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Index of reports
> Cases with Off Label Use (16)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vesicare (Solifenacin) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Vesicare side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male, weighing 102.0 kg (224.4 pounds)
Reactions: Off Label Use, Proteinuria, Diabetic Nephropathy, Renal Cyst
Drug(s) suspected as cause:
Vesicare
Indication: Lower Urinary Tract Symptoms
Vesicare
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Start date: 2009-12-01
Vesicare
Indication: Micturition Urgency
Vesicare
Indication: Urge Incontinence
Vesicare
Indication: Urinary Tract Obstruction
Vesicare
Indication: Pollakiuria
Other drugs received by patient: Vitamin D; Aspirin; Pravastatin; Metformin HCL; Lortab; Bupropion HCL
Possible Vesicare side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Choking Sensation, Drug Ineffective, Somnolence, Throat Tightness, Eating Disorder, Off Label Use, Abdominal Discomfort, Vision Blurred, Decreased Appetite
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Metformin; Aspirin; Metoprolol Tartrate; Synthroid; Simvastatin; Glimepiride
Possible Vesicare side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: male
Reactions: Night Sweats, Movement Disorder, Weight Decreased, Polycythaemia, Haematochezia, Off Label Use, Hospitalisation, Malaise, Fatigue, Aspartate Aminotransferase Increased, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Pepcid; Lisinopril
Possible Vesicare side effects in
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient:
Reactions: Choking Sensation, Drug Ineffective, Somnolence, Throat Tightness, Eating Disorder, Off Label Use, Abdominal Discomfort, Vision Blurred, Decreased Appetite
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Synthroid; Aspirin; Metformin Hydrochloride; Simvastatin; Glimepiride; Metoprolol Tartrate
Possible Vesicare side effects in
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient:
Reactions: Off Label Use, Intraocular Pressure Increased
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Glaucoma Medications
Possible Vesicare side effects in 68 year old male
Reported by a consumer/non-health professional from United States on 2012-03-30
Patient: 68 year old male
Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Hiatus Hernia, Therapeutic Response Unexpected, Oesophageal Stenosis
Drug(s) suspected as cause:
Vesicare
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Micturition Urgency
Vesicare
Dosage: 5 mg, qod
Administration route: Oral
Indication: Nocturia
Possible Vesicare side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-14
Patient: female, weighing 67.0 kg (147.4 pounds)
Reactions: Off Label Use, HIP Surgery
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Mobic; Boniva
Possible Vesicare side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-07
Patient: female
Reactions: Off Label Use, Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesicare
Possible Vesicare side effects in
Reported by a physician from United States on 2012-01-10
Patient:
Reactions: Off Label Use, Accidental Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Morphine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Vesicare
Dosage: unk
Administration route: Oral
Indication: Back Disorder
End date: 2011-09-03
Other drugs received by patient: Unspecified Medications
Possible Vesicare side effects in male
Reported by a physician from France on 2011-12-27
Patient: male
Reactions: Off Label Use, Prostatitis, Urinary Tract Infection, Urinary Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesicare
Possible Vesicare side effects in 50 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-01
Patient: 50 year old female, weighing 54.5 kg (119.9 pounds)
Reactions: Off Label Use, Alopecia, Vision Blurred, Skin Burning Sensation
Drug(s) suspected as cause:
Vesicare
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Hypertonic Bladder
Start date: 2010-12-20
End date: 2011-03-10
Vesicare
Dosage: 5 mg, uid/qd
Administration route: Oral
Indication: Cystitis Interstitial
Other drugs received by patient: Viscotears; Acetaminophen with Propoxyphene HCL TAB; Micronor; Ventolin; Diazepam; Echinacea; Rhinolast; Acetaminophen and Codeine Phosphate; Solifenacin Succinate; Omeprazole; Temazepam
Possible Vesicare side effects in female
Reported by a consumer/non-health professional from Canada on 2011-11-21
Patient: female
Reactions: Off Label Use, Weight Decreased, Malaise, Pain, Urinary Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Cymbalta; Lorazepam; Acetaminophen; Pantoprazole Sodium; Aspirin; Ramipril; Tylenol W / Codeine NO. 2
Possible Vesicare side effects in
Reported by a consumer/non-health professional from United States on 2011-11-14
Patient:
Reactions: Off Label Use, Accidental Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Morphine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Vesicare
Dosage: unk
Administration route: Oral
Indication: Back Disorder
End date: 2011-09-03
Other drugs received by patient: Unspecified Medications
Possible Vesicare side effects in 50 year old female
Reported by a individual with unspecified qualification from United Kingdom on 2011-11-10
Patient: 50 year old female
Reactions: Off Label Use, Palpitations, Alopecia, Skin Burning Sensation, Skin Disorder, Vision Blurred, DRY Eye
Drug(s) suspected as cause:
Omeprazole
Dosage: 20 mg;qd
Vesicare
Dosage: po
Administration route: Oral
Indication: Hypertonic Bladder
Start date: 2010-12-16
End date: 2011-03-10
Other drugs received by patient: Micronor; Diazepam; Temazepam; Diazepam; Ventolin; Acetaminophen W / Codeine; CO-Proxamol (Aporex); Rhinolast (Azelastine Hydrochloride)
Possible Vesicare side effects in female
Reported by a consumer/non-health professional from Canada on 2011-10-20
Patient: female
Reactions: Off Label Use, Pain, Urinary Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Lorazepam; Cymbalta; Pantoprazole Sodium; Aspirin; Tylenol-500; Ramipril; Tylenol W / Codeine NO. 2
Possible Vesicare side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2011-10-14
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Off Label Use
Drug(s) suspected as cause:
Vesicare
Other drugs received by patient: Irbesartan; Finasteride
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