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FOSINOPRIL SODIUM

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Fosinopril Sodium Adverse Events Reported to the FDA Over Time

How are Fosinopril Sodium adverse event reports trending over time?

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

Most Common Fosinopril Sodium Adverse Events Reported to the FDA

What are the most common Fosinopril Sodium adverse events reported to the FDA?

Hyperkalaemia
63 (2.95%)
Renal Failure Acute
61 (2.86%)
Angioedema
36 (1.69%)
Cough
36 (1.69%)
Completed Suicide
33 (1.55%)
Blood Urea Increased
31 (1.45%)
Blood Creatinine Increased
25 (1.17%)
Dizziness
25 (1.17%)
Asthenia
24 (1.13%)
Orthostatic Hypotension
24 (1.13%)
Renal Failure
24 (1.13%)
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Swelling Face
24 (1.13%)
Abdominal Pain Upper
23 (1.08%)
Hypotension
23 (1.08%)
Syncope
23 (1.08%)
Blood Pressure Increased
22 (1.03%)
Drug Ineffective
22 (1.03%)
Pneumonia
22 (1.03%)
Dyspnoea
21 (.98%)
Nausea
20 (.94%)
Vomiting
20 (.94%)
Pleural Effusion
19 (.89%)
Dehydration
17 (.8%)
Loss Of Consciousness
17 (.8%)
Swollen Tongue
17 (.8%)
Fatigue
16 (.75%)
Hyponatraemia
16 (.75%)
Death
14 (.66%)
Diarrhoea
14 (.66%)
Drug Interaction
14 (.66%)
Pulmonary Congestion
14 (.66%)
Pulmonary Oedema
14 (.66%)
Bundle Branch Block Left
13 (.61%)
Cardiac Arrest
12 (.56%)
Hypertension
12 (.56%)
Lactic Acidosis
12 (.56%)
Renal Impairment
12 (.56%)
Atrial Fibrillation
11 (.52%)
Oedema Peripheral
11 (.52%)
Wheezing
11 (.52%)
Dysphagia
10 (.47%)
Headache
10 (.47%)
Medication Error
10 (.47%)
Renal Disorder
10 (.47%)
Abdominal Pain
9 (.42%)
Blood Glucose Increased
9 (.42%)
Blood Potassium Increased
9 (.42%)
Bradycardia
9 (.42%)
Drug Hypersensitivity
9 (.42%)
Dry Mouth
9 (.42%)
Left Ventricular Failure
9 (.42%)
Pruritus
9 (.42%)
Qrs Axis Abnormal
9 (.42%)
Rash
9 (.42%)
Tachycardia
9 (.42%)
Blood Pressure Inadequately Control...
8 (.38%)
C-reactive Protein Increased
8 (.38%)
Cardiac Failure
8 (.38%)
Failure To Thrive
8 (.38%)
Haemoglobin Decreased
8 (.38%)
Inflammation
8 (.38%)
Malaise
8 (.38%)
Pharyngeal Oedema
8 (.38%)
Pyrexia
8 (.38%)
White Blood Cell Count Decreased
8 (.38%)
Blood Chloride Decreased
7 (.33%)
Blood Cholesterol Increased
7 (.33%)
Blood Potassium Decreased
7 (.33%)
Chest Pain
7 (.33%)
Confusional State
7 (.33%)
Decreased Appetite
7 (.33%)
Hypersensitivity
7 (.33%)
Listless
7 (.33%)
Oedema
7 (.33%)
Pregnancy
7 (.33%)
Prothrombin Time Prolonged
7 (.33%)
Red Blood Cell Count Decreased
7 (.33%)
Vision Blurred
7 (.33%)
Abasia
6 (.28%)
Anaemia
6 (.28%)
Caesarean Section
6 (.28%)
Drug Exposure During Pregnancy
6 (.28%)
Hypocalcaemia
6 (.28%)
Hypokalaemia
6 (.28%)
Hypomagnesaemia
6 (.28%)
Lobar Pneumonia
6 (.28%)
Mental Impairment
6 (.28%)
Metabolic Acidosis
6 (.28%)
Monocyte Count Decreased
6 (.28%)
Neuropathy Peripheral
6 (.28%)
Neutropenia
6 (.28%)
Neutrophil Count Decreased
6 (.28%)
Overdose
6 (.28%)
Pain
6 (.28%)
Respiratory Distress
6 (.28%)
Road Traffic Accident
6 (.28%)
Somnolence
6 (.28%)
Vertigo
6 (.28%)
Aphasia
5 (.23%)
Arteriovenous Fistula Operation
5 (.23%)
Arthralgia
5 (.23%)

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

What are the most common Fosinopril Sodium adverse events reported to the FDA?

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

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

Hypertension
837
Drug Use For Unknown Indication
177
Product Used For Unknown Indication
76
Blood Pressure
70
Blood Pressure Increased
19
Blood Pressure Abnormal
19
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Cardiac Disorder
18
Essential Hypertension
18
Diabetes Mellitus
17
Cardiac Failure Congestive
14
Cardiac Failure
12
Ill-defined Disorder
12
Prophylaxis
7
Drug Exposure During Pregnancy
6
Coronary Artery Disease
3
Proteinuria
3
Cardiovascular Disorder
3
Arteritis
2
Renal Disorder
2
Acute Coronary Syndrome
2
Angina Pectoris
2
Renal Failure Chronic
2
Unevaluable Event
2
Gastrooesophageal Reflux Disease
2
Cardiomyopathy
2
Blood Creatinine Increased
1
Hypertensive Heart Disease
1
Arthritis
1
Thyroid Therapy
1
Nephropathy
1
Diuretic Therapy
1
Hyperlipidaemia
1
Vein Disorder
1
Osteoarthritis
1
Suicidal Ideation
1
Renal Impairment
1
Diabetes Mellitus Non-insulin-depen...
1
Renal Failure
1
Stent Placement
1
Atrial Fibrillation
1
Accidental Exposure
1
Type 2 Diabetes Mellitus
1
Malignant Hypertension
1
Blood Pressure Management
1
Myocardial Ischaemia
1
Menopausal Symptoms
1

Drug Labels

LabelLabelerEffective
Fosinopril Sodium And HydrochlorothiazideGreenstone LLC10-SEP-09
Fosinopril Sodium And HydrochlorothiazideGlenmark Generics Inc., USA07-DEC-09
Fosinopril Sodium And HydrochlorothiazidePhysicians Total Care, Inc.07-DEC-09
Fosinopril SodiumGlenmark Generics Inc., USA07-JUL-10
Fosinopril Sodium And HydrochlorothiazideAurobindo Pharma Limited22-JUL-10
Fosinopril SodiumCamber Pharmceuticals Inc.25-JAN-11
Fosinopril SodiumAurobindo Pharma Limited31-MAR-11
Fosinopril SodiumGolden State Medical Supply, Inc.19-MAY-11
Fosinopril SodiumExelan Pharmaceuticals, Inc.21-NOV-11
Fosinopril SodiumGolden State Medical Supply, Inc.09-JAN-12
Fosinopril Sodium And HydrochlorothiazideHeritage Pharmaceuticals Inc.10-MAR-12
Fosinopril SodiumAphena Pharma Solutions - Tennessee, Inc.17-JUL-12
Fosinopril SodiumTeva Pharmaceuticals USA Inc03-AUG-12
Fosinopril SodiumPhysicians Total Care, Inc.05-FEB-13
Fosinopril SodiumEon Labs, Inc.20-MAR-13
Fosinopril Sodium And HydrochlorothiazideEon Labs, Inc.20-MAR-13

Fosinopril Sodium Case Reports

What Fosinopril Sodium 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 Fosinopril Sodium. 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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