
DRY SKIN
1
PS
SLEEP DISORDER
ENERGY INCREASED
2
PS
SLEEP DISORDER
ERYTHEMA
1
PS
SLEEP DISORDER
HEART RATE INCREASED
2
PS
SLEEP DISORDER
HYPERSENSITIVITY
1
PS
SLEEP DISORDER
INSOMNIA
5
PS
SLEEP DISORDER
MALAISE
2
PS
SLEEP DISORDER
OSTEOARTHRITIS
1
PS
SLEEP DISORDER
RESTLESSNESS
1
PS
SLEEP DISORDER
WEIGHT DECREASED
1
PS
SUPPLEMENTATION THERAPY
CONVULSION
2
PS
THYROID DISORDER
AGITATION
1
PS
THYROID DISORDER
DRUG INEFFECTIVE
1
PS
THYROID DISORDER
INSOMNIA
1
PS
THYROID DISORDER
RESTLESSNESS
1
PS
VITAMIN SUPPLEMENTATION
OSTEOARTHRITIS
2
PS
VITAMIN SUPPLEMENTATION
WEIGHT DECREASED
2
SS
ARTHRALGIA
AGITATION
1
SS
ARTHRALGIA
DRUG INEFFECTIVE
3
SS
ARTHRALGIA
INSOMNIA
1
SS
ARTHRALGIA
RESTLESSNESS
1
SS
ARTHROPATHY
CONVULSION
2
SS
BACK PAIN
DRUG INEFFECTIVE
2
SS
BACK PAIN
HYPOAESTHESIA
2
SS
BACK PAIN
MIDDLE INSOMNIA
2
SS
BACK PAIN
SINUS HEADACHE
3
SS
BLOOD CHOLESTEROL ABNORMAL
OSTEOARTHRITIS
1
SS
BLOOD POTASSIUM DECREASED
DRUG INEFFECTIVE
2
SS
BLOOD PRESSURE ABNORMAL
DRUG INEFFECTIVE
2
SS
BLOOD PRESSURE ABNORMAL
OSTEOARTHRITIS
1
SS
BONE DISORDER
OSTEOARTHRITIS
1
SS
CARDIAC DISORDER
CONVULSION
2
SS
CARDIAC DISORDER
OSTEOARTHRITIS
1
SS
CARDIAC MURMUR
OSTEOARTHRITIS
1
SS
CARDIAC OPERATION
HAEMATOCHEZIA
1
SS
EYE DISORDER
OSTEOARTHRITIS
1
SS
HYPERTENSION
AGITATION
1
SS
HYPERTENSION
DRUG INEFFECTIVE
1
SS
HYPERTENSION
INSOMNIA
1
SS
HYPERTENSION
RESTLESSNESS
1
SS
HYPERTENSION
SINUS HEADACHE
6
SS
INSOMNIA
CONVULSION
2
SS
INSOMNIA
DRUG INEFFECTIVE
4
SS
INSOMNIA
HYPOAESTHESIA
2
SS
INSOMNIA
MIDDLE INSOMNIA
2
SS
INSOMNIA
SINUS HEADACHE
3
SS
MUSCLE SPASMS
FATIGUE
1
SS
MUSCLE SPASMS
HYPERSOMNIA
1
SS
MUSCLE SPASMS
OVERDOSE
1
SS
MUSCLE SPASMS
SOMNOLENCE
1
SS
MUSCULOSKELETAL CHEST PAIN
SINUS HEADACHE
3
SS
MUSCULOSKELETAL PAIN
DRUG INEFFECTIVE
4
SS
MYALGIA
CONVULSION
2
SS
NECK PAIN
SINUS HEADACHE
3
SS
OSTEOARTHRITIS
OSTEOARTHRITIS
1
SS
PAIN
DRUG INEFFECTIVE
2
SS
PAIN
FATIGUE
1
SS
PAIN
HYPERSENSITIVITY
1
SS
PAIN
HYPERSOMNIA
1
SS
PAIN
HYPOAESTHESIA
2
SS
PAIN
MIDDLE INSOMNIA
2
SS
PAIN
OVERDOSE
1
SS
PAIN
SOMNOLENCE
1
SS
SLEEP DISORDER
AGITATION
1
SS
SLEEP DISORDER
DRUG INEFFECTIVE
4
SS
SLEEP DISORDER
DRY SKIN
1
SS
SLEEP DISORDER
ERYTHEMA
1
SS
SLEEP DISORDER
HYPERSENSITIVITY
1
SS
SLEEP DISORDER
INSOMNIA
1
SS
SLEEP DISORDER
OSTEOARTHRITIS
1
SS
SLEEP DISORDER
RESTLESSNESS
1
SS
SUPPLEMENTATION THERAPY
CONVULSION
2
SS
THYROID DISORDER
AGITATION
1
SS
THYROID DISORDER
DRUG INEFFECTIVE
1
SS
THYROID DISORDER
INSOMNIA
1
SS
THYROID DISORDER
RESTLESSNESS
1
SS
VITAMIN SUPPLEMENTATION
OSTEOARTHRITIS
2
C
ANXIETY
CHEST PAIN
1
C
ANXIETY
DYSPNOEA
1
C
ANXIETY
HAEMOPTYSIS
1
C
ANXIETY
NON-CARDIAC CHEST PAIN
1
C
ANXIETY
PULMONARY EMBOLISM
1
C
ANXIETY
PULMONARY FUNCTION TEST DECREASED
1
C
ANXIETY
PULMONARY INFARCTION
1
C
CHEST DISCOMFORT
DRUG INEFFECTIVE
1
C
CHRONIC MYELOID LEUKAEMIA
ABDOMINAL PAIN UPPER
1
C
CHRONIC MYELOID LEUKAEMIA
ACUTE CORONARY SYNDROME
3
C
CHRONIC MYELOID LEUKAEMIA
ARTERIOSCLEROSIS CORONARY ARTERY
2
C
CHRONIC MYELOID LEUKAEMIA
CORONARY ARTERY DISEASE
1
C
CHRONIC MYELOID LEUKAEMIA
DIASTOLIC DYSFUNCTION
2
C
CHRONIC MYELOID LEUKAEMIA
PULMONARY HYPERTENSION
3
C
CHRONIC MYELOID LEUKAEMIA
TROPONIN INCREASED
2
C
CHRONIC MYELOID LEUKAEMIA
VASCULITIS
3
C
DYSMENORRHOEA
ANXIETY
1
C
DYSMENORRHOEA
ASTHENIA
1
C
DYSMENORRHOEA
CHEST PAIN
1
C
DYSMENORRHOEA
DEEP VEIN THROMBOSIS
1
C
DYSMENORRHOEA
DYSPNOEA
1
C
DYSMENORRHOEA
EMOTIONAL DISTRESS
1
C
DYSMENORRHOEA
FATIGUE
1
C
DYSMENORRHOEA
FEAR OF DISEASE
1
C
DYSMENORRHOEA
OEDEMA PERIPHERAL
1
C
DYSMENORRHOEA
PAIN IN EXTREMITY
1
C
DYSMENORRHOEA
PULMONARY EMBOLISM
1
C
HEADACHE
ABDOMINAL PAIN UPPER
1
C
HEADACHE
ACUTE CORONARY SYNDROME
3
C
HEADACHE
ARTERIOSCLEROSIS CORONARY ARTERY
2
C
HEADACHE
CORONARY ARTERY DISEASE
1
C
HEADACHE
DIASTOLIC DYSFUNCTION
2
C
HEADACHE
PULMONARY HYPERTENSION
3
C
HEADACHE
TROPONIN INCREASED
2
C
HEADACHE
VASCULITIS
3
C
INSOMNIA
CHEST PAIN
1
C
INSOMNIA
DYSPNOEA
1
C
INSOMNIA
HAEMOPTYSIS
1
C
INSOMNIA
NON-CARDIAC CHEST PAIN
1
C
INSOMNIA
PULMONARY EMBOLISM
1
C
INSOMNIA
PULMONARY FUNCTION TEST DECREASED
1
C
INSOMNIA
PULMONARY INFARCTION
1
C
MULTIPLE SCLEROSIS
ABDOMINAL PAIN UPPER
2
C
MULTIPLE SCLEROSIS
FALL
1
C
MULTIPLE SCLEROSIS
HEAD INJURY
1
C
MULTIPLE SCLEROSIS
HEADACHE
1
C
MULTIPLE SCLEROSIS
MUSCLE SPASMS
2
C
MULTIPLE SCLEROSIS
PAIN
2
C
MULTIPLE SCLEROSIS
ROAD TRAFFIC ACCIDENT
1
C
MULTIPLE SCLEROSIS
TEMPERATURE INTOLERANCE
1
C
NEUROPATHY PERIPHERAL
ABDOMINAL PAIN UPPER
1
C
NEUROPATHY PERIPHERAL
MUSCLE SPASMS
1
C
NEUROPATHY PERIPHERAL
PAIN
1
C
PAIN IN EXTREMITY
ABDOMINAL PAIN UPPER
1
C
PAIN IN EXTREMITY
ACUTE CORONARY SYNDROME
3
C
PAIN IN EXTREMITY
ARTERIOSCLEROSIS CORONARY ARTERY
2
C
PAIN IN EXTREMITY
CORONARY ARTERY DISEASE
1
C
PAIN IN EXTREMITY
DIASTOLIC DYSFUNCTION
2
C
PAIN IN EXTREMITY
PULMONARY HYPERTENSION
3
C
PAIN IN EXTREMITY
TROPONIN INCREASED
2
C
PAIN IN EXTREMITY
VASCULITIS
3
C
PREMEDICATION
FALL
2
C
PREMEDICATION
HEAD INJURY
2
C
PREMEDICATION
HEADACHE
2
C
PREMEDICATION
ROAD TRAFFIC ACCIDENT
2
C
PREMEDICATION
TEMPERATURE INTOLERANCE
2
C
PREMENSTRUAL SYNDROME
ANXIETY
1
C
PREMENSTRUAL SYNDROME
ASTHENIA
1
C
PREMENSTRUAL SYNDROME
CHEST PAIN
1
C
PREMENSTRUAL SYNDROME
DEEP VEIN THROMBOSIS
1
C
PREMENSTRUAL SYNDROME
DYSPNOEA
1
C
PREMENSTRUAL SYNDROME
EMOTIONAL DISTRESS
1
C
PREMENSTRUAL SYNDROME
FATIGUE
1
C
PREMENSTRUAL SYNDROME
FEAR OF DISEASE
1
C
PREMENSTRUAL SYNDROME
OEDEMA PERIPHERAL
1
C
PREMENSTRUAL SYNDROME
PAIN IN EXTREMITY
1
C
PREMENSTRUAL SYNDROME
PULMONARY EMBOLISM
1
C
SLEEP DISORDER
DRUG INEFFECTIVE
1
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