Tiazac Side Effects

Generic Name: diltiazem

Please note - some side effects for Tiazac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Tiazac - for the Consumer

Tiazac 24-Hour Extended-Release Beads Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tiazac 24-Hour Extended-Release Beads Capsules:

Constipation; dizziness; facial flushing; headache; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; irregular heartbeat; swelling of the feet or hands; tender, bleeding, or swollen gums.

Tiazac Side Effects - for the Professional

Tiazac

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 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.

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 extrasysto-les.

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, 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.

Side Effects by Body System

General

Diltiazem is generally well-tolerated. Side effects occur in approximately 5% of patients, are usually dose-related, and are of mild to moderate severity.

Cardiovascular

Nodal bigeminy progressing to complete heart block has been reported in one cardiac patient who ingested a large amount of diltiazem in a suicide attempt.

Cardiovascular side effects have been reported the most frequently. These have included asymptomatic hypotension (4% to 13%), symptomatic hypotension (3% to 13%), flushing (2%), edema (2%), and atrioventricular heart block (1% to 3%). Cardiovascular side effects reported in 1% of patients have included sinoatrial depression, atrioventricular depression, sinoatrial heart block, and bradycardia. Several cases of sinus arrest, atrioventricular dissociation, and junctional bradycardia have been reported. A case of nodal bigeminy progressing to complete heart block has also been reported.

Gastrointestinal

A 72-year-old man developed gingival hyperplasia while receiving diltiazem. The hyperplasia recurred after surgical removal, and disappeared without recurrence after diltiazem was discontinued.

A 76-year-old man with CHF and an uncomplicated inguinal hernia developed epigastric pain, nausea, and vomiting associated with an unchanged ECG within 2 hours after starting diltiazem. Plain abdominal X-rays were suggestive of intestinal obstruction. The patient recovered within 24 hours after nasogastric suction, discontinuation of oral intake, and discontinuation of diltiazem. Rechallenge was not done.

Gastrointestinal side effects reported in 1% to 5% of patients have included nausea, vomiting, constipation, and diarrhea. At least one case of gingival hyperplasia has been reported. At least one case of reversible, functional intestinal obstruction and paralytic ileus has been reported. At least one case of Intestinal obstruction and epigastric pain has been reported.

Nervous system

Nervous system side effects reported in 7% of patients have included dizziness and headache. Dysosmia, dysgeusia, and sensory loss have been reported. At least one case of acute Parkinsonism has been reported. At least two cases of hyperactive symptoms or akathisia have been reported. Myoclonus has also been reported.

A 62-year-old man with diabetes mellitus, congestive heart failure, and aortic stenosis developed uncontrollable hyperactivity within 24 hours after starting diltiazem. The akathisia was unresponsive to antihistamines and sedatives, and only resolved after discontinuation of diltiazem. A rechallenge was positive.

Dermatologic

In reported cases of acute generalized exanthematous pustular dermatitis, the rash developed 10 to 20 days after initiating diltiazem therapy and resolved after discontinuation of the drug.

Dermatological side effects have been reported rarely. These have included exfoliative dermatitis (10%) and toxic epidermal necrolysis (1%). Rarely, acute generalized exanthematous pustular dermatitis, subacute cutaneous, and lupoid lesions have been reported. At least six cases of photodistributed hyperpigmentation have been reported. At least three cases of acute generalized exanthematous pustular dermatitis have been reported.

Hypersensitivity

A 42-year-old man with a history of hypertension developed a generalized erythematous, purpuric rash associated with mucosal ulceration, fever, and elevated liver function tests within two days after starting diltiazem. A skin biopsy revealed histology consistent with Stevens-Johnson syndrome or severe erythema multiforme. The rash and liver function tests gradually resolved after discontinuation of diltiazem and institution of corticosteroid therapy. An extensive evaluation failed to reveal an infectious source.

Hypersensitivity side effects have included erythema multiforme (7%), Stevens-Johnson syndrome (4%), erythematous rash (1%), and urticarial rash (1%). Rarely, cutaneous vasculitis and purpuric rash have been reported.

Hepatic

Hepatic side effects reported in 1% of patients have included mild and transient increases in liver function tests. Rarely, granulomatous hepatitis and hepatorenal failure have been reported. Extremely rarely, acute hepatitis has been reported. A case of jaundice associated with elevated serum transaminases has been reported.

One patient developed both renal and hepatic failure while taking diltiazem. Although the drug was discontinued and renal and hepatic function were improving, the patient developed cardiogenic shock and died.

A 61-year-old man with hypertension and angina pectoris presented with fever and a generalized rash associated with hepatomegaly, a mild leukocytosis, thrombocytopenia, and elevated liver function tests. An infectious etiology was not found. After all of the patient's medications were continued except for diltiazem, his signs and symptoms resolved within six days. A macrophage inhibitory factor test and mast cell degranulation test done in the presence of diltiazem were positive.

Hematologic

Hematological side effects have been reported rarely. These have included platelet dysfunction and increased bleeding times. At least two cases of thrombocytopenia have been reported. At least one case of mild leukocytosis has been reported.

A 23-year-old man with a carotid aneurysm and delirium developed an increased bleeding time (15 minutes) after starting aminocaproic acid, phenobarbital, and diltiazem. His bleeding time resolved to his pretreatment time of 6 minutes after diltiazem alone was discontinued.

A 61-year-old man with hypertension and angina pectoris presented with fever and a generalized rash associated with hepatomegaly, a mild leukocytosis, thrombocytopenia, and elevated liver function tests. An infectious etiology was not found. After all of the patient's medications were continued except for diltiazem, his signs and symptoms resolved within six days. A macrophage inhibitory factor test and mast cell degranulation test done in the presence of diltiazem were positive.

Renal

A 53-year-old man, with hypertension and ischemic heart disease, developed a rash and acute renal failure associated with elevated liver function tests following a single dose of diltiazem.

Several case reports have been published describing renal failure, which appear to be related to diltiazem. A 72-year-old man with coronary artery disease and esophagitis developed a urticarial rash and jaundice associated with elevated serum transaminases, metabolic acidosis, and hyperkalemia. The patient died of cardiogenic shock complicated by pulmonary edema.

Renal side effects have rarely included acute renal failure.

Psychiatric

A 72-year-old woman with hypertension and angina pectoris developed auditory and visual hallucinations, paranoia, and misinterpretations within two days after beginning diltiazem. In the absence of any other obvious cause, the diltiazem was stopped, and her psychosis resolved over the next three days. Nifedipine was successfully substituted.

Psychiatric side effects have been reported rarely. These have included reversible mania, depression, and acute psychosis. At least one case of auditory and visual hallucinations, paranoia, and misinterpretations has been reported.

Musculoskeletal

Musculoskeletal side effects have been reported rarely. At least one case of acute myopathy has been reported.

A 58-year-old man with hypertension, coronary artery disease, and hypercholesterolemia developed acute and generalized extremity weakness and chest pain while receiving diltiazem, lovastatin, nitrates, and enalapril. The patient's muscles were tender to palpation. An ECG was unchanged. With normal liver and thyroid function tests, lovastatin was discontinued, but the patient's creatine phosphokinase (CPK) levels remained elevated (all CPK-MM) and the patient's symptoms persisted. There was no evidence of a connective tissue disease, rhabdomyolysis, or renal failure. The patient refused muscle biopsy. Upon discontinuation of diltiazem, the signs and symptoms of myopathy rapidly resolved, even after lovastatin was readministered. All signs and symptoms recurred upon rechallenge with diltiazem.

Metabolic

Metabolic side effects have been reported rarely. These have included insulin resistance and diabetes-like symptoms. A case of attenuated hypoglycemia and symptoms of hypoglycemia has been reported. A case of polyuria, polydipsia, and elevated blood glucose has been reported. A case of frank hyperosmolar nonketotic hyperglycemic coma has been reported. A case of insulinoma has been reported. At least one case of metabolic acidosis and hyperkalemia has been reported.

A 72-year-old man with coronary artery disease and esophagitis developed a urticarial rash and jaundice associated with elevated serum transaminases, metabolic acidosis, and hyperkalemia. The patient died of cardiogenic shock complicated by pulmonary edema.

A 46-year-old woman with insulinoma demonstrated suppressed serum insulin levels after diltiazem 44 mg intravenously was administered. The patient was subsequently treated with orally administered diltiazem, with a significant decrease in the frequency of hypoglycemic attacks.

Respiratory

Respiratory side effects include at least one case of eosinophilic pleural effusion that resolved following discontinuation of diltiazem.

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