Drug information for DALIRESP

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	500MCG	Prescription	(Reference Drug)	ROFLUMILAST	Roflumilast	FOREST RES INST INC	22522 2012-01-06 Medication Guide 2011-04-14 Review 2011-04-14 Summary Review 2011-03-10 Label 2011-03-07 Letter

Drug Adverse Effects information for DALIRESP

Role code	Indications	Reaction	# Reports
PS	ASTHMA	ABDOMINAL PAIN	1
PS	ASTHMA	ANTICONVULSANT DRUG LEVEL DECREASED	1
PS	ASTHMA	CONVULSION	1
PS	ASTHMA	DIARRHOEA	1
PS	ASTHMA	FLUID RETENTION	1
PS	ASTHMA	OFF LABEL USE	2
PS	ASTHMA	STATUS ASTHMATICUS	1
PS	ASTHMA	VOMITING	1
PS	ATRIAL FIBRILLATION	DRUG INTERACTION	1
PS	ATRIAL FIBRILLATION	GASTROINTESTINAL HAEMORRHAGE	1
PS	ATRIAL FIBRILLATION	INTERNATIONAL NORMALISED RATIO INCREASED	1
PS	BRONCHITIS CHRONIC	SUICIDAL IDEATION	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ABDOMINAL PAIN	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ABDOMINAL PAIN UPPER	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ANXIETY	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ASTHENIA	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ATRIAL FIBRILLATION	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	BACK PAIN	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	BUNDLE BRANCH BLOCK RIGHT	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CEREBRAL ATROPHY	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CEREBRAL HAEMORRHAGE	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CHEST DISCOMFORT	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CHILLS	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CONDITION AGGRAVATED	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CONVULSION	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DEATH	4
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DECREASED APPETITE	6
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DEHYDRATION	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DEPRESSION	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DIARRHOEA	8
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DIZZINESS	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DRUG INTERACTION	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DYSPNOEA	6
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ELECTROCARDIOGRAM ABNORMAL	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	EMPHYSEMA	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FACIAL BONES FRACTURE	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FALL	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FEAR	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FEELING HOT	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	GASTROINTESTINAL HAEMORRHAGE	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HAEMATOCRIT DECREASED	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HAEMOGLOBIN DECREASED	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HALLUCINATION	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HALLUCINATION, VISUAL	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HEADACHE	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HYPOXIA	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	IMPULSIVE BEHAVIOUR	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	INFLUENZA LIKE ILLNESS	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	INSOMNIA	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	INTERNATIONAL NORMALISED RATIO INCREASED	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	LIPASE INCREASED	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	LIVER FUNCTION TEST ABNORMAL	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	MENTAL DISORDER	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	MOOD ALTERED	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	NAUSEA	5
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	OXYGEN SATURATION DECREASED	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	PSYCHOTIC DISORDER	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RASH	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RENAL FAILURE ACUTE	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RESPIRATORY DISORDER	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RESPIRATORY FAILURE	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RESPIRATORY TRACT CONGESTION	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	SINUS TACHYCARDIA	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	SUICIDAL IDEATION	5
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	SUICIDE ATTEMPT	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	TREMOR	3
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	VENTRICULAR TACHYCARDIA	2
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	VOMITING	4
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	WEIGHT DECREASED	2
PS	DEPRESSION	CHILLS	1
PS	DEPRESSION	DECREASED APPETITE	2
PS	DEPRESSION	DIARRHOEA	2
PS	DEPRESSION	DYSPNOEA	1
PS	DEPRESSION	FEAR	2
PS	DEPRESSION	MOOD ALTERED	2
PS	DEPRESSION	NAUSEA	2
PS	DEPRESSION	TREMOR	2
PS	DEPRESSION	VOMITING	2
PS	EMPHYSEMA	DYSPNOEA	1
PS	INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	ARRHYTHMIA	1
PS	INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	HEART RATE DECREASED	1
PS	INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	HYPOTENSION	1
PS	INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	VENTRICULAR EXTRASYSTOLES	1
PS	LUNG DISORDER	ACTIVITIES OF DAILY LIVING IMPAIRED	1
PS	LUNG DISORDER	ASTHENIA	1
PS	LUNG DISORDER	CHEST PAIN	1
PS	LUNG DISORDER	COLD SWEAT	1
PS	LUNG DISORDER	DECREASED APPETITE	1
PS	LUNG DISORDER	DIZZINESS	1
PS	LUNG DISORDER	DYSPEPSIA	1
PS	LUNG DISORDER	DYSPNOEA	1
PS	LUNG DISORDER	HEADACHE	1
PS	LUNG DISORDER	MOOD SWINGS	1
PS	LUNG DISORDER	PAIN	1
PS	LUNG DISORDER	WEIGHT DECREASED	1
PS	LUNG INFECTION	FEELING ABNORMAL	1
PS	LUNG INFECTION	THINKING ABNORMAL	1
PS	RESPIRATION ABNORMAL	ABDOMINAL PAIN UPPER	1
PS	RESPIRATION ABNORMAL	ABNORMAL DREAMS	1
PS	RESPIRATION ABNORMAL	DECREASED APPETITE	1
PS	RESPIRATION ABNORMAL	DEPRESSION	1
PS	RESPIRATION ABNORMAL	DIZZINESS	1
PS	RESPIRATION ABNORMAL	HEADACHE	1
PS	RESPIRATION ABNORMAL	INSOMNIA	1
PS	RESPIRATION ABNORMAL	IRRITABILITY	1
PS	RESPIRATION ABNORMAL	MOOD SWINGS	1
PS	RESPIRATION ABNORMAL	NAUSEA	1
PS	RESPIRATION ABNORMAL	NERVOUSNESS	1
PS	RESPIRATION ABNORMAL	TREMOR	1
PS	SUPPLEMENTATION THERAPY	ANTICONVULSANT DRUG LEVEL DECREASED	1
PS	SUPPLEMENTATION THERAPY	CONVULSION	1
PS	SUPPLEMENTATION THERAPY	FLUID RETENTION	1
PS	SUPPLEMENTATION THERAPY	OFF LABEL USE	1
SS	ANTICOAGULANT THERAPY	BLOOD GLUCOSE INCREASED	1
SS	ANXIETY	BLOOD GLUCOSE INCREASED	2
SS	BENIGN PROSTATIC HYPERPLASIA	BLOOD GLUCOSE INCREASED	1
SS	BLOOD CHOLESTEROL INCREASED	BLOOD GLUCOSE INCREASED	1
SS	CHEST PAIN	BLOOD GLUCOSE INCREASED	1
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	BLOOD GLUCOSE INCREASED	7
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	2
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CONDITION AGGRAVATED	2
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DECREASED APPETITE	4
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DIARRHOEA	4
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DYSPNOEA	6
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FEAR	4
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	MOOD ALTERED	4
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	NAUSEA	4
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RESPIRATORY TRACT CONGESTION	2
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	SUICIDAL IDEATION	2
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	TREMOR	4
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	VENTRICULAR TACHYCARDIA	2
SS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	VOMITING	4
SS	DIABETES MELLITUS	BLOOD GLUCOSE INCREASED	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	BLOOD GLUCOSE INCREASED	1
SS	GLAUCOMA	BLOOD GLUCOSE INCREASED	1
SS	HIATUS HERNIA	BLOOD GLUCOSE INCREASED	1
SS	HYPERTENSION	BLOOD GLUCOSE INCREASED	3
SS	PAIN IN EXTREMITY	BLOOD GLUCOSE INCREASED	1
C	ASTHMA	CHILLS	7
C	ASTHMA	DECREASED APPETITE	7
C	ASTHMA	DIZZINESS	7
C	ASTHMA	DYSPEPSIA	7
C	ASTHMA	DYSPNOEA	7
C	ASTHMA	FATIGUE	7
C	ASTHMA	HYPOAESTHESIA	7
C	ASTHMA	NAUSEA	7
C	ASTHMA	PARAESTHESIA	7
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	BACTERIAL INFECTION	2
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CHILLS	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DECREASED APPETITE	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DIZZINESS	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DYSPEPSIA	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DYSPNOEA	4
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FATIGUE	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	FOOT FRACTURE	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HYPOAESTHESIA	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	NAUSEA	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	PARAESTHESIA	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	UPPER RESPIRATORY TRACT INFECTION	3
C	DIABETES MELLITUS	CHILLS	1
C	DIABETES MELLITUS	DECREASED APPETITE	1
C	DIABETES MELLITUS	DIZZINESS	1
C	DIABETES MELLITUS	DYSPEPSIA	1
C	DIABETES MELLITUS	DYSPNOEA	1
C	DIABETES MELLITUS	FATIGUE	1
C	DIABETES MELLITUS	HYPOAESTHESIA	1
C	DIABETES MELLITUS	NAUSEA	1
C	DIABETES MELLITUS	PARAESTHESIA	1
C	EMPHYSEMA	BACTERIAL INFECTION	4
C	EMPHYSEMA	DYSPNOEA	6
C	EMPHYSEMA	FOOT FRACTURE	2
C	EMPHYSEMA	UPPER RESPIRATORY TRACT INFECTION	6
C	GASTROOESOPHAGEAL REFLUX DISEASE	CHILLS	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DECREASED APPETITE	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DIZZINESS	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPEPSIA	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPNOEA	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	FATIGUE	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	HYPOAESTHESIA	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	NAUSEA	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	PARAESTHESIA	1
C	GOUT	CHILLS	2
C	GOUT	DECREASED APPETITE	2
C	GOUT	DIZZINESS	2
C	GOUT	DYSPEPSIA	2
C	GOUT	DYSPNOEA	2
C	GOUT	FATIGUE	2
C	GOUT	HYPOAESTHESIA	2
C	GOUT	NAUSEA	2
C	GOUT	PARAESTHESIA	2
C	OBSTRUCTIVE AIRWAYS DISORDER	BONE PAIN	3
C	OBSTRUCTIVE AIRWAYS DISORDER	CHEST X-RAY ABNORMAL	1
C	OBSTRUCTIVE AIRWAYS DISORDER	DIZZINESS	3
C	OBSTRUCTIVE AIRWAYS DISORDER	INFUSION RELATED REACTION	1
C	OBSTRUCTIVE AIRWAYS DISORDER	LOSS OF CONSCIOUSNESS	3
C	OBSTRUCTIVE AIRWAYS DISORDER	LUNG DISORDER	1
C	OBSTRUCTIVE AIRWAYS DISORDER	MYALGIA	3
C	OBSTRUCTIVE AIRWAYS DISORDER	SYNCOPE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	CHILLS	2
C	PRODUCT USED FOR UNKNOWN INDICATION	DECREASED APPETITE	2
C	PRODUCT USED FOR UNKNOWN INDICATION	DIZZINESS	2
C	PRODUCT USED FOR UNKNOWN INDICATION	DYSPEPSIA	2
C	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	2
C	PRODUCT USED FOR UNKNOWN INDICATION	FATIGUE	2
C	PRODUCT USED FOR UNKNOWN INDICATION	HYPOAESTHESIA	2
C	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	2
C	PRODUCT USED FOR UNKNOWN INDICATION	PARAESTHESIA	2
C	PULMONARY ARTERIAL HYPERTENSION	BLOOD GLUCOSE DECREASED	1
C	PULMONARY ARTERIAL HYPERTENSION	BLOOD POTASSIUM DECREASED	1
C	PULMONARY ARTERIAL HYPERTENSION	DIZZINESS	1
C	PULMONARY ARTERIAL HYPERTENSION	HEADACHE	1
C	PULMONARY ARTERIAL HYPERTENSION	NAUSEA	1
C	PULMONARY OEDEMA	CHILLS	1
C	PULMONARY OEDEMA	DECREASED APPETITE	1
C	PULMONARY OEDEMA	DIZZINESS	1
C	PULMONARY OEDEMA	DYSPEPSIA	1
C	PULMONARY OEDEMA	DYSPNOEA	1
C	PULMONARY OEDEMA	FATIGUE	1
C	PULMONARY OEDEMA	HYPOAESTHESIA	1
C	PULMONARY OEDEMA	NAUSEA	1
C	PULMONARY OEDEMA	PARAESTHESIA	1

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