Sanctura XR Side Effects

Generic name: trospium

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

Some side effects of Sanctura XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to trospium: oral capsule extended release, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking trospium (the active ingredient contained in Sanctura XR) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using trospium and call your doctor at once if you have a serious side effect such as:

• severe stomach pain or bloating;

• severe constipation;

• urinating less than usual or not at all; or

• confusion, hallucinations.

Less serious side effects of trospium may include:

• dry mouth or throat;

• headache;

• mild constipation;

• upset stomach, gas;

• dizziness, drowsiness, or

• dry eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to trospium: oral capsule extended release, oral tablet

Cardiovascular

Cardiovascular side effects including palpitations, supraventricular tachycardia, chest pain, and hypertensive crisis have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects most commonly reported have included dry mouth (20.1% to 21.8%), constipation (9.5% to 9.6%), and abdominal pain (3.1%). Abdominal distention, dry throat, upper abdominal pain, aggravated constipation, dyspepsia, vomiting, dysgeusia, and flatulence have been reported in less than 2% of patients. Gastritis has been reported during postmarketing experience. At least one case of abdominal cramps has also been reported.

Nervous system

Nervous system side effects have included headache (4.2%). Nervous system side effects reported postmarketing have included dizziness, confusion, hallucinations, and somnolence.

Renal

Renal side effects have included urinary retention.

Ocular

Ocular side effects have included dry eyes and blurred vision. Abnormal vision has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects including hallucinations and delirium have been reported during postmarketing experience.

Other

Other side effects have included fatigue.

Dermatologic

Dermatologic side effects have included dry skin. Rash has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction have been reported during postmarketing experience.

Metabolic

Metabolic side effects including rhabdomyolysis have been reported during postmarketing experience.

Immunologic

Immunologic side effects including Stevens-Johnson syndrome have been reported during postmarketing experience.

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