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CIPRALEX

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Cipralex Adverse Events Reported to the FDA Over Time

How are Cipralex adverse event reports trending over time?

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

Most Common Cipralex Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
80 (2.08%)
Completed Suicide
70 (1.82%)
Dizziness
63 (1.64%)
Drug Interaction
62 (1.62%)
Anxiety
49 (1.28%)
Depression
49 (1.28%)
Hyponatraemia
46 (1.2%)
Nausea
45 (1.17%)
Convulsion
44 (1.15%)
Loss Of Consciousness
40 (1.04%)
Somnolence
40 (1.04%)
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Pregnancy
39 (1.02%)
Intentional Overdose
35 (.91%)
Suicide Attempt
35 (.91%)
Drug Withdrawal Syndrome
33 (.86%)
Vomiting
32 (.83%)
Confusional State
31 (.81%)
Grand Mal Convulsion
31 (.81%)
Overdose
31 (.81%)
Condition Aggravated
30 (.78%)
Tremor
29 (.76%)
Agitation
27 (.7%)
Fall
26 (.68%)
Caesarean Section
25 (.65%)
Fatigue
25 (.65%)
Insomnia
25 (.65%)
Restlessness
25 (.65%)
Diarrhoea
24 (.63%)
Rhabdomyolysis
23 (.6%)
Suicidal Ideation
23 (.6%)
Abortion Spontaneous
22 (.57%)
Hyperhidrosis
22 (.57%)
Hypotension
21 (.55%)
Pneumonia
19 (.5%)
Tachycardia
19 (.5%)
Asthenia
18 (.47%)
Epilepsy
18 (.47%)
Headache
18 (.47%)
Intra-uterine Death
18 (.47%)
Serotonin Syndrome
18 (.47%)
Dyspnoea
17 (.44%)
Multiple Drug Overdose Intentional
17 (.44%)
Paraesthesia
17 (.44%)
Syncope
17 (.44%)
Abdominal Pain
16 (.42%)
Dyskinesia
16 (.42%)
Hypertension
16 (.42%)
Sleep Disorder
16 (.42%)
Hospitalisation
14 (.36%)
International Normalised Ratio Incr...
14 (.36%)
Aspartate Aminotransferase Increase...
13 (.34%)
Electrocardiogram Qt Prolonged
13 (.34%)
Neuroleptic Malignant Syndrome
13 (.34%)
Palpitations
13 (.34%)
Renal Failure
13 (.34%)
Treatment Noncompliance
13 (.34%)
Balance Disorder
12 (.31%)
Blood Lactate Dehydrogenase Increas...
12 (.31%)
Blood Potassium Decreased
12 (.31%)
Bradycardia
12 (.31%)
Cerebral Haemorrhage
12 (.31%)
Cerebrovascular Accident
12 (.31%)
Depressed Level Of Consciousness
12 (.31%)
Depressive Symptom
12 (.31%)
Muscle Twitching
12 (.31%)
Pyrexia
12 (.31%)
Abdominal Pain Upper
11 (.29%)
Amnesia
11 (.29%)
Burning Sensation
11 (.29%)
Delirium
11 (.29%)
Disorientation
11 (.29%)
Drug Abuser
11 (.29%)
Drug Ineffective
11 (.29%)
Extrapyramidal Disorder
11 (.29%)
Galactorrhoea
11 (.29%)
General Physical Health Deteriorati...
11 (.29%)
Hyperkalaemia
11 (.29%)
Leukopenia
11 (.29%)
Myocardial Infarction
11 (.29%)
Psychotic Disorder
11 (.29%)
Circulatory Collapse
10 (.26%)
Contusion
10 (.26%)
Hallucination
10 (.26%)
Malaise
10 (.26%)
Myoclonus
10 (.26%)
Nervousness
10 (.26%)
Panic Attack
10 (.26%)
Parkinsonism
10 (.26%)
Postpartum Depression
10 (.26%)
Pruritus
10 (.26%)
Sopor
10 (.26%)
Urticaria
10 (.26%)
Vertigo
10 (.26%)
Aggression
9 (.23%)
Blood Prolactin Increased
9 (.23%)
Blood Sodium Decreased
9 (.23%)
Cerebral Infarction
9 (.23%)
Drug Dependence
9 (.23%)
Dysarthria
9 (.23%)
Memory Impairment
9 (.23%)
Pre-eclampsia
9 (.23%)

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

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

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

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

Depression
660
Drug Use For Unknown Indication
94
Anxiety
89
Product Used For Unknown Indication
42
Major Depression
27
Anxiety Disorder
18
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Bipolar Disorder
14
Panic Attack
13
Generalised Anxiety Disorder
11
Panic Disorder
10
Schizophrenia
10
Affective Disorder
10
Psychotic Disorder
8
Schizoaffective Disorder
7
Post-traumatic Stress Disorder
6
Depressed Mood
6
Drug Exposure During Pregnancy
6
Bipolar I Disorder
6
Antidepressant Therapy
6
Adjustment Disorder
5
Neurosis
5
Postpartum Depression
5
Ill-defined Disorder
5
Intentional Overdose
5
Mental Disorder
5
Social Phobia
4
Phobia
4
Depressive Symptom
4
Overdose
4
Prophylaxis
3
Fear
3
Restlessness
3
Suicidal Ideation
3
Palpitations
2
Personality Disorder
2
Migraine Prophylaxis
2
Anxiolytic Therapy
2
Cyclothymic Disorder
2
Apathy
2
Suicide Attempt
2
Alcoholism
2
Somatisation Disorder
1
Fibromyalgia
1
Stress
1
Conduct Disorder
1
Stress Symptoms
1
Agitation
1
Sedation
1
Blunted Affect
1
Cognitive Disorder
1
Nervousness
1

Cipralex Case Reports

What Cipralex 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 Cipralex. 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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