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Elmiron (Pentosan Polysulfate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Elmiron (Pentosan Polysulfate) 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 (94)
Death (9)
Life Threatening Events (1)

Reports by Reaction Type

Drug Ineffective (13)Gastrooesophageal Reflux Disease (11)Dysgeusia (11)Abnormal Loss of Weight (10)Incorrect Dose Administered (10)Abdominal Pain Upper (9)Cystitis Interstitial (9)Fatigue (9)Blood Cholesterol Increased (9)Product Quality Issue (9)Hypertension (9)Tinnitus (8)

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

Possible Elmiron side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 84.4 kg (185.6 pounds)

Reactions: Back Pain, Breast Cancer, Myalgia, Arthralgia, Haematuria, Urinary Tract Infection, Pyuria, Ovarian Failure, Cystitis Interstitial

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial

Vesicare
    Dosage: for every night
    Administration route: Oral
    Indication: Cystitis Interstitial

Sildenafil Citrate
    Dosage: 1 tablet approximately 1 hour before sexual activity
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: AN Unknown Medication



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: LIP Swelling, Adverse Drug Reaction, Drug Prescribing Error, Somnolence, Fall, Cystitis Interstitial, Hypokinesia, Mental Disorder, Abnormal Loss of Weight, Depression, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Wellbutrin
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-01-01

Paxil
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Lortab
    Indication: Cystitis Interstitial
    Start date: 2012-08-14

Trazodone Hydrochloride
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Remeron
    Indication: Depression



Possible Elmiron side effects in 32 year old female

Reported by a physician from United States on 2012-08-22

Patient: 32 year old female, weighing 62.1 kg (136.7 pounds)

Reactions: Protein S Decreased, Maternal Exposure During Pregnancy, Ectopic Pregnancy

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Multi-Vitamins



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female, weighing 58.5 kg (128.7 pounds)

Reactions: Diabetic Neuropathy

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in 30 year old female

Reported by a physician from United States on 2012-08-20

Patient: 30 year old female, weighing 62.1 kg (136.7 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Multi-Vitamins



Possible Elmiron side effects in male

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

Patient: male

Reactions: Wrong Technique in Drug Usage Process, Therapeutic Response Unexpected, Diverticulitis, Irritable Bowel Syndrome, Drug Prescribing Error, Constipation

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Underdose, Drug Administration Error, Oxygen Supplementation

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in male

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

Patient: male, weighing 96.6 kg (212.6 pounds)

Reactions: Arterial Disorder, Blood Cholesterol Increased, Drug Prescribing Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in

Reported by a pharmacist from United States on 2012-08-03

Patient:

Reactions: Obesity Surgery

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female, weighing 48.5 kg (106.8 pounds)

Reactions: Irritability, Blood Pressure Increased, Heart Rate Increased, Mental Disorder, Depression, Pelvic Pain

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Metformin Hydrochloride; Meclizine; Onglyza; Onglyza; Levemir; Metformin Hydrochloride; Levemir; Metformin Hydrochloride; Novolog; Cinnamon; Unknown Medication; Pravachol



Possible Elmiron side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: male, weighing 88.5 kg (194.6 pounds)

Reactions: Burning Sensation, Blood Pressure Inadequately Controlled, Intentional Drug Misuse, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Start date: 2011-10-01
    End date: 2011-11-01

Elmiron
    Dosage: 100 mg plus 100 mg in am and 100 mg plus 100 mg in pm
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2011-11-01

Other drugs received by patient: Lisinopril; Aggrenox; Atenolol; Acid Reflux Medication; Crestor



Possible Elmiron side effects in female

Reported by a physician from United States on 2012-07-30

Patient: female, weighing 48.5 kg (106.8 pounds)

Reactions: Blood Pressure Increased, Irritability, Heart Rate Increased, Mental Disorder, Pelvic Pain, Depression

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Novolog; Levemir; Onglyza; Onglyza; Cinnamon; Metformin Hydrochloride; Unknown Medication; Levemir; Pravachol; Metformin Hydrochloride; Metformin Hydrochloride; Meclizine



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female, weighing 64.0 kg (140.7 pounds)

Reactions: Weight Decreased, Vomiting, Fatigue, Drug Ineffective, Alopecia, Headache, Asthenia, Convulsion

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Nubain; Vistaril; Percocet



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: female, weighing 48.1 kg (105.8 pounds)

Reactions: Blood Pressure Increased, Irritability, Heart Rate Increased, Mental Disorder, Depression, Pelvic Pain

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Levemir



Possible Elmiron side effects in female

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

Patient: female, weighing 64.0 kg (140.7 pounds)

Reactions: Vomiting, Fatigue, Drug Ineffective, Alopecia, Asthenia, Convulsion

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Nubain; Vistaril



Possible Elmiron side effects in female

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

Patient: female, weighing 51.3 kg (112.8 pounds)

Reactions: Breast Cancer

Drug(s) suspected as cause:
Elmiron
    Dosage: morning
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2010-01-01

Elmiron
    Dosage: evening
    Administration route: Oral
    Start date: 2010-01-01

Other drugs received by patient: ALL Other Therapeutic Product



Possible Elmiron side effects in

Reported by a pharmacist from United States on 2012-06-29

Patient:

Reactions: Surgery

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: female, weighing 52.2 kg (114.8 pounds)

Reactions: Hypersensitivity, Sleep Disorder, Osteoporosis, Abnormal Loss of Weight, Feeding Disorder, Hypertension, Muscle Spasms

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 1998-01-01

Evista
    Administration route: Oral
    Indication: Osteoporosis
    End date: 2010-01-01

Other drugs received by patient: Fortical; Amitriptyline HCL; Vitamin D; Fosamax; Calcium; Levothyroxine



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female

Reactions: Nervous System Disorder, Headache

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in female

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

Patient: female, weighing 48.5 kg (106.8 pounds)

Reactions: Blood Pressure Increased, Irritability, Heart Rate Increased, Mental Disorder, Depression

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Levemir



Possible Elmiron side effects in female

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

Patient: female, weighing 52.2 kg (114.8 pounds)

Reactions: Hypersensitivity, Sleep Disorder, Osteoporosis, Abnormal Loss of Weight, Feeding Disorder, Hypertension, Muscle Spasms

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 1998-01-01

Evista
    Administration route: Oral
    Indication: Osteoporosis
    End date: 2010-01-01

Other drugs received by patient: Amitriptyline HCL; Calcium; Fortical; Fosamax; Vitamin D; Levothyroxine Sodium



Possible Elmiron side effects in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: 34 year old female, weighing 48.5 kg (106.8 pounds)

Reactions: Social Avoidant Behaviour, Anger, Depression

Drug(s) suspected as cause:
Elmiron



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: female, weighing 81.7 kg (179.6 pounds)

Reactions: Cholelithiasis, Hospitalisation, Post Procedural Complication, Bladder Pain, Intentional Drug Misuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Start date: 2009-01-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial

Other drugs received by patient: Ambien; Citalopram; Estrogen; Levothyroxine Sodium; Moexipril Hydrochloride; Omeprazole; Ciprofloxacin HCL



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: female, weighing 87.5 kg (192.6 pounds)

Reactions: Breast Lump Removal, Breast Cancer, Drug Ineffective, Expired Drug Administered

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-05-01

Elmiron
    Administration route: Oral
    Start date: 2010-10-01
    End date: 2010-11-01

Elmiron
    Dosage: once a day or upto thrice a day as needed
    Administration route: Oral
    Start date: 2010-06-01
    End date: 2010-10-01

Elmiron
    Administration route: Oral
    Start date: 2011-02-01
    End date: 2011-01-01

Other drugs received by patient: Chlorthalidone; Omeprazole; Naproxen



Possible Elmiron side effects in female

Reported by a pharmacist from United States on 2012-05-29

Patient: female, weighing 79.8 kg (175.6 pounds)

Reactions: Drug Ineffective, Pain, Treatment Noncompliance, Appetite Disorder, Abdominal Pain Upper, Faeces Discoloured, Malaise, Overdose, Fatigue, Abnormal Loss of Weight, Inappropriate Schedule of Drug Administration, Product Quality Issue, Nausea, Urinary Tract Infection, Haematochezia, Dysgeusia, Ageusia, Micturition Disorder, Dysuria, Insomnia, Bladder Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Start date: 2011-02-01
    End date: 2011-09-22

Elmiron
    Administration route: Oral
    Start date: 2011-10-01

Elmiron
    Administration route: Oral
    Start date: 2011-12-11

Elmiron
    Administration route: Oral
    Start date: 2011-10-01
    End date: 2011-12-11

Elmiron
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-01-01

Elmiron
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-09-22

Elmiron
    Administration route: Oral
    End date: 2012-01-27

Elmiron
    Administration route: Oral
    Start date: 2011-05-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2011-01-01
    End date: 2011-06-01

Elmiron
    Administration route: Oral
    Start date: 2010-02-01
    End date: 2010-04-01

Other drugs received by patient: Viramune; Lipitor; Plavix; Prilosec; Premarin; Aspirin; Levothyroxine Sodium; Prilosec; Truvada; Atenolol



Possible Elmiron side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: male, weighing 88.5 kg (194.6 pounds)

Reactions: Bladder Spasm, Urethral Obstruction, Bladder Catheterisation, Blood Cholesterol Increased, Cystitis, Urinary Bladder Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Cystitis Haemorrhagic
    Start date: 2002-01-01

Elmiron
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2002-01-01

Other drugs received by patient: Simvastatin; Celexa



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: female

Reactions: Drug Ineffective, Condition Aggravated, Ulcer

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Elmiron
    Administration route: Oral



Possible Elmiron side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: 40 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: PRE-Existing Disease, Nerve Compression

Drug(s) suspected as cause:
Hydroxyzine
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-01-01

Amitriptyline HCL
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-01-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-01-01



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Hysterectomy, Incorrect Dose Administered, Adverse Event, Headache, Treatment Noncompliance, Sinusitis

Drug(s) suspected as cause:
Elmiron

Other drugs received by patient: Hydrocodone; Levofloxacin; Nasonex; Cymbalta; Tramadol HCL



Possible Elmiron side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: female, weighing 79.8 kg (175.6 pounds)

Reactions: Drug Ineffective, Pain, Appetite Disorder, Treatment Noncompliance, Abdominal Pain Upper, Faeces Discoloured, Malaise, Overdose, Fatigue, Abnormal Loss of Weight, Product Quality Issue, Inappropriate Schedule of Drug Administration, Nausea, Urinary Tract Infection, Dysgeusia, Haematochezia, Micturition Disorder, Ageusia, Insomnia, Dysuria, Bladder Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Start date: 2011-10-01
    End date: 2011-12-11

Elmiron
    Administration route: Oral
    Start date: 2011-12-11

Elmiron
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-01-01

Elmiron
    Administration route: Oral
    Start date: 2010-02-01
    End date: 2010-04-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2011-01-01
    End date: 2011-06-01

Elmiron
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-09-22

Elmiron
    Administration route: Oral
    Start date: 2011-05-01

Elmiron
    Administration route: Oral
    Start date: 2011-02-01
    End date: 2011-09-22

Elmiron
    Administration route: Oral
    Start date: 2011-10-01

Elmiron
    Administration route: Oral
    End date: 2012-01-27

Other drugs received by patient: Premarin; Atenolol; Aspirin; Prilosec; Truvada; Levothyroxine Sodium; Viramune; Lipitor; Plavix; Prilosec

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