Applies to pentosan polysulfate sodium: oral capsule.

Serious side effects

Along with its needed effects, pentosan polysulfate sodium may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pentosan polysulfate sodium:

Less common

• Black, tarry stools
• bleeding of the gums
• blindness
• blood in the urine or stools
• blue-yellow color
• blurred, decreased, or other changes in vision
• bruising
• burning, dry, or itching eyes
• burning feeling in the chest or stomach
• chest pain or tightness
• chills
• cough
• difficulty breathing or swallowing
• discharge, excessive tearing
• dizziness
• eye pain
• fast heartbeat
• heartburn
• hives, itching, skin rash
• indigestion
• large, flat, blue or purplish patches in the skin
• loss of appetite
• nosebleed
• painful or difficult urination
• pain or burning in the throat
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach cramps, tenderness, or upset
• swollen glands
• uncontrolled eye movements
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• watery or bloody diarrhea
• weight loss

Rare

• Yellow eyes or skin

Other side effects

Some side effects of pentosan polysulfate sodium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Belching
• bloating
• body aches or pain
• constipation
• continuing ringing or buzzing or other unexplained noise in ears
• diarrhea
• discouragement
• dizziness
• dryness of the throat
• excess air or gas in the stomach or bowels
• feeling sad or empty
• full feeling
• headache
• hearing loss
• hoarseness
• increased body movements
• increased sensitivity of skin to sunlight
• increased sweating
• indigestion
• irritability
• itching of the vagina or genital area
• loss of interest or pleasure
• nausea
• pain during sexual intercourse
• passing gas
• redness or other discoloration of the skin
• runny or stuffy nose
• severe sunburn
• sneezing
• stomach discomfort, upset, or pain
• thick, white vaginal discharge with no odor or with a mild odor
• thinning or loss of hair
• trouble concentrating
• trouble sleeping
• voice changes

Rare

• Absent, missed, or irregular menstrual periods
• difficulty in moving
• joint pain
• muscle pain or stiffness
• stopping of menstrual bleeding

For Healthcare Professionals

Applies to pentosan polysulfate sodium: oral capsule, oral delayed release capsule.

General

The most frequently reported side effects were alopecia, diarrhea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities, and dizziness.^[Ref]

Dermatologic

Common (1% to 10%): Alopecia, rash

Frequency not reported: Ecchymosis, photosensitivity, pruritus, urticaria, sweating increased^[Ref]

Hepatic

Common (1% to 10%): Liver function abnormal

Frequency not reported: Liver function test elevated^[Ref]

Genitourinary

Common (1% to 10%): Urinary frequency

Frequency not reported: Vaginitis, pelvic pain^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, dyspepsia, abdominal pain

Frequency not reported: Vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, gum hemorrhage, enlarged abdomen

Postmarketing reports: Rectal hemorrhage^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Frequency not reported: Hyperkinesia^[Ref]

Hematologic

Frequency not reported: Anemia, prothrombin time increased, partial thromboplastin time increased, leukopenia, thrombocytopenia, coagulation disorder^[Ref]

Respiratory

Frequency not reported: Pharyngitis, rhinitis, epistaxis, dyspnea^[Ref]

Ocular

Frequency not reported: Conjunctivitis, optic neuritis, amblyopia, retinal hemorrhage, lacrimation, nystagmus^[Ref]

Immunologic

Frequency not reported: Allergic reaction^[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia^[Ref]

Psychiatric

Frequency not reported: Emotional lability/depression, insomnia, mood swings, suicidal ideation^[Ref]

Other

Uncommon (0.1% to 1%): Weight gain, weight loss

Frequency not reported: Tinnitus, peripheral edema, asthenia^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Myalgia, arthralgia^[Ref]