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 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 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 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: Haematochezia, Dysgeusia, Overdose, Drug Ineffective, Abnormal Loss of Weight, Abdominal Pain Upper
Drug(s) suspected as cause:
Elmiron
Administration route: Oral
Indication: Cystitis
Start date: 2011-02-01
End date: 2011-05-01
Elmiron
Administration route: Oral
Start date: 2011-05-01
End date: 2012-01-27
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