Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: • Worsening angina or myocardial infarction [see Warnings and Precautions (5) ] • Worsening heart failure [see Warnings and Precautions (5) ].
• Worsening AV block [see Contraindications (4) ].
• Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Hypertension and Angina : Most adverse reactions have been mild and transient.
The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea, shortness of breath, bradycardia, and rash.
Heart Failure : In the MERIT-HF study comparing metoprolol succinate extended-release tablets in daily doses up to 200 mg (mean dose 159 mg once-daily;
n=1,990) to placebo (n=2,001), 10.3% of metoprolol succinate extended-release tablets patients discontinued for adverse reactions vs.
5 WARNINGS AND PRECAUTIONS • Abrupt cessation may exacerbate myocardial ischemia.
( 5.1 ) • Heart Failure: Worsening cardiac failure may occur.
( 5.2 ) • Bronchospastic Disease: Avoid beta-blockers.
( 5.3 ) • Concomitant use of glycosides, clonidine, diltiazem and verapamil with beta-blockers can increase the risk of bradycardia.
( 5.4 ) • Pheochromocytoma: Initiate therapy with an alpha-blocker.
Like all medications, Metoprolol Succinate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: