Diltiazem side effects

Side effects
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.

In domestic placebo-controlled angina trials, the incidence of adverse reactions reported during Diltiazem 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 Diltiazem has not been established. The most common occurrences from these studies, as well as their frequency of presentation, are: edema (2.4%), headache (2.1%), nausea (1.9%), dizziness (1.5%), rash (1.3%), asthenia (1.2%).

In addition, the following events were reported infrequently (less than 1%):

Cardiovascular Nervous System Dermatologic Other

Cardiovascular
Angina, arrhythmia, AV block (first degree), AV block (second or third degree), bradycardia, bundle branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

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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.

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Dermatologic
Petechiae, photosensitivity, pruritus, urticaria.

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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 Diltiazem:


 * allergic reactions,
 * alopecia,
 * angioedema (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,
 * 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 Diltiazem therapy cannot yet be established. Exfoliative dermatitis (proven by rechallenge) has also been reported.

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