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Daliresp (Roflumilast) - Side Effect Reports to FDA

 
 



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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