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AMLODIPINE BESYLATE

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Amlodipine Besylate Adverse Events Reported to the FDA Over Time

How are Amlodipine Besylate adverse event reports trending over time?

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

Most Common Amlodipine Besylate Adverse Events Reported to the FDA

What are the most common Amlodipine Besylate adverse events reported to the FDA?

Oedema Peripheral
899 (2.02%)
Dizziness
766 (1.72%)
Blood Pressure Increased
640 (1.44%)
Drug Ineffective
616 (1.39%)
Hypertension
570 (1.28%)
Headache
522 (1.17%)
Death
519 (1.17%)
Hypotension
501 (1.13%)
Fatigue
431 (.97%)
Malaise
398 (.9%)
Blood Pressure Inadequately Control...
394 (.89%)
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Dyspnoea
388 (.87%)
Nausea
362 (.81%)
Drug Interaction
319 (.72%)
Asthenia
284 (.64%)
Fall
278 (.63%)
Loss Of Consciousness
276 (.62%)
Pain In Extremity
271 (.61%)
Joint Swelling
260 (.58%)
Feeling Abnormal
259 (.58%)
Blood Pressure Decreased
258 (.58%)
Cerebrovascular Accident
253 (.57%)
Rash
251 (.56%)
Chest Pain
234 (.53%)
Renal Failure Acute
228 (.51%)
Vomiting
224 (.5%)
Insomnia
218 (.49%)
Overdose
217 (.49%)
Completed Suicide
214 (.48%)
Syncope
214 (.48%)
Palpitations
213 (.48%)
Suicide Attempt
212 (.48%)
Cough
210 (.47%)
Pruritus
210 (.47%)
Pyrexia
199 (.45%)
Myocardial Infarction
198 (.45%)
Renal Failure
197 (.44%)
Pain
194 (.44%)
Diarrhoea
190 (.43%)
Muscle Spasms
188 (.42%)
Somnolence
187 (.42%)
Weight Decreased
185 (.42%)
Arthralgia
180 (.4%)
Oedema
180 (.4%)
Condition Aggravated
175 (.39%)
Bradycardia
170 (.38%)
Weight Increased
160 (.36%)
Myalgia
159 (.36%)
Hypersensitivity
158 (.36%)
Swelling
152 (.34%)
Gait Disturbance
146 (.33%)
Pneumonia
146 (.33%)
Back Pain
143 (.32%)
Dry Mouth
143 (.32%)
Constipation
141 (.32%)
Heart Rate Increased
141 (.32%)
Blood Cholesterol Increased
140 (.31%)
Intentional Overdose
140 (.31%)
Blood Creatine Phosphokinase Increa...
139 (.31%)
Cardiac Arrest
138 (.31%)
Tremor
137 (.31%)
Vision Blurred
133 (.3%)
Rhabdomyolysis
130 (.29%)
Blood Creatinine Increased
129 (.29%)
Depression
129 (.29%)
Diabetes Mellitus
128 (.29%)
Blood Glucose Increased
127 (.29%)
Hyponatraemia
125 (.28%)
Alanine Aminotransferase Increased
121 (.27%)
Dehydration
120 (.27%)
Renal Impairment
120 (.27%)
Drug Hypersensitivity
119 (.27%)
Interstitial Lung Disease
119 (.27%)
Anaemia
118 (.27%)
Aspartate Aminotransferase Increase...
118 (.27%)
Erythema
117 (.26%)
Abdominal Pain
116 (.26%)
Decreased Appetite
114 (.26%)
Muscular Weakness
114 (.26%)
Depressed Level Of Consciousness
113 (.25%)
Hepatic Function Abnormal
113 (.25%)
Hypokalaemia
113 (.25%)
Cardiac Disorder
109 (.25%)
Alopecia
108 (.24%)
Anxiety
108 (.24%)
Abdominal Pain Upper
107 (.24%)
Convulsion
106 (.24%)
Atrial Fibrillation
105 (.24%)
Confusional State
105 (.24%)
Pulmonary Oedema
105 (.24%)
Hyperkalaemia
102 (.23%)
Platelet Count Decreased
102 (.23%)
Paraesthesia
100 (.22%)
Abdominal Distension
99 (.22%)
Cardiac Failure
99 (.22%)
Chest Discomfort
98 (.22%)
Blood Pressure Systolic Increased
97 (.22%)
Haemoglobin Decreased
97 (.22%)
Urticaria
97 (.22%)
Blood Pressure Fluctuation
96 (.22%)
Hypoaesthesia
96 (.22%)

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

What are the most common Amlodipine Besylate adverse events reported to the FDA?

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

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

Hypertension
15256
Drug Use For Unknown Indication
1921
Product Used For Unknown Indication
1769
Blood Pressure
958
Ill-defined Disorder
485
Essential Hypertension
288
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Cardiac Disorder
284
Blood Pressure Increased
276
Blood Pressure Abnormal
255
Angina Pectoris
135
Coronary Artery Disease
62
Chest Pain
61
Myocardial Ischaemia
52
Prophylaxis
46
Raynauds Phenomenon
30
Blood Pressure Management
28
Suicide Attempt
25
Pulmonary Hypertension
23
Cerebrovascular Accident
22
Renal Hypertension
22
Cardiac Failure
21
Cardiovascular Disorder
20
Myocardial Infarction
19
Atrial Fibrillation
18
Pneumonia
17
Migraine
15
Rheumatoid Arthritis
14
Lung Disorder
14
Hypertensive Heart Disease
13
Blood Cholesterol Increased
11
Cardiac Failure Congestive
11
Hyperlipidaemia
11
Blood Cholesterol
10
Diabetes Mellitus
10
Hypertonia
9
Pain
9
Depression
8
Renal Disorder
8
Hypercholesterolaemia
8
Blood Pressure Inadequately Control...
8
Musculoskeletal Pain
8
Cardiovascular Event Prophylaxis
7
Transient Ischaemic Attack
7
Palpitations
7
Oesophageal Spasm
7
Arthritis
7
Intentional Overdose
7
Atrioventricular Block
7
Hypertriglyceridaemia
6
Arrhythmia
6
Ischaemic Cardiomyopathy
6

Drug Labels

LabelLabelerEffective
Amlodipine BesylateDr Reddy's Laboratories31-JUL-07
Amlodipine BesylateGlenmark Generics Inc., USA18-JUN-09
Amlodipine BesylateSTAT RX USA LLC12-MAR-10
AmlobenzBryant Ranch Prepack19-APR-10
Amlodipine BesylateUnit Dose Services01-MAY-10
Amlodipine Besylate And Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.09-MAY-10
Amlodipine Besylate And Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.09-MAY-10
Amlodipine Besylate And Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.09-MAY-10
Amlodipine Besylate And Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.09-MAY-10
Amlodipine BesylateBryant Ranch Prepack10-MAY-10
Amlodipine BesylateBryant Ranch Prepack10-MAY-10
Amlodipine BesylateBryant Ranch Prepack10-MAY-10
Amlodipine BesylateState of Florida DOH Central Pharmacy21-MAY-10
Amlodipine BesylateState of Florida DOH Central Pharmacy12-AUG-10
Amlodipine Besylate Lake Erie Medical DBA Quality Care Products LLC04-NOV-10
NorvascRebel Distributors Corp28-DEC-10
AmlobenzRebel Distributors Corp04-JAN-11
Amlodipine Besylate And Benazepril HydrochloridePhysicians Total Care, Inc.10-JAN-11
Amlodipine BesylateWOCKHARDT USA LLC.11-JAN-11
Amlodipine BesylateWOCKHARDT LIMITED11-JAN-11
Amlodipine BesylateMylan Pharmaceuticals Inc.17-JAN-11
Amlodipine BesylateLake Erie Medical DBA Quality Care Products LLC04-FEB-11
Amlodipine BesylateREMEDYREPACK INC. 08-APR-11
Amlodipine Besylate And Benazepril HclAmerican Health Packaging21-APR-11
Amlodipine BesylateWest-ward Pharmaceutical Corp27-APR-11
Amlodipine BesylateContract Pharmacy Services-PA02-MAY-11
Amlodipine BesylateCardinal Health05-MAY-11
Amlodipine BesylatePD-Rx Pharmaceuticals, Inc.12-MAY-11
Amlodipine BesylatePD-Rx Pharmaceuticals, Inc.12-MAY-11
Amlodipine Besylate AvPAK18-MAY-11
Amlodipine Besylate PD-Rx Pharmaceuticals, Inc.27-MAY-11
Amlodipine Besylate PD-Rx Pharmaceuticals, Inc.27-MAY-11
Amlodipine BesylatePreferred Pharmaceuticals, Inc15-JUN-11
Amlodipine BesylateGolden State Medical Supply, Inc.01-JUL-11
Amlodipine BesylateMedVantx, Inc.11-JUL-11
Amlodipine BesylateHikma Pharmaceutical19-JUL-11
AmlobenzRebel Distributors Corp20-JUL-11
Amlodipine BesylateRedPharm Drug Inc.03-AUG-11
Amlodipine BesylateRedPharm Drug Inc.03-AUG-11
Amlodipine BesylateREMEDYREPACK INC. 22-AUG-11
Amlodipine BesylateREMEDYREPACK INC. 22-AUG-11
Amlodipine Besylate St Marys Medical Park Pharmacy07-SEP-11
Amlodipine BesylateMcKesson Contract Packaging14-SEP-11
Amlodipine BesylateREMEDYREPACK INC. 14-SEP-11
Amlodipine BesylateREMEDYREPACK INC. 14-SEP-11
Amlodipine BesylateCardinal Health30-SEP-11
LotrelPD-Rx Pharmaceuticals, Inc.10-OCT-11
LotrelPD-Rx Pharmaceuticals, Inc.10-OCT-11
Amlodipine BesylateExelan Pharmaceuticals, Inc.11-OCT-11
NorvascPD-Rx Pharmaceuticals, Inc.17-OCT-11
Amlodipine BesylateCardinal Health26-OCT-11
Amlodipine BesylateEpic Pharma, LLC31-OCT-11
Amlodipine BesylateQualitest Pharmaceuticals01-NOV-11
Amlodipine BesylateNCS HealthCare of KY, Inc dba Vangard Labs09-NOV-11
Amlodipine BesylateAmerican Health Packaging11-NOV-11
NorvascLake Erie Medical & Surgical Supplies DBA Quality Care Products LLC23-NOV-11
Amlodipine Besylate And Benazepril HydrochlorideRebel Distributors Corp20-DEC-11
Amlodipine BesylateZydus Pharmaceuticals (USA) Inc.21-DEC-11
Amlodipine BesylateCadila Healthcare Limited05-JAN-12
Amlodipine BesylateAmneal Pharmaceuticals06-JAN-12
Amlodipine Besylate And Benazepril HydrochlorideSandoz Inc10-JAN-12
Amlodipine BesylateAurobindo Pharma Limited19-JAN-12
Amlodipine BesylateCardinal Health26-JAN-12
Amlodipine BesylateTorrent Pharmaceuticals Limited30-JAN-12
Amlodipine Besylate And Benazepril HydrochlorideWatson Laboratories, Inc.01-FEB-12
Amlodipine Besylate And Benazepril HydrochlorideWatson Laboratories, Inc.01-FEB-12
Amlodipine BesylateRoxane Laboratories, Inc01-MAR-12
LotrelPhysicians Total Care, Inc.02-MAR-12
NorvascCardinal Health29-MAR-12
Amlodipine Besylate And Benazepril HydrochloridePhysicians Total Care, Inc.10-APR-12
Amlodipine Besylate And Benazepril HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs09-MAY-12
Amlodipine BesylateLake Erie Medical & Surgical Supply DBA Quality Care Products LLC21-MAY-12
Amlodipine BesylateUpsher-Smith Laboratories, Inc.25-MAY-12
Amlodipine Besylate And Atorvastatin CalciumPhysicians Total Care, Inc.27-JUN-12
Amlodipine BesylateMajor Pharmaceuticals16-JUL-12
Amlodipine BesylateMajor Pharmaceuticals23-JUL-12
Amlodipine Besylate Unit Dose Services06-AUG-12
Amlodipine Besylate Unit Dose Services06-AUG-12
Amlodipine BesylateCamber Pharmaceuticals06-AUG-12
Amlodipine BesylateSecan Pharmaceuticals Inc23-AUG-12
Amlodipine Besylate/atorvastatin CalciumMylan Pharmaceuticals Inc.01-OCT-12
Amlodipine Besylate And Atorvastatin CalciumRanbaxy Pharmaceuticals Inc01-OCT-12
Amlodipine BesylateMylan Institutional Inc.05-OCT-12
Amlodipine BesylateInternational Labs, Inc.15-OCT-12
Amlodipine BesylatePreferred Pharmaceuticals, Inc15-OCT-12
Amlodipine Besylate Physicians Total Care, Inc.19-OCT-12
LotrelNovartis Pharmaceuticals Corporation31-OCT-12
Amlodipine BesylateLupin Pharmaceuticals, Inc.01-NOV-12
Amlodipine Besylate And Benazepril HydrochlorideAurobindo Pharma Limited08-NOV-12
Amlodipine BesylateCaraco Pharmaceutical Laboratories, Ltd.08-NOV-12
Amlodipine BesylateLake Erie Medical DBA Quality Care Products LLC09-NOV-12
Amlodipine Besylate And Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.13-NOV-12
Amlodipine Besylate And Benazepril HydrochlorideDr.Reddy's Laboratories Limited16-NOV-12
CaduetPfizer Laboratories Div Pfizer Inc16-NOV-12
Amlodipine Besylate And Benazepril HydrochlorideDr.Reddy's Laboratories Limited16-NOV-12
Amlodipine Besylate And Benazepril Hydrochloride Par Pharmaceutical Inc.28-NOV-12
Amlodipine Besylate And Benazepril HydrochlorideMylan Pharmaceuticals Inc.30-NOV-12
Amlodipine Besylate And Benazepril HydrochlorideTeva Pharmaceuticals USA Inc21-DEC-12
Amlodipine BesylateQualitest Pharmaceuticals01-JAN-13
Amlodipine Besylate And Benazepril HydrochlorideLupin Pharmaceuticals, Inc.09-JAN-13
Amlodipine Besylate And Benazepril Hydrochloride Bryant Ranch Prepack18-JAN-13
NorvascPfizer Laboratories Div Pfizer Inc22-JAN-13
Amlodipine BesylateInternational Labs, Inc.23-JAN-13
Amlodipine BesylateGreenstone LLC31-JAN-13
Amlodipine BesylateApotex Corp.01-FEB-13
Amlodipine BesylateLake Erie Medical DBA Quality Care Products LLC06-FEB-13
Amlodipine BesylateAscend Laboratories, LLC07-FEB-13
Amlodipine Macleods Pharmaceuticals Limited07-FEB-13
Amlodipine BesylateTeva Pharmaceuticals USA Inc22-FEB-13
Amlodipine BesylateREMEDYREPACK INC. 27-FEB-13
NorvascREMEDYREPACK INC. 04-MAR-13
Amlodipine BesylateREMEDYREPACK INC. 06-MAR-13
Amlodipine BesylateREMEDYREPACK INC. 06-MAR-13
Amlodipine BesylateLegacy Pharmaceutical Packaging11-MAR-13
Amlodipine BesylateTorrent Pharmaceuticals Limited29-MAR-13
Amlodipine BesylateCardinal Health05-APR-13
Amlodipine BesylateREMEDYREPACK INC. 10-APR-13
Amlodipine BesylateSt Marys Medical Park Pharmacy25-APR-13
Amlodipine BesylateTeva Pharmaceuticals USA Inc06-MAY-13

Amlodipine Besylate Case Reports

What Amlodipine Besylate 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 Amlodipine Besylate. 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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