Myrbetriq

Myrbetriq

Myrbetriq Side Effects Center

Medical Editor: John Cunha, DO, FACOEP

Myrbetriq (mirabegron) is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Side effects of Myrbetriq can include increased blood pressure, the inability to full empty the bladder (urinary retention), inflammation of the nasal passages, dry mouth, constipation, and memory issues.

The recommended starting dose of Myrbetriq is 25 mg once daily, with or without food. 25 mg is effective within 8 weeks, though the dose may be increased to 50 mg once daily. Myrbetriq should be swallowed whole and should not be crushed, divided or chewed. Myrbetriq may interact with metoprolol, desipramine, or digoxin. Tell your doctor all medications you use. During pregnancy, Myrbetriq should be used only if the benefit to the mother outweighs the potential risk to the fetus. Myrbetriq is predicted to be excreted in human milk and is not recommended for nursing mothers.

Our Myrbetriq 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 Prescribing information?

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

Myrbetriq FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 clinical practice.

In three, 12 week, double-blind, placebo-controlled, safety and efficacy studies in patients with overactive bladder (Studies 1, 2, and 3), Myrbetriq was evaluated for safety in 2736 patients [see Clinical Studies]. Study 1 also included an active control. For the combined Studies 1, 2, and 3, 432 patients received Myrbetriq 25 mg, 1375 received Myrbetriq 50 mg, and 929 received Myrbetriq 100 mg once daily. In these studies, the majority of the patients were Caucasian (94%), and female (72%) with a mean age of 59 years (range 18 to 95 years).

Myrbetriq was also evaluated for safety in 1632 patients who received Myrbetriq 50 mg once daily (n=812 patients) or Myrbetriq 100 mg (n=820 patients) in a 1 year, randomized, fixed dose, double-blind, active controlled, safety study in patients with overactive bladder (Study 4). Of these patients, 731 received Myrbetriq in a previous 12 week study. In Study 4, 1385 patients received Myrbetriq continuously for at least 6 months, 1311 patients received Myrbetriq for at least 9 months, and 564 patients received Myrbetriq for at least 1 year.

The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2 and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness and tachycardia.

Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by more than 1 patient and at a rate greater than placebo.

Table 1 lists adverse reactions, derived from all adverse events, that were reported in Studies 1, 2 and 3 at an incidence greater than placebo and in 1% or more of patients treated with Myrbetriq 25 mg or 50 mg once daily for up to 12 weeks. The most commonly reported adverse reactions (greater than 2% of Myrbetriq patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection and headache.

Table 1: Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Exceeding Placebo Rate and Reported by 1% or More Patients Treated With Myrbetriq 25 mg or 50 mg Once Daily in Studies 1, 2, and 3

  Placebo (%) Myrbetriq 25 mg (%) Myrbetriq 50 mg (%)
Number of Patients 1380 432 1375
Hypertension* 7.6 11.3 7.5
Nasopharyngitis 2.5 3.5 3.9
Urinary Tract Infection 1.8 4.2 2.9
Headache 3.0 2.1 3.2
Constipation 1.4 1.6 1.6
Upper Respiratory Tract Infection 1.7 2.1 1.5
Arthralgia 1.1 1.6 1.3
Diarrhea 1.3 1.2 1.5
Tachycardia 0.6 1.6 1.2
Abdominal Pain 0.7 1.4 0.6
Fatigue 1.0 1.4 1.2
*Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring predominantly in subjects with baseline hypertension.

Other adverse reactions reported by less than 1% of patients treated with Myrbetriq in Studies 1, 2, or 3 included:

Cardiac disorders: palpitations, blood pressure increased [see CLINICAL PHARMACOLOGY]

Eye Disorders: glaucoma [see CLINICAL PHARMACOLOGY]

Gastrointestinal disorders: dyspepsia, gastritis, abdominal distension

Infections and Infestations: sinusitis, rhinitis

Investigations: GGT increased, AST increased, ALT increased, LDH increased

Renal and urinary disorders: nephrolithiasis, bladder pain

Reproductive system and breast disorders: vulvovaginal pruritis, vaginal infection

Skin and subcutaneous tissue disorders: urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, lip edema

Table 2 lists the rates of the most commonly reported adverse reactions, derived from all adverse events in patients treated with Myrbetriq 50 mg for up to 52 weeks in Study 4. The most commonly reported adverse reactions ( > 3% of Myrbetriq patients) were hypertension, urinary tract infection, headache, and nasopharyngitis.

Table 2: Percentages of Patients with Adverse Reactions, Derived from all Adverse Events, Reported by Greater Than 2% of Patients Treated With Myrbetriq 50 mg Once Daily in Study 4

  Myrbetriq 50 mg (%) Active Control (%)
Number of Patients 812 812
Hypertension 9.2 9.6
Urinary Tract Infection 5.9 6.4
Headache 4.1 2.5
Nasopharyngitis 3.9 3.1
Back Pain 2.8 1.6
Constipation 2.8 2.7
Dry Mouth 2.8 8.6
Dizziness 2.7 2.6
Sinusitis 2.7 1.5
Influenza 2.6 3.4
Arthralgia 2.1 2.0
Cystitis 2.1 2.3

In Study 4, in patients treated with Myrbetriq 50 mg once daily, adverse reactions leading to discontinuation reported by more than 2 patients and at a rate greater than active control included: constipation (0.9%), headache (0.6%), dizziness (0.5%), hypertension (0.5%), dry eyes (0.4%), nausea (0.4%), vision blurred (0.4%), and urinary tract infection (0.4%). Serious adverse events reported by at least 2 patients and exceeding active control included cerebrovascular accident (0.4%) and osteoarthritis (0.2%). Serum ALT/AST increased from baseline by greater than 10-fold in 2 patients (0.3%) taking Myrbetriq 50 mg, and these markers subsequently returned to baseline while both patients continued Myrbetriq.

In Study 4, serious adverse events of neoplasm were reported by 0.1%, 1.3%, and 0.5% of patients treated with Myrbetriq 50 mg, Myrbetriq 100 mg and active control once daily, respectively. Neoplasms reported by 2 patients treated with Myrbetriq 100 mg included breast cancer, lung neoplasm malignant and prostate cancer.

In a separate clinical study in Japan, a single case was reported as Stevens-Johnson syndrome with increased serum ALT, AST and bilirubin in a patient taking Myrbetriq 100 mg as well as an herbal medication (Kyufu Gold).

Postmarketing Experience

Because these spontaneously reported events are from the worldwide postmarketing experience, from a population of uncertain size, the frequency of events and the role of mirabegron in their causation cannot be reliably determined. The following events have been reported in association with mirabegron use in worldwide postmarketing experience:

Urologic: urinary retention [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Myrbetriq (Mirabegron) »

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Additional Myrbetriq Information

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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