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Nifedipine Adverse Events Reported to the FDA Over Time

How are Nifedipine adverse event reports trending over time?

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

Most Common Nifedipine Adverse Events Reported to the FDA

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

Hypotension
237 (2.33%)
Drug Exposure During Pregnancy
175 (1.72%)
Dizziness
166 (1.63%)
Drug Ineffective
165 (1.62%)
Blood Pressure Increased
152 (1.49%)
Drug Interaction
130 (1.28%)
Headache
121 (1.19%)
Completed Suicide
117 (1.15%)
Oedema Peripheral
116 (1.14%)
Dyspnoea
111 (1.09%)
Hypertension
111 (1.09%)
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Cardiac Arrest
107 (1.05%)
Malaise
107 (1.05%)
Bradycardia
89 (.87%)
Palpitations
87 (.85%)
Overdose
86 (.84%)
Nausea
84 (.83%)
Asthenia
76 (.75%)
Shock
72 (.71%)
Chest Pain
68 (.67%)
Caesarean Section
65 (.64%)
Premature Baby
64 (.63%)
Blood Pressure Decreased
62 (.61%)
Hypoxia
61 (.6%)
Vomiting
61 (.6%)
Condition Aggravated
60 (.59%)
Renal Failure Acute
59 (.58%)
Blood Pressure Inadequately Control...
58 (.57%)
Heart Rate Increased
58 (.57%)
Fatigue
57 (.56%)
Pulmonary Oedema
57 (.56%)
Multi-organ Failure
56 (.55%)
Metabolic Acidosis
51 (.5%)
Renal Failure
51 (.5%)
Loss Of Consciousness
50 (.49%)
Confusional State
46 (.45%)
Drug Toxicity
45 (.44%)
Drug Effect Decreased
42 (.41%)
Intra-uterine Death
42 (.41%)
Tachycardia
42 (.41%)
Depressed Level Of Consciousness
41 (.4%)
Medication Residue
39 (.38%)
Abdominal Pain
38 (.37%)
Suicide Attempt
38 (.37%)
Flushing
36 (.35%)
Feeling Abnormal
35 (.34%)
Rash
35 (.34%)
Back Pain
34 (.33%)
Multiple Drug Overdose
34 (.33%)
Orthostatic Hypotension
34 (.33%)
Rhabdomyolysis
34 (.33%)
Syncope
34 (.33%)
Erythema
33 (.32%)
Respiratory Arrest
33 (.32%)
Alanine Aminotransferase Increased
32 (.31%)
Oedema
31 (.3%)
Pyrexia
31 (.3%)
Acute Pulmonary Oedema
30 (.29%)
Blood Creatinine Increased
30 (.29%)
Cardiac Failure
30 (.29%)
Jaundice
30 (.29%)
Muscle Spasms
30 (.29%)
Musculoskeletal Stiffness
29 (.28%)
Myocardial Infarction
29 (.28%)
Blood Pressure Systolic Increased
28 (.28%)
Muscular Weakness
28 (.28%)
Arrhythmia
27 (.27%)
Blood Potassium Decreased
27 (.27%)
Lactic Acidosis
27 (.27%)
Pain
27 (.27%)
Pruritus
27 (.27%)
Sinus Tachycardia
27 (.27%)
Angina Pectoris
26 (.26%)
Atrial Fibrillation
26 (.26%)
Diarrhoea
26 (.26%)
Hypoglycaemia
26 (.26%)
Cardio-respiratory Arrest
25 (.25%)
Constipation
25 (.25%)
Cyanosis
25 (.25%)
Death
25 (.25%)
Pleural Effusion
25 (.25%)
Renal Impairment
25 (.25%)
Somnolence
25 (.25%)
Arthralgia
24 (.24%)
Chest Discomfort
24 (.24%)
Convulsion
24 (.24%)
Cough
24 (.24%)
No Therapeutic Response
24 (.24%)
Paraesthesia
24 (.24%)
Aspartate Aminotransferase Increase...
23 (.23%)
Dysgeusia
23 (.23%)
Intentional Overdose
23 (.23%)
Toxic Epidermal Necrolysis
23 (.23%)
Tremor
23 (.23%)
Anxiety
22 (.22%)
Blood Glucose Increased
22 (.22%)
Dialysis
22 (.22%)
Heart Rate Irregular
22 (.22%)
Joint Swelling
22 (.22%)
Pancreatic Carcinoma
22 (.22%)
Premature Labour
22 (.22%)

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

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

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

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

Hypertension
2040
Drug Use For Unknown Indication
632
Product Used For Unknown Indication
398
Blood Pressure
115
Ill-defined Disorder
96
Blood Pressure Increased
95
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Raynauds Phenomenon
92
Tocolysis
82
Angina Pectoris
65
Premature Labour
52
Essential Hypertension
42
Blood Pressure Abnormal
36
Cardiac Disorder
29
Suicide Attempt
19
Overdose
15
Chest Pain
15
Coronary Artery Disease
14
Prophylaxis
13
Insomnia
13
Pulmonary Hypertension
12
Foetal Exposure During Pregnancy
12
Atrial Fibrillation
12
Blood Pressure Management
12
Myocardial Ischaemia
11
Drug Exposure During Pregnancy
10
Supraventricular Tachycardia
10
Duodenal Ulcer
9
Systemic Sclerosis
8
Arteriospasm Coronary
7
Renovascular Hypertension
7
Pregnancy Induced Hypertension
7
Hypertensive Crisis
7
Cardiovascular Disorder
7
Cardiovascular Event Prophylaxis
6
Atrioventricular Block
5
Pain
5
Threatened Labour
5
Hypertensive Emergency
5
Furuncle
5
Heart Rate Irregular
5
Accidental Exposure
5
Pain In Extremity
4
Aortic Dissection
4
Pre-eclampsia
4
Poor Peripheral Circulation
4
Hemiplegia
4
Renal Hypertension
4
Prinzmetal Angina
3
Catheterisation Cardiac
3
Renal Failure
3
Anorectal Disorder
3

Drug Labels

LabelLabelerEffective
NifedipineMylan Pharmaceuticals Inc.14-AUG-03
Nifedipine GAVIS Pharmaceuticals, LLC03-AUG-09
NifedipineIVC Industries, Inc. dba Inverness Medical Nutritionals Group21-OCT-09
Nifedipine bryant ranch prepack11-JAN-10
NifedipineContract Pharmacy Services-PA12-APR-10
NifedipineMylan Pharmaceuticals Inc.18-MAY-10
Nifediac CcState of Florida DOH Central Pharmacy07-JUN-10
NifedipineState of Florida DOH Central Pharmacy07-JUN-10
NifedipineState of Florida DOH Central Pharmacy07-JUN-10
Nifediac CcState of Florida DOH Central Pharmacy07-JUN-10
NifedipineMcKesson Packaging Services Business Unit of McKesson Corporation19-JUL-10
NifedipineActavis Elizabeth LLC19-NOV-10
NifedipineRebel Distributors Corp03-JAN-11
NifedipineRebel Distributors Corp03-JAN-11
Nifedipine ErAvPAK11-JAN-11
Adalat CcSchering Corporation28-FEB-11
NifedipineActavis South Atlantic LLC28-MAR-11
Adalat CcBayer HealthCare Pharmaceuticals Inc.08-APR-11
NifedipineRebel Distributors Corp13-APR-11
NifedipineActavis Inc.04-MAY-11
NifedipineMylan Pharmaceuticals Inc.11-MAY-11
NifedipineSTAT RX USA LLC09-JUN-11
NifedipineMcKesson Packaging Servives a business unit of McKesson Corporation01-JUL-11
NifedipineSTAT RX USA LLC04-AUG-11
NifedipineMylan Institutional Inc.09-SEP-11
NifedipineREMEDYREPACK INC. 17-OCT-11
NifedipineKremers Urban Pharmaceuticals Inc.21-OCT-11
Procardia XlPfizer Laboratories Div Pfizer Inc09-DEC-11
NifedipineRebel Distributors Corp27-DEC-11
NifedipineGolden State Medical Supply, Inc.09-JAN-12
NifedipineMajor Pharmaceuticals16-JAN-12
NifedipinePhysicians Total Care, Inc.01-FEB-12
NifedipinePreferred Pharmaceuticals, Inc14-FEB-12
AfeditabcrWatson Laboratories, Inc.07-MAR-12
NifedipineCardinal Health26-MAR-12
NifedipineAmerican Health Packaging02-APR-12
ProcardiaxlCardinal Health10-MAY-12
NifedipineAmerican Health Packaging30-MAY-12
NifedipinePhysicians Total Care, Inc.26-JUN-12
NifedipineInternational Labs, Inc.19-JUL-12
Nifediac CcTeva Pharmaceuticals USA Inc10-AUG-12
NifedicalxlTeva Pharmaceuticals USA Inc17-AUG-12
Nifediac CcTEVA PHARMACEUTICALS USA17-AUG-12
Nifediac CcTEVA PHARMACEUTICALS USA17-AUG-12
Nifedipine Physicians Total Care, Inc.25-SEP-12
NifedipineBryant Ranch Prepack12-OCT-12
NifedipineTEVA PHARMACEUTICALS USA26-NOV-12
Nifedipineextended ReleasePar Pharmaceutical, Inc.29-NOV-12
Nifedipineextended ReleasePar Pharmaceutical, Inc.29-NOV-12
NifedipineTEVA PHARMACEUTICALS USA07-DEC-12
NifedipineTEVA PHARMACEUTICALS USA11-DEC-12
NifedicalxlBryant Ranch Prepack17-JAN-13
Nifediac CcBryant Ranch Prepack18-JAN-13
NifedicalxlBryant Ranch Prepack18-JAN-13
AfeditabcrBryant Ranch Prepack21-JAN-13
NifedipineGreenstone LLC15-FEB-13
ProcardiaPfizer Laboratories Div Pfizer Inc15-FEB-13
ProcardiaREMEDYREPACK INC. 25-FEB-13
NifedipineNCS HealthCare of KY, Inc dba Vangard Labs25-FEB-13
NifedipineGreenstone LLC04-MAR-13
NifedipineCardinal Health18-MAR-13
NifedipinePreferred Pharmaceuticals, Inc.19-MAR-13
NifedipineCardinal Health05-APR-13
NifedipineHeritage Pharmaceuticals Inc.30-APR-13
Nifediac CcTEVA PHARMACEUTICALS USA03-MAY-13
Nifediac CcTEVA PHARMACEUTICALS USA03-MAY-13

Nifedipine Case Reports

What Nifedipine 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 Nifedipine. 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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