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RIFABUTIN

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Rifabutin Adverse Events Reported to the FDA Over Time

How are Rifabutin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Rifabutin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Rifabutin is flagged as the suspect drug causing the adverse event.

Most Common Rifabutin Adverse Events Reported to the FDA

What are the most common Rifabutin adverse events reported to the FDA?

Pyrexia
37 (2.98%)
Uveitis
37 (2.98%)
Diarrhoea
22 (1.77%)
Neutropenia
22 (1.77%)
Decreased Appetite
21 (1.69%)
Thrombocytopenia
21 (1.69%)
Pneumonia
16 (1.29%)
Pancytopenia
15 (1.21%)
White Blood Cell Count Decreased
15 (1.21%)
Drug Interaction
14 (1.13%)
Platelet Count Decreased
14 (1.13%)
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Asthenia
13 (1.05%)
Hepatic Function Abnormal
13 (1.05%)
Immune Reconstitution Syndrome
13 (1.05%)
Nausea
13 (1.05%)
Leukopenia
11 (.89%)
Loss Of Consciousness
11 (.89%)
Confusional State
10 (.81%)
Death
10 (.81%)
Liver Disorder
10 (.81%)
Anaemia
9 (.72%)
Condition Aggravated
9 (.72%)
Drug Eruption
9 (.72%)
General Physical Health Deteriorati...
9 (.72%)
Malaise
9 (.72%)
Myocardial Infarction
9 (.72%)
Weight Decreased
9 (.72%)
Convulsion
8 (.64%)
Myalgia
8 (.64%)
Rash
8 (.64%)
Cardiac Arrest
7 (.56%)
Cardiac Failure Acute
7 (.56%)
Cholestasis
7 (.56%)
Cough
7 (.56%)
Hyperkalaemia
7 (.56%)
Mycobacterium Avium Complex Infecti...
7 (.56%)
Rash Papular
7 (.56%)
Rectal Haemorrhage
7 (.56%)
Renal Tubular Necrosis
7 (.56%)
Tuberculosis
7 (.56%)
Arthralgia
6 (.48%)
Atypical Mycobacterial Infection
6 (.48%)
Blood Alkaline Phosphatase Increase...
6 (.48%)
Cardiogenic Shock
6 (.48%)
Drug Ineffective
6 (.48%)
Eosinophilia
6 (.48%)
Hepatitis
6 (.48%)
Hyponatraemia
6 (.48%)
Intestinal Obstruction
6 (.48%)
Lymphadenopathy
6 (.48%)
Mycobacterial Infection
6 (.48%)
Renal Impairment
6 (.48%)
Atrial Septal Defect
5 (.4%)
Atypical Mycobacterial Lymphadeniti...
5 (.4%)
Chills
5 (.4%)
Coma
5 (.4%)
Cytomegalovirus Chorioretinitis
5 (.4%)
Erythema
5 (.4%)
Eye Pain
5 (.4%)
Haematuria
5 (.4%)
Hyperhidrosis
5 (.4%)
Hypoaesthesia
5 (.4%)
Hypospadias
5 (.4%)
Hypoxia
5 (.4%)
International Normalised Ratio Incr...
5 (.4%)
Kidney Malformation
5 (.4%)
Malnutrition
5 (.4%)
Melaena
5 (.4%)
Microtia
5 (.4%)
Neutrophil Count Decreased
5 (.4%)
Oesophageal Atresia
5 (.4%)
Polydactyly
5 (.4%)
Rash Maculo-papular
5 (.4%)
Renal Failure Acute
5 (.4%)
Respiratory Failure
5 (.4%)
Toxic Skin Eruption
5 (.4%)
Ventricular Septal Defect
5 (.4%)
Visual Field Defect
5 (.4%)
White Blood Cell Disorder
5 (.4%)
Bone Marrow Failure
4 (.32%)
Dehydration
4 (.32%)
Dyspnoea
4 (.32%)
Gamma-glutamyltransferase Increased
4 (.32%)
Gastritis
4 (.32%)
Gastroenteritis
4 (.32%)
Hepatomegaly
4 (.32%)
Hepatotoxicity
4 (.32%)
Hypokalaemia
4 (.32%)
Insomnia
4 (.32%)
Interstitial Lung Disease
4 (.32%)
Lung Infection
4 (.32%)
Meningitis Bacterial
4 (.32%)
Multi-organ Failure
4 (.32%)
Oedema Peripheral
4 (.32%)
Pruritus
4 (.32%)
Renal Failure
4 (.32%)
Rhabdomyolysis
4 (.32%)
Stomatitis
4 (.32%)
Tremor
4 (.32%)
Vision Blurred
4 (.32%)
Visual Acuity Reduced
4 (.32%)

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This graph shows the top adverse events submitted to the FDA for Rifabutin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rifabutin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Rifabutin

What are the most common Rifabutin adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Rifabutin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rifabutin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Rifabutin According to Those Reporting Adverse Events

Why are people taking Rifabutin, according to those reporting adverse events to the FDA?

Mycobacterium Avium Complex Infecti...
166
Tuberculosis
51
Product Used For Unknown Indication
38
Pulmonary Tuberculosis
22
Atypical Mycobacterial Infection
20
Drug Use For Unknown Indication
20
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Mycobacterial Infection
20
Antibiotic Prophylaxis
14
Disseminated Tuberculosis
12
Atypical Mycobacterial Lymphadeniti...
9
Mycobacteria Test
7
Pneumonia Bacterial
5
Infection
4
Bronchopulmonary Aspergillosis
4
Helicobacter Infection
4
Ill-defined Disorder
4
Antibiotic Therapy
3
Hiv Infection
3
Bursitis
3
Lymph Node Tuberculosis
3
Prophylaxis
3
Maternal Exposure During Pregnancy
2
Antibacterial Prophylaxis
2
Helicobacter Gastritis
2
Perineal Abscess
2
Histiocytosis Haematophagic
2
Lymphadenitis
1
Osteomyelitis
1
Lung Infection
1
Bone Tuberculosis
1
Intervertebral Discitis
1
Mycoplasma Infection
1
Pulmonary Sarcoidosis
1
Lung Disorder
1
Mycobacterium Kansasii Pneumonia
1
Bronchiectasis
1
Respiratory Tract Infection
1
Mycobacterium Abscessus Infection
1
Evidence Based Treatment
1
Pneumonia
1
Bovine Tuberculosis
1
Maternal Exposure Timing Unspecifie...
1
Cytomegalovirus Chorioretinitis
1
Latent Tuberculosis
1
Atypical Mycobacterium Pericarditis
1
Infection Prophylaxis
1
Meningitis Tuberculous
1

Drug Labels

LabelLabelerEffective
MycobutinPhysicians Total Care, Inc.04-JUN-10
MycobutinPharmacia and Upjohn Company14-MAR-11

Rifabutin Case Reports

What Rifabutin safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Rifabutin. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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