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RIBASPHERE

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Ribasphere Adverse Events Reported to the FDA Over Time

How are Ribasphere adverse event reports trending over time?

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

Most Common Ribasphere Adverse Events Reported to the FDA

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

Fatigue
461 (3.35%)
Nausea
341 (2.48%)
Anaemia
325 (2.36%)
White Blood Cell Count Decreased
323 (2.35%)
Weight Decreased
319 (2.32%)
Depression
277 (2.01%)
Asthenia
251 (1.83%)
Dizziness
225 (1.64%)
Vomiting
224 (1.63%)
Dyspnoea
208 (1.51%)
Insomnia
181 (1.32%)
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Platelet Count Decreased
171 (1.24%)
Headache
167 (1.21%)
Dehydration
164 (1.19%)
Alopecia
158 (1.15%)
Diarrhoea
158 (1.15%)
Pain
141 (1.03%)
Pyrexia
125 (.91%)
Decreased Appetite
117 (.85%)
Anxiety
116 (.84%)
Haemoglobin Decreased
111 (.81%)
Rash
111 (.81%)
Loss Of Consciousness
107 (.78%)
Condition Aggravated
104 (.76%)
Red Blood Cell Count Decreased
103 (.75%)
Arthralgia
102 (.74%)
Cough
100 (.73%)
Chest Pain
97 (.71%)
Anorexia
92 (.67%)
Back Pain
87 (.63%)
Influenza Like Illness
84 (.61%)
Suicidal Ideation
82 (.6%)
Fall
80 (.58%)
Tremor
77 (.56%)
Pneumonia
76 (.55%)
Vision Blurred
76 (.55%)
Pruritus
74 (.54%)
Malaise
71 (.52%)
Chills
68 (.49%)
Irritability
66 (.48%)
Myalgia
66 (.48%)
Feeling Abnormal
65 (.47%)
Abdominal Pain
64 (.47%)
Anger
61 (.44%)
Abdominal Pain Upper
59 (.43%)
Constipation
59 (.43%)
Memory Impairment
59 (.43%)
Blood Glucose Increased
58 (.42%)
Disturbance In Attention
58 (.42%)
Dry Skin
58 (.42%)
Confusional State
54 (.39%)
Hyperhidrosis
53 (.39%)
Hypertension
53 (.39%)
Muscle Spasms
52 (.38%)
Blood Potassium Decreased
51 (.37%)
Neutropenia
51 (.37%)
Dysgeusia
46 (.33%)
Epistaxis
46 (.33%)
Injection Site Erythema
46 (.33%)
Dry Mouth
45 (.33%)
Crying
44 (.32%)
Hypoaesthesia
39 (.28%)
Pain In Extremity
38 (.28%)
Sinusitis
38 (.28%)
Convulsion
37 (.27%)
Drug Exposure During Pregnancy
37 (.27%)
Somnolence
37 (.27%)
Hypotension
35 (.25%)
Pallor
35 (.25%)
Bronchitis
34 (.25%)
Drug Ineffective
34 (.25%)
Balance Disorder
33 (.24%)
Chest Discomfort
33 (.24%)
Mood Swings
33 (.24%)
Hypothyroidism
32 (.23%)
Oropharyngeal Pain
32 (.23%)
Palpitations
32 (.23%)
Amnesia
30 (.22%)
Drug Dose Omission
30 (.22%)
Haematocrit Decreased
30 (.22%)
Migraine
30 (.22%)
Contusion
29 (.21%)
Rash Pruritic
29 (.21%)
Treatment Noncompliance
29 (.21%)
Dyspnoea Exertional
28 (.2%)
Haemolytic Anaemia
28 (.2%)
Hypersomnia
28 (.2%)
Muscular Weakness
28 (.2%)
Nasopharyngitis
28 (.2%)
Pancytopenia
28 (.2%)
Abdominal Distension
27 (.2%)
Disorientation
27 (.2%)
Dysphagia
27 (.2%)
Head Injury
27 (.2%)
Oedema Peripheral
27 (.2%)
Thirst
26 (.19%)
Dysuria
25 (.18%)
Ear Infection
25 (.18%)
Blood Pressure Increased
24 (.17%)
Burning Sensation
24 (.17%)
Haemorrhage
24 (.17%)

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

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

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

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

Hepatitis C
1677
Product Used For Unknown Indication
93
Drug Use For Unknown Indication
52
Hepatitis
21
Hepatitis C Virus
21
Hepatitis C Virus Test
11
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Hepatitis B
5
Hepatitis A
1
Hepatic Cirrhosis
1
Chronic Hepatitis
1

Drug Labels

LabelLabelerEffective
Ribasphere RibapakPAR Pharmaceutical Companies, Inc.07-JAN-10
RibasphereREMEDYREPACK INC. 18-AUG-11
Ribasphere REMEDYREPACK INC. 30-NOV-11
RibasphereKadmon Pharmaceuticals, LLC27-DEC-12
Ribasphere RibapakKadmon Pharmaceuticals, LLC04-JAN-13
RibasphereKadmon Pharmaceuticals, LLC04-JAN-13

Ribasphere Case Reports

What Ribasphere 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 Ribasphere. 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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