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Oxybutynin (Oxybutynin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Oxybutynin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (106)
Death (29)
Life Threatening Events (3)
Disability (7)

Reports by Reaction Type

DRY Mouth (15)Constipation (14)Toxicity To Various Agents (13)Completed Suicide (12)Drug Ineffective (10)Overdose (9)Dysuria (9)Dizziness (7)Confusional State (6)Pain (6)Drug Abuse (6)Abdominal Pain Upper (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Oxybutynin. For a complete list or a specific selection of reports, please use the links above.

Possible Oxybutynin side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-24

Patient: 61 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Incorrect Route of Drug Administration, Haematuria, Dysuria, Urinary Retention

Drug(s) suspected as cause:
Bupivacaine HCL
    Indication: Spinal Anaesthesia

Fentanyl Citrate
    Indication: Spinal Anaesthesia

Midazolam
    Indication: Spinal Anaesthesia

Oxybutynin
    Indication: Hypertonic Bladder

Sufentanil Citrate
    Indication: Spinal Anaesthesia

Other drugs received by patient: Simvastatin



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female, weighing 61.3 kg (134.8 pounds)

Reactions: Drug Dose Omission, Weight Decreased, Chills, Pain, Drug Interaction, Pyrexia, Headache, Abdominal Pain Upper, Fatigue, Malaise, DRY Mouth, Oedema Peripheral, Dizziness, Muscle Spasms, Nausea, Breast Neoplasm, Paraesthesia, Insomnia, Vision Blurred, Gait Disturbance, Hypertension, Mobility Decreased, Influenza Like Illness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Fish OIL
    Indication: Product Used FOR Unknown Indication

Lovastatin
    Indication: Blood Cholesterol Increased

Lyrica
    Indication: Pain in Extremity

Lyrica
    Administration route: Oral
    Indication: Skin Burning Sensation
    Start date: 2012-07-26
    End date: 2012-07-28

Oxybutynin
    Indication: Hypertonic Bladder

Rivastigmine
    Indication: Dementia

Other drugs received by patient possibly interacting with the suspect drug:
Aspirin
    Dosage: daily
    Indication: Anticoagulant Therapy

Aspirin
    Indication: Hypertension

Hydrocodone Bitartrate + Acetaminophen
    Dosage: one or two times a day
    Indication: Spinal Disorder

Hydrocodone Bitartrate + Acetaminophen
    Indication: Arthritis

Hydrocodone Bitartrate + Acetaminophen
    Indication: Pain

Lisinopril
    Indication: Hypertension

Multi-Vitamins
    Indication: Product Used FOR Unknown Indication

Synthroid
    Dosage: daily
    Indication: Thyroid Disorder

Xanax
    Indication: Panic Attack

Xanax
    Indication: Anxiety



Possible Oxybutynin side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 74 year old female, weighing 60.3 kg (132.7 pounds)

Reactions: Bladder Spasm, Drug Dose Omission, Bladder Prolapse, Drug Ineffective, Vulvovaginal Dryness, Pollakiuria, Expired Drug Administered, Vulvovaginal Pain

Drug(s) suspected as cause:
Oxybutynin
    Dosage: unk
    Indication: Urge Incontinence

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Vulvovaginal Dryness

Premarin
    Dosage: 0.625 mg, 2x/day
    Indication: Vulvovaginal Dryness
    Start date: 2012-06-08

Premarin
    Indication: Vulvovaginal Discomfort

Toviaz
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Urge Incontinence
    Start date: 2012-06-08

Vagifem
    Dosage: unk



Possible Oxybutynin side effects in 10 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 10 year old male, weighing 43.1 kg (94.8 pounds)

Reactions: Medication Residue

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 49 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Insomnia, Pain, Swelling, Oedema Peripheral, Feeling Abnormal, DRY Eye, Eye Disorder

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 80 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 80 year old female, weighing 73.5 kg (161.6 pounds)

Reactions: Drug Ineffective, Feeling Jittery, Nocturia, Hypertonic Bladder

Drug(s) suspected as cause:
Detrol LA
    Dosage: 4 mg, 1x/day
    Administration route: Oral
    Indication: Hypertonic Bladder
    End date: 2012-01-01

Oxybutynin
    Dosage: 5 mg, 2x/day
    Indication: Hypertonic Bladder
    Start date: 2012-01-01
    End date: 2012-01-01

Sanctura XR
    Dosage: 60 mg, daily
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2012-01-01

Other drugs received by patient: Citracal; Vitamin D



Possible Oxybutynin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-04

Patient:

Reactions: Dyspepsia, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Baclofen

Betaseron

Imitrex

Meloxicam

Oxybutynin

Prilosec
    Administration route: Oral

Testim

Tizanidine Hydrochloride

Wellbutrin XL

Zocor
    Administration route: Oral



Possible Oxybutynin side effects in

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: , weighing 68.1 kg (149.8 pounds)

Reactions: Cholelithiasis, Burning Sensation, Rash Generalised, Flatulence, Erythema, Abdominal Pain Upper

Drug(s) suspected as cause:
Metformin Hydrochloride
    Indication: Product Used FOR Unknown Indication

Niaspan
    Dosage: every night
    Indication: Blood Cholesterol Increased
    Start date: 2011-08-15

Niaspan
    Indication: High Density Lipoprotein Decreased

Oxybutynin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin; Pravastatin; Jayln



Possible Oxybutynin side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-30

Patient: 42 year old male

Reactions: Erythromelalgia

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 73 year old female, weighing 74.8 kg (164.7 pounds)

Reactions: Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: 79 year old male, weighing 55.1 kg (121.2 pounds)

Reactions: HIP Fracture, Femoral Neck Fracture, Dizziness, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxybutynin
    Dosage: mg bid po
    Administration route: Oral
    Indication: Bladder Pain
    Start date: 2012-05-08
    End date: 2012-05-11

Oxycodone HCL
    Dosage: mg po
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-08
    End date: 2012-05-11



Possible Oxybutynin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-13

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Nausea, Pain, Oedema Peripheral, Muscular Weakness, Headache, Muscle Spasms

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 61 year old male

Reported by a physician from Brazil on 2012-07-03

Patient: 61 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Haemorrhage Urinary Tract, Haematuria, Urinary Retention Postoperative

Drug(s) suspected as cause:
Fentanyl Citrate
    Dosage: 15microg
    Indication: Spinal Anaesthesia

Oxybutynin
    Indication: Hypertonic Bladder

Other drugs received by patient: Simvastatin; Midazolam; Bupivacaine HCL; Sufentanil Citrate; Ephedrine; Sodium Chloride



Possible Oxybutynin side effects in 64 year old male

Reported by a pharmacist from United States on 2012-07-03

Patient: 64 year old male, weighing 66.5 kg (146.3 pounds)

Reactions: Agitation, Confusional State, Anger, Mental Status Changes, Homicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 61 year old male

Reported by a physician from Brazil on 2012-07-03

Patient: 61 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Haemorrhage Urinary Tract, Haematuria, Urinary Retention Postoperative

Drug(s) suspected as cause:
Fentanyl Citrate
    Dosage: 15microg
    Indication: Spinal Anaesthesia

Oxybutynin
    Indication: Hypertonic Bladder

Other drugs received by patient: Midazolam; Bupivacaine HCL; Sodium Chloride; Simvastatin; Sufentanil Citrate; Ephedrine



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Detrol LA
    Dosage: unk

Oxybutynin
    Dosage: unk



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: female, weighing 77.1 kg (169.6 pounds)

Reactions: Pain, Musculoskeletal Disorder

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient: 58 year old female

Reactions: Lung Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Oxybutynin
    Indication: Product Used FOR Unknown Indication

Xyrem
    Dosage: oral ; 9 g, (4.5 gm,2 in 1 d),oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2008-04-25

Other drugs received by patient: Methylphenidate; Diazepam; Quetiapine; Pregabalin; Polyethylene Glycol; Ibandronate Sodium; Oxycodone HCL; Pantoprazole Sodium; Alendronate Sodium; Carbidopa



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female, weighing 81.6 kg (179.6 pounds)

Reactions: Cataract, Hypersensitivity, Drug Ineffective, Upper Limb Fracture, Dementia, JAW Fracture, Chronic Obstructive Pulmonary Disease, Brain Injury, Accident, Fibromyalgia, Eyelid Operation, Heart Rate Irregular, Arthritis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Codeine Sulfate
    Dosage: unk

Detrol LA
    Dosage: unk, 2x/day
    Indication: Urge Incontinence

Hydrocodone Bitartrate + Acetaminophen
    Indication: Fibromyalgia

Hydrocodone Bitartrate + Acetaminophen
    Dosage: 7.5-650 mg, 3x/day
    Indication: Arthritis
    Start date: 2011-01-01

Oxybutynin
    Dosage: 5 mg, 3x/day
    Indication: Urge Incontinence

Other drugs received by patient: Doxepin



Possible Oxybutynin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25

Patient: male

Reactions: Cognitive Disorder

Drug(s) suspected as cause:
Detrol LA
    Dosage: unk
    Indication: Prostate Cancer
    Start date: 2008-01-01

Oxybutynin
    Dosage: unk
    Start date: 2012-05-01



Possible Oxybutynin side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-22

Patient: male

Reactions: Megacolon, Volvulus, Intestinal Dilatation, Subileus, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clonazepam
    Dosage: 2.5 mg/ml drinkable solution, 5 drops/day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-28
    End date: 2012-04-25

Fenofibrate
    Indication: Product Used FOR Unknown Indication

Oxybutynin
    Dosage: daily 10mg, 1 df x 2
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-07-22
    End date: 2012-04-17

Other drugs received by patient: Permixon; Rabeprazole Sodium; Atenolol; Cetirizine; Kardegic 75 MG; Pravastatine Sodique; Lantus; Adancor



Possible Oxybutynin side effects in 77 year old male

Reported by a physician from Italy on 2012-06-21

Patient: 77 year old male

Reactions: Anaemia, Dizziness, Pyrexia, Epistaxis

Drug(s) suspected as cause:
Chlorpromazine HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lasix
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Oxybutynin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Valproate Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Oxybutynin side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: 56 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Peyronie's Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from Germany on 2012-06-19

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Night Blindness, Retinitis Pigmentosa, Condition Aggravated, Visual Acuity Reduced

Drug(s) suspected as cause:
Oxybutynin

Other drugs received by patient: Heparin Ratio 60 000; Ranitidin 150; Omeprazole; Antistax Extra; Cortisone Acetate; Voltaren; L Thyroxin 100 / 150



Possible Oxybutynin side effects in male

Reported by a physician from France on 2012-06-19

Patient: male

Reactions: Megacolon, Volvulus, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clonazepam
    Dosage: form: drops
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-28
    End date: 2012-04-26

Oxybutynin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-07-22
    End date: 2012-04-17

Other drugs received by patient: Permixon; Adancor; Pravastatin Sodium; Atenolol; Rabeprazole Sodium; Aspirin; Cetirizine; Lantus



Possible Oxybutynin side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 53 year old female, weighing 78.9 kg (173.6 pounds)

Reactions: Dyspnoea, Dyspepsia, DRY Mouth, Thirst

Drug(s) suspected as cause:
Oxybutynin



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Azithromycin
    Dosage: unk

Celestone
    Dosage: unk

Cymbalta
    Dosage: unk

Flagyl
    Dosage: unk

Lyrica
    Dosage: unk

Macrobid
    Dosage: unk

Macrodantin
    Dosage: unk

Ofloxacin
    Dosage: unk

Oxybutynin
    Dosage: unk

Phenobarbital TAB
    Dosage: unk

Prednisone
    Dosage: unk

Ticlid
    Dosage: unk

Verapamil HCL
    Dosage: unk



Possible Oxybutynin side effects in 78 year old female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: 78 year old female

Reactions: Incontinence, Tooth Fracture, DRY Mouth, Tooth Disorder

Drug(s) suspected as cause:
Oxybutynin

Rhinocort



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female, weighing 63.0 kg (138.7 pounds)

Reactions: DRY Mouth, Constipation

Drug(s) suspected as cause:
Oxybutynin
    Dosage: 5 mg, daily
    Administration route: Oral
    Indication: Pollakiuria
    Start date: 2012-02-01
    End date: 2012-01-01

Toviaz
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Pollakiuria
    Start date: 2012-04-01
    End date: 2012-01-01

Toviaz
    Dosage: 8 mg, daily
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Carvedilol



Possible Oxybutynin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female, weighing 113.0 kg (248.6 pounds)

Reactions: Drug Ineffective, DRY Mouth

Drug(s) suspected as cause:
Oxybutynin
    Dosage: unk
    Indication: Urinary Incontinence
    Start date: 2011-12-01
    End date: 2012-05-25

Toviaz
    Dosage: 8 mg, daily
    Administration route: Oral
    Indication: Urinary Incontinence
    Start date: 2009-01-01
    End date: 2011-11-01

Toviaz
    Dosage: 8 mg, daily
    Administration route: Oral
    Start date: 2012-05-01

Other drugs received by patient: Verapamil

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