Spiriva Side Effects

Generic Name: tiotropium

Note: This page contains side effects data for the generic drug tiotropium. It is possible that some of the dosage forms included below may not apply to the brand name Spiriva.

It is possible that some side effects of Spiriva may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tiotropium: inhalation capsule, inhalation spray

As well as its needed effects, tiotropium (the active ingredient contained in Spiriva) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tiotropium, check with your doctor immediately:

More common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast or irregular heartbeat
  • nausea
  • shortness of breath
  • sweating
Less common
  • Cough
  • difficulty with swallowing
  • dizziness
  • hives, itching, or skin rash
  • painful blisters on the trunk of body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
  • Fainting
  • fast, pounding, or irregular heartbeat or pulse
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some tiotropium side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chest pain
  • chills
  • congestion
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • dry mouth
  • dryness of the throat
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • heartburn
  • hoarseness
  • indigestion
  • loss of voice
  • lower back or side pain
  • pain or tenderness around the eyes and cheekbones
  • runny or stuffy nose
  • sneezing
  • sore throat
  • stomach discomfort, upset, or pain
  • tender, swollen glands in the neck
  • trouble with swallowing
  • troubled breathing
  • unusual tiredness or weakness
  • voice changes
Less common
  • Abdominal or stomach pain
  • bloody nose
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • canker sores
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • lack of appetite
  • large amount of cholesterol in the blood
  • leg pain
  • loss of interest or pleasure
  • muscle pain
  • nausea
  • painful or difficult urination
  • skeletal pain
  • sore mouth or tongue
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • sweating
  • swelling or inflammation of the mouth
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • troubled breathing
  • unexplained weight loss
  • vomiting
  • white patches in the mouth and/or on the tongue
Incidence not known
  • Bloating
  • change in vision
  • diarrhea
  • red skin

For Healthcare Professionals

Applies to tiotropium: inhalation aerosol, inhalation capsule


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.[Ref]


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.[Ref]


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.[Ref]

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.[Ref]


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.[Ref]


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.[Ref]


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


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


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.[Ref]


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


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.[Ref]


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.[Ref]


1. "Product Information. Spiriva (tiotropium)." Boehringer Ingelheim (Canada) Ltd, Burlington, ON.

2. "Tiotropium (Spiriva) for COPD." Med Lett Drugs Ther 46 (2004): 41-42

3. Grosso A, Douglas I, Hingorani AD, MacAllister R, Hubbard R, Smeeth L "Inhaled tiotropium bromide and risk of stroke." Br J Clin Pharmacol 68 (2009): 731-6

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