Source: OpenFDA label data · Not medical advice · For personal tracking only
Important warning themes extracted from the FDA label. Review the full label warnings below for source wording.
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 ) Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection to atorvastatin ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp at 1-800- 706-5575 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, the 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 and Atorvastatin Amlodipine and atorvastatin 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 and atorvastatin was well tolerated For the most part, adverse reactions have been mild or moderate in severity In clinical trials with amlodipine and atorvastatin, 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 The following information is based on the clinical experience with amlodipine and atorvastatin Amlodipine Amlodipine has been evaluated for safety in more than 11,000 patients in U.S and foreign clinical trials In general, treatment with amlodipine was well tolerated at doses up to 10 mg daily Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity In controlled clinical trials directly comparing amlodipine (N=1,730) at doses up to 10 mg to placebo (N=1,250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%) The most commonly reported side effects more frequent than placebo are dizziness and edema The incidence (%) of side effects that occurred in a doserelated manner are as follows: Amlodpine 2.5 mg N=275 5 mg N=296 10 mg N=268 Placebo N=520 Edema 1.8 3 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0 Palpitations 0.7 1.4 4.5 0.6 Other adverse reactions that were not clearly dose related but were reported at an incidence greater than 1.0% in placebo-controlled clinical trials include the following: Amlodipine (%) (N=1,730) Placebo (%) (N=1,250) Fatigue 4.5 2.8 Nausea 2.9 1.9 Abdominal Pain 1.6 0.3 Somnolece 1.4 0.6 Edema, flushing, palpitations, and somnolence appear to be more common in women than in men The following events occurred in 0.1% of patients treated with amlodipine in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain they are listed to alert the physician to a possible relationship: Cardiovascular : arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis Central and Peripheral Nervous System : hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo Gastrointestinal : anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia General : allergic reaction, asthenia, 2 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease Musculoskeletal System : arthralgia, arthrosis, muscle cramps, 2 myalgia Psychiatric : sexual dysfunction (male 2 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization Respiratory System : dyspnea, 2 epistaxis Skin and Appendages : angioedema, erythema multiforme, pruritus, 2 rash, 2 rash erythematous, rash maculopapular Special Senses : abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus Urinary System : micturition frequency, micturition disorder, nocturia Autonomic Nervous System : dry mouth, sweating increased Metabolic and Nutritional : hyperglycemia, thirst
These may signal more serious reactions and may require prompt medical attention.
Frequently reflected in adverse reaction or label text.
An immune reaction that may cause rash, swelling, hives, itching, or breathing problems.
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6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 )
Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection to atorvastatin ( 6.1 )
To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp
at 1-800- 706-5575 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, the 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
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Amlodipine and Atorvastatin Amlodipine and atorvastatin 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 and atorvastatin was well tolerated
For the most part, adverse reactions have been mild or moderate in severity
In clinical trials with amlodipine and atorvastatin, 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
The following information is based on the clinical experience with amlodipine and atorvastatin
Amlodipine Amlodipine has been evaluated for safety in more than 11,000 patients in U.S
and foreign clinical trials
In general, treatment with amlodipine was well tolerated at doses up to 10 mg daily
Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity
In controlled clinical trials directly comparing amlodipine (N=1,730) at doses up to 10 mg to placebo (N=1,250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%)
The most commonly reported side effects more frequent than placebo are dizziness and edema
The incidence (%) of side effects that occurred in a doserelated manner are as follows: Amlodpine 2.5 mg N=275 5 mg N=296 10 mg N=268 Placebo N=520 Edema 1.8 3 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0 Palpitations 0.7 1.4 4.5 0.6 Other adverse reactions that were not clearly dose related but were reported at an incidence greater than 1.0% in placebo-controlled clinical trials include the following: Amlodipine (%) (N=1,730) Placebo (%) (N=1,250) Fatigue 4.5 2.8 Nausea 2.9 1.9 Abdominal Pain 1.6 0.3 Somnolece 1.4 0.6 Edema, flushing, palpitations, and somnolence appear to be more common in women than in men
The following events occurred in 0.1% of patients treated with amlodipine in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain
they are listed to alert the physician to a possible relationship: Cardiovascular : arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis
Central and Peripheral Nervous System : hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo
Gastrointestinal : anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia
General : allergic reaction, asthenia, 2 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease
Musculoskeletal System : arthralgia, arthrosis, muscle cramps, 2 myalgia
Psychiatric : sexual dysfunction (male 2 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization
Respiratory System : dyspnea, 2 epistaxis
Skin and Appendages : angioedema, erythema multiforme, pruritus, 2 rash, 2 rash erythematous, rash maculopapular
Special Senses : abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus
Urinary System : micturition frequency, micturition disorder, nocturia
Autonomic Nervous System : dry mouth, sweating increased
Metabolic and Nutritional : hyperglycemia, thirst