Medication Guide App

Tiotropium Side Effects

It is possible that some side effects of tiotropium 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 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
Rare
  • 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

General

The most commonly reported adverse reaction was dry mouth, usually mild and often resolved during continued treatment.
Other reactions consistent with possible anticholinergic effects included constipation, tachycardia, blurred vision, glaucoma (new onset or worsening), dysuria, and urinary retention.[Ref]

Respiratory

Very common (10% or more): Pharyngitis (11.5%)
Common (1% to 10%): Respiratory tract infection, cough, sinusitis, rhinitis, epistaxis, dysphonia, chest pain, laryngitis
Rare (less than 0.1%): Epistaxis, bronchospasm,
Postmarketing reports: Pharyngolaryngeal pain, throat irritation, hoarseness[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, angina pectoris (including aggravated angina pectoris)
Uncommon (0.1% to 1%): Atrial fibrillation
Rare (less than 0.1%): Palpitations, supraventricular tachycardia, tachycardia[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash
Rare (less than 0.1%): Angioneurotic edema, urticaria, skin infection, skin ulcer, dry skin[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth, constipation, gastroesophageal reflux, oropharyngeal candidiasis, dyspepsia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Dysphagia, gingivitis, intestinal obstruction including ileus paralytic, stomatitis (including ulcerative stomatitis)
Rare (less than 0.1%): Dental caries, glossitis
Frequency not reported: Nausea
Postmarketing reports: Oral candidiasis, throat irritation, mouth ulceration[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary retention, dysuria[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions
Rare (less than 0.1%): Angioedema, hypersensitivity (including immediate reactions)
Frequency not reported: Anaphylactic reactions[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia, hyperglycemia
Frequency not reported: Dehydration[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthritis, skeletal pain, leg pain
Frequency not reported: Join swelling[Ref]

Nervous system

Common (1% to 10%): Dizziness, paresthesia
Uncommon (0.1% to 1%): Headache, insomnia, taste disorder[Ref]

Ocular

Common (1% to 10%): Cataract
Uncommon (0.1% to 1%): Blurred vision
Rare (less than 0.1%): Glaucoma, intraocular pressure increased[Ref]

Other

Common (1% to 10%): Edema, infections, moniliasis, influenza-like symptoms, herpes zoster[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

References

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

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Spiriva (tiotropium)." Boehringer Ingelheim, Ridgefield, CT.

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

6. 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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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