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RIFATER

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Rifater Adverse Events Reported to the FDA Over Time

How are Rifater adverse event reports trending over time?

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

Most Common Rifater Adverse Events Reported to the FDA

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

Immune Reconstitution Syndrome
32 (3.41%)
Pyrexia
31 (3.3%)
Cytolytic Hepatitis
24 (2.56%)
Drug Rash With Eosinophilia And Sys...
19 (2.02%)
Eosinophilia
17 (1.81%)
Impaired Gastric Emptying
17 (1.81%)
Renal Failure
17 (1.81%)
Lymphadenopathy
16 (1.7%)
Renal Failure Acute
14 (1.49%)
Alanine Aminotransferase Increased
13 (1.38%)
Hepatic Failure
13 (1.38%)
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Liver Function Test Abnormal
13 (1.38%)
Nausea
12 (1.28%)
Neuropathy Peripheral
12 (1.28%)
Proteinuria
12 (1.28%)
Cholestasis
11 (1.17%)
Aspartate Aminotransferase Increase...
10 (1.06%)
Rash
10 (1.06%)
Vomiting
10 (1.06%)
Anaemia
9 (.96%)
Colour Blindness
9 (.96%)
Oedema Peripheral
9 (.96%)
Agranulocytosis
8 (.85%)
Blood Alkaline Phosphatase Increase...
8 (.85%)
General Physical Health Deteriorati...
8 (.85%)
Hepatitis
8 (.85%)
Hyperbilirubinaemia
8 (.85%)
Hypomagnesaemia
8 (.85%)
Asthenia
7 (.75%)
Drug Ineffective
7 (.75%)
Liver Disorder
7 (.75%)
Thrombocytopenia
7 (.75%)
Transaminases Increased
7 (.75%)
Tuberculosis
7 (.75%)
Abdominal Pain
6 (.64%)
Acidosis
6 (.64%)
Convulsion
6 (.64%)
Death
6 (.64%)
Drug Exposure During Pregnancy
6 (.64%)
Dyspnoea
6 (.64%)
Lipase Increased
6 (.64%)
Multi-organ Failure
6 (.64%)
Neutropenia
6 (.64%)
Pancreatitis
6 (.64%)
Pancytopenia
6 (.64%)
Stevens-johnson Syndrome
6 (.64%)
Toxic Skin Eruption
6 (.64%)
Blood Bilirubin Increased
5 (.53%)
Confusional State
5 (.53%)
Epilepsy
5 (.53%)
Hypertension
5 (.53%)
Hypoalbuminaemia
5 (.53%)
Jaundice
5 (.53%)
Malaise
5 (.53%)
Pruritus
5 (.53%)
Weight Decreased
5 (.53%)
Abortion Spontaneous
4 (.43%)
Blood Creatine Phosphokinase Increa...
4 (.43%)
Erythema
4 (.43%)
Extrapyramidal Disorder
4 (.43%)
Haemorrhage
4 (.43%)
Headache
4 (.43%)
Hepatitis Fulminant
4 (.43%)
Hepatomegaly
4 (.43%)
Rash Maculo-papular
4 (.43%)
Systemic Inflammatory Response Synd...
4 (.43%)
Activities Of Daily Living Impaired
3 (.32%)
Anorexia
3 (.32%)
Anuria
3 (.32%)
Arthritis Fungal
3 (.32%)
Blood Amylase Increased
3 (.32%)
Bone Marrow Failure
3 (.32%)
Coma Hepatic
3 (.32%)
Condition Aggravated
3 (.32%)
Decreased Appetite
3 (.32%)
Delirium
3 (.32%)
Disease Progression
3 (.32%)
Drug Interaction
3 (.32%)
Encephalitis
3 (.32%)
Haematoma
3 (.32%)
Hepatic Enzyme Increased
3 (.32%)
Hepatocellular Injury
3 (.32%)
Hyperthermia
3 (.32%)
Hyperuricaemia
3 (.32%)
Hypoglycaemia
3 (.32%)
Inflammation
3 (.32%)
Mixed Liver Injury
3 (.32%)
Petechiae
3 (.32%)
Pleural Neoplasm
3 (.32%)
Psychotic Disorder
3 (.32%)
Tongue Haemorrhage
3 (.32%)
Vasculitis
3 (.32%)
Acute Hepatic Failure
2 (.21%)
Acute Respiratory Distress Syndrome
2 (.21%)
Anaemia Haemolytic Autoimmune
2 (.21%)
Aplasia
2 (.21%)
Bacterial Infection
2 (.21%)
Bicytopenia
2 (.21%)
Blister
2 (.21%)
C-reactive Protein Increased
2 (.21%)
Caesarean Section
2 (.21%)

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This graph shows the top adverse events submitted to the FDA for Rifater, 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 Rifater 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 Rifater

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

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This graph shows the top categories of adverse events submitted to the FDA for Rifater, 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 Rifater 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 Rifater According to Those Reporting Adverse Events

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

Tuberculosis
143
Pulmonary Tuberculosis
57
Lymph Node Tuberculosis
13
Drug Use For Unknown Indication
13
Product Used For Unknown Indication
6
Bone Tuberculosis
6
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Hiv Infection
5
Hodgkins Disease
5
Tuberculous Pleurisy
4
Arterial Injury
3
Mycobacterial Infection
3
Prophylaxis
2
Cervical Gland Tuberculosis
2
Disseminated Tuberculosis
2
Non-hodgkins Lymphoma
1
Prostatitis
1
Renal Tuberculosis
1
Dermatitis
1
Meningitis Tuberculous
1
Lymphogranuloma Venereum
1
Mycobacteria Urine Test Positive
1
Meningitis
1
Mycobacterium Kansasii Pneumonia
1
Ill-defined Disorder
1
Dermo-hypodermitis
1
Mycobacterium Avium Complex Infecti...
1

Drug Labels

LabelLabelerEffective
Rifater REMEDYREPACK INC. 15-SEP-10
Rifatersanofi-aventis U.S. LLC07-OCT-11
Rifatersanofi-aventis U.S. LLC19-APR-13

Rifater Case Reports

What Rifater 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 Rifater. 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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