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Daliresp (Roflumilast) - Insomnia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Insomnia (37)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Daliresp (Roflumilast) where reactions include insomnia. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 37   Next >>

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 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 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 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 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:
Xanax
    Dosage: unk
    End date: 2012-04-05

Soma
    Dosage: unk
    End date: 2012-04-05

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

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 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 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:
Vfend
    Dosage: 400 mg
    Administration route: Oral
    Indication: Aspergillosis
    Start date: 2010-01-01

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

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



Possible Daliresp side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: 66 year old female, weighing 81.2 kg (178.6 pounds)

Reactions: Back Pain, Insomnia, Decreased Appetite

Drug(s) suspected as cause:
Daliresp
    Dosage: 500mcg one daily po
    Administration route: Oral
    Indication: Emphysema
    Start date: 2012-05-02
    End date: 2012-06-20

Daliresp
    Dosage: 500mcg one daily po
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-05-02
    End date: 2012-06-20

Daliresp
    Dosage: 500mcg one daily po
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-05-02
    End date: 2012-06-20



Possible Daliresp side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 46 year old female

Reactions: Abdominal Pain, Dyspnoea, Vomiting, Nausea, Pain, Bruxism, Delusion, Tremor, Anxiety, Panic Attack, Palpitations, Mood Altered, Insomnia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg
    Administration route: Oral
    Start date: 2012-04-22

Daliresp
    Dosage: 500 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-01
    End date: 2012-04-11

Soma
    End date: 2012-04-05

Xanax
    End date: 2012-04-05

Oxycontin
    End date: 2012-04-05

Other drugs received by patient: Bentyl; Lidocaine; Norco; Patanol; Metoprolol Tartrate; Spiriva; Ventolin HFA; Nasonex; Nexium; Estrace; Amlodipine



Possible Daliresp side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: 70 year old male, weighing 106.1 kg (233.5 pounds)

Reactions: Diarrhoea, Arthralgia, Insomnia, Vasculitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Hyperimmune EGG; Prednisone Pack



Possible Daliresp side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: 48 year old female

Reactions: Supraventricular Tachycardia, Insomnia

Drug(s) suspected as cause:
Roflumilast
    Dosage: 500mcg per day
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-01-01
    End date: 2012-03-01

Daliresp
    Dosage: 500mcg per day
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-01-01
    End date: 2012-03-01

Albuterol
    Indication: Asthma
    End date: 2012-03-01



Possible Daliresp side effects in 63 year old male

Reported by a physician from United States on 2012-05-23

Patient: 63 year old male

Reactions: Renal Failure, Fatigue, Nausea, Liver Function Test Abnormal, Insomnia, Atrial Fibrillation, Cardiomyopathy, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-04-01
    End date: 2012-05-16

Metolazone
    Start date: 2012-04-01

Other drugs received by patient: Synthroid; Metoformin; Spiriva; Lasix; Allopurinol



Possible Daliresp side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: female, weighing 76.2 kg (167.6 pounds)

Reactions: Back Pain, Pruritus, Drug Ineffective, Diarrhoea, Dysuria, Insomnia, Abdominal Pain Upper

Drug(s) suspected as cause:
Daliresp



Possible Daliresp side effects in female

Reported by a individual with unspecified qualification from United States on 2012-05-22

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Weight Decreased, Blood Pressure Increased, Dyspnoea, Diarrhoea, Insomnia

Drug(s) suspected as cause:
Daliresp
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-03-09

Daliresp
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-04-14

Daliresp
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-04-13



Possible Daliresp side effects in female

Reported by a physician from United States on 2012-05-15

Patient: female

Reactions: Off Label Use, Supraventricular Tachycardia, Insomnia

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-01-01
    End date: 2012-03-01

Ventolin
    Indication: Asthma
    End date: 2012-03-01

Other drugs received by patient: Levaquin; Symbicort



Possible Daliresp side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-05-01

Patient: 46 year old female

Reactions: Abdominal Pain, Vomiting, Dyspnoea, Nausea, Pain, Drug Abuse, Delusion, Tremor, Anxiety, Panic Attack, Palpitations, Insomnia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg, daily
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-01
    End date: 2012-04-11

Xanax
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-05

Oxycontin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-05

Soma
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-05

Other drugs received by patient: Patanol; Amlodipine; Metoprolol Tartrate; Lidocaine; Nasonex; Spiriva; Ventolin HFA; Norco; Estrace; Bentyl; Nexium



Possible Daliresp side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 46 year old female

Reactions: Abdominal Pain, Dyspnoea, Vomiting, Nausea, Pain, Delusion, Tremor, Anxiety, Panic Attack, Palpitations, Insomnia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xanax
    End date: 2012-04-05

Daliresp
    Dosage: 500 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-01
    End date: 2012-04-11

Soma
    End date: 2012-04-05

Oxycontin
    End date: 2012-04-05

Other drugs received by patient: Nasonex; Estrace; Amlodipine; Spiriva; Metoprolol Tartrate; Lidocaine; Bentyl; Norco; Nexium; Ventolin HFA; Patanol



Possible Daliresp side effects in female

Reported by a physician from United States on 2012-04-13

Patient: female

Reactions: Insomnia, Supraventricular Tachycardia

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Symbicort; Levaquin



Possible Daliresp side effects in 91 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-03

Patient: 91 year old female

Reactions: Insomnia, Ventricular Tachycardia

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Duoneb



Possible Daliresp side effects in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 77 year old male

Reactions: Back Pain, Off Label Use, Diarrhoea, Flatulence, Insomnia, Dizziness, Headache

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg (500 mcg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Emphysema
    Start date: 2011-10-20
    End date: 2011-10-26

Daliresp
    Dosage: 500 mcg (500 mcg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-10-20
    End date: 2011-10-26

Other drugs received by patient: Mucinex (Guaifenesin) (Guaifenesin); Finasteride (Finasteride) (Finasteride); Terazosin (Terazosin) (Terazosin); Spiriva (Tiotropium Bromide) (Tiotropium Bromide); Foradil (Formoterol Fumarate) (Formoterol Fumarate)



Possible Daliresp side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 61 year old female

Reactions: Back Pain, Dyspnoea, Diarrhoea, Nausea, Insomnia, Headache

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg (500 mcg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Emphysema
    Start date: 2011-11-22

Daliresp
    Dosage: 500 mcg (500 mcg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-22

Other drugs received by patient: Xopenex (Levosalbutamol Hydrochloride); Spiriva; Singulair; Zebeta; Advair HFA; Synthroid; Fosamax



Possible Daliresp side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 65 year old female

Reactions: Palpitations, Heart Rate Increased, Insomnia, Tremor

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Combivent (Combivent) (Combivent); Xanax; Advair (Seretide) (Seretide); Amoxicillin; Budesonide; Oxygen (Oxygen) (Oxygen); Tylenol #3 (Acetaminophen, Codeine) (Acetaminophen, Codeine)



Possible Daliresp side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 70 year old male

Reactions: Nausea, Insomnia, Dizziness, Paraesthesia

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: MVI (Mvi) (Mvi); Calcium (Calcium) (Calcium); Aspirin; Spiriva (Tiotropium Bromide) (Tiotropium Bromide); Symbicort (Budesonide W / Formoterol Fumarate) (Budesonide W / Formoterol



Possible Daliresp side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 83 year old female

Reactions: Blood Pressure Increased, Back Pain, Headache, Tremor, Abdominal Pain Upper, Diarrhoea, Insomnia, Influenza Like Illness

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg (500 mcg,1 in 1 d), oral
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-07-10
    End date: 2011-07-01

Azithromycin
    Dosage: 150 mg (150mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2011-12-05

Daliresp
    Dosage: 500 mcg,1 in 1 d),oral
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-10

Azithromycin
    Dosage: 150 mg (150 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2011-11-10
    End date: 2011-11-19

Other drugs received by patient: Asmanex (Mometasone Furate) (Mometasone Furate); Lisinopril; Albuterol (Albuterol) (Albuterol); Foradil (Formoterol) (Formoterol); Valium; Copd Medications NOS (Copd Medications Nos) (Copd Medications Nos)



Possible Daliresp side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 71 year old female

Reactions: Back Pain, Nausea, Restlessness, Insomnia, Dizziness, Headache

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg (500 mcg, 1 in 1 d), oral; 250 mcg (250 mcg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-13
    End date: 2011-11-27

Daliresp
    Dosage: 500 mcg (500 mcg, 1 in 1 d), oral; 250 mcg (250 mcg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-28

Other drugs received by patient: Spiriva (Tiotropium Bromide) (Tiotropium Bromide); Zoloft; Advair (Seretide) (Seretide); Simvastatin; Vitamin B12 (Vitamin B12) (Vitamin B12); Vitamin C (Ascorbic Acid) (Ascorbic Acid); Vitamin E (Vitamin E) (Vitamin E)



Possible Daliresp side effects in 64 year old female

Reported by a physician from United States on 2012-03-05

Patient: 64 year old female

Reactions: Back Pain, Drug Ineffective, Bone Pain, Headache, Suicidal Ideation, Anxiety, Diarrhoea, Arthralgia, Insomnia, Anger, Depression, Depressed Mood, Influenza Like Illness

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Albuterol Sulfate (Salbutamol Sulfate) (Salbutamol Sulfate); Atenolol (Atenolol) (Inhalant) (Atenolol)



Possible Daliresp side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 69 year old female

Reactions: Dysgeusia, Diarrhoea, Nausea, Insomnia, Headache

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Lisinopril



Possible Daliresp side effects in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-03-02

Patient: 78 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Nausea, Impulsive Behaviour, Headache, Suicidal Ideation, Anxiety, Mood Altered, Insomnia, Dizziness, Suicide Attempt, Depression, Decreased Appetite, Influenza Like Illness

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Daliresp

Other drugs received by patient: Alprazolam



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