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 serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 ) ] Liver enzyme abnormalities [see Warnings and Precautions ( 5.3 ) ] Most common adverse reaction (3% greater than placebo) to amlodipine is edema ( 6.1 ).
Most common adverse reactions leading to atorvastatin discontinuation were myalgia and diarrhea ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy’s Laboratories, Inc.
at 1-888-375-3784 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.
Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium has been evaluated for safety in 1,092 patients in double-blind placebo-controlled studies treated for co-morbid hypertension and dyslipidemia.
In general, treatment with amlodipine besylate and atorvastatin calcium was well tolerated.
For the most part, adverse reactions have been mild or moderate in severity.
In clinical trials with amlodipine besylate and atorvastatin calcium, no adverse reactions peculiar to this combination have been observed.
Adverse reactions are similar in terms of nature, severity, and frequency to those reported previously with amlodipine and atorvastatin.
5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness.
Amlodipine besylate and atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected ( 2 , 5.1 , 8.5 ).
Immune-Mediated Necrotizing Myopathy (IMNM): Monitor for myalgia and treat ( 5.2 ).
Hepatic Transaminitis: Monitor liver enzymes before and during treatment ( 5.3 ).
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
Like all medications, Amlodipine Besylate And Atorvastatin Calcium 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: