Note: This document contains side effect information about trospium. Some dosage forms listed on this page may not apply to the brand name Sanctura XR.

Applies to trospium: oral capsule extended release, oral tablet.

Serious side effects of Sanctura XR

Along with its needed effects, trospium (the active ingredient contained in Sanctura XR) 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 trospium:

More common

• Bladder pain
• bloody or cloudy urine
• decrease in the frequency of urination
• decrease in urine volume
• difficult or burning urination
• difficulty in passing urine (dribbling)
• frequent urge to urinate
• lower back or side pain
• painful urination

Less common

• Chills
• cough
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Blistering, peeling, or loosening of the skin
• changes in vision
• clammy skin
• confusion as to time, place, or person
• dark-colored urine
• difficulty with swallowing
• dizziness
• enlarged pupils
• fainting
• fast or slow heartbeat
• hallucinations
• hives
• holding false beliefs that cannot be changed by fact
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold
• itching
• muscle cramps or spasms
• muscle stiffness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• severe chest pain
• severe headache
• shortness of breath
• skin rash
• sores, ulcers, or white spots in the mouth or on the lips
• stiff or sore neck
• tightness in the chest
• unusual excitement, nervousness, or restlessness
• wheezing

Other side effects of Sanctura XR

Some side effects of trospium 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:

More common

• Back pain
• blurred vision
• difficulty having a bowel movement (stool)
• dry mouth
• dry skin
• sleepiness or unusual drowsiness

Less common

• Acid or sour stomach
• belching
• bloated or full feeling
• dry eyes
• excess air or gas in the stomach or intestines
• heartburn
• indigestion
• passing gas
• stomach discomfort, upset, or pain
• stuffy nose
• trouble with urinating
• unable to have a bowel movement (stool)
• upper stomach pain

Incidence not known

• Burning feeling in the chest or stomach
• change in taste
• dry throat
• indigestion
• loss of taste
• swelling of the abdomen or stomach area
• tenderness in the stomach area

For Healthcare Professionals

Applies to trospium: oral capsule extended release, oral tablet.

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, chest pain

Frequency not reported: Tachyarrhythmia

Postmarketing reports: Palpitations, supraventricular tachycardia, chest pain, syncope, hypertensive crisis^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, constipation aggravated, dyspepsia, flatulence, nausea, dyspepsia, abdominal distension

Uncommon (0.1% to 1%): Abdominal distention, vomiting, dry throat, diarrhea

Postmarketing reports: Gastritis^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dysgeusia

Rare (less than 0.1%): Dizziness^[Ref]

Ocular

Common (1% to 10%): Dry eyes

Uncommon (0.1% to 1%): Blurred vision

Rare (less than 0.1%): Vision disorders

Postmarketing reports: Vision abnormal^[Ref]

Psychiatric

Postmarketing reports: Confusion, hallucinations, somnolence, delirium, agitation^[Ref]

Other

Common (1% to 10%): Fatigue^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dry skin

Rare (0.01% to 0.1%): Rash

Very rare (less than 0.01%): Angioedema

Frequency not reported: Pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction^[Ref]

Immunologic

Common (1% to 10%): Influenza^[Ref]

Musculoskeletal

Rare (less than 0.1%): Myalgia, arthralgia

Postmarketing reports: Rhabdomyolysis^[Ref]

Hepatic

Frequency not reported: Mild to moderate increase in serum transaminase levels^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, nasal dryness

Frequency not reported: Dyspnea^[Ref]