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Toviaz

"April 9, 2012 -- Drugs that treat incontinence caused by an overactive bladder offer modest benefits to some women, and they often come with significant side effects, a new review of research shows.

The government-funded review compar"...

Toviaz

Toviaz Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Toviaz (fesoterodine fumarate) is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence. It is a muscarinic receptor antagonist, which reduces spasms of the bladder muscles. Common side effects include dry mouth, dry eyes, constipation, dizziness, drowsiness, or blurred vision.

The recommended starting dose of Toviaz is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. Toviaz may interact with arsenic trioxide, conivaptan, antibiotics, antifungals, antidepressants, anti-malaria medications, heart rhythm medicines, HIV/AIDS medicines, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, or narcotics. Tell your doctor all medications you use. During pregnancy, Toviaz should be used only when prescribed. It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Our Toviaz (fesoterodine fumarate) 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.

Toviaz in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

  • chest pain, fast or uneven heart rate;
  • swelling of your hands or feet;
  • urinating less than usual or not at all; or
  • painful or difficult urination.

Less serious side effects may include:

  • dry mouth, dry eyes;
  • blurred vision;
  • dizziness, drowsiness;
  • constipation;
  • stomach pain or upset;
  • cough, dry throat;
  • back pain; or
  • sleep problems (insomnia).

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 Toviaz (Fesoterodine Fumarate Extended-Release Tablets) »

What is Patient Information Overview?

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

Toviaz Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, dry eyes, constipation, dizziness, drowsiness, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (such as stimulant-type with stool softener).

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: constipation lasting 3 or more days, severe stomach/abdominal pain, trouble urinating, signs of kidney infection (such as burning/painful urination, lower back pain, fever).

Seek immediate medical attention if any of these rare but serious side effects occur: fast heartbeat, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following signs of a serious allergic reaction: 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 Toviaz (Fesoterodine Fumarate Extended-Release Tablets)»

What is Prescribing information?

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

Toviaz FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

The safety of Toviaz was evaluated in Phase 2 and 3 controlled trials in a total of 2859 patients with overactive bladder, of which 2288 were treated with fesoterodine. Of this total, 782 received Toviaz 4 mg/day, and 785 received Toviaz 8 mg/day in Phase 2 or 3 studies with treatment periods of 8 or 12 weeks. Approximately 80% of these patients had > 10 weeks exposure to Toviaz in these trials.

A total of 1964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent open-label extension studies. In these two studies combined, 554 patients received Toviaz 4 mg/day and 566 patients received Toviaz 8 mg/day.

In Phase 2 and 3 placebo-controlled trials combined, the incidences of serious adverse events in patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg were 1.9%, 3.5%, and 2.9%, respectively. All serious adverse events were judged to be not related or unlikely to be related to study medication by the investigator, except for four patients receiving Toviaz who reported one serious adverse event each: angina, chest pain, gastroenteritis, and QT prolongation on ECG.

The most commonly reported adverse event in patients treated with Toviaz was dry mouth. The incidence of dry mouth was higher in those taking 8 mg/day (35%) and in those taking 4 mg/day (19%), as compared to placebo (7%). Dry mouth led to discontinuation in 0.4%, 0.4%, and 0.8% of patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg, respectively. For those patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

The second most commonly reported adverse event was constipation. The incidence of constipation was 2% in those taking placebo, 4% in those taking 4 mg/day, and 6% in those taking 8 mg/day.

Table 1 lists adverse events, regardless of causality, that were reported in the combined Phase 3, randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with Toviaz 4 or 8 mg once daily for up to 12 weeks.

Table 1: Adverse events with an incidence exceeding the placebo rate and reported by ≥ 1% of patients from double-blind, placebo-controlled Phase 3 trials of 12 weeks treatment duration

System organ class/Preferred term Placebo
N=554
%
Toviaz
4 mg/day
N=554
%
Toviaz
8 mg/day
N=566
%
Gastrointestinal disorders
  Dry mouth 7.0 18.8 34.6
  Constipation 2.0 4.2 6.0
  Dyspepsia 0.5 1.6 2.3
  Nausea 1.3 0.7 1.9
  Abdominal pain upper 0.5 1.1 0.5
Infections
  Urinary tract infection 3.1 3.2 4.2
  Upper respiratory tract infection 2.2 2.5 1.8
Eye disorders
  Dry eyes 0 1.4 3.7
Renal and urinary disorders
  Dysuria 0.7 1.3 1.6
  Urinary retention 0.2 1.1 1.4
Respiratory disorders
  Cough 0.5 1.6 0.9
  Dry throat 0.4 0.9 2.3
General disorders
  Edema peripheral 0.7 0.7 1.2
Musculoskeletal disorders
  Back pain 0.4 2.0 0.9
Psychiatric disorders
  Insomnia 0.5 1.3 0.4
Investigations
  ALT increased 0.9 0.5 1.2
  GGT increased 0.4 0.4 1.2
Skin disorders
  Rash 0.5 0.7 1.1
ALT = alanine aminotransferase; GGT = gamma glutamyltransferase

Patients also received Toviaz for up to three years in open-label extension phases of one Phase 2 and two Phase 3 controlled trials. In all open-label trials combined, 857, 701, 529, and 105 patients received Toviaz for at least 6 months, 1 year, 2 years, and 3 years, respectively. The adverse events observed during long-term, open-label studies were similar to those observed in the 12-week, placebo-controlled studies, and included dry mouth, constipation, dry eyes, dyspepsia, and abdominal pain. Similar to the controlled studies, most adverse events of dry mouth and constipation were mild to moderate in intensity. Serious adverse events, judged to be at least possibly related to study medication by the investigator and reported more than once during the open-label treatment period of up to 3 years, included urinary retention (3 cases), diverticulitis (3 cases), constipation (2 cases), irritable bowel syndrome (2 cases), and electrocardiogram QT corrected interval prolongation (2 cases).

Post-marketing Experience

The following events have been reported in association with fesoterodine use in worldwide post-marketing experience: Eye disorders: Blurred vision; Cardiac disorders: Palpitations; General disorders and administrative site conditions: Hypersensitivity reactions, including angioedema with airway obstruction, face edema; Central nervous system disorders: Dizziness, headache, somnolence; Skin and subcutaneous tissue disorders: Urticaria, pruritus

Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of fesoterodine in their causation cannot be reliably determined.

Read the entire FDA prescribing information for Toviaz (Fesoterodine Fumarate Extended-Release Tablets) »

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Toviaz - User Reviews

Toviaz User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Toviaz sorted by most helpful. Patient Discussions FAQs

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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