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Index of reports
> Cases resulting in a serious event (112)
> Cases with Drug Ineffective (12)
Below is the selection of adverse event reports related to Provigil (Modafinil) that includes cases resulting in a serious event where reactions include drug ineffective.
Adverse event in male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-31
Patient: male, weighing 87.1 kg (191.6 pounds)
Adverse reactions / side effects: Asthma, Dyspnoea, Drug Ineffective, Tachycardia, Chest Pain, Oedema, Vasodilatation, Hypertension
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Provigil
Dosage: 400 mg tid oral
Administration route: Oral
Indication: Narcolepsy
End date: 2007-07-01
Provigil
Dosage: 200 mg tid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-07-01
End date: 2007-07-01
Provigil
Dosage: 400 mg tid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-07-01
Other drugs received by patient: Adderall 10
Adverse event in 72 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-26
Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Oral Discomfort, Dermatitis Contact, Photosensitivity Reaction, Stomatitis, Swelling Face, Drug Ineffective, Rash Erythematous, Oedema Mouth, Rash Pruritic
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2000-01-01
End date: 2007-09-01
Provigil
Dosage: 200 mg bid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-09-14
Other drugs received by patient: Lisinopril; Glucophage; Ditropan XL; Lamisil; Allopurinol
Adverse event in 59 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-26
Patient: 59 year old male, weighing 90.7 kg (199.6 pounds)
Adverse reactions / side effects: Back Pain, Chest Discomfort, Fatigue, Drug Ineffective, Blood Cholesterol Increased, Condition Aggravated, Hypertension, Cardiac Disorder
Suspect drug(s):
Provigil
Dosage: 400 mg qd oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2004-01-01
End date: 2004-01-01
Provigil
Dosage: 400 mg bid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2004-01-01
Other drugs received by patient: Ritalin; Amphetamine and Dextroamphetamine Salts; Desoxyn
Adverse event in 72 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-26
Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Narcolepsy, Photosensitivity Reaction, Stomatitis, Swelling Face, Drug Ineffective, Condition Aggravated, Erythema, Rash Pruritic, Dermatitis Contact, Oral Discomfort, Oral Pain, Oedema Mouth
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2000-01-01
End date: 2007-09-01
Provigil
Dosage: 200 mg bid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-09-14
Other drugs received by patient: Lisinopril; Glucophage; Ditrophan XL; Lamisil / 00992601 /; Allopurinol
Adverse event in 48 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-23
Patient: 48 year old female, weighing 190.5 kg (419.1 pounds)
Adverse reactions / side effects: Pruritus, Drug Ineffective, Dyskinesia, Oral Discomfort, Hypoaesthesia Oral, Dyspepsia, LIP Exfoliation, Candidiasis, Migraine, Respiratory Rate Increased, Stomatitis, Dysphagia, LIP DRY, Nausea, Paraesthesia Oral, Malnutrition, Anaemia, Muscle Twitching, Tremor, Visual Disturbance, Choking, Impaired Gastric Emptying, Tardive Dyskinesia
Adverse event resulted in: hospitalization
Suspect drug(s):
Provigil
Dosage: qd oral
Administration route: Oral
Indication: Fatigue
Start date: 2006-09-01
End date: 2006-09-15
Risperdal
Dosage: 3 mg qd oral
Administration route: Oral
Indication: Depression
Start date: 2002-01-01
End date: 2006-09-15
Other drugs received by patient: Effexor XR; Lithium Carbonate; Prilosec; Enablex; Lipitor; Triamterene; Mirapex; Potassium Chloride; Coumadin
Adverse event in 72 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-12
Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Narcolepsy, Swelling Face, Stomatitis, Drug Ineffective, Condition Aggravated, Oedema Mouth, Erythema
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: High Blood Pressure; Glucophage; Detrol
Adverse event in 72 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-12
Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Narcolepsy, Aphthous Stomatitis, Swelling Face, Drug Ineffective, Condition Aggravated, Erythema, Somnolence
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: High Blood Pressure Medication; Glucophage; Detrol / 01350201 /
Adverse event in 58 year old male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-04-09
Patient: 58 year old male, weighing 72.6 kg (159.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Tonic Clonic Movements, Drug Interaction, Drug Withdrawal Syndrome, Disorientation, Muscle Rigidity, Mental Disorder, Hypervigilance, Drug Level Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Methadone HCL
Dosage: 30 mg, tid, oral
Administration route: Oral
Indication: Back Pain
Start date: 2007-01-01
End date: 2007-01-22
Methadone HCL
Dosage: 30 mg, tid, oral
Administration route: Oral
Indication: Pain
Start date: 2006-01-01
End date: 2007-01-01
Provigil
Dosage: 200 mg, qd at bedtime, oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-12-01
End date: 2007-01-22
Adverse event in male receiving Provigil (Modafinil)
Reported by a lawyer from United States on 2007-03-23
Patient: male
Adverse reactions / side effects: Anoxic Encephalopathy, Drug Ineffective, Intentional Overdose, Hypotension, Pain, Coma, Anxiety, Completed Suicide, Narcotic Intoxication, Respiratory Arrest, Suicide Attempt, Depression, Cardiac Arrest
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Dextrothyroxine
Neurontin
Administration route: Oral
Indication: Neuralgia
Oxycontin
Administration route: Oral
Indication: Pain
Provigil
Other drugs received by patient: Keppra; Mirtazapine; Elavil; Gabitril; Nsaid's; Zanaflex; Cymbalta; Duragesic-100; Morphine
Adverse event in male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-03-08
Patient: male
Adverse reactions / side effects: Drug Ineffective, Intentional Overdose, Pain, Coma, Completed Suicide, Narcotic Intoxication, Pupil Fixed, Depression, Anoxic Encephalopathy, Pain in Extremity, Hypotension, Inadequate Analgesia, Anxiety, NO Therapeutic Response, Suicide Attempt, Respiratory Arrest, Cardiac Arrest, Cardiovascular Disorder
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Dextrothyroxine
Neurontin
Administration route: Oral
Indication: Neuralgia
Oxycontin
Administration route: Oral
Indication: Pain
Provigil
Other drugs received by patient: Keppra; Mirtazapine
Adverse event in 58 year old male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-03-06
Patient: 58 year old male, weighing 72.6 kg (159.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Drug Interaction, Tonic Clonic Movements, Drug Withdrawal Syndrome, Drug Level Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Methadone HCL
Dosage: 30 mg, tid, oral
Administration route: Oral
Indication: Back Pain
Start date: 2007-01-01
End date: 2007-01-22
Provigil
Dosage: qd,oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-12-01
End date: 2007-01-22
Other drugs received by patient: Methadone HCL
Adverse event in 58 year old male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-03-06
Patient: 58 year old male, weighing 72.6 kg (159.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Drug Interaction, Tonic Clonic Movements, Drug Withdrawal Syndrome
Adverse event resulted in: hospitalization
Suspect drug(s):
Methadone HCL
Dosage: 30 mg, tid, oral
Administration route: Oral
Indication: Back Pain
Start date: 2007-01-01
End date: 2007-01-22
Provigil
Dosage: qd, oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-12-01
End date: 2007-01-22
Other drugs received by patient: Methadose
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