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Tiazac (Diltiazem Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Serious adverse reactions have been rare in studies with Tiazac®, as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. A total of 256 hypertensives were treated for between 4 and 8 weeks; a total of 207 patients with chronic stable angina were treated for 3 weeks with doses of Tiazac® ranging from 120-540 mg once daily. Two patients experienced first-degree AV block at 540 mg dose. The following table presents the most common adverse reactions, whether or not drug-related, reported in placebo-controlled trials in patients receiving Tiazac® up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS *
Adverse Events
(COSTART Term)
Placebo Tiazac® Adverse Events
(COSTART Term)
Placebo Tiazac®
n = 57
# pts(%)
Up to
360 mg
n = 149
# pts(%)
480-
540 mg
n = 48
# pts(%)
n = 57
# pts(%)
Up to
360 mg
n = 149
# pts(%)
480-
540 mg
n = 48
# pts(%)
edema, peripheral 1 (2) 8 (5) 7 (15) rash 0 (0) 3 (2) 0 (0)
dizziness 4 (7) 6 (4) 2 (4) infection 2 (4) 2 (1) 3 (6)
vasodilation 1 (2) 5 (3) 1 (2) diarrhea 0 (0) 2 (1) 1 (2)
dyspepsia 0 (0) 7 (5) 0 (0) palpitations 0 (0) 2 (1) 1 (2)
pharyngitis 2 (4) 3 (2) 3 (6) nervousness 0 (0) 3 (2) 0 (0)

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALS *
Adverse Events
(COSTART Term)
Placebo Tiazac® Adverse Events
(COSTART Term)
Placebo Tiazac®
n = 50
# pts(%)
Up to
360 mg
n = 158
# pts(%)
540 mg
n = 49
# pts(%)
n = 50
# pts(%)
Up to
360 mg
n = 158
# pts(%)
540 mg
n = 49
# pts(%)
headache 1 (2) 13 (8)   4 (8) flu syndrome 0 (0) 0 (0) 1 (2)
edema, peripheral 1 (2)   3 (2) 5 (10) cough increase 0 (0) 2 (1) 1 (2)
pain 1 (2) 10 (6)   3 (6) extrasystoles 0 (0) 0 (0) 1 (2)
dizziness 0 (0)   5 (3) 5 (10) gout 0 (0) 2 (1) 1 (2)
asthenia 0 (0)   1 (1)   2 (4) myalgia 0 (0) 0 (0) 1 (2)
dyspepsia 0 (0)   2 (1)   3 (6) impotence 0 (0) 0 (0) 1 (2)
dyspnea 0 (0)   1 (1)   3 (6) conjunctivitis 0 (0) 0 (0) 1 (2)
bronchitis 0 (0)   1 (1)   2 (4) rash 0 (0) 2 (1) 1 (2)
AV block 0 (0)   0 (0)   2 (4) abdominal 0 (0) 0 (0) 1 (2)
infection 0 (0)   2 (1)   1 (2)   enlargement
* Adverse events occurring in treated patients at 2% or more than placebo-treated patients.

In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:

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, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see hepatic warnings), nausea, thirst, vomiting, weight increase.

Dermatological.    Petechiae, photosensitivity, pruritus.

Other.    Albuminuria, allergic reaction, amblyopia, asthenia, CPK increase, crystalluria, dyspnea, edema, epistaxis, eye irritation, headache, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, neck rigidity, nocturia, osteoarticular pain, pain, polyuria, rhinitis, sexual difficulties, gynecomastia.

In addition, the following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, purpura, retinopathy, 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, characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established.



REPORTS OF SUSPECTED TIAZAC SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Tiazac side effects / adverse reactions in 87 year old female

Reported by a physician from United States on 2011-10-27

Patient: 87 year old female

Reactions: Hepatic Enzyme Increased

Suspect drug(s):
Multaq
    Start date: 2011-01-01

Multaq
    End date: 2011-07-01

Tiazac
    Dosage: 240 mg (240 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-05-08
    End date: 2011-07-01

Lipitor
    Dosage: 10 mg (10 mg, 1 in 1 d)
    End date: 2011-07-01

Other drugs received by patient: Benicar; Lasix; Warfarin Sodium



Possible Tiazac side effects / adverse reactions in 87 year old female

Reported by a physician from United States on 2011-11-07

Patient: 87 year old female

Reactions: Hepatic Enzyme Increased

Suspect drug(s):
Lipitor
    Dosage: 10 mg, 1x/day
    End date: 2011-07-01

Tiazac
    Dosage: 240 mg, 1x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-05-08
    End date: 2011-07-01

Dronedarone HCL
    Dosage: unk
    End date: 2011-07-01

Other drugs received by patient: Benicar; Lasix; Warfarin



Possible Tiazac side effects / adverse reactions in 57 year old male

Reported by a consumer/non-health professional from United States on 2011-11-09

Patient: 57 year old male

Reactions: Blood Pressure Increased, Drug Effect Decreased

Suspect drug(s):
Tiazac

Other drugs received by patient: Accupril; Penicillin (Penicillin); Lipitor (Atorvastatin Calciuim); Ibuprofen; Centrum Silver Multivitamin (Centrum Silver Multivitamin); Glyburide; Clonidine; Glucophage; Aspirin; Furosemide; Cardura



See index of all Tiazac side effect reports >>

Drug label data at the top of this Page last updated: 2006-04-04

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