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
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