This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Daliresp (Roflumilast) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (260)
Death (20)
Life Threatening Events (7)
Disability (6)
Reports by Reaction Type
Diarrhoea (46),
Nausea (42),
Decreased Appetite (37),
Insomnia (37),
Weight Decreased (33),
Headache (27),
Dyspnoea (27),
Dizziness (25),
Tremor (23),
Anxiety (22),
Suicidal Ideation (21),
Back Pain (19)
Below are a few examples of reports where side effects / adverse reactions may be related to Daliresp (Roflumilast). For a complete list or a specific selection of reports, please use the links above.
Possible Daliresp side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female
Reactions: Anaphylactic Shock
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in 64 year old female
Reported by a physician from United States on 2012-08-23
Patient: 64 year old female
Reactions: Mouth Haemorrhage
Drug(s) suspected as cause:
Daliresp
Other drugs received by patient: Spiriva; Metoprolol Tartrate; Clonazepam; Alprazolam; Atorvastatin; Albuterol
Possible Daliresp side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 70 year old male
Reactions: Diarrhoea, Arthralgia, Insomnia, Skin Disorder, Vasculitis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female
Reactions: Diarrhoea, Dehydration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in 55 year old female
Reported by a pharmacist from United States on 2012-08-20
Patient: 55 year old female, weighing 78.0 kg (171.6 pounds)
Reactions: Suicidal Ideation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Dosage: 500 mcg daily po
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Daliresp
Dosage: 500 mcg daily po
Administration route: Oral
Indication: Chronic Respiratory Failure
Possible Daliresp side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Weight Decreased, Pneumonia, Insomnia, Decreased Appetite, Rash Pruritic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Other drugs received by patient: Fluticasone Propionate; Spiriva; Multi-Vitamins; Amlodipine; Boost; Flonase; Protonix; Nebulizer NOS
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-08-15
Patient: male
Reactions: Anxiety, Hallucination
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-08-13
Patient: male
Reactions: Mania, Vascular Dementia
Drug(s) suspected as cause:
Daliresp
Dosage: 500 mcg
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-03-05
End date: 2012-06-06
Daliresp
Indication: Upper Respiratory Tract Infection
Other drugs received by patient: Symbicort; Sotalol HCL; Atorvastatin; Donepezil HCL; Lasix; Uroxatral; Ventolin; Nexium
Possible Daliresp side effects in female
Reported by a physician from United States on 2012-08-07
Patient: female
Reactions: Cholecystitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-08-07
Patient: male
Reactions: Mental Status Changes, Anger
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in 57 year old male
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: 57 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Weight Decreased, Paranoia, Headache, Suicidal Ideation, Abdominal Discomfort, Anxiety, Panic Attack, Diarrhoea, Insomnia, Visual Impairment, Depression, Decreased Appetite
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03
Patient:
Reactions: Weight Decreased, Swelling Face, Nausea, Muscular Weakness, Tremor, Eructation, Dysgeusia, Frequent Bowel Movements, Ageusia, Oedema Peripheral, DRY Mouth, Bronchitis, Gastrooesophageal Reflux Disease, Asthenia, Decreased Appetite
Drug(s) suspected as cause:
Daliresp
Dosage: 500 microgram, unk
Levaquin
Zocor
Dosage: 10 mg, unk
Administration route: Oral
Other drugs received by patient: Vitamin E; Spiriva; Albuterol; Multi-Vitamins; Ascorbic Acid; Aspirin; Vitamin D (Unspecified); Asmanex Twisthaler; Foradil; Allopurinol
Possible Daliresp side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: male
Reactions: Weight Decreased, Fall, Eructation, Frequent Bowel Movements, DRY Mouth, Oedema Peripheral, Gastrooesophageal Reflux Disease, Decreased Appetite, Swelling Face, Pneumonia, Nausea, Muscular Weakness, Atrial Fibrillation, Tremor, Dysgeusia, Ageusia, Compression Fracture, Sepsis, Bronchitis, Asthenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Daliresp
Dosage: 500 mcg
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2011-11-28
Levaquin
Indication: Bronchitis
Start date: 2012-03-01
End date: 2012-03-01
Simvastatin
Dosage: 10 mg
Indication: Blood Cholesterol Increased
End date: 2012-04-01
Other drugs received by patient: Albuterol; Ascorbic Acid; Vitamin D; Multi-Vitamins; Spiriva; Foradil; Asmanex Twisthaler; Vitamin E; Aspirin; Allopurinol
Possible Daliresp side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient:
Reactions: Weight Decreased, Swelling Face, Drug Ineffective, Muscular Weakness, Frequent Bowel Movements, Oedema Peripheral, Asthenia, Gastrooesophageal Reflux Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Daliresp
Administration route: Oral
Levaquin
Zocor
Administration route: Oral
Other drugs received by patient: Aspirin; Spiriva; Ascorbic Acid; Vitamin D (Unspecified); Vitamin E; Albuterol; Asmanex Twisthaler; Allopurinol; Multi-Vitamins; Foradil
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-07-26
Patient: male
Reactions: Tremor
Drug(s) suspected as cause:
Daliresp
Indication: Chronic Obstructive Pulmonary Disease
Spiriva
Dosage: 18 mcg
Indication: Chronic Obstructive Pulmonary Disease
Possible Daliresp side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-07-24
Patient: 60 year old female
Reactions: Tooth Infection
Drug(s) suspected as cause:
Daliresp
Other drugs received by patient: Spiriva; Prednisone; Advair Diskus 100 / 50; Xopenex
Possible Daliresp side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: 75 year old male, weighing 106.6 kg (234.5 pounds)
Reactions: Back Pain, Pain in Extremity, Chest Pain, Insomnia
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in 62 year old male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 62 year old male
Reactions: Anxiety, Panic Attack, Respiratory Failure, Insomnia, Dizziness, Headache, Chronic Obstructive Pulmonary Disease, Tremor
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Daliresp
Other drugs received by patient: Proair HFA; Crestor; Symbicort; Advair Diskus 100 / 50; Levaquin; Spiriva; Solu-Medrol; Lexapro; Flomax; Xyzal
Possible Daliresp side effects in female
Reported by a physician from United States on 2012-07-18
Patient: female
Reactions: Weight Decreased, Asthma, Hypersensitivity, Diabetes Mellitus, Restless Legs Syndrome, Malaise, Fatigue, Blood Pressure Abnormal, Depression, Gastrooesophageal Reflux Disease, Cough, Vomiting, Nausea, Stress, Diarrhoea, Bronchitis
Drug(s) suspected as cause:
Daliresp
Dosage: unk ukn, unk
Diovan
Dosage: 80 mg, unk
Diovan
Dosage: 160 mg, unk
Other drugs received by patient: Xyzal; Spiriva; Albuterol Sulfate; Combivent; Mirapex; Zoloft; Symbicort; Ibuprofen; Xanax; Atrovent; Patanol; Singulair; Xolair; Buspar; Vitamin D; Norco; Vitamin B-12; Zantac; Tussionex; Prevacid; Oxygen; Benzonatate; Skelaxin
Possible Daliresp side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: 46 year old female
Reactions: Abdominal Pain, Dyspnoea, Vomiting, Nausea, Pain, Tremor, Delusion, Anxiety, Panic Attack, Palpitations, Insomnia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Dosage: 500 ug, unk
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2011-11-01
End date: 2012-04-11
Oxycontin
Dosage: unk
End date: 2012-04-05
Soma
Dosage: unk
End date: 2012-04-05
Xanax
Dosage: unk
End date: 2012-04-05
Other drugs received by patient: Estrace; Amlodipine; Patanol; Ventolin; Spiriva; Metoprolol; Nexium; Nasonex; Bentyl; Lidocaine; Norco
Possible Daliresp side effects in 62 year old male
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: 62 year old male
Reactions: Death, Anxiety, Panic Attack, Insomnia, Dizziness, Headache, Tremor
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Daliresp
Other drugs received by patient: Proair HFA; Flomax; Lexapro; Symbicort; Spiriva; Crestor; Xyzal
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-07-11
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Guillain-Barre Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Dosage: 500 ug, daily
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-04-18
End date: 2012-05-02
Medrol
Dosage: unk
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-04-18
End date: 2012-01-01
Other drugs received by patient: Ranitidine; Crestor; Albuterol; Xopenex; Brovana; Symbicort; Plavix; Amlodipine; Clonidine; Budesonide; Aspirin; Lisinopril; Fexofenadine
Possible Daliresp side effects in 67 year old male
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: 67 year old male
Reactions: Dyspnoea
Drug(s) suspected as cause:
Daliresp
Dosage: 500 ug, 1x/day (500 mcg, 1 in 1 d, oral)
Administration route: Oral
Indication: Bronchitis Chronic
Start date: 2012-06-25
Lipitor
Dosage: unk
Indication: Blood Cholesterol Increased
Other drugs received by patient: Singulair; Clonidine; Advair Diskus 100 / 50; Spiriva; Clobetasol; Amlodipine
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-07-10
Patient: male, weighing 94.3 kg (207.6 pounds)
Reactions: Fibrin D Dimer Increased, Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Other drugs received by patient: Metoprolol; Spiriva; Hydrochlorothiazide; Isosorbide Mononitrate; Singulair; Proair HFA; Amlodipine; Celexa; Gemfibrozil; Plavix; Glimepiride; Albuterol; Nitroglycerin; Omeprazole; Aspirin; Advair Diskus 100 / 50; Potassium Chloride; Ambien
Possible Daliresp side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10
Patient: 66 year old male
Reactions: Fatigue, Tachycardia, Dizziness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Dosage: 500 mcg
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Daliresp
Dosage: 500 mcg
Administration route: Oral
Other drugs received by patient: Lisinopril; Albuterol; Jayln; Metoprolol Succinate; Cardizem; Duoneb; Advair Diskus 100 / 50; Coumadin; Lasix; Flonase; Pepcid; Spiriva
Possible Daliresp side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10
Patient: female, weighing 76.3 kg (167.9 pounds)
Reactions: Off Label Use, Back Pain, Pruritus, Micturition Disorder, Diarrhoea, Insomnia, Abdominal Pain Upper
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-07-03
Patient: male, weighing 83.5 kg (183.6 pounds)
Reactions: Guillain-Barre Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Daliresp
Dosage: 500 mcg
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-04-18
End date: 2012-05-02
Medrol
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-04-18
End date: 2012-01-01
Other drugs received by patient: Aspirin; Fexofenadine; Clonidine; Amlodipine; Crestor; Brovana; Ranitidine; Xopenex; Albuterol; Lisinopril; Budesonide; Plavix; Symbicort
Possible Daliresp side effects in male
Reported by a physician from United States on 2012-07-02
Patient: male
Reactions: Cerebrovascular Accident
Drug(s) suspected as cause:
Daliresp
Possible Daliresp side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: 74 year old female, weighing 48.5 kg (106.7 pounds)
Reactions: Swelling Face, Nausea, Skin Cancer, Paraesthesia
Drug(s) suspected as cause:
Biaxin
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-01
Daliresp
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-03-01
Other drugs received by patient: Spironolactone; Thyroid TAB; Acetaminophen
Possible Daliresp side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27
Patient: male, weighing 69.5 kg (153.0 pounds)
Reactions: Muscular Weakness, Mental Status Changes, Cognitive Disorder, Thirst Decreased, Suicidal Ideation, Irritability, Frequent Bowel Movements, Diarrhoea, Insomnia, Gait Disturbance, Sluggishness, Decreased Appetite, Lethargy
Drug(s) suspected as cause:
Daliresp
Dosage: 500 mcg
Administration route: Oral
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-01-06
End date: 2012-01-13
Daliresp
Dosage: 500 mcg
Administration route: Oral
Start date: 2012-01-17
End date: 2012-01-29
Daliresp
Dosage: 500 mcg
Administration route: Oral
Start date: 2012-01-17
End date: 2012-02-03
Vfend
Dosage: 400 mg
Administration route: Oral
Indication: Aspergillosis
Start date: 2010-01-01
Other drugs received by patient: Vitamin B-12; Potassium Chloride; Mucinex; Vitamin D; EYE Vitamin; Aspirin; Advair Diskus 100 / 50; Lasix; Avapro; Multi-Vitamins; Atrovent
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