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Tiazac

Last reviewed on RxList: 8/7/2017
Tiazac Side Effects Center

Last reviewed on RxList 8/07/2017

Tiazac (diltiazem hydrochloride) is a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Tiazac is available in generic form. Common side effects of Tiazac include:

Tell your doctor if you have unlikely but serious side effects of Tiazac including:

  • fainting,
  • slow/irregular/pounding/fast heartbeat,
  • swelling ankles or feet,
  • shortness of breath,
  • unusual tiredness,
  • unexplained or sudden weight gain,
  • mental/mood changes (such as depression, agitation), or
  • unusual dreams.

Doasge of Tiazac depends on the individual, their response to the medication and the condition being treated. Usual starting doses are 120 to 240 mg once daily. Tiazac may interact with amiodarone, buspirone, carbamazepine, cimetidine, cyclosporine, digoxin, lovastatin, rifampin, quinidine, sedatives, antibiotics, antifungals, beta-blockers, or HIV/AIDS medicines. Tell your doctor all medications you are taking. Tiazac should be used only when prescribed during pregnancy. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Tiazac (diltiazem hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tiazac Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • chest pain;
  • slow heartbeats;
  • pounding heartbeats or fluttering in your chest;
  • a light-headed feeling, like you might pass out; or
  • heart problems--swelling, rapid weight gain, feeling short of breath.

Common side effects may include:

  • swelling;
  • dizziness, weakness;
  • headache;
  • nausea; or
  • rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tiazac (Diltiazem Hcl)

QUESTION

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Tiazac Professional Information

SIDE EFFECTS

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 to 540 mg once daily. Two patients experienced first-degree AV block at the 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
n=57
# pts (%)
Up to 360 mg
n=149
# pts (%)
480 - 540 mg
n=48
# pts (%)
edema, peripheral 1 (2) 8 (5) 7 (15)
dizziness 4 (7) 6 (4) 2 (4)
vasodilation 1 (2) 5 (3) 1 (2)
dyspepsia 0 (0) 7 (5) 0 (0)
pharyngitis 2 (4) 3 (2) 3 (6)
rash 0 (0) 3 (2) 0 (0)
infection 2 (4) 2 (1) 3 (6)
diarrhea 0 (0) 2 (1) 1 (2)
palpitations 0 (0) 2 (1) 1 (2)
nervousness 0 (0) 3 (2) 0 (0)

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALS*

Adverse Events (COSTART Term) Placebo Tiazac
n=50
# pts (%)
Up to 360 mg
n=158
# pts (%)
540 mg
n=49
# pts (%)
headache 1 (2) 13 (8) 4 (8)
edema, peripheral 1 (2) 3 (2) 5 (10)
pain 1 (2) 10 (6) 3 (6)
dizziness 0 (0) 5 (3) 5 (10)
asthenia 0 (0) 1 (1) 2 (4)
dyspepsia 0 (0) 2 (1) 3 (6)
dyspnea 0 (0) 1 (1) 3 (6)
bronchitis 0 (0) 1 (1) 2 (4)
AV block 0 (0) 0 (0) 2 (4)
infection 0 (0) 2 (1) 1 (2)
flu syndrome 0 (0) 0 (0) 1 (2)
cough increase 0 (0) 2 (1) 1 (2)
extrasystoles 0 (0) 0 (0) 1 (2)
gout 0 (0) 2 (1) 1 (2)
myalgia 0 (0) 0 (0) 1 (2)
impotence 0 (0) 0 (0) 1 (2)
conjunctivitis 0 (0) 0 (0) 1 (2)
rash 0 (0) 2 (1) 1 (2)
abdominal enlargement 0 (0) 0 (0) 1 (2)
* 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 WARNINGS, Acute Hepatic Injury), 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: acute generalized exanthematous pustulosis, alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), 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.

Read the entire FDA prescribing information for Tiazac (Diltiazem Hcl)

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