Caduet Adverse Reactions

amlodipine + atorvastatin


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Full Prescribing Info
Adverse Reactions
Combination therapy with amlodipine and atorvastatin has been evaluated for safety in 1092 patients in double-blind, placebo-controlled studies treated for concomitant hypertension and dyslipidemia. In clinical trials, no adverse events peculiar to combination therapy with amlodipine and atorvastatin have been observed. Adverse events have been limited to those that were reported previously with amlodipine and/or atorvastatin (see respective adverse event experiences as follows).
In general, combination therapy with amlodipine and atorvastatin was well tolerated. For the most part, adverse events have been mild or moderate in severity. In controlled clinical trials, discontinuation of therapy due to adverse events or laboratory abnormalities was required in 5.1% of patients treated with both amlodipine and atorvastatin compared to 4.0% of patients given placebo.
The following information is based on clinical trials and post-marketing experience with amlodipine and atorvastatin.
Amlodipine Experience: Amlodipine is well tolerated. In placebo-controlled clinical trials involving patients with hypertension or angina, the most commonly observed side effects were: (see Table 6).

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In these clinical trials, no pattern of clinically significant laboratory test abnormalities related to amlodipine has been observed.
The following events occurred in =1% but >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 System: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.
Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.
Gastrointestinal Disorders: anorexia, constipation, dyspepsia,** dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
General Disorders: allergic reaction, asthenia,** back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.
Musculoskeletal System: arthralgia, arthrosis, muscle cramps,** myalgia.
Psychiatric Disorders: sexual dysfunction (male** and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.
Respiratory System: dyspnea,** epistaxis.
Skin and Appendages: angioedema, erythema multiforme, pruritus,** rash,** rash erythematous, rash maculopapular.
**These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
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 Disorders: hyperglycaemia, thirst.
Hemopoietic System: leukopenia, purpura, thrombocytopenia.
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: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia.
Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states, such as myocardial infarction and angina.
Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
Less commonly observed side effects in marketing experience with amlodipine include: (see Table 7).

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Hepatitis, jaundice and hepatic enzyme elevations have also been reported very infrequently (mostly consistent with cholestasis). Some cases severe enough to require hospitalization have been reported in association with use of amlodipine. In many instances, causal association is uncertain.
Rarely reported events were allergic reaction including pruritus, rash, angioedema, and erythema multiforme.
As with other calcium channel blockers, the following adverse events have been rarely reported and cannot be distinguished from the natural history of the underlying disease: MI, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) and chest pain.
Pediatric Patients (Aged 6-17 years): Amlodipine is well tolerated in children. Adverse events were similar to those seen in adults. In a study of 268 children, the most frequently reported adverse events were: (see Table 8).

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The majority of adverse events were mild or moderate. Severe adverse events (predominantly headache) were experienced by 7.2% with amlodipine 2.5 mg, 4.5% with amlodipine 5 mg, and 4.6% with placebo. The most common cause of discontinuation from the study was uncontrolled hypertension. There were no discontinuations due to laboratory abnormalities. There was no significant change in heart rate.
Atorvastatin Experience: Atorvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 atorvastatin vs. 7311 placebo) patients treated for a median period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
The following adverse events were reported, regardless of causality assessment, in patients treated with atorvastatin in clinical trials. The events in italics occurred in =2% of patients and the events in plain type occurred in <2% of patients.
Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction, generalized edema.
Digestive System: Nausea, gastroenteritis, liver function tests abnormal, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice, diarrhea, dyspepsia, flatulence.
Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis, pharyngolaryngeal pain.
Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, libido decreased, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesia, hypertonia.
Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling.
Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer.
Urogenital System: Urinary tract infection, urinary frequency, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage.
Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion.
Cardiovascular System: Palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension.
Metabolic and Nutritional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia.
Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.
The most frequent (≥1%) adverse effects that may be associated with atorvastatin therapy, reported in patients participating in placebo-controlled clinical studies include: Infections and infestations: nasopharyngitis.
Metabolism and nutrition disorders: hyperglycaemia.
Respiratory, thoracic and mediastinal disorders: pharyngolaryngeal pain, epistaxis.
Gastrointestinal disorders: diarrhoea, dyspepsia, nausea, flatulence.
Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling.
Investigations: liver function test abnormal, blood creatine phosphokinase increased.
Additional adverse effects reported in atorvastatin placebo-controlled clinical trials include: Psychiatric Disorders: nightmare.
Eye Disorders: vision blurred.
Ear and Labyrinth Disorders: tinnitus.
Gastrointestinal Disorders: abdominal discomfort, eructation.
Hepatobiliary Disorders: hepatitis, cholestasis.
Skin and Subcutaneous Tissue Disorders: urticaria.
Musculoskeletal and Connective Tissue Disorders: muscle fatigue, neck pain.
General Disorders and Administration Site Conditions: malaise, pyrexia.
Investigations: white blood cells urine positive.
Not all effects previously listed have been causally associated with atorvastatin therapy.
Post introduction Reports with Atorvastatin: Adverse events associated with atorvastatin therapy reported since market introduction, that are not previously listed, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and rhabdomyolysis.
Post-marketing Experience: In post-marketing experience, the following additional undesirable effects have been reported with atorvastatin: Blood and Lymphatic System Disorders: thrombocytopenia.
Immune System Disorders: allergic reactions (including anaphylaxis).
Injury, Poisoning and Procedural Complications: tendon rupture.
Metabolism and Nutrition Disorders: weight gain.
Nervous System Disorders: hypoesthesia, amnesia, dizziness, dysgeusia.
Gastrointestinal Disorders: pancreatitis.
Ear and Labyrinth Disorders: tinnitus.
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme, bullous rashes.
Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis, immune-mediated necrotising myopathy, myositis, back pain.
General Disorders and Administration Site Conditions: chest pain, peripheral oedema, fatigue.
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