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Index of reports
> Cases resulting in life threatening events (6)
> Cases with Cardiac Disorder (3)
Below is the selection of adverse event reports related to Provigil (Modafinil) that includes cases resulting in life threatening events where reactions include cardiac disorder.
Adverse event in 54 year old male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-02
Patient: 54 year old male, weighing 113.6 kg (249.9 pounds)
Adverse reactions / side effects: Agitation, Confusional State, Ischaemic Cardiomyopathy, Narcolepsy, Pulmonary Hypertension, Pain, Coma, Fall, Cardiac Disorder, Speech Disorder, Dizziness, Myocardial Infarction, Cardiac Failure Congestive, Pain in JAW, Blood Pressure Increased, Vomiting, Hypotension, Encephalopathy, Coronary Artery Disease, Cardiogenic Shock, Aggression, Renal Failure, Respiratory Failure, Heart Rate Increased, Ejection Fraction Decreased, Influenza Like Illness
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Dexedrine
Dosage: 70mg per day
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 1992-01-01
Provigil
Dosage: 400mg per day
Administration route: Oral
Start date: 2006-10-01
End date: 2007-07-01
Other drugs received by patient: Cymbalta; Gabapentin; Vytorin; Minocycline HCL
Adverse event in 22 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-07-26
Patient: 22 year old male
Adverse reactions / side effects: Pneumonia Aspiration, Rhabdomyolysis, Hepatic Failure, Cardiac Disorder, Resuscitation, Ileus, Acute Respiratory Distress Syndrome, Pneumothorax, Bacterial Infection, Multiple Drug Overdose Intentional, Hypovolaemia, Mechanical Ventilation, Metabolic Acidosis, Encephalopathy, Status Epilepticus, Convulsive Threshold Lowered, Convulsion, Bronchopleural Fistula, Grand MAL Convulsion, Renal Failure, Mechanical Ventilation Complication, Respiratory Failure, Nervous System Disorder, Blood Pressure Decreased, Sinus Tachycardia
Adverse event resulted in: death, life threatening event, hospitalization
Suspect drug(s):
Provigil
Dosage: 6000 mg once oral
Administration route: Oral
Start date: 2007-05-19
End date: 2007-05-19
Adderall 10
Dosage: 50 mg once oral
Administration route: Oral
Start date: 2007-05-19
End date: 2007-05-19
Other drugs received by patient: Zonegran
Adverse event in 22 year old male receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-29
Patient: 22 year old male
Adverse reactions / side effects: Rhabdomyolysis, Hepatic Failure, Cardiac Disorder, Aspiration, Pneumothorax, Multiple Drug Overdose Intentional, Acute Respiratory Distress Syndrome, Hypovolaemia, Medical Device Complication, Metabolic Acidosis, Encephalopathy, Status Epilepticus, Convulsive Threshold Lowered, Convulsion, Bronchopleural Fistula, Renal Failure, Lung Disorder, Pneumonia Bacterial, Respiratory Failure, Lung Infiltration, Blood Pressure Decreased, Sinus Tachycardia
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Provigil
Dosage: 6000 mg once oral
Administration route: Oral
Start date: 2007-05-19
End date: 2007-05-19
Adderall 10
Dosage: 50 mg once oral
Administration route: Oral
Start date: 2007-05-19
End date: 2007-05-19
Other drugs received by patient: Zonegran
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