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Rifater

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Rifater

Rifater

Rifater Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rifater (rifampin, isoniazid and pyrazinamide) is used to treat tuberculosis (TB). Rifampin, isoniazid, and pyrazinamide are antibiotics. Common side effects include nausea/vomiting, upset stomach, heartburn, mild muscle/joint pain, or headache.

Rifater is recommended in the initial phase of short-course therapy, which is usually continued for 2 months. Dose is determined by the patient's body weight. Rifater may interact with cyclosporine, haloperidol, nortriptyline, probenecid, theophylline, antibiotics, antifungal medications, barbiturates, birth control pills or hormone replacement therapy, blood thinners, oral diabetes medications, heart or blood pressure medications, heart rhythm medications, narcotics, sedatives, seizure medications, steroids, or sulfa drugs. Many other medicines can interact with Rifater. Tell your doctor all prescription and over-the-counter medications you use. During pregnancy, Rifater should be used only when prescribed. When rifampin is taken during the last few weeks of pregnancy, the risk of bleeding in both mother and infant may be increased. Tell your doctor if you notice any bleeding in your newborn. This medication passes into breast milk but the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Rifater (rifampin, isoniazid and pyrazinamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rifater in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Isoniazid, pyrazinamide, and rifampin can cause severe liver symptoms. Stop taking this medication and call your doctor at once if you have any of these liver symptoms:

  • low fever;
  • nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have any other serious side effects such as:

  • fever, chills, body aches, flu symptoms, weakness, sores in your mouth and throat;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • feeling short of breath, feeling like you might pass out;
  • cough, chest pain or tightness;
  • diarrhea that is watery or bloody;
  • vision problems;
  • urinating less than usual or not at all; or
  • drowsiness, mood changes, increased thirst, swelling, weight gain.

Less serious side effects may include:

  • mild stomach pain, heartburn, diarrhea;
  • mild rash or itching;
  • muscle or joint pain;
  • drowsiness, dizziness, spinning sensation;
  • ringing in your ears; or
  • numbness or tingling in your legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rifater (Rifampin, Isoniazid and Pyrazinamide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rifater Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, upset stomach, heartburn, mild muscle/joint pain, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn reddish. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may become permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, painful/swollen joints.

Tell your doctor immediately if any of these rare but serious side effects occur: change in the amount of urine, increased thirst/urination, bloody urine, vision changes, fast heartbeat, easy bruising/bleeding, signs of a new infection (such as fever, persistent sore throat), mental/mood changes (such as confusion, psychosis), seizures.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rifater (Rifampin, Isoniazid and Pyrazinamide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rifater FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Experiences During the Clinical Trial

Adverse event data reported for the RIFATER and the separate drug treatment groups during the first 2 months of the trial are shown in the table below.

Adverse Events Reported During the Clinical Study

Adverse Events by Body Systems During First 2 Months of Trial Number of Patients With Adverse Events*
RIFATER
n = 122‡
Separate†
n = 123‡
Cutaneous (rash, erythroderma, erythema, exfoliative dermatitis, Lyell syndrome, urticaria, localized skin rash, diffuse skin rash, pruritus, generalized hypersensitivity) 8 (7%) 21 (17%)
Gastrointestinal (nausea, vomiting, digestive pain, diarrhea) 8 (7%) 14 (11%)
Musculoskeletal (arthralgia, long bones pain, phlebitis, localized joint pain, diffuse joint pain, edema of the legs) 5 (4%) 8 (7%)
Hearing and Vestibular (tinnitus, vertigo, vertigo with loss of equilibrium) 3 (2%) 6 (5%)
Liver and Biliary (hepatitis with conjunctival jaundice, hepatitis with deep jaundice) 0 (0%) 2 (2%)
Central and Peripheral Nervous System (sweating, headache, insomnia, diffuse paresthesia of the legs, anxiety, diabetic coma) 5 (4%) 4 (3%)
Total Body (spiking fever, persistent fever) 2 (2%) 4 (3%)
Cardiorespiratory (tightness in chest, coughing, diffuse chest pain, hemoptysis, angina, palpitation, total pneumothorax) 8 (7%) 3 (2%)
Total number of patients with one or more adverse events 29 43
* A given patient may have experienced ≥ 1 adverse event.
† Isoniazid, rifampin and pyrazinamide dosed as separate tablets and capsules.
‡ A total of 250 patients (124 RIFATER; 126 separate) were originally enrolled in the study. Five patients (2 RIFATER; 3 separate) were excluded due to admission errors.

No serious adverse events were reported in the patients receiving RIFATER tablets. Three serious adverse events were reported in the patients given isoniazid, rifampin, and pyrazinamide as separate tablets and capsules. The three serious adverse events were two general hypersensitivity reactions and one jaundice reaction.

There were no significant differences between the two treatment groups in standard liver function, renal function and hematological laboratory test values measured at baseline and after 8 weeks of treatment. As would be expected for these drugs, there were alterations in liver enzymes (SGOT, SGPT) and serum uric acid levels. The adverse reactions reported during therapy with RIFATER are consistent with those described below for the individual components.

Adverse Reactions Reported for Individual Components

Rifampin

Gastrointestinal: Heartburn, epigastric distress, anorexia, nausea, vomiting, jaundice, flatulence, cramps, and diarrhea have been noted in some patients. Although Clostridium difficile has been shown in vitro to be sensitive to rifampin, pseudomembranous colitis has been reported with the use of rifampin (and other broad spectrum antibiotics). Therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with antibiotic use.

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

Hematologic: Thrombocytopenia has occurred primarily with high dose intermittent therapy, but has also been noted after resumption of interrupted treatment. It rarely occurs during well-supervised daily therapy. This effect is reversible if the drug is discontinued as soon as purpura occurs. Cerebral hemorrhage and fatalities have been reported when rifampin administration has been continued or resumed after the appearance of purpura.

Rare reports of disseminated intravascular coagulation have been observed.

Leukopenia, hemolytic anemia, and decreased hemoglobin have been observed.

Agranulocytosis has been reported rarely.

Central Nervous System: Headache, fever, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, behavioral changes, muscular weakness, pains in extremities, and generalized numbness have been observed.

Psychoses have been rarely reported.

Rare reports of myopathy have also been observed.

Ocular: Visual disturbances have been observed.

Endocrine: Menstrual disturbances have been observed.

Rare reports of adrenal insufficiency in patients with compromised adrenal function have been observed.

Renal: Elevations in BUN and serum uric acid have been reported. Rarely, hemolysis, hemoglobinuria, hematuria, interstitial nephritis, acute tubular necrosis, 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.

Dermatologic: Cutaneous reactions are mild and self-limiting and do not appear to be hypersensitivity reactions. Typically, they consist of flushing and itching with or without a rash. More serious cutaneous reactions which may be due to hypersensitivity occur but are uncommon.

Hypersensitivity Reactions: Occasionally pruritus, urticaria, rash, pemphigoid reaction, erythema multiforme including Stevens-Johnson Syndrome, toxic epidermal necrolysis, vasculitis, eosinophilia, sore mouth, sore tongue and conjunctivitis have been observed.

Anaphylaxis has been reported rarely.

Miscellaneous: Edema of the face and extremities have been reported. Other reactions which have occurred with intermittent dosage regimens include “flu” syndrome (such as episodes of fever, chills, headache, dizziness, and bone pain), shortness of breath, wheezing, decrease in blood pressure and shock. The “flu” syndrome may also appear if rifampin is taken irregularly by the patient or if daily administration is resumed after a drug free interval.

Isoniazid

The most frequent reactions are those affecting the nervous system and the liver. (See the BOXED WARNING)

Nervous System: 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 paresthesia 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: Pancreatitis, nausea, vomiting, and epigastric distress.

Hepatic: 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% 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% of those over 50 years of age.

Hematologic: Agranulocytosis; hemolytic, sideroblastic, or aplastic anemia; thrombocytopenia; and eosinophilia.

Hypersensitivity Reactions: Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, anaphylactic reactions, Stevens-Johnson syndrome, and vasculitis.

Metabolic and Endocrine: Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, and gynecomastia.

Miscellaneous: Rheumatic syndrome and systemic lupus erythematosus-like syndrome.

Pyrazinamide

The principal adverse effect is a hepatic reaction (See WARNINGS). Hepatotoxicity appears to be dose related and may appear at any time during therapy. Pyrazinamide can cause hyperuricemia and gout (See PRECAUTIONS).

Gastrointestinal: GI disturbances including nausea, vomiting, and anorexia have also been reported.

Hematologic and Lymphatic: Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum concentration have occurred rarely with this drug. Adverse effects on blood clotting mechanisms have also been rarely reported.

Other: Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, pruritus, and erythema have been reported. Angioedema has been reported rarely. Fever, acne, photosensitivity, porphyria, dysuria, and interstitial nephritis have been reported rarely.

Read the entire FDA prescribing information for Rifater (Rifampin, Isoniazid and Pyrazinamide) »

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