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Spiriva

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Spiriva

Spiriva Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Spiriva HandiHaler (tiotropium bromide) Inhalation Powder is used to prevent bronchospasm (narrowing of the airways in the lungs) in people with bronchitis, emphysema, or COPD (chronic obstructive pulmonary disease). It is an anticholinergic drug. Common side effects include dry mouth or constipation.

The recommended dose of Spiriva HandiHaler is two inhalations of the powder contents of one Spiriva capsule, once-daily, with the HandiHaler device. Spiriva may interact with atropine, belladonna, cimetidine, clidinium, dicyclomine, glycopyrrolate, hyoscyamine, mepenzolate, methantheline, methscopolamine, propantheline, or scopolamine. Tell your doctor all medications you use. During pregnancy, Spiriva should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Spiriva (tiotropium bromide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Spiriva in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Spiriva (Tiotropium Bromide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Spiriva Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth or constipation may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if you have any serious side effects, including: vision changes (such as blurred vision, seeing halos), eye pain, difficult/painful urination, fast heartbeat.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Spiriva (Tiotropium Bromide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Spiriva FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6-Month to 1-Year Trials

The data described below reflect exposure to SPIRIVA HandiHaler in 2663 patients. SPIRIVA HandiHaler was studied in two 1-year placebo-controlled trials, two 1-year active-controlled trials, and two 6-month placebo-controlled trials in patients with COPD. In these trials, 1308 patients were treated with SPIRIVA HandiHaler at the recommended dose of 18 mcg once a day. The population had an age ranging from 39 to 87 years with 65% to 85% males, 95% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 39% to 43%. Patients with narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials. An additional 6-month trial conducted in a Veteran's Affairs setting is not included in this safety database because only serious adverse events were collected.

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

Four multicenter, 1-year, placebo-controlled and active-controlled trials evaluated SPIRIVA HandiHaler in patients with COPD. Table 1 shows all adverse reactions that occurred with a frequency of ≥ 3% in the SPIRIVA HandiHaler group in the 1-year placebo-controlled trials where the rates in the SPIRIVA HandiHaler group exceeded placebo by ≥ 1%. The frequency of corresponding reactions in the ipratropium-controlled trials is included for comparison.

Table 1 : Adverse Reactions (% Patients) in One-Year COPD Clinical Trials

Body System (Event) Placebo-Controlled Trials Ipratropium-Controlled Trials
SPIRIVA
(n = 550)
Placebo
(n = 371)
SPIRIVA
(n = 356)
Ipratropium
(n = 179)
Body as a Whole
Chest Pain (non-specific) 7 5 5 2
Edema, Dependent 5 4 3 5
Gastrointestinal System Disorders
Dry Mouth 16 3 12 6
Dyspepsia 6 5 1 1
Abdominal Pain 5 3 6 6
Constipation 4 2 1 1
Vomiting 4 2 1 2
Musculoskeletal System
Myalgia 4 3 4 3
Resistance Mechanism Disorders
Infection 4 3 1 3
Moniliasis 4 2 3 2
Respiratory System (Upper)
Upper Respiratory Tract Infection 41 37 43 35
Sinusitis 11 9 3 2
Pharyngitis 9 7 7 3
Rhinitis 6 5 3 2
Epistaxis 4 2 1 1
Skin and Appendage Disorders
Rash 4 2 2 2
Urinary System
Urinary Tract Infection 7 5 4 2

Arthritis, coughing, and influenza-like symptoms occurred at a rate of ≥ 3% in the SPIRIVA HandiHaler treatment group, but were < 1% in excess of the placebo group.

Other reactions that occurred in the SPIRIVA HandiHaler group at a frequency of 1% to 3% in the placebo-controlled trials where the rates exceeded that in the placebo group include: Body as a Whole: allergic reaction, leg pain; Central and Peripheral Nervous System: dysphonia, paresthesia; Gastrointestinal System Disorders: gastrointestinal disorder not otherwise specified (NOS), gastroesophageal reflux, stomatitis (including ulcerative stomatitis); Metabolic and Nutritional Disorders: hypercholesterolemia, hyperglycemia; Musculoskeletal System Disorders: skeletal pain; Cardiac Events: angina pectoris (including aggravated angina pectoris); Psychiatric Disorder: depression; Infections: herpes zoster; Respiratory System Disorder (Upper): laryngitis; Vision Disorder: cataract. In addition, among the adverse reactions observed in the clinical trials with an incidence of < 1% were atrial fibrillation, supraventricular tachycardia, angioedema, and urinary retention.

In the 1-year trials, the incidence of dry mouth, constipation, and urinary tract infection increased with age [see Use In Specific Populations].

Two multicenter, 6-month, controlled studies evaluated SPIRIVA HandiHaler in patients with COPD. The adverse reactions and the incidence rates were similar to those seen in the 1-year controlled trials.

4-Year Trial

The data described below reflect exposure to SPIRIVA HandiHaler in 5992 COPD patients in a 4-year placebo-controlled trial. In this trial, 2986 patients were treated with SPIRIVA HandiHaler at the recommended dose of 18 mcg once a day. The population had an age range from 40 to 88 years, was 75% male, 90% Caucasian, and had COPD with a mean pre-bronchodilator FEV1 percent predicted of 40%. Patients with narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials. When the adverse reactions were analyzed with a frequency of ≥ 3% in the SPIRIVA HandiHaler group where the rates in the SPIRIVA HandiHaler group exceeded placebo by ≥ 1%, adverse reactions included (SPIRIVA HandiHaler, placebo): pharyngitis (12.5%, 10.8%), sinusitis (6.5%, 5.3%), headache (5.7%, 4.5%), constipation (5.1%, 3.7%), dry mouth (5.1%, 2.7%), depression (4.4%, 3.3%), insomnia (4.4%, 3.0%), and arthralgia (4.2%, 3.1%).

Additional Adverse Reactions

Other adverse reactions not previously listed that were reported more frequently in COPD patients treated with SPIRIVA HandiHaler than placebo include: dehydration, skin ulcer, stomatitis, gingivitis, oropharyngeal candidiasis, dry skin, skin infection, and joint swelling.

Postmarketing Experience

Adverse reactions have been identified during worldwide post-approval use of SPIRIVA HandiHaler. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are: application site irritation (glossitis, mouth ulceration, and pharyngolaryngeal pain), dizziness, dysphagia, hoarseness, intestinal obstruction including ileus paralytic, intraocular pressure increased, oral candidiasis, palpitations, pruritus, tachycardia, throat irritation, and urticaria.

Read the entire FDA prescribing information for Spiriva (Tiotropium Bromide) »

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Spiriva - User Reviews

Spiriva User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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