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SERESTA

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Seresta Adverse Events Reported to the FDA Over Time

How are Seresta adverse event reports trending over time?

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

Most Common Seresta Adverse Events Reported to the FDA

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

Fall
34 (2.38%)
Somnolence
34 (2.38%)
Drug Exposure During Pregnancy
33 (2.31%)
Coma
19 (1.33%)
Confusional State
18 (1.26%)
Hypotension
17 (1.19%)
Pyrexia
16 (1.12%)
Eosinophilia
14 (.98%)
Abnormal Behaviour
13 (.91%)
Cytolytic Hepatitis
13 (.91%)
Dehydration
13 (.91%)
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Hyponatraemia
12 (.84%)
Intra-uterine Death
12 (.84%)
Thrombocytopenia
12 (.84%)
Agitation
10 (.7%)
Condition Aggravated
10 (.7%)
Drug Withdrawal Syndrome Neonatal
10 (.7%)
General Physical Health Deteriorati...
10 (.7%)
Malaise
10 (.7%)
Renal Failure
10 (.7%)
Renal Failure Acute
10 (.7%)
Suicide Attempt
10 (.7%)
Altered State Of Consciousness
9 (.63%)
Asthenia
9 (.63%)
Bradycardia
9 (.63%)
Drug Interaction
9 (.63%)
Dyspnoea
9 (.63%)
Gamma-glutamyltransferase Increased
9 (.63%)
Intentional Overdose
9 (.63%)
Overdose
9 (.63%)
Premature Baby
9 (.63%)
Rash Maculo-papular
9 (.63%)
Tremor
9 (.63%)
Alanine Aminotransferase Increased
8 (.56%)
Blood Creatinine Increased
8 (.56%)
Convulsion
8 (.56%)
Hyperkalaemia
8 (.56%)
Hypotonia
8 (.56%)
Interstitial Lung Disease
8 (.56%)
Loss Of Consciousness
8 (.56%)
Pulmonary Embolism
8 (.56%)
Skin Exfoliation
8 (.56%)
Disorientation
7 (.49%)
Erythema
7 (.49%)
Hellp Syndrome
7 (.49%)
Hypoglycaemia
7 (.49%)
Hypoxia
7 (.49%)
Jaundice
7 (.49%)
Lactic Acidosis
7 (.49%)
Myalgia
7 (.49%)
Pruritus
7 (.49%)
Sleep Disorder
7 (.49%)
Toxic Skin Eruption
7 (.49%)
Blood Pressure Increased
6 (.42%)
Caesarean Section
6 (.42%)
Cardiac Failure
6 (.42%)
Drug Rash With Eosinophilia And Sys...
6 (.42%)
Drug Toxicity
6 (.42%)
Extrapyramidal Disorder
6 (.42%)
Fatigue
6 (.42%)
Foetal Growth Retardation
6 (.42%)
Multiple Drug Overdose Intentional
6 (.42%)
Rhabdomyolysis
6 (.42%)
Vomiting
6 (.42%)
Aggression
5 (.35%)
Anaemia
5 (.35%)
Aspartate Aminotransferase Increase...
5 (.35%)
Cardiac Arrest
5 (.35%)
Cardio-respiratory Arrest
5 (.35%)
Cerebral Atrophy
5 (.35%)
Chest Pain
5 (.35%)
Diarrhoea
5 (.35%)
Disseminated Intravascular Coagulat...
5 (.35%)
Disturbance In Attention
5 (.35%)
Drug Ineffective
5 (.35%)
Dyskinesia
5 (.35%)
Hepatic Enzyme Increased
5 (.35%)
Hypertonia
5 (.35%)
Hypotonia Neonatal
5 (.35%)
Incorrect Route Of Drug Administrat...
5 (.35%)
Insomnia
5 (.35%)
International Normalised Ratio Incr...
5 (.35%)
Lung Disorder
5 (.35%)
Lymphadenopathy
5 (.35%)
Miosis
5 (.35%)
Multi-organ Failure
5 (.35%)
Neutropenia
5 (.35%)
Pleural Effusion
5 (.35%)
Transaminases Increased
5 (.35%)
Withdrawal Syndrome
5 (.35%)
Apparent Death
4 (.28%)
Blood Creatine Phosphokinase Increa...
4 (.28%)
Bradypnoea
4 (.28%)
Cholestasis
4 (.28%)
Creatinine Renal Clearance Decrease...
4 (.28%)
Death
4 (.28%)
Depression
4 (.28%)
Dizziness
4 (.28%)
Drug Withdrawal Syndrome
4 (.28%)
Dysphagia
4 (.28%)
Ecchymosis
4 (.28%)

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

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

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

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

Drug Use For Unknown Indication
118
Anxiety
70
Depression
40
Product Used For Unknown Indication
35
Insomnia
16
Personality Disorder
13
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Sleep Disorder
9
Agitation
9
Psychotic Disorder
9
Bipolar I Disorder
7
Aggression
6
Drug Exposure During Pregnancy
6
Anxiety Disorder
6
Schizophrenia
5
Bipolar Disorder
5
Ill-defined Disorder
4
Unevaluable Event
3
Major Depression
3
Parkinsons Disease
3
Neuralgia
2
Brief Psychotic Disorder, With Post...
2
Pruritus
2
Dysthymic Disorder
2
Suicide Attempt
2
Dependence
2
Abnormal Behaviour
1
Mental Disorder
1
Restlessness
1
Alcohol Withdrawal Syndrome
1
Acute Stress Disorder
1
Accidental Exposure
1
Avoidant Personality Disorder
1
Alcohol Detoxification
1
Obsessive-compulsive Disorder
1
Schizophrenia, Paranoid Type
1
Drug Administration Error
1
Anorexia
1
Multiple Drug Overdose Intentional
1
Alcohol Poisoning
1
Delirium Tremens
1
Affective Disorder
1
Childhood Psychosis
1
Alcohol Use
1
Psychomotor Agitation
1

Seresta Case Reports

What Seresta 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 Seresta. 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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