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Index of reports
> Cases resulting in other serious reactions (66)
> Cases with Oedema Mouth (6)
Below is the selection of adverse event reports related to Provigil (Modafinil) that includes cases resulting in other serious reactions where reactions include oedema mouth.
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 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 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 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 53 year old female receiving Provigil (Modafinil)
Reported by a physician from United Kingdom on 2007-02-20
Patient: 53 year old female
Adverse reactions / side effects: Oral Pain, Dyskinesia, Condition Aggravated, Oedema Mouth
Adverse event resulted in: disablity
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Quetiapine Fumarate; Priadel / 00033702 /; Venlafaxine HCL; Levothyroxine Sodium; Procyclidine Hydrochloride 2MG TAB; Zopiclone; Inhalers
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