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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