Spiriva Side Effects

Generic name: tiotropium

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

Some side effects of Spiriva 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 tiotropium: inhalation capsule

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

Call your doctor at once if you have a serious side effect such as:

• wheezing, chest pain or tightness, trouble breathing;

• pain or burning when you urinate;

• blurred vision, eye pain or redness, seeing halos around lights;

• rapid heart rate;

• sores or white patches of your mouth, lips, or tongue; or

• urinating less than usual or not at all.

Less serious side effects of tiotropium may include:

• dry mouth;

• constipation, upset stomach, vomiting;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• nosebleed; or

• muscle pain.

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 tiotropium: inhalation capsule

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 43%), pharyngitis (up to 12.5%), sinusitis (up to 11%), rhinitis (up to 6%), epistaxis (up to 4%), laryngitis (up to 3%), coughing (3% or greater), and paradoxical bronchospasm. Hoarseness and throat irritation have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included dry mouth (up to 16%), abdominal pain (up to 6%), dyspepsia (up to 6%), constipation (up to 5.1%), vomiting (up to 4%), gastrointestinal disorder not otherwise specified (up to 3%), gastroesophageal reflux (up to 3%), stomatitis (including ulcerative stomatitis; up to 3%), gingivitis, and oropharyngeal candidiasis. Dysphagia, oral candidiasis, and intestinal obstruction including paralytic ileus have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included angina pectoris (including aggravated angina pectoris; up to 3%), atrial fibrillation (less than 1%), supraventricular tachycardia (less than 1%), and tachycardia. Tachycardia and palpitations have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (5.7%), dysphonia (up to 3%), and paresthesia (up to 3%). Dizziness has been reported during postmarketing experience.

Other

Other side effects have included nonspecific chest pain (up to 7%), dependent edema (up to 5%), infection (up to 4%), moniliasis (up to 4%), influenza-like symptoms (3% or greater), and herpes zoster (up to 3%). Application site irritation (glossitis, mouth ulceration, and pharyngolaryngeal pain) has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (up to 4%), skin ulcer, dry skin, and skin infection. Urticaria and pruritus have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypercholesterolemia (up to 3%), hyperglycemia (up to 3%), and dehydration.

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 7%), urinary retention (less than 1%), worsening of urinary retention, urinary difficulty, and dysuria.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (up to 3%) and angioedema (less than 1%). Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching, have been reported.

Psychiatric

Psychiatric side effects have included depression (up to 4.4%) and insomnia (4.4%).

Ocular

Ocular side effects have included cataracts (up to 3%), glaucoma (new onset or worsening), worsening of narrow-angle glaucoma, and blurred vision. Increased intraocular pressure has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthritis (up to 4.2%), myalgia (4%), skeletal pain (up to 3%), leg pain (up to 3%), and joint swelling.

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