ADVERSE REACTIONS
Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.
In the hypertension study, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a diltiazem hydrochloride extended-release formulation (once-a-day dosing) up to 540 mg.
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Placebo
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Diltiazem hydrochloride extended-release
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Adverse Reactions (MedDRA Term)
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n= 120
# pts (%)
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120-360 mg
n= 501
# pts (%)
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540 mg
n= 123
# pts (%)
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Edema lower limb
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4 (3)
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24 (5)
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10 (8)
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Sinus congestion
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0 (0)
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2 (1)
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2 (2)
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Rash NOS
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0 (0)
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3 (1)
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2 (2)
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In the angina study, the adverse event profile of CARDIZEM LA was consistent with what has been previously described for CARDIZEM LA and other formulations of diltiazem HCl. The most frequent adverse effects experienced by CARDIZEM LA-treated patients were edema lower-limb (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), first-degree atrioventricular block (3.2%), and cough (2%).
In clinical trials of other diltiazem formulations involving over 3200 patients, the most common events (i.e., greater than 1%) were edema (4.6%), headache (4.6%), dizziness (3.5%), asthenia (2.6%), first-degree AV block (2.4%), bradycardia (1.7%), flushing (1.4%), nausea (1.4%), and rash (1.2%).
In addition, the following events have been reported infrequently (less than 1%) in angina or hypertension trials:
Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.
Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.
Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase.
Dermatological: Petechiae, photosensitivity, pruritus, urticaria.
Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.
The following postmarketing events have been reported infrequently in patients receiving Cardizem: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and Cardizem: therapy is yet to be established.
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REPORTS OF SUSPECTED CARDIZEM SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Cardizem. The information is not vetted and should not be considered as verified clinical evidence.
Possible Cardizem side effects / adverse reactions in 49 year old female
Reported by a individual with unspecified qualification from United States on 2011-10-25
Patient: 49 year old female
Reactions: Blood Urea Increased, Dyspnoea, Hypotension, Blood Chloride Increased, Loss of Consciousness, Overdose, Chest Pain, Bradycardia, Blood Sodium Decreased, Blood Creatinine Increased, Atrioventricular Block First Degree
Adverse event resulted in: hospitalization
Suspect drug(s):
Cardizem
Indication: Product Used FOR Unknown Indication
Klonopin
Indication: Product Used FOR Unknown Indication
Toprol-XL
Indication: Product Used FOR Unknown Indication
Possible Cardizem side effects / adverse reactions in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-25
Patient: 49 year old female
Reactions: Hypoglycaemia, Acidosis, Loss of Consciousness, Multiple Drug Overdose Accidental, Chest Pain, Blood Creatinine Increased, Blood Sodium Decreased, Oxygen Saturation Decreased, Nodal Arrhythmia, Dyspnoea, Blood Urea Increased, Hypothermia, Hypotension, Condition Aggravated, Toxicity TO Various Agents, Hypothyroidism, Atrioventricular Block First Degree
Adverse event resulted in: hospitalization
Suspect drug(s):
Metoprolol Tartrate
Dosage: one time not the prescribed amount, df
Indication: Product Used FOR Unknown Indication
Clonazepam
Dosage: one time not the prescribed amount, df
Indication: Product Used FOR Unknown Indication
Cardizem
Dosage: one time not the prescribed amount, df
Indication: Product Used FOR Unknown Indication
Possible Cardizem side effects / adverse reactions in 54 year old male
Reported by a consumer/non-health professional from France on 2011-10-26
Patient: 54 year old male
Reactions: Haemoptysis, Platelet Count Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Cardizem
Other drugs received by patient: Amiodarone HCL; Glyceryl Trinitrate
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