Mykrox Side Effects

Generic Name: metolazone,metolazone

Please note - some side effects for Mykrox 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).

Mykrox Side Effects - for the Professional

Mykrox

Adverse experience information is available from more than 14 years of accumulated marketing experience with other formulations of metolazone for which reliable quantitative information is lacking and from controlled clinical trials with Mykrox from which incidences can be calculated.

In controlled clinical trials with Mykrox, adverse experiences resulted in discontinuation of therapy in 6.7-6.8% of patients given ½ to 1 mg of Mykrox.

Adverse experiences occurring in controlled clinical trials with Mykrox with an incidence of >2%, whether or not considered drug-related, are summarized in the following table.

Some of the adverse effects reported in association with Mykrox also occur frequently in untreated hypertensive patients, such as headache and dizziness, which occurred in 14.8 and 7.4% of patients in a smaller parallel placebo group.

The following adverse effects were reported in less than 2% of the Mykrox treated patients.

Cardiovascular

Cold extremities, edema, orthostatic hypotension, palpitations.

Central and Peripheral Nervous System

Anxiety, depression, dry mouth, impotence, nervousness, neuropathy, weakness, “weird” feeling.

Dermatological

Pruritus, rash, skin dryness.

Eyes, Ears, Nose, Throat

Cough, epistaxis, eye itching, sinus congestion, sore throat, tinnitus.

Gastrointestinal

Abdominal discomfort (pain, bloating), bitter taste, constipation, diarrhea, nausea, vomiting.

Genitourinary

Nocturia.

Musculoskeletal

Back pain.

Other Adverse Experiences

Adverse experiences reported with other marketed metolazone formulations and most thiazide diuretics, for which quantitative data are not available, are listed in decreasing order of severity within body systems. Several are single or rare occurrences.

Cardiovascular

excessive volume depletion, hemoconcentration, venous thrombosis.

Central and Peripheral Nervous System

syncope, paresthesias, drowsiness, restlessness (sometimes resulting in insomnia).

Dermatologic/Hypersensitivity

toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome, necrotizing angiitis (cutaneous vasculitis), skin necrosis, purpura, petechiae, dermatitis, photosensitivity, urticaria, pruritus, skin rashes.

Gastrointestinal

hepatitis, intrahepatic cholestatic jaundice, pancreatitis, anorexia, nausea, diarrhea, abdominal pain.

Hematologic

aplastic (hypoplastic) anemia, agranulocytosis, leukopenia, thrombocytopenia.

Metabolic

hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hypochloremic alkalosis, hyperglycemia, glycosuria, increase in serum urea nitrogen (BUN) or creatinine, hypophosphatemia, hypomagnesemia, hypercalcemia.

Musculoskeletal

acute gouty attacks.

Other

transient blurred vision, chills.

In addition, rare adverse experiences reported in association with similar antihypertensive-diuretics but not reported to date for metolazone include: sialadenitis, xanthopsia, respiratory distress (including pneumonitis), and anaphylactic reactions. These experiences could occur with clinical use of metolazone.

Side Effects by Body System

Metabolic

A rare case of hyperosmolar nonketotic hyperglycemia is associated with metolazone.

Metabolic side effects are the most common and profound. The rapid onset of hyponatremia or hypokalemia is often sudden and may be profound, particularly if metolazone is given with a loop diuretic. Hypokalemia may be important in patients with underlying cardiac arrhythmias. Metolazone may increase serum calcium and uric acid levels and lower serum magnesium and phosphate levels. Glucose intolerance is reported in rare cases.

Cardiovascular

Cardiovascular side effects are uncommon. Postural hypotension is reported in less than 5% of patients. Rare cases of venous thrombosis are reported, thought to be due to metolazone-induced hypovolemia and increased serum concentrations of clotting factors. Rare cardiovascular side effects also include palpitations, hypovolemia, and chest pain.

Renal

Renal insufficiency, manifest as a rise in serum creatinine and BUN, may occur, although, in most cases, creatinine clearance increases as a result of metolazone therapy.

Nervous system

Nervous system side effects include headache, dizziness, and fatigue. Two cases of syncope and seizures are reported. Metolazone-induced hypovolemia and electrolyte changes may induce hepatic encephalopathy in some patients.

It is not clear whether the patients who developed syncope and seizure activity were hypotensive or hypovolemic at the time of the seizures or that metolazone can definitively be implicated. In one case the patient was also taking theophylline and had hypomagnesemia, which may be a complication of metolazone therapy.

Hypersensitivity

Hypersensitivity reactions include rare case reports of necrotizing vasculitis, angiitis, and pruritic rashes.

A case of cutaneous hypersensitivity angiitis has been reported in a patient who had previously tolerated thiazide diuretics, indicating that, despite the chemical similarity between thiazides and metolazone, there is not necessarily cross-reactivity.

Hematologic

Hematologic abnormalities are rare. Cases of reversible hypoplastic anemia, aplastic anemia, agranulocytosis, and mild leukopenia are reported.

Gastrointestinal

Gastrointestinal side effects are rare, and include a case of acute pancreatitis. Nausea, vomiting, anorexia, and abdominal bloating are also rare.

Hepatic

Hepatic side effects include a rare case of cholestatic jaundice.

Musculoskeletal

Musculoskeletal cramps are associated with metolazone therapy, as with other diuretics, and may be associated with electrolyte disorders and rapid intravascular volume shifts.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.