Rifamate Side Effects

Please note - some side effects for Rifamate 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 Rifamate - for the Consumer

Rifamate

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 Rifamate:

Diarrhea; dizziness; drowsiness; gas; headache; heartburn; mild stomach upset or cramps; nausea; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Rifamate:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or dark urine; change in the amount of urine produced; changes in vision; dark, tarry, or bloody stools; fever, chills, or sore throat; general feeling of discomfort; increased thirst or urination; joint pain or swelling; loss of appetite; memory problems; menstrual changes; mental or mood changes; muscle pain or weakness; seizures; severe diarrhea, nausea, or stomach cramps; shortness of breath; stomach pain or tenderness; swelling of the hands or legs; symptoms of low vitamin B₆ levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

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.

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Rifamate Side Effects - for the Professional

Rifamate

Rifampin

Nervous system reactions: headache, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, visual disturbances, muscular weakness, pain in extremities, and generalized numbness

Gastrointestinal disturbances: in some patients heartburn, epigastric distress, anorexia, nausea, vomiting, gas, cramps, and diarrhea

Hepatic reactions: transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, BSP, alkaline phosphatase, serum transaminases) have been observed. Rarely, hepatitis or a shocklike syndrome with hepatic involvement and abnormal liver function tests.

Renal reactions: elevations in BUN and serum uric acid have been reported. Rarely, hemolysis, hemoglobinuria, hematuria, interstitial nephritis, renal insufficiency, and acute renal failure have been noted. These are generally considered to be hypersensitivity reactions. They usually occur during intermittent therapy or when treatment is resumed following intentional or accidental interruption of a daily dosage regimen, and are reversible when rifampin is discontinued and appropriate therapy instituted.

Hematologic reactions: thrombocytopenia, leukopenia, hemolytic anemia, eosinophilia, and decreased hemoglobin have been observed. Thrombocytopenia has occurred when rifampin and ethambutol were administered concomitantly according to an intermittent dose schedule twice weekly and in high doses. Agranulocytosis has been reported very rarely.

Allergic and immunological reactions: occasionally pruritus, urticaria, rash, pemphigoid reaction, eosinophilia, sore mouth, sore tongue, and exudative conjunctivitis. Rarely, hemolysis, hemoglobinuria, hematuria, renal insufficiency or acute renal failure have been reported which are generally considered to be hypersensitivity reactions. These have usually occurred during intermittent therapy or when treatment was resumed following intentional or accidental interruption of a daily dosage regimen and were reversible when rifampin was discontinued and appropriate therapy instituted.

Although rifampin has been reported to have an immunosuppressive effect in some animal experiments, available human data indicate that this has no clinical significance.

Metabolic reactions: elevations in BUN and serum uric acid have occurred.

Miscellaneous reactions: fever and menstrual disturbances have been noted.

Isoniazid

The most frequent reactions are those affecting the nervous system and the liver.

Nervous system reactions: peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics), and is usually preceded by paresthesias of the feet and hands. The incidence is higher in "slow inactivators."

Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment, and toxic psychosis.

Gastrointestinal reactions: nausea, vomiting, and epigastric distress

Hepatic reactions: elevated serum transaminases (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice, and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms are anorexia, nausea, vomiting, fatigue, malaise, and weakness. Mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of persons taking isoniazid. The abnormality usually occurs in the first 4 to 6 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal with no necessity to discontinue medication. In occasional instances, progressive liver damage occurs, with accompanying symptoms. In these cases, the drug should be discontinued immediately. The frequency of progressive liver damage increases with age. It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age.

Hematologic reactions: agranulocytosis, hemolytic sideroblastic or aplastic anemia, thrombocytopenia, and eosinophilia

Hypersensitivity reactions: fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, and vasculitis

Metabolic and endocrine reactions: pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, and gynecomastia

Miscellaneous reactions: rheumatic syndrome and systemic lupus erythematosus-like syndrome

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Side Effects by Body System - for Healthcare Professionals

General

The most common side effects reported with isoniazid were those affecting the nervous system and the liver.

Hepatic

Hepatic side effects have been reported frequently with isoniazid and have included elevated serum transaminases (SGOT, SGPT), bilirubinemia, bilirubinuria, jaundice, and occasionally severe and sometimes fatal hepatitis. Transient liver function test abnormalities (such as elevated serum bilirubin, alkaline phosphatase, serum transaminases) and, rarely, hepatitis or a shocklike syndrome (with liver involvement and abnormal liver function tests) have been reported with rifampin use. Rarely, fulminant hepatitis (i.e., acute hepatitis with hepatic encephalopathy) has been reported in patients treated with isoniazid-rifampin.

Prodromal symptoms are often observed with isoniazid-associated liver reactions and usually include anorexia, nausea, vomiting, fatigue, malaise, and weakness. Mild and transient elevation of serum transaminase levels occurs in 10% to 20% of patients taking isoniazid. The abnormality usually occurs in the first 4 to 6 months of treatment but can occur at any time during therapy. Enzyme levels usually return to normal even with treatment continuation; however, progressive liver damage occurs in some cases. Isoniazid should be discontinued at once if signs or symptoms indicative of liver damage are detected. The frequency of progressive liver damage increases with age. It is rare in patients under 20, but occurs in up to 2.3% of patients over 50 years of age.

Nervous system

Peripheral neuropathy associated with isoniazid is dose-dependent, most often occurs in malnourished patients and in patients predisposed to neuritis (such as alcoholics and diabetics), and generally follows paresthesias of the hands and feet. The rate is higher in slow acetylators.

Nervous system side effects have been reported frequently with isoniazid and have included peripheral neuropathy and paresthesias. Convulsions and toxic encephalopathy have rarely been reported with standard isoniazid doses. Headache, drowsiness, fatigue, ataxia, dizziness, pain in extremities, and generalized numbness have been reported with rifampin use.

Renal

Renal hypersensitivity reactions usually occur during intermittent treatment or in patients resuming treatment following intentional or accidental interruption of the daily regimen. These reactions are reversible when rifampin is discontinued and appropriate therapy started.

Renal side effects associated with rifampin have included elevations in blood urea nitrogen. Hemolysis, hemoglobinuria, hematuria, interstitial nephritis, renal insufficiency, and acute renal failure have rarely been reported and are usually considered hypersensitivity reactions.

Hematologic

Thrombocytopenia has occurred with concomitant rifampin and ethambutol use according to a twice weekly dose schedule and in high doses.

Hematologic side effects associated with isoniazid have included agranulocytosis, anemia (hemolytic, sideroblastic, or aplastic), thrombocytopenia, and eosinophilia. Thrombocytopenia, leukopenia, hemolytic anemia, eosinophilia, decreased hemoglobin, and agranulocytosis (rare) have been reported with rifampin use.

Hypersensitivity

Hypersensitivity side effects associated with isoniazid have included fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, and vasculitis. Occasionally pruritus, urticaria, rash, pemphigoid reaction, eosinophilia, sore mouth, sore tongue, exudative conjunctivitis, and, rarely, renal hypersensitivity reactions have been reported with rifampin use.

Metabolic

Metabolic side effects associated with isoniazid have included pyridoxine deficiency, pellagra, hyperglycemia, and metabolic acidosis. Elevated serum uric acid has been reported with rifampin.

Gastrointestinal

Gastrointestinal side effects associated with isoniazid have included nausea, vomiting, and epigastric distress. Heartburn, epigastric distress, anorexia, nausea, vomiting, gas, cramps, diarrhea, and a red-orange discoloration of feces, saliva, and sputum have been reported with rifampin use.

Psychiatric

Psychiatric side effects associated with isoniazid are infrequent with standard doses and have included memory impairment and toxic psychosis. Inability to concentrate and mental confusion have been reported with rifampin use.

Ocular

Ocular side effects associated with isoniazid are infrequent with standard doses and have included optic neuritis and atrophy. Visual disturbances and a red-orange discoloration of tears have been reported with rifampin use.

Other

Other side effects associated with isoniazid have included systemic lupus erythematosus-like syndrome. Fever and a red-orange discoloration of sweat have been reported with rifampin use.

Musculoskeletal

Musculoskeletal side effects associated with isoniazid have included rheumatic syndrome. Muscular weakness has been reported with rifampin use.

Endocrine

Endocrine side effects associated with isoniazid have included gynecomastia.

Genitourinary

Genitourinary side effects associated with rifampin have included menstrual disturbances and a red-orange discoloration of urine.

Immunologic

Immunologic side effects associated with rifampin have included an immunosuppressive effect in some animal experiments; however, available human data indicate that this has no clinical significance.

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