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FELODIPINE

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Felodipine Adverse Events Reported to the FDA Over Time

How are Felodipine adverse event reports trending over time?

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

Most Common Felodipine Adverse Events Reported to the FDA

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

Dizziness
53 (2.15%)
Headache
52 (2.11%)
Dyspnoea
51 (2.07%)
Hypotension
50 (2.03%)
Oedema Peripheral
48 (1.94%)
Syncope
38 (1.54%)
Arthralgia
35 (1.42%)
Asthenia
31 (1.26%)
Fall
31 (1.26%)
Myalgia
30 (1.22%)
Drug Interaction
29 (1.18%)
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Hypertension
29 (1.18%)
Renal Failure Acute
28 (1.13%)
Bradycardia
23 (.93%)
Orthostatic Hypotension
23 (.93%)
Swollen Tongue
23 (.93%)
Drug Ineffective
22 (.89%)
Hyperkalaemia
22 (.89%)
Pruritus
22 (.89%)
Overdose
21 (.85%)
Blood Pressure Increased
20 (.81%)
Erythema
20 (.81%)
Fatigue
20 (.81%)
Vomiting
20 (.81%)
Musculoskeletal Pain
19 (.77%)
Back Pain
18 (.73%)
Nausea
18 (.73%)
Oedema
18 (.73%)
Palpitations
18 (.73%)
Drug Prescribing Error
17 (.69%)
Dyskinesia
17 (.69%)
Feeling Abnormal
17 (.69%)
Malaise
16 (.65%)
Swelling
16 (.65%)
Swelling Face
16 (.65%)
Weight Decreased
16 (.65%)
Angioedema
15 (.61%)
Drug Dispensing Error
15 (.61%)
Sinus Bradycardia
15 (.61%)
Anxiety
14 (.57%)
Leukocytoclastic Vasculitis
14 (.57%)
Paraesthesia
14 (.57%)
Salivary Hypersecretion
14 (.57%)
Temperature Intolerance
14 (.57%)
Cerebrovascular Accident
13 (.53%)
Eczema
13 (.53%)
Hyponatraemia
13 (.53%)
Pain In Extremity
13 (.53%)
Asthma
12 (.49%)
Cough
12 (.49%)
Gait Disturbance
12 (.49%)
Pain
12 (.49%)
Scratch
12 (.49%)
Skin Disorder
12 (.49%)
Skin Warm
12 (.49%)
Tachycardia
12 (.49%)
Tremor
12 (.49%)
Alanine Aminotransferase Increased
11 (.45%)
Aspartate Aminotransferase Increase...
11 (.45%)
Chest Pain
11 (.45%)
Wrong Drug Administered
11 (.45%)
Hyperhidrosis
10 (.41%)
Joint Swelling
10 (.41%)
Rash
10 (.41%)
Renal Failure
10 (.41%)
Constipation
9 (.36%)
International Normalised Ratio Decr...
9 (.36%)
Respiratory Arrest
9 (.36%)
Anxiety Disorder
8 (.32%)
Bile Duct Stone
8 (.32%)
Blood Alkaline Phosphatase Increase...
8 (.32%)
Blood Lactate Dehydrogenase Increas...
8 (.32%)
Completed Suicide
8 (.32%)
Condition Aggravated
8 (.32%)
Dehydration
8 (.32%)
Diarrhoea
8 (.32%)
Eye Pain
8 (.32%)
Liver Disorder
8 (.32%)
Muscular Weakness
8 (.32%)
Abasia
7 (.28%)
Anaemia
7 (.28%)
Angina Pectoris
7 (.28%)
Balance Disorder
7 (.28%)
Blood Creatinine Increased
7 (.28%)
Decreased Appetite
7 (.28%)
Drooling
7 (.28%)
Flushing
7 (.28%)
Muscle Spasms
7 (.28%)
Nodal Rhythm
7 (.28%)
Oedema Mouth
7 (.28%)
Pleural Effusion
7 (.28%)
Abdominal Pain
6 (.24%)
Blood Pressure Decreased
6 (.24%)
Blood Pressure Inadequately Control...
6 (.24%)
Breast Cancer
6 (.24%)
Cardiac Arrest
6 (.24%)
Chest Discomfort
6 (.24%)
Coma
6 (.24%)
Convulsion
6 (.24%)
Drug Exposure During Pregnancy
6 (.24%)
Face Oedema
6 (.24%)

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

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

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

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

Hypertension
915
Drug Use For Unknown Indication
265
Product Used For Unknown Indication
237
Blood Pressure
86
Essential Hypertension
39
Blood Pressure Increased
26
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Ill-defined Disorder
24
Blood Pressure Abnormal
14
Coronary Artery Disease
13
Cardiac Disorder
12
Atrial Fibrillation
8
Myocardial Ischaemia
8
Blood Cholesterol Increased
5
Angina Pectoris
4
Hypertonia
4
Rheumatoid Arthritis
3
Prophylaxis
3
Transient Ischaemic Attack
3
Myocardial Infarction
2
Ischaemic Heart Disease Prophylaxis
2
Arrhythmia
2
Blood Pressure Systolic Increased
2
Hormone Replacement Therapy
2
Renal Impairment
2
Extremity Necrosis
2
Ocular Hypertension
2
Hypotension
2
Renal Failure Chronic
1
Suicide Attempt
1
Hyperlipidaemia
1
Mitral Valve Incompetence
1
Hypersensitivity
1
Headache
1
Prostate Cancer
1
Peripheral Arterial Occlusive Disea...
1
Cardiac Failure Congestive
1
Raynauds Phenomenon
1
Pulmonary Hypertension
1
Cardiovascular Event Prophylaxis
1
Pain
1
Drug Therapy
1
Dyspepsia
1
Hypertensive Heart Disease
1
Systolic Hypertension
1
Carotid Artery Occlusion
1

Drug Labels

LabelLabelerEffective
FelodipinePD-Rx Pharmaceuticals, Inc.17-JUL-09
FelodipinePhysicians Total Care, Inc.17-JUL-09
FelodipinePD-Rx Pharmaceuticals, Inc.17-JUL-09
FelodipineUDL Laboratories, Inc.26-FEB-10
FelodipineWOCKHARDT LIMITED22-NOV-10
FelodipineWOCKHARDT USA LLC22-NOV-10
FelodipineREMEDYREPACK INC. 20-APR-11
FelodipineTorrent Pharmaceuticals Limited02-DEC-11
FelodipineGlenmark Generics, Inc. USA01-JUL-12
FelodipineNCS HealthCare of KY, Inc dba Vangard Labs31-OCT-12
PlendilAstraZeneca LP31-OCT-12
FelodipineMutual Pharmaceutical Company, Inc.12-NOV-12
FelodipineRichmond Pharmaceuticals, Inc.13-NOV-12
FelodipineAurobindo Pharma Limited05-JAN-13
FelodipineQualitest Pharmaceuticals11-JAN-13
PlendilBryant Ranch Prepack17-JAN-13
FelodipineBryant Ranch Prepack18-JAN-13
FelodipineMylan Pharmaceuticals Inc.28-FEB-13

Felodipine Case Reports

What Felodipine 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 Felodipine. 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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