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Altace Adverse Events Reported to the FDA Over Time

How are Altace adverse event reports trending over time?

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

Most Common Altace Adverse Events Reported to the FDA

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

Renal Failure Acute
378 (2.41%)
Hypotension
290 (1.85%)
Cough
285 (1.82%)
Drug Interaction
268 (1.71%)
Dyspnoea
268 (1.71%)
Dehydration
252 (1.61%)
Hyperkalaemia
227 (1.45%)
Dizziness
203 (1.29%)
Nausea
201 (1.28%)
Blood Creatinine Increased
195 (1.24%)
Vomiting
194 (1.24%)
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Drug Ineffective
174 (1.11%)
Asthenia
171 (1.09%)
Diarrhoea
166 (1.06%)
Malaise
162 (1.03%)
Hyponatraemia
144 (.92%)
Fall
141 (.9%)
Blood Pressure Increased
128 (.82%)
Fatigue
128 (.82%)
Syncope
127 (.81%)
Renal Failure
126 (.8%)
Bradycardia
114 (.73%)
Headache
111 (.71%)
Oedema Peripheral
110 (.7%)
Pruritus
106 (.68%)
General Physical Health Deteriorati...
105 (.67%)
Angioedema
99 (.63%)
Chest Pain
98 (.63%)
Confusional State
93 (.59%)
Loss Of Consciousness
91 (.58%)
Abdominal Pain
80 (.51%)
Weight Decreased
79 (.5%)
Hypertension
78 (.5%)
Somnolence
76 (.48%)
Blood Urea Increased
73 (.47%)
Cardiac Failure
72 (.46%)
Pain In Extremity
70 (.45%)
Palpitations
70 (.45%)
Feeling Abnormal
69 (.44%)
Pyrexia
68 (.43%)
Rash
68 (.43%)
Atrial Fibrillation
65 (.41%)
Erythema
62 (.4%)
Cerebrovascular Accident
61 (.39%)
Myocardial Infarction
61 (.39%)
Anaemia
57 (.36%)
Tachycardia
57 (.36%)
Convulsion
53 (.34%)
Myalgia
51 (.33%)
Swollen Tongue
51 (.33%)
Insomnia
50 (.32%)
Renal Impairment
50 (.32%)
Hypoglycaemia
48 (.31%)
Jaundice
47 (.3%)
Orthostatic Hypotension
47 (.3%)
Swelling Face
47 (.3%)
Abdominal Pain Upper
46 (.29%)
Hypersensitivity
46 (.29%)
Anxiety
45 (.29%)
Anorexia
44 (.28%)
Lip Swelling
43 (.27%)
Arthralgia
42 (.27%)
Pharyngeal Oedema
42 (.27%)
Decreased Appetite
40 (.26%)
Disorientation
39 (.25%)
Dysphagia
39 (.25%)
Hyperhidrosis
39 (.25%)
Paraesthesia
39 (.25%)
Hypoaesthesia
38 (.24%)
Rhabdomyolysis
38 (.24%)
Circulatory Collapse
37 (.24%)
Hypokalaemia
37 (.24%)
Tinnitus
37 (.24%)
Urticaria
37 (.24%)
Back Pain
36 (.23%)
Gait Disturbance
36 (.23%)
Alanine Aminotransferase Increased
35 (.22%)
Blood Pressure Decreased
35 (.22%)
Bronchitis
35 (.22%)
Depressed Level Of Consciousness
35 (.22%)
Depression
35 (.22%)
Thrombocytopenia
35 (.22%)
Cardiac Arrest
34 (.22%)
Laryngeal Oedema
34 (.22%)
Blood Potassium Increased
33 (.21%)
Pain
33 (.21%)
Alopecia
32 (.2%)
Blood Glucose Increased
32 (.2%)
Dysphonia
32 (.2%)
Pulmonary Oedema
32 (.2%)
Abdominal Discomfort
31 (.2%)
Condition Aggravated
31 (.2%)
Death
31 (.2%)
Heart Rate Decreased
31 (.2%)
Lactic Acidosis
31 (.2%)
Muscle Spasms
31 (.2%)
Blood Creatine Phosphokinase Increa...
30 (.19%)
C-reactive Protein Increased
30 (.19%)
Overdose
30 (.19%)
Pneumonia
30 (.19%)
Sepsis
30 (.19%)

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

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

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

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

Hypertension
2067
Drug Use For Unknown Indication
388
Product Used For Unknown Indication
333
Blood Pressure
141
Cardiac Failure
106
Cardiac Disorder
101
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Essential Hypertension
96
Prophylaxis
89
Blood Pressure Increased
61
Myocardial Infarction
48
Cardiac Failure Congestive
42
Blood Pressure Abnormal
40
Diabetes Mellitus
32
Coronary Artery Disease
26
Myocardial Ischaemia
17
Blood Pressure Management
15
Ill-defined Disorder
13
Angina Pectoris
12
Cardiovascular Event Prophylaxis
11
Atrial Fibrillation
11
Cardiomyopathy
11
Cardiovascular Disorder
10
Renal Disorder
10
Hypertensive Heart Disease
9
Stent Placement
9
Left Ventricular Failure
7
Ischaemic Cardiomyopathy
7
Proteinuria
7
Microalbuminuria
6
Chest Pain
6
Arterial Disorder
5
Echography Abnormal
5
Ventricular Dysfunction
5
Transient Ischaemic Attack
5
Renal Failure
4
Oedema Due To Cardiac Disease
4
Acute Coronary Syndrome
4
Echocardiogram Abnormal
4
Cerebrovascular Accident
4
Pruritus
3
Dresslers Syndrome
3
Arteriosclerosis
3
Blood Cholesterol Increased
3
Albuminuria
3
Glomerulonephritis Membranous
3
Intentional Overdose
3
Type 2 Diabetes Mellitus
3
Hypertonia
3
Diabetes Mellitus Non-insulin-depen...
3
Oedema
2
Acute Myocardial Infarction
2

Drug Labels

LabelLabelerEffective
AltaceLake Erie Medical & Surgical Supply DBA Quality Care Products LLC17-NOV-11
AltaceMonarch Pharmaceuticals, Inc.30-APR-12

Altace Case Reports

What Altace 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 Altace. 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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