Rifater Side Effects
Generic name: isoniazid / pyrazinamide / rifampin
Medically reviewed by Drugs.com. Last updated on Oct 9, 2022.
Note: This document contains side effect information about isoniazid / pyrazinamide / rifampin. Some dosage forms listed on this page may not apply to the brand name Rifater.
Applies to isoniazid / pyrazinamide / rifampin: oral tablet.
- This drug may cause very bad and sometimes deadly liver problems like hepatitis. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- The chance of liver problems is higher the older you are. The chance may also be raised by drinking alcohol every day, long-term liver problems, or injection drug use. The chance of liver problems may also be raised in women, mainly women who are black or Hispanic or who have just had a baby. Most of the time, liver problems caused by this drug happen within the first 3 months of care, but they can happen at any time. Most of the time, liver function has gone back to normal but sometimes it has not. Blood work will need to be done before starting this drug and while taking it. If you have questions, talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- If you have active liver disease, talk with your doctor. This drug may not be right for you.
Serious side effects of Rifater
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Chest pain or pressure.
- Coughing up blood.
- Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
- Flu-like signs.
- A heartbeat that does not feel normal.
- Swollen gland.
- Joint pain or swelling.
- Period (menstrual) changes.
- Ringing in ears.
- Muscle pain or weakness.
- Shortness of breath.
- Sweating a lot.
- Swelling in the arms or legs.
- Purple spots or redness of the skin.
- Dizziness or passing out.
- A burning, numbness, or tingling feeling that is not normal.
- Memory problems or loss.
- Change in eyesight, eye pain, or very bad eye irritation.
- Change in balance.
- Feeling confused, not able to focus, or change in behavior.
- Change in tooth color. These changes may be long-lasting.
Other side effects of Rifater
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Change in color of body fluids to orange or red.
- Feeling sleepy.
- Upset stomach or throwing up.
- Stomach pain or cramps.
- Trouble sleeping.
- Not hungry.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Isoniazid: The most frequently reported side effects are those affecting the nervous system and liver.
Pyrazinamide: The most frequently reported side effects are those affecting the liver.
Common (1% to 10%): Hepatitis with conjunctival jaundice, hepatitis with deep jaundice
Frequency not reported: ALT alterations, AST alterations, jaundice reaction, liver enzyme alterations
Very common (10% or more): Mild/transient serum transaminase elevations (up to 20%)
Common (1% to 10%): Progressive liver damage
Uncommon (0.1% to 1%): Severe hepatitis/fatal hepatitis
Frequency not reported: Bilirubinemia, elevated serum transaminases (ALT, AST), jaundice
Common (1% to 10%): Symptomless abnormality of hepatic cell function
Frequency not reported: Acute yellow liver atrophy/fatal acute yellow liver atrophy, clinical jaundice, hepatotoxicity, liver tenderness
Common (1% to 10%): ALT increased, AST increased, blood bilirubin increased
Rare (0.01% to 0.1%): Abnormal liver function tests, hepatitis, shock-like syndrome with hepatic involvement
Frequency not reported: Cholestasis, hepatic enzyme increased, hepatitis, hepatotoxicity, hyperbilirubinemia, increased GGT, increased serum alkaline phosphatase, increased serum bilirubin, increased serum transaminases, jaundice, transient liver function test abnormalities[Ref]
Mild and transient transaminase elevations usually occurred in the first 4 to 6 months of treatment with isoniazid, and enzyme levels typically returned to normal without patients needing to discontinue treatment.
Progressive liver damage was age-related, and more commonly occurred in patients over 50 years of age.[Ref]
Frequency not reported: Acne, exfoliative dermatitis, exfoliative skin eruptions, maculopapular skin eruptions, morbilliform skin eruptions, pemphigus, purpuric skin eruptions, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis
Rare (0.01% to 0.1%): Acne, photosensitivity
Frequency not reported: Erythema, pruritus, rash, urticaria
Frequency not reported: Acute generalized exanthematous pustulosis, allergic dermatitis, cutaneous reactions, erythema multiforme, face edema, itching with/without rash, pemphigoid/pemphigoid reaction, pruritus, rash pruritic, serious cutaneous reactions, skin reaction, Stevens-Johnson syndrome, sweat discoloration, toxic epidermal necrolysis, urticaria[Ref]
Common (1% to 10%): Peripheral neuropathy
Uncommon (0.1% to 1%): Convulsions, memory impairment, neurotoxicity, toxic encephalopathy
Frequency not reported: Loss of tendon reflexes, neuritis, paresthesia, polyneuritis, seizures, vertigo
Common (1% to 10%): Dizziness, headache
Cerebral hemorrhage and fatal cerebral hemorrhage have occurred in patients who have continued or resumed treatment with rifampin after the appearance of purpura.
Polyneuritis associated with isoniazid (e.g., muscle weakness, loss of tendon reflexes, paresthesia) was unlikely to occur at the recommended daily dose of this combination drug.
High doses of isoniazid have resulted in convulsions and toxic encephalopathy.[Ref]
Common (1% to 10%): Diarrhea, digestive pain, nausea, vomiting
Frequency not reported: Constipation, dry mouth, epigastric distress, nausea, pancreatitis, vomiting
Frequency not reported: Nausea, peptic ulcer aggravation, vomiting
Common (1% to 10%): Nausea, vomiting
Uncommon (0.1% to 1%): Diarrhea
Frequency not reported: Abdominal discomfort, cramps, epigastric distress, flatulence, gastrointestinal disorder, heartburn, pseudomembranous colitis, sore mouth, sore tongue, tooth discoloration/permanent tooth discoloration[Ref]
Common (1% to 10%): Angina, chest tightness, diffuse chest pain, leg edema, palpitation, phlebitis
Frequency not reported: Vasculitis
Frequency not reported: Bleeding, blood pressure decreased, edema, edema extremities, flushing with/without rash, shock, vasculitis[Ref]
Common (1% to 10%): Persistent fever, spiking fever, tinnitus
Frequency not reported: Fatigue, fever, malaise, weakness
Rare (0.01% to 0.1%): Death, fever
Frequency not reported: Malaise
Common (1% to 10%): Chills, pyrexia
Frequency not reported: Fatigue, fetal-maternal hemorrhage, fever, postpartum hemorrhage[Ref]
Common (1% to 10%): Arthralgia, diffuse joint pain, long bone pain
Frequency not reported: Muscle weakness, systemic lupus erythematosus-like syndrome
Common (1% to 10%): Mild arthralgia, myalgia
Frequency not reported: Arthralgia
Rare (0.01% to 0.1%): Myopathy
Frequency not reported: Bone pain, extremity pain, muscle weakness[Ref]
Common (1% to 10%): Coughing, hemoptysis, total pneumothorax
Common (1% to 10%): Anxiety, insomnia
Uncommon (0.1% to 1%): Toxic psychosis
Rare (0.01% to 0.1%): Psychoses
Frequency not reported: Behavioral changes, mental confusion, psychotic disorder[Ref]
Common (1% to 10%): Localized joint pain, localized skin rash[Ref]
Thrombocytopenia with/without purpura usually occurred with intermittent rifampin treatment or upon resumption of interrupted treatment, but was typically reversible if the drug was discontinued as soon as purpura occurred.[Ref]
Rare (0.01% to 0.1%): Adverse effects on blood clotting mechanisms, erythrocyte vacuolation, increased concentration of erythrocytes
Frequency not reported: Sideroblastic anemia, sideroblastic anemia with erythroid hyperplasia, thrombocytopenia with/without purpura
Common (1% to 10%): Thrombocytopenia with/without purpura
Uncommon (0.1% to 1%): Leukopenia
Rare (0.01% to 0.1%): Agranulocytosis, disseminated intravascular coagulation, hemolysis
Frequency not reported: Abnormally prolonged prothrombin time, decreased hemoglobin, eosinophilia, hemolytic anemia, low vitamin K-dependent coagulation factors, vitamin K-dependent coagulation disorders[Ref]
Common (1% to 10%): Generalized hypersensitivity
Frequency not reported: Anaphylactic reactions, hypersensitivity reactions
Rare (0.01% to 0.1%): Angioedema
Frequency not reported: Hypersensitivity reactions
Rare (0.01% to 0.1%): Anaphylaxis
Acute renal failure, acute tubular necrosis, hematuria, hemoglobinuria, hemolysis, interstitial nephritis, and renal insufficiency are considered hypersensitivity reactions to rifampin, and usually occurred during intermittent treatment or upon resumption of treatment following intentional/accidental interruption of a daily regimen; these reactions were reversible when this drug was discontinued and appropriate therapy was given.[Ref]
Rare (0.01% to 0.1%): Interstitial nephritis
Rare (0.01% to 0.1%): Acute renal failure, acute tubular necrosis, interstitial nephritis, renal dysfunction
Frequency not reported: Bilirubinuria
Rare (0.01% to 0.1%): Dysuria
Rare (0.01% to 0.1%): Hematuria, hemoglobinuria
Frequency not reported: Chromaturia, menstrual disorder[Ref]
Frequency not reported: Serum uric acid level alterations
Rare (0.01% to 0.1%): Porphyria
Frequency not reported: Active gout, anorexia, gout, hyperuricemia, reduced urate excretion
Frequency not reported: Anorexia, decreased appetite, porphyria, serum uric acid elevated[Ref]
Frequency not reported: Gynecomastia
Rare (0.01% to 0.1%): Adrenal insufficiency[Ref]
Frequency not reported: Antinuclear antibodies present, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, rheumatic syndrome
Frequency not reported: DRESS syndrome
Flu syndrome usually occurred in patients taking intermittent rifampin regimens; however, this side effect has also occurred in patients taking rifampin irregularly and in those resuming treatment after a drug-free interval.[Ref]
Uncommon (0.1% to 1%): Optic atrophy, optic neuritis
Frequency not reported: Erythroid hyperplasia[Ref]
More about Rifater (isoniazid / pyrazinamide / rifampin)
- Check interactions
- Drug images
- Dosage information
- During pregnancy
- Drug class: antituberculosis combinations
Related treatment guides
1. "Product Information. Rifater (isoniazid / pyrazinamide / rifampin)." SmithKline Beecham (2001):
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.