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
Ads by Google