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Sebivo Adverse Events Reported to the FDA Over Time

How are Sebivo adverse event reports trending over time?

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

Most Common Sebivo Adverse Events Reported to the FDA

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

Blood Creatine Phosphokinase Increa...
185 (4.29%)
Myalgia
127 (2.95%)
Fatigue
92 (2.13%)
Myoglobin Blood Increased
90 (2.09%)
Muscular Weakness
87 (2.02%)
Blood Lactate Dehydrogenase Increas...
80 (1.86%)
Pain In Extremity
72 (1.67%)
Rhabdomyolysis
71 (1.65%)
Nausea
70 (1.62%)
Blood Lactic Acid Increased
68 (1.58%)
Vomiting
66 (1.53%)
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Aspartate Aminotransferase Increase...
65 (1.51%)
Blood Creatine Phosphokinase Mb Inc...
64 (1.48%)
Lactic Acidosis
64 (1.48%)
Asthenia
59 (1.37%)
Dyspnoea
56 (1.3%)
Gait Disturbance
56 (1.3%)
Death
55 (1.28%)
Oedema Peripheral
52 (1.21%)
Drug Exposure During Pregnancy
49 (1.14%)
Alanine Aminotransferase Increased
45 (1.04%)
Hypoaesthesia
44 (1.02%)
Myopathy
37 (.86%)
Neuropathy Peripheral
36 (.83%)
Palpitations
36 (.83%)
Hepatitis B
35 (.81%)
Renal Impairment
35 (.81%)
Metabolic Acidosis
33 (.77%)
Pain
33 (.77%)
Gastritis
32 (.74%)
Blood Uric Acid Increased
31 (.72%)
Heart Rate Increased
31 (.72%)
Chest Discomfort
30 (.7%)
Blood Pressure Decreased
29 (.67%)
Blood Urea Increased
29 (.67%)
Caesarean Section
29 (.67%)
Multi-organ Failure
29 (.67%)
Muscle Atrophy
29 (.67%)
Hepatitis B Dna Increased
27 (.63%)
Normal Newborn
27 (.63%)
Decreased Appetite
25 (.58%)
Renal Failure Acute
24 (.56%)
Weight Decreased
23 (.53%)
Abdominal Discomfort
22 (.51%)
Blood Bilirubin Increased
22 (.51%)
Myositis
21 (.49%)
Oliguria
21 (.49%)
Electrolyte Imbalance
20 (.46%)
Lung Infection
20 (.46%)
Anuria
19 (.44%)
Abdominal Pain Upper
18 (.42%)
Blood Creatinine Increased
18 (.42%)
Chromaturia
18 (.42%)
Malaise
18 (.42%)
Musculoskeletal Stiffness
18 (.42%)
Abdominal Pain
17 (.39%)
Blood Gases Abnormal
17 (.39%)
Haemodialysis
17 (.39%)
Hepatic Cirrhosis
17 (.39%)
Shock
17 (.39%)
Coma
16 (.37%)
Jaundice
16 (.37%)
Loss Of Consciousness
16 (.37%)
Muscle Injury
16 (.37%)
Ascites
15 (.35%)
Muscle Swelling
15 (.35%)
Tachypnoea
15 (.35%)
Acid Base Balance Abnormal
14 (.32%)
Arthralgia
14 (.32%)
Blood Ph Decreased
14 (.32%)
Hypophagia
14 (.32%)
Pleural Effusion
14 (.32%)
Respiratory Rate Increased
14 (.32%)
Sinus Tachycardia
14 (.32%)
Somnolence
14 (.32%)
White Blood Cell Count Increased
14 (.32%)
Hypotension
13 (.3%)
Cough
12 (.28%)
Dysstasia
12 (.28%)
Fall
12 (.28%)
Muscle Disorder
12 (.28%)
Viral Load Increased
12 (.28%)
Arrhythmia
11 (.26%)
Feeling Abnormal
11 (.26%)
Hepatic Neoplasm Malignant
11 (.26%)
Polyneuropathy
11 (.26%)
Pyrexia
11 (.26%)
Acidosis
10 (.23%)
Circulatory Collapse
10 (.23%)
Mechanical Ventilation
10 (.23%)
Urine Ketone Body Present
10 (.23%)
Abasia
9 (.21%)
Anorexia
9 (.21%)
Back Pain
9 (.21%)
Bilirubin Conjugated Increased
9 (.21%)
Blood Urine Present
9 (.21%)
Hypokalaemia
9 (.21%)
Joint Swelling
9 (.21%)
Nerve Injury
9 (.21%)
Paraesthesia
9 (.21%)
Rales
9 (.21%)

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

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

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

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

Hepatitis B
346
Hepatitis
12
Hepatic Cirrhosis
9
Hepatitis B Surface Antigen
7
Hepatitis B Surface Antigen Positiv...
3
Chronic Hepatitis
3
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Hepatitis C
2
Hepatitis B E Antigen Positive
2
Parvovirus Infection
2
Hepatic Neoplasm Malignant
2
Viral Hepatitis Carrier
2
Hepatitis B Positive
2
Hepatitis B Core Antigen Positive
2
Hiv Infection
1
Viral Load Increased
1
Product Used For Unknown Indication
1
Drug Use For Unknown Indication
1
Antiviral Treatment
1

Sebivo Case Reports

What Sebivo 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 Sebivo. 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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