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 usually have been excluded.
In domestic placebo-controlled angina trials, the incidence of adverse reactions reported during CARDIZEM therapy was not greater than that reported during placebo therapy.
The following represent occurrences observed in clinical studies of angina patients. In many cases, the relationship to CARDIZEM has not been established. The most common occurrences from these studies, as well their frequency of presentation, are edema (2.4%), headache (2.1%), nausea (1.9%), dizziness (1.5%), rash (1.3%), and asthenia (1.2%). In addition, the following events were reported infrequently (less than 1 %):
Cardiovascular: Angina, arrhythmia, AV block (first degree), AV block (second or third degree – see conduction warning), bradycardia bundle branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.
Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor
Gastrointestinal: Anorexia, constipation, diarrhea, dysgeusia, dyspepsia, mild elevations of alkaline phosphatase, SGOT, SGPT, and LDH (see hepatic warnings), thirst, vomiting, weight increase
Dermatological: Petechiae, photosensitivity, pruritus, urticaria
Other: Amblyopia, CPK elevation, dry mouth, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties, tinnitus
The following postmarketing events have been reported infrequently in patients receiving CARDIZEM: allergic reactions, alopecia, angloedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, purpura, retinopathy, myopathy, and thrombocytopenia. There have been observed cases of a generalized rash, some characterized as leukocytoclastic vasculitis. 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 definitive cause and effect relationship between these events and CARDIZEM therapy cannot yet be established. Exfoliative dermatitis (proven by rechallenge) has also been reported.
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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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