Rifamate Side Effects
Generic name: isoniazid / rifampin
Medically reviewed by Drugs.com. Last updated on Oct 23, 2024.
Note: This document provides detailed information about Rifamate Side Effects associated with isoniazid / rifampin. Some dosage forms listed on this page may not apply specifically to the brand name Rifamate.
Applies to isoniazid / rifampin: oral capsule.
Important warnings
This medicine can cause some serious health issues
You should not use isoniazid and rifampin if you have active liver disease (including hepatitis or cirrhosis), or a history of liver problems caused by taking isoniazid.
Serious and sometimes fatal liver problems may occur during treatment with isoniazid and rifampin or after you stop taking this medication, even months after stopping. The risk of liver problems is highest in adults between the ages of 35 and 65. Your liver function may need to be checked every month while you are taking this medicine.
Call your doctor right away if you have: nausea, upper stomach pain, loss of appetite, and unusual weakness or tiredness.
Avoid drinking alcohol. It may increase your risk of liver damage while you are taking isoniazid and rifampin.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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nausea, upper stomach pain, feeling weak or tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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vision changes, confusion, hallucinations, unusual thoughts or behavior;
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fever, unusual weakness, pale skin; or
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easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.
Common side effects may include:
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red-orange coloration of tears, sweat, saliva, urine, or stools;
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numbness, tingling, itching, mild rash;
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drowsiness, dizziness, headache;
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muscle pain or weakness;
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heartburn, gas, diarrhea; or
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mouth pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
See also:
For healthcare professionals
Applies to isoniazid / rifampin: oral capsule.
General adverse events
Doses greater than 600 mg of rifampin given once or twice weekly have resulted in a higher incidence of adverse reactions, including the "flu syndrome" (fever, chills, malaise); hematopoietic reactions (leukopenia, thrombocytopenia, acute hemolytic anemia); shortness of breath; shock; anaphylaxis; renal failure; and cutaneous, gastrointestinal, and hepatic reactions.[Ref]
Cardiovascular
- Frequency not reported: Vasculitis
Rifampin:
- Frequency not reported: Flushing, decreased blood pressure[Ref]
Dermatologic
- Frequency not reported: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (TEN), rash
Isoniazid:
- Frequency not reported: Acne, exfoliative dermatitis, pemphigus
Rifampin:
- Frequency not reported: Erythema multiforme, skin reaction, pruritus, pruritic rash, urticaria, allergic dermatitis, pemphigoid, sweat discoloration, cutaneous reactions[Ref]
Endocrine
Isoniazid:
- Frequency not reported: Gynecomastia, hyperglycemia
Rifampin:
- Rare (less than 0.1%): Adrenal insufficiency
- Frequency not reported: Menstrual disorder/disturbances[Ref]
Gastrointestinal
- Frequency not reported: Nausea, vomiting, epigastric distress, diarrhea
Isoniazid:
- Frequency not reported: Constipation, dry mouth, pancreatitis
Rifampin:
- Frequency not reported: Gastrointestinal disorder, abdominal discomfort, heartburn, flatulence, cramps, pseudomembranous colitis, sore mouth, sore tongue[Ref]
Hematologic
- Frequency not reported: Thrombocytopenia, eosinophilia, agranulocytosis, hemolytic anemia
Isoniazid:
- Frequency not reported: Anemia, aplastic anemia, lymphadenopathy
Rifampin:
- Uncommon (0.1% to 1%): Leukopenia
- Rare (less than 0.1%): Disseminated intravascular coagulation
- Frequency not reported: Decreased hemoglobin[Ref]
Hepatic
- Frequency not reported: Hepatitis, elevated serum transaminases (SGOT, SGPT), bilirubinemia, bilirubinuria, jaundice
Rifampin:
- Common (1% to 10%): Elevated alkaline phosphatase
- Rare (less than 0.1%): Abnormal liver function, shock-like syndrome with hepatic involvement
- Frequency not reported: Hyperbilirubinemia[Ref]
Hypersensitivity
Rifampin:
- Rare (less than 0.1%): Anaphylaxis[Ref]
Metabolic
Isoniazid:
- Frequency not reported: Pellagra, pyridoxine deficiency, metabolic acidosis
Rifampin:
- Frequency not reported: Decreased appetite, anorexia[Ref]
Musculoskeletal
Isoniazid:
- Frequency not reported: Systemic lupus erythematosus-like syndrome, rheumatic syndrome
Rifampin:
- Rare (less than 0.1%): Myopathy
- Frequency not reported: Muscle weakness, bone pain[Ref]
Nervous system
Isoniazid:
- Common (1% to 10%): Peripheral neuropathy
- Uncommon (0.1% to 1%): Convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment
- Frequency not reported: Vertigo, polyneuritis (presenting as paresthesia, muscle weakness, loss of tendon reflexes)
Rifampin:
- Frequency not reported: Headache, drowsiness, cerebral hemorrhage, ataxia, dizziness, inability to concentrate, muscular weakness, pains in extremities, generalized numbness[Ref]
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.[Ref]
Ocular
Rifampin:
- Frequency not reported: Tear discoloration, visual disturbances, conjunctivitis[Ref]
Other
- Frequency not reported: Fever
Isoniazid:
- Frequency not reported: Anti-nuclear antibodies
Rifampin:
- Frequency not reported: Influenza-like syndrome, post-partum hemorrhage, fetal-maternal hemorrhage, porphyria, edema, fatigue, facial edema, edema of the extremities, shock[Ref]
Psychiatric
Isoniazid:
- Frequency not reported: Toxic psychosis
Rifampin:
- Frequency not reported: Psychotic disorder/psychoses, mental confusion, behavioral changes[Ref]
Renal
Rifampin:
- Rare (less than 0.1%): Hemolysis, hemoglobinuria, hematuria, interstitial nephritis, acute tubular necrosis, renal insufficiency, acute renal failure
- Frequency not reported: Acute kidney injury, chromaturia, increased blood creatinine, elevated BUN, elevated serum uric acid[Ref]
Respiratory
Rifampin:
- Frequency not reported: Dyspnea, wheezing, discolored sputum, shortness of breath[Ref]
References
1. (2001) "Product Information. Rifamate (isoniazid-rifampin)." Aventis Pharmaceuticals
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
More about Rifamate (isoniazid / rifampin)
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- During pregnancy
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Further information
Rifamate side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.