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Dilt-CD (Diltiazem Hydrochloride) - Side Effects and Adverse Reactions

 
 



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.

The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsules up to 360 mg with rates in placebo patients shown for comparison.

Diltiazem Hydrochloride Extended-Release Capsule Placebo-Controlled Angina and Hypertension Trials Combined
Adverse Reactions Diltiazem Hydrochloride Extended-Release Capsules
(n=607)
Placebo
(n=301)
Headache 5.4% 5.0%
Dizziness 3.0% 3.0%
Bradycardia 3.3% 1.3%
AV Block First Degree 3.3% 0.0%
Edema 2.6% 1.3%
ECG Abnormality 1.6% 2.3%
Asthenia 1.8% 1.7%

In clinical trials of diltiazem hydrochloride extended-release capsules, diltiazem hydrochloride tablets, and diltiazem hydrochloride sustained-release capsules 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 were 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 diltiazem hydrochloride 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 diltiazem therapy is yet to be established.



REPORTS OF SUSPECTED DILT-CD SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Dilt-CD. The information is not vetted and should not be considered as verified clinical evidence.

Possible Dilt-CD side effects / adverse reactions in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: 62 year old male

Reactions: Fatigue, Drug Interaction, Renal Failure Acute, Decreased Appetite, Sinus Bradycardia, Tremor

Adverse event resulted in: hospitalization

Suspect drug(s):
Dilt-CD
    Dosage: 240 mg;qd
    Indication: Product Used FOR Unknown Indication

Tacrolimus
    Indication: Renal Transplant

Ranolazine
    Dosage: 500 mg;bid ; 1000 mg;bid
    Indication: Myocardial Ischaemia



Possible Dilt-CD side effects / adverse reactions in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25

Patient: 62 year old male

Reactions: Urine Output Decreased, Drug Interaction, Toxicity TO Various Agents, Sinus Bradycardia, Tremor, Fatigue, Decreased Appetite, Renal Failure Acute, Lethargy

Adverse event resulted in: hospitalization

Suspect drug(s):
Dilt-CD
    Dosage: 240 mg;qd
    Indication: Product Used FOR Unknown Indication

Ranolazine
    Dosage: 500mg;bid ; 1000 mg;bid
    Indication: Myocardial Ischaemia

Prednisone
    Indication: Product Used FOR Unknown Indication

Tacrolimus
    Indication: Renal Transplant

Enalapril Maleate
    Dosage: 2.5 mg;qd
    Indication: Product Used FOR Unknown Indication



See index of all Dilt-CD side effect reports >>

Drug label data at the top of this Page last updated: 2011-11-02

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