pharmacopeia
GET
/api/v1/drug/rifampin

Mechanism of action

Sourced from openFDA

Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible Mycobacterium tuberculosis organisms. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

Nucleic Acid SynthesisProtease

Indications

Sourced from openFDA
  • In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment.ICD-10: A15.9

Contraindications

Sourced from openFDA
  • RIFADIN is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (See WARNINGS .) Rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity.contraindicated

Dosage & administration

Sourced from openFDA

Rifampin can be administered by the oral route or by IV infusion (see INDICATIONS AND USAGE ). IV doses are the same as those for oral. See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure. Tuberculosis Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral or IV Pediatric Patients: 10–20 mg/kg, not to exceed 600 mg/day, oral or IV It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months.

Warnings & precautions

Sourced from openFDA

Hepatotoxicity of hepatocellular, cholestatic, and mixed patterns has been reported in patients treated with rifampin. Severity ranged from asymptomatic elevations in liver enzymes, isolated jaundice/hyperbilirubinemia, symptomatic self-limited hepatitis to fulminant liver failure and death. Severe hepatic dysfunction including fatalities were reported in patients with liver disease and in patients taking rifampin with other hepatotoxic agents. Monitor for symptoms and clinical/laboratory signs of liver injury, especially if treatment is prolonged or given with other hepatotoxic drugs. Patients with impaired liver function should be given rifampin only in cases of necessity and then under strict medical supervision. In these patients, careful monitoring of liver function should be done prior to therapy and then every 2 to 4 weeks during therapy. If signs of hepatic damage occur or worsen, discontinue rifampin. Rifampin has enzyme-inducing properties, including induction of delta amino levulinic acid synthetase. Isolated reports have associated porphyria exacerbation with rifampin administration. The possibility of rapid emergence of resistant meningococci restricts the use of RIFADIN to short-term treatment of the asymptomatic carrier state. RIFADIN is not to be used for the treatment of meningococcal disease. Systemic hypersensitivity reactions were reported with RIFADIN administration.

Adverse reactions

Sourced from openFDA

The following adverse reactions associated with the use of RIFADIN were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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. Tooth discoloration (which may be permanent) may occur. Hepatic Hepatotoxicity including transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, alkaline phosphatase, serum transaminases, gamma-glutamyl transferase), hepatitis, shock-like syndrome with hepatic involvement and abnormal liver function tests, and cholestasis have been reported (see WARNINGS ). Hematologic Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, have been reported (see WARNINGS ). 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.

Use in specific populations

Sourced from openFDA

Pregnancy–Teratogenic Effects There are no adequate and well-controlled studies of RIFADIN in pregnant women. Rifampin has been reported to cross the placental barrier and appear in cord blood. While available studies cannot definitively establish the absence of risk, published data over decades of use have not established an association with RIFADIN during pregnancy and major birth defects or miscarriage. Rifampin has been shown to be teratogenic in rodents. Congenital malformations, primarily spina bifida, were increased in the offspring of pregnant rats given rifampin during organogenesis at oral doses of 150 to 250 mg/kg/day (about 1 to 2 times the maximum recommended human dose based on body surface area comparisons). Cleft palate was increased in a dose-dependent fashion in fetuses of pregnant mice treated at oral doses of 50 to 200 mg/kg (about 0.2 to 0.8 times the maximum recommended human dose based on body surface area comparisons). Imperfect osteogenesis and embryotoxicity were also reported in pregnant rabbits given rifampin at oral doses up to 200 mg/kg/day (about 3 times the maximum recommended human dose based on body surface area comparisons). The clinical relevance of the nonclinical data is uncertain. Despite the animal findings, it would appear that the possibility of fetal harm is remote, if the drug is used during pregnancy.

Overdosage

Sourced from openFDA

Signs and Symptoms Nausea, vomiting, abdominal pain, pruritus, headache, and increasing lethargy will probably occur within a short time after ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces will occur, and its intensity is proportional to the amount ingested. Liver enlargement, possibly with tenderness, can develop within a few hours after severe overdosage; bilirubin levels may increase and jaundice may develop rapidly. Hepatic involvement may be more marked in patients with prior impairment of hepatic function. Other physical findings remain essentially normal. A direct effect upon the hematopoietic system, electrolyte levels, or acid-base balance is unlikely. Facial or periorbital edema has also been reported in pediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures, and cardiac arrest were reported in some fatal cases. Acute Toxicity The minimum acute lethal or toxic dose is not well established.

Approval history

Sourced from openFDA
  • May 25, 1989NDANDA050627Sanofi Aventis Us
  • May 28, 1997ANDAANDA064150Epic Pharma Llc
  • Mar 28, 2008ANDAANDA065390Chartwell Molecular
  • May 22, 2008ANDAANDA065421Mylan Labs Ltd
  • Aug 21, 2013ANDAANDA090034Lupin Pharms
  • Aug 21, 2014ANDAANDA091181Fresenius Kabi Usa
  • Mar 3, 2016ANDAANDA205039Hikma Pharms

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Rifadin, Injection, 600 mg/10 mL (NDC 0068-0597-01)Active
    Sponsor: Sanofi-Aventis U.S. LLC · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Rifadin, Injection, 600 mg/10 mL (NDC 0068-0597-01)To be discontinued
    Sponsor: Sanofi-Aventis U.S. LLC
    Updated
  • Rifampin, Capsule, 150 mg (NDC 42806-801-01)Active
    Sponsor: Epic Pharma, LLC · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Rifampin, Capsule, 150 mg (NDC 42806-801-30)Active
    Sponsor: Epic Pharma, LLC
    Updated
  • Rifampin, Capsule, 150 mg (NDC 68180-658-06)Active
    Sponsor: Lupin Pharmaceuticals, Inc. · Reason: Shortage of an active ingredient
    Updated
  • Rifampin, Capsule, 300 mg (NDC 42806-799-01)Active
    Sponsor: Epic Pharma, LLC · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Rifampin, Capsule, 300 mg (NDC 42806-799-05)Active
    Sponsor: Epic Pharma, LLC · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Rifampin, Capsule, 300 mg (NDC 42806-799-30)Active
    Sponsor: Epic Pharma, LLC · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Rifampin, Capsule, 300 mg (NDC 42806-799-60)Active
    Sponsor: Epic Pharma, LLC
    Updated
  • Rifampin, Capsule, 300 mg (NDC 68180-659-06)Active
    Sponsor: Lupin Pharmaceuticals, Inc. · Reason: Shortage of an active ingredient
    Updated
  • Rifampin, Capsule, 300 mg (NDC 68180-659-07)Active
    Sponsor: Lupin Pharmaceuticals, Inc. · Reason: Shortage of an active ingredient
    Updated
  • Rifampin, Injection, 600 mg (NDC 63323-351-20)Active
    Sponsor: Fresenius Kabi USA, LLC · Reason: Delay in shipping of the drug
    Updated
  • Rifampin, Injection, 600 mg/10 mL (NDC 67457-445-60)Active
    Sponsor: Mylan Institutional, a Viatris Company
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
14,030 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1,53811%
  2. 2Off Label Use1,1568.2%
  3. 3Drug Interaction1,0427.4%
  4. 4Drug Reaction With Eosinophilia And Systemic Symptoms7335.2%
  5. 5Nausea6484.6%
  6. 6Condition Aggravated5894.2%
  7. 7Product Use In Unapproved Indication5874.2%
  8. 8Pyrexia5594.0%
  9. 9Vomiting4623.3%
  10. 10Drug Resistance4533.2%
  11. 11Drug Intolerance4173.0%
  12. 12Acute Kidney Injury4122.9%
  13. 13Dyspnoea4012.9%
  14. 14Rash3922.8%
  15. 15Diarrhoea3892.8%

Literature

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Recent PubMed references pinned to Rifampin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 700 ClinicalTrials.gov registrations naming Rifampin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Rifampin work?
Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible Mycobacterium tuberculosis organisms. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.
What is Rifampin used for?
According to FDA labeling, Rifampin carries indications including: In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Rifampin?
Rifampin is classified as Antibiotics, Rifamycin Antibacterial, Nucleic Acid Synthesis Inhibitors, Protease Inhibitors, Decreased RNA Replication, Decreased Transcription to RNA.
What are the brand names for Rifampin?
Rifampin is marketed under brand names including Rifadin.
What are the contraindications for Rifampin?
Rifampin labeling lists contraindications including: RIFADIN is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (See WARNINGS .) Rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity.. Always consult the full prescribing information and a clinician.
Note. Data for rifampin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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