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Index of reports
> Cases resulting in other serious reactions (66)
> Cases with Dysphagia (8)
Below is the selection of adverse event reports related to Provigil (Modafinil) that includes cases resulting in other serious reactions where reactions include dysphagia.
Adverse event in 56 year old female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-29
Patient: 56 year old female, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Oral Mucosal Blistering, Dysphagia, Dystonia, Impaired Work Ability, Swollen Tongue, Throat Tightness, Speech Disorder, Oral Pain, Uterine Dilation and Curettage, Oedema Mouth, Gastrooesophageal Reflux Disease
Adverse event resulted in: disablity
Suspect drug(s):
Provigil
Dosage: 50 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-01-01
End date: 2006-09-01
Provigil
Dosage: 100 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-09-01
End date: 2007-09-29
Other drugs received by patient: Lyrica; Nefazodone HCL; Crestor; Evista; Metoclopramide; Lisinopril; Nexium
Adverse event in 56 year old female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-29
Patient: 56 year old female, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Oral Mucosal Blistering, Dysphagia, Dystonia, Impaired Work Ability, Swollen Tongue, Throat Tightness, Speech Disorder, Impaired Driving Ability, Oral Pain, Oedema Mouth, Gastrooesophageal Reflux Disease
Adverse event resulted in: disablity
Suspect drug(s):
Provigil
Dosage: 50 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-01-01
End date: 2006-09-01
Provigil
Dosage: 100 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-09-01
End date: 2007-09-29
Other drugs received by patient: Lyrica; Nefazodone HCL; Crestor; Evista; Metoclopramide; Lisinopril; Nexium
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 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: Choking Sensation, Pruritus, Dyskinesia, Pain, Photopsia, Oral Discomfort, Hypoaesthesia Oral, Laboratory Test Abnormal, Oral Candidiasis, Eye Disorder, LIP Exfoliation, Respiratory Rate Increased, Migraine, Dysphagia, Vomiting, Stomatitis, Nausea, Paraesthesia Oral, LIP DRY, Anaemia, Ill-Defined Disorder, Muscle Twitching, Eye Pain, Tremor, Mucosal Inflammation, Oral Pain, Visual Disturbance, Oral Disorder, Impaired Gastric Emptying, Tardive Dyskinesia, Inflammation
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; Prilosec / 00661201 /; Enablex; Lipitor; Triamterene; Mirapex; Potassium Chloride; Coumadin
Adverse event in 56 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-18
Patient: 56 year old female, weighing 79.4 kg (174.6 pounds)
Adverse reactions / side effects: Oral Mucosal Blistering, Speech Disorder, Dysphagia, Dystonia, Uterine Dilation and Curettage, Throat Tightness
Suspect drug(s):
Provigil
Dosage: 50 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-01-01
End date: 2006-09-01
Provigil
Dosage: 100 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-09-01
End date: 2007-09-29
Other drugs received by patient: Lyrica
Adverse event in 58 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-04-25
Patient: 58 year old male, weighing 102.3 kg (225.1 pounds)
Adverse reactions / side effects: Dysphagia, Fatigue, Respiratory Tract Infection, Stevens-Johnson Syndrome, Influenza Like Illness
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-02-21
End date: 2007-02-27
Provigil
Dosage: 200 mg once oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-03-01
End date: 2007-03-01
Provigil
Dosage: 100 mg once oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-03-01
End date: 2007-03-01
Other drugs received by patient: Omega 3; Multi-Vitamin; Advil; Adderall 10; Alka-Seltzer Plus Cold; Dayquil
Adverse event in 58 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-04-25
Patient: 58 year old male, weighing 102.3 kg (225.1 pounds)
Adverse reactions / side effects: Dysphagia, Nasopharyngitis, Rhinorrhoea, Cheilitis, Fatigue, Throat Irritation, Oesophagitis, Erythema Multiforme, Respiratory Tract Infection, Stevens-Johnson Syndrome, Influenza Like Illness
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-02-21
End date: 2007-02-27
Provigil
Dosage: 200 mg once oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-03-01
End date: 2007-03-01
Provigil
Dosage: 100 mg once oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-03-01
End date: 2007-03-01
Other drugs received by patient: Omega 3; Multi-Vitamin; Advil; Adderall 10; Alka-Seltzer; Dayquil
Adverse event in 58 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-04-02
Patient: 58 year old male, weighing 102.3 kg (225.1 pounds)
Adverse reactions / side effects: Oral Intake Reduced, Nasopharyngitis, Dysphagia, Erythema Multiforme, Stevens-Johnson Syndrome, Influenza Like Illness
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-02-21
End date: 2007-02-27
Provigil
Dosage: 200 mg once oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-03-01
End date: 2007-03-01
Provigil
Dosage: 100 mg once oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2007-03-01
End date: 2007-03-01
Other drugs received by patient: Omega 3; Multivitamin / 00831701 /; Advil / 00109201 /; Adderall 10; Alka-Seltzer Plus Cold / 00446801; Dayquil / 00761701
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