Myrbetriq Side Effects Center
Medical Editor: John Cunha, DO, FACOEP
Myrbetriq (mirabegron) is a beta-3 adrenergic agonist used to treat overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Side effects of Myrbetriq include increased blood pressure, the inability to fully empty the bladder (urinary retention), sinus pain, dry mouth, sore throat, diarrhea, constipation, bloating, memory issues, headache, joint pain, dizziness, blurred vision, tired feeling, stomach pain, and nausea.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Myrbetriq 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.
Stop using mirabegron and call your doctor at once if you have a serious side effect such as:
- fast or pounding heartbeats;
- pain or burning when you urinate;
- painful or difficult urinatinn, trouble emptying your bladder; or
- dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);
Less serious side effects may include:
- headache, joint pain;
- dizziness, blurred vision;
- tired feeling;
- dry mouth, stomach pain, nausea;
- diarrhea, constipation, bloating; or
- sinus pain, sore throat.
Read the entire detailed patient monograph for Myrbetriq (Mirabegron)
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
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.
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|
|Urinary Tract Infection||1.8||4.2||2.9|
|Upper Respiratory Tract Infection||1.7||2.1||1.5|
|*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:
Investigations: GGT increased, AST increased, ALT increased, LDH increased
Reproductive system and breast disorders: vulvovaginal pruritus, vaginal infection
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|
|Urinary Tract Infection||5.9||6.4|
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).
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:
Gastrointestinal disorders: nausea
Urologic: urinary retention [see WARNINGS AND PRECAUTIONS]
Read the entire FDA prescribing information for Myrbetriq (Mirabegron)
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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