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NICARDIPINE

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Nicardipine Adverse Events Reported to the FDA Over Time

How are Nicardipine adverse event reports trending over time?

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

Most Common Nicardipine Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
102 (2.96%)
Acute Pulmonary Oedema
75 (2.17%)
Hypotension
49 (1.42%)
Caesarean Section
47 (1.36%)
Drug Interaction
46 (1.33%)
Fall
44 (1.28%)
Cardiac Arrest
36 (1.04%)
Drug Rash With Eosinophilia And Sys...
35 (1.01%)
Pyrexia
35 (1.01%)
Premature Baby
30 (.87%)
Dyspnoea
29 (.84%)
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Hypoxia
29 (.84%)
Malaise
28 (.81%)
Pulmonary Oedema
28 (.81%)
Phlebitis
27 (.78%)
Hypertension
26 (.75%)
Renal Failure
26 (.75%)
Bradycardia
25 (.72%)
Coma
25 (.72%)
Respiratory Distress
25 (.72%)
Condition Aggravated
24 (.7%)
Tachycardia
24 (.7%)
Blood Pressure Decreased
22 (.64%)
Depressed Level Of Consciousness
21 (.61%)
Orthostatic Hypotension
21 (.61%)
Pleural Effusion
21 (.61%)
Thrombocytopenia
21 (.61%)
Pruritus
19 (.55%)
Renal Failure Acute
19 (.55%)
Toxic Epidermal Necrolysis
19 (.55%)
Anaemia
18 (.52%)
C-reactive Protein Increased
18 (.52%)
Haemoglobin Decreased
18 (.52%)
Hyponatraemia
18 (.52%)
Oedema Peripheral
18 (.52%)
Blood Creatinine Increased
16 (.46%)
Cerebral Infarction
16 (.46%)
Cough
16 (.46%)
Oxygen Saturation Decreased
16 (.46%)
Post Procedural Complication
16 (.46%)
Erythema
15 (.43%)
Heart Rate Increased
15 (.43%)
Septic Shock
15 (.43%)
Agranulocytosis
14 (.41%)
Cerebral Haematoma
14 (.41%)
Vomiting
14 (.41%)
White Blood Cell Count Increased
14 (.41%)
Confusional State
13 (.38%)
Drug Ineffective
13 (.38%)
Drug Level Increased
13 (.38%)
Leukopenia
13 (.38%)
Purpura
13 (.38%)
Rales
13 (.38%)
Rash Maculo-papular
13 (.38%)
Angioedema
12 (.35%)
Blood Lactate Dehydrogenase Increas...
12 (.35%)
Cholestasis
12 (.35%)
Loss Of Consciousness
12 (.35%)
Multi-organ Failure
12 (.35%)
Rhabdomyolysis
12 (.35%)
Cerebral Haemorrhage
11 (.32%)
Foetal Distress Syndrome
11 (.32%)
Interstitial Lung Disease
11 (.32%)
Neonatal Respiratory Distress Syndr...
11 (.32%)
Renal Impairment
11 (.32%)
Shock
11 (.32%)
Cardiac Failure
10 (.29%)
Cholestasis Of Pregnancy
10 (.29%)
Disorientation
10 (.29%)
Medication Error
10 (.29%)
Oedema
10 (.29%)
Patent Ductus Arteriosus
10 (.29%)
Apgar Score Low
9 (.26%)
Arrhythmia
9 (.26%)
Atrial Fibrillation
9 (.26%)
Cardio-respiratory Arrest
9 (.26%)
Dizziness
9 (.26%)
Eczema
9 (.26%)
Eosinophilia
9 (.26%)
Erythema Multiforme
9 (.26%)
Hepatitis Cholestatic
9 (.26%)
Infection
9 (.26%)
Intestinal Ischaemia
9 (.26%)
Transplant Rejection
9 (.26%)
Troponin Increased
9 (.26%)
Abdominal Pain
8 (.23%)
Acute Respiratory Distress Syndrome
8 (.23%)
Alanine Aminotransferase Increased
8 (.23%)
Aortic Dissection
8 (.23%)
Aspartate Aminotransferase Increase...
8 (.23%)
Blood Potassium Decreased
8 (.23%)
Blood Pressure Increased
8 (.23%)
Chills
8 (.23%)
Cholelithiasis
8 (.23%)
Circulatory Collapse
8 (.23%)
Death
8 (.23%)
Ejection Fraction Decreased
8 (.23%)
Electromechanical Dissociation
8 (.23%)
Haematemesis
8 (.23%)
Headache
8 (.23%)
International Normalised Ratio Incr...
8 (.23%)

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

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

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

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

Hypertension
515
Drug Use For Unknown Indication
210
Product Used For Unknown Indication
70
Tocolysis
50
Essential Hypertension
26
Pre-eclampsia
25
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Premature Labour
23
Blood Pressure Increased
21
Ill-defined Disorder
14
Blood Pressure Management
13
Threatened Labour
13
Tachycardia
13
Cerebrovascular Spasm
12
Prophylaxis
9
Vasospasm
8
Aortic Dissection
7
Procedural Hypertension
6
Blood Pressure
6
Myocardial Ischaemia
6
Pregnancy Induced Hypertension
5
Subarachnoid Haemorrhage
4
Angina Pectoris
4
Poisoning
4
Cerebral Haemorrhage
4
Uterine Contractions During Pregnan...
4
Blood Pressure Abnormal
3
Cardiac Failure
3
Cardiovascular Disorder
3
Vasodilatation
2
Cardiomyopathy
2
Drug Exposure During Pregnancy
2
Chest Pain
2
Hypertensive Emergency
2
Acute Myeloid Leukaemia
2
Secondary Hypertension
2
Off Label Use
2
Malignant Hypertension
2
Ischaemic Cardiomyopathy
2
Arrhythmia
2
Palpitations
2
Cervix Disorder
2
Myocardial Infarction
2
Cardiac Failure Acute
2
Oedema
1
Coronary No-reflow Phenomenon
1
Aortic Aneurysm Syphilitic
1
Cardiovascular Event Prophylaxis
1
Complication Of Pregnancy
1
Hypotension
1
Rheumatoid Arthritis
1
Overdose
1

Drug Labels

LabelLabelerEffective
Nicardipine HydrochlorideMylan Pharmaceuticals Inc.07-NOV-06
Nicardipine Hydrochloride GeneraMedix Inc.13-NOV-09
Nicardipine HydrochloridePharmaForce, Inc.17-NOV-09
Nicardipine HydrochlorideSun Pharma Global Inc.19-NOV-09
Nicardipine HydrochlorideEmcure Pharmaceuticals Ltd.04-DEC-09
Nicardipine Hydrochloride AvKARE, Inc.25-OCT-10
Cardene I.v.EKR Therapeutics, Inc.27-OCT-10
Cardene I.v.EKR Therapeutics, Inc.27-OCT-10
Cardene SrEKR Therapeutics09-NOV-10
Cardene I.v.EKR Therapeutics22-NOV-10
Nicardipine HydrochlorideSandoz Inc. 17-MAY-11
Nicardipine HydrochlorideSandoz Inc. 13-JUL-11
Nicardipine HydrochlorideMylan Institutional LLC19-JUL-11
Nicardipine HydrochlorideWest-ward Pharmaceutical Corp13-FEB-12
Nicardipine HydrochlorideEpic Pharma, LLC08-AUG-12
Nicardipine HydrochlorideWockhardt USA LLC.11-OCT-12
Nicardipine HydrochlorideWockhardt Limited11-OCT-12

Nicardipine Case Reports

What Nicardipine 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 Nicardipine. 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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