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RIBAVIRIN

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Ribavirin Adverse Events Reported to the FDA Over Time

How are Ribavirin adverse event reports trending over time?

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

Most Common Ribavirin Adverse Events Reported to the FDA

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

Anaemia
1746 (2.44%)
Fatigue
1596 (2.23%)
Nausea
1336 (1.86%)
Weight Decreased
1183 (1.65%)
White Blood Cell Count Decreased
1115 (1.56%)
Vomiting
1042 (1.45%)
Depression
996 (1.39%)
Asthenia
953 (1.33%)
Dehydration
945 (1.32%)
Dyspnoea
906 (1.26%)
Pyrexia
802 (1.12%)
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Insomnia
774 (1.08%)
Diarrhoea
752 (1.05%)
Dizziness
744 (1.04%)
Headache
735 (1.03%)
Platelet Count Decreased
686 (.96%)
Haemoglobin Decreased
666 (.93%)
Pain
578 (.81%)
Decreased Appetite
486 (.68%)
Red Blood Cell Count Decreased
464 (.65%)
Pneumonia
446 (.62%)
Loss Of Consciousness
443 (.62%)
Anxiety
437 (.61%)
Rash
434 (.61%)
Influenza Like Illness
413 (.58%)
Malaise
409 (.57%)
Alopecia
406 (.57%)
Fall
400 (.56%)
Chest Pain
389 (.54%)
Arthralgia
372 (.52%)
Confusional State
355 (.5%)
Dysgeusia
340 (.47%)
Pruritus
340 (.47%)
Neutropenia
337 (.47%)
Syncope
325 (.45%)
Thrombocytopenia
322 (.45%)
Back Pain
309 (.43%)
Condition Aggravated
296 (.41%)
Anorexia
294 (.41%)
Chills
294 (.41%)
Feeling Abnormal
291 (.41%)
Convulsion
284 (.4%)
Memory Impairment
283 (.4%)
Cough
265 (.37%)
Suicidal Ideation
263 (.37%)
Abdominal Pain Upper
262 (.37%)
Abdominal Pain
250 (.35%)
Myalgia
238 (.33%)
Pancytopenia
237 (.33%)
Vision Blurred
236 (.33%)
Oedema Peripheral
230 (.32%)
Death
226 (.32%)
Ascites
223 (.31%)
Drug Ineffective
220 (.31%)
Irritability
217 (.3%)
Hyperhidrosis
214 (.3%)
Dry Skin
211 (.29%)
Hepatic Cirrhosis
209 (.29%)
Muscle Spasms
207 (.29%)
Amnesia
205 (.29%)
Pain In Extremity
202 (.28%)
Renal Failure
201 (.28%)
Hypotension
200 (.28%)
Blood Glucose Increased
199 (.28%)
Epistaxis
199 (.28%)
Dry Mouth
194 (.27%)
Hepatitis C
193 (.27%)
Blood Potassium Decreased
192 (.27%)
Alanine Aminotransferase Increased
187 (.26%)
Hypertension
187 (.26%)
Leukopenia
184 (.26%)
Neutrophil Count Decreased
183 (.26%)
Aspartate Aminotransferase Increase...
181 (.25%)
Sepsis
181 (.25%)
Renal Failure Acute
173 (.24%)
Abdominal Distension
165 (.23%)
Anger
165 (.23%)
Tremor
163 (.23%)
Gait Disturbance
162 (.23%)
Hypothyroidism
158 (.22%)
Constipation
157 (.22%)
Injection Site Erythema
152 (.21%)
Migraine
151 (.21%)
Cholelithiasis
148 (.21%)
Hypoaesthesia
147 (.21%)
Haematemesis
144 (.2%)
Haematocrit Decreased
142 (.2%)
Contusion
141 (.2%)
Deep Vein Thrombosis
137 (.19%)
Blood Pressure Increased
135 (.19%)
Hepatic Failure
135 (.19%)
Somnolence
134 (.19%)
Rash Pruritic
133 (.19%)
Pulmonary Embolism
130 (.18%)
Staphylococcal Infection
130 (.18%)
Hypokalaemia
129 (.18%)
Thrombosis
128 (.18%)
Urinary Tract Infection
125 (.17%)
Hepatic Neoplasm Malignant
122 (.17%)
Crying
121 (.17%)
Weight Increased
119 (.17%)

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

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

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

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

Hepatitis C
12817
Product Used For Unknown Indication
511
Drug Use For Unknown Indication
425
Hepatitis C Virus
134
Hepatitis
70
Hepatitis C Virus Test
58
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Hepatic Cirrhosis
51
Chronic Hepatitis
36
Hepatitis B
28
Severe Acute Respiratory Syndrome
20
Drug Exposure During Pregnancy
12
Hiv Infection
12
Antiviral Treatment
12
Liver Disorder
11
Hepatitis Chronic Active
9
Antiviral Prophylaxis
8
Respiratory Syncytial Virus Infecti...
8
Hepatitis Viral
7
Maternal Exposure During Pregnancy
6
Anaemia Of Chronic Disease
6
Infection
5
Adenovirus Infection
5
Thrombocytopenia
4
Meningitis
4
Antiretroviral Therapy
4
Hepatitis C Virus Test Positive
4
Pregnancy
3
Cryoglobulinaemia
3
Ill-defined Disorder
3
Vasculitis
3
Anti-infective Therapy
3
Influenza
2
Pancytopenia
2
Disease Recurrence
2
Hepatitis B Virus
2
Leukocytoclastic Vasculitis
2
Hepatitis Infectious
2
Glomerulonephritis
2
Arthritis
2
H1n1 Influenza
2
Coma Hepatic
2
Rabies
2
Hepatitis Cholestatic
2
Liver Transplant
2
Coma
2
Pneumonia Parainfluenzae Viral
2
Human Immunodeficiency Virus Transm...
2
Off Label Use
2
Avian Influenza
2
Viral Load
1
Choriomeningitis Lymphocytic
1

Drug Labels

LabelLabelerEffective
RibavirinState of Florida DOH Central Pharmacy08-JUN-10
RibavirinState of Florida DOH Central Pharmacy29-JUL-10
RibavirinZydus Pharmaceuticals (USA) Inc.25-MAR-11
RibavirinAmerican Health Packaging31-MAR-11
RibavirinCadila Healthcare Limited01-APR-11
RibavirinCadila Healthcare Limited01-APR-11
RibavirinAurobindo Pharma Limited05-APR-11
RibavirinZydus Pharmaceuticals (USA) Inc.11-APR-11
RibavirinSandoz Inc13-APR-11
RibavirinSandoz Inc07-OCT-11
Ribavirin Aurobindo Pharma Limited06-DEC-11
RibavirinAmerican Health Packaging20-JAN-12
VirazoleValeant Pharmaceuticals North America LLC04-JUN-12
RibavirinTEVA Pharmaceuticals USA Inc23-JUL-12
RibavirinRichmond Pharmaceuticals, Inc.20-AUG-12
RibavirinRichmond Pharmaceuticals, Inc.20-AUG-12
RibasphereKadmon Pharmaceuticals, LLC27-DEC-12
Ribasphere RibapakKadmon Pharmaceuticals, LLC04-JAN-13
RibasphereKadmon Pharmaceuticals, LLC04-JAN-13
RebetolMerck Sharp & Dohme Corp.06-FEB-13
CopegusGenentech, Inc.19-FEB-13
RibavirinTeva Pharmaceuticals USA Inc03-APR-13

Ribavirin Case Reports

What Ribavirin 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 Ribavirin. 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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