Tiazac Side Effects

Generic Name: diltiazem,diltiazem hydrochloride

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.

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; lightheadedness; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mood or mental changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness or breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 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.

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, 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.

Side Effects by Body System - for Healthcare Professionals

General

Diltiazem was generally well-tolerated. Serious side effects have been rare during studies; however, patients with impaired ventricular function and cardiac conduction abnormalities have generally been excluded from these studies. Side effects were usually dose-related and of mild to moderate severity.

Cardiovascular

Cardiovascular side effects have included asymptomatic hypotension (4.3%), atrioventricular (AV) block (up to 4%), bradycardia (up to 3.6%), first-degree AV block (up to 3.3%), symptomatic hypotension (3.2%), vasodilation (up to 3%), palpitations (up to 2%), and extrasystoles (up to 2%). Angina, angina pectoris, arrhythmia (including junctional rhythm or isorhythmic dissociation), atrial fibrillation, atrial flutter, AV block (second- or third-degree), bundle branch block, sinus bradycardia, bigeminal extrasystole, congestive heart failure, electrocardiogram abnormalities, hypotension, postural hypotension, hypertension, myocardial infarct, myocardial ischemia, sinus pause, sinus node dysfunction, tachycardia, phlebitis, ST elevation, vasodilatation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, and ventricular extrasystoles have been reported in less than 2% of patients. Sinoatrial depression, atrioventricular depression, sinoatrial heart block, and 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. Events such as myocardial infarction, which are not readily distinguishable from the natural history of the disease, and asystole have been reported during postmarketing experience.

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.

Other

Other side effects have included peripheral edema (up to 15%), lower limb edema (up to 8%), pain (up to 6%), infection (up to 6%), asthenia/fatigue (up to 4.8%), edema (up to 4.6%), influenza syndrome (up to 2.3%), and abdominal enlargement (up to 2%). Increased weight, fever, chest pain, malaise, flushing, pallor, abdominal pain, neck pain, ear pain, otitis media, accidental injury, and unevaluable reaction have been reported in less than 2% of patients.

Nervous system

Nervous system side effects have included dizziness (up to 10%) and headache (up to 8.9%). Amnesia, abnormal thinking, gait abnormality, hallucinations, insomnia, neuropathy, paresthesia, somnolence, syncope, tinnitus, vertigo, hypertonia, and tremor have been reported in less than 2% of patients. Dysosmia, dysgeusia, sensory loss, at least one case of acute Parkinsonism, and at least 2 cases of hyperactive symptoms or akathisia have been reported. Myoclonus has also been reported. Extrapyramidal symptoms have been reported during postmarketing experience.

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.

Respiratory

Respiratory side effects have included rhinitis (up to 9.6%), dyspnea (up to 6%), pharyngitis (up to 6%), bronchitis (up to 4%), increased cough (up to 3%), sinusitis (2%), and sinus congestion (up to 2%). Epistaxis, nasal congestion, respiratory distress, and respiratory disorder have been reported in less than 2% of patients. At least one case of eosinophilic pleural effusion that resolved following discontinuation of diltiazem has been reported.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (up to 6%), constipation (up to 3.6%), nausea (up to 2.2%), vomiting (up to 2%), and diarrhea (up to 2%). Anorexia, colitis, dry mouth, dysgeusia, flatulence, gastrointestinal hemorrhage, stomach ulcers, tooth disorder, eructation, taste perversion, and thirst have been reported in less than 2% of patients. 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. Gingival hyperplasia has been reported during postmarketing experience.

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.

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.

Dermatologic side effects have included rash (up to 2%). Petechiae, photosensitivity, contact dermatitis, pruritus, sweating, skin hypertrophy (nevus), and urticaria have been reported in less than 2% of patients. Rarely, acute generalized exanthematous pustular dermatitis (at least 3 cases), subacute cutaneous, and lupoid lesions have been reported. At least 6 cases of photodistributed hyperpigmentation have been reported. Acute generalized exanthematous pustulosis, alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), and cases of generalized rash (characterized as leukocytoclastic vasculitis) have been reported during postmarketing experience.

Hepatic

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.

Hepatic side effects have included mild elevations of SGOT and SGPT in less than 2% of patients. Mild and transient increases in liver function tests have been reported. 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.

Musculoskeletal

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.

Musculoskeletal side effects have included back pain (up to 2.9%), myalgia (up to 2.3%), and gout (up to 2%). Muscle cramps, neck rigidity, arthralgia, arthrosis, bursitis, bone pain, and osteoarticular pain have been reported in less than 2% of patients. At least one case of acute myopathy has been reported.

Metabolic

Metabolic side effects have included hyperglycemia, hyperuricemia, mild elevations of lactate dehydrogenase, mild elevations of alkaline phosphatase, and increased creatine phosphokinase in less than 2% of patients. Insulin resistance, diabetes-like symptoms, a case of attenuated hypoglycemia and symptoms of hypoglycemia, a case of polyuria, polydipsia, and elevated blood glucose, a case of frank hyperosmolar nonketotic hyperglycemic coma, a case of insulinoma, and at least one case of metabolic acidosis and hyperkalemia have 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.

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 allergic reaction (less than 2%). Erythematous rash, urticarial rash, and, rarely, cutaneous vasculitis and purpuric rash have been reported. Angioedema (including facial or periorbital edema) has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included nervousness (up to 2%). Abnormal dreams, depression, and personality change have been reported in less than 2% of patients. Reversible mania, acute psychosis, and at least one case of auditory and visual hallucinations, paranoia, and misinterpretations have been reported.

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.

Hematologic

Hematologic side effects have included platelet dysfunction and at least one case of mild leukocytosis. Hemolytic anemia, increased bleeding time, leukopenia, lymphadenopathy, purpura, and thrombocytopenia have been reported during postmarketing experience.

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.

Ocular

Ocular side effects have included conjunctivitis (up to 2%). Amblyopia, eye irritation, eye hemorrhage, and ophthalmitis have been reported in less than 2% of patients. Retinopathy has been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included impotence (up to 2%). Albuminuria, crystalluria, cystitis, kidney calculus, dysmenorrheal, nocturia, polyuria, sexual difficulties, vaginitis, prostate disease, gynecomastia, and urinary tract infection have been reported in less than 2% of patients.

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 included kidney failure and pyelonephritis in less than 1% of patients. Acute renal failure has been reported.

Local

Local side effects have included injection site reactions (e.g., itching, burning) in 3.9% of patients.

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