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NOVONORM

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Novonorm Adverse Events Reported to the FDA Over Time

How are Novonorm adverse event reports trending over time?

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

Most Common Novonorm Adverse Events Reported to the FDA

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

Hypoglycaemia
93 (6.4%)
Drug Interaction
39 (2.68%)
Hypoglycaemic Coma
31 (2.13%)
Renal Failure Acute
30 (2.06%)
Death
22 (1.51%)
Vomiting
22 (1.51%)
Thrombocytopenia
21 (1.45%)
Somnolence
20 (1.38%)
Confusional State
19 (1.31%)
Fall
19 (1.31%)
Renal Failure
19 (1.31%)
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Diarrhoea
18 (1.24%)
Blood Glucose Increased
17 (1.17%)
Loss Of Consciousness
16 (1.1%)
Abdominal Pain
15 (1.03%)
Dysarthria
15 (1.03%)
Hepatitis
15 (1.03%)
Pruritus
15 (1.03%)
Dyspnoea
14 (.96%)
Nausea
14 (.96%)
Malaise
13 (.89%)
Alanine Aminotransferase Increased
12 (.83%)
Dehydration
12 (.83%)
Diabetes Mellitus Inadequate Contro...
12 (.83%)
Eczema
12 (.83%)
Pyrexia
12 (.83%)
Transaminases Increased
12 (.83%)
Constipation
11 (.76%)
General Physical Health Deteriorati...
11 (.76%)
Anaemia Haemolytic Autoimmune
10 (.69%)
Asthenia
10 (.69%)
Cardiac Failure
10 (.69%)
Hypoglycaemic Unconsciousness
10 (.69%)
Inflammation
10 (.69%)
Aspartate Aminotransferase Increase...
9 (.62%)
Haemoglobin Decreased
9 (.62%)
Hyperhidrosis
9 (.62%)
Hypotension
9 (.62%)
Overdose
9 (.62%)
Pancreatitis Acute
9 (.62%)
Rash
9 (.62%)
Femur Fracture
8 (.55%)
Respiratory Failure
8 (.55%)
Weight Increased
8 (.55%)
Acidosis
7 (.48%)
Acute Generalised Exanthematous Pus...
7 (.48%)
Aphasia
7 (.48%)
Blood Creatinine Increased
7 (.48%)
Cytolytic Hepatitis
7 (.48%)
Depressed Level Of Consciousness
7 (.48%)
Lactic Acidosis
7 (.48%)
Pneumonia
7 (.48%)
Cardiac Arrest
6 (.41%)
Coma
6 (.41%)
Drug Rash With Eosinophilia And Sys...
6 (.41%)
Dysphagia
6 (.41%)
Epilepsy
6 (.41%)
Gamma-glutamyltransferase Increased
6 (.41%)
Hemiparesis
6 (.41%)
Hepatic Function Abnormal
6 (.41%)
Localised Oedema
6 (.41%)
Lung Infection
6 (.41%)
Macular Oedema
6 (.41%)
Myocardial Infarction
6 (.41%)
Rash Erythematous
6 (.41%)
Tongue Oedema
6 (.41%)
Acute Respiratory Failure
5 (.34%)
Anaemia
5 (.34%)
Anorexia
5 (.34%)
Blood Glucose Decreased
5 (.34%)
Cerebral Infarction
5 (.34%)
Condition Aggravated
5 (.34%)
Diabetic Coma
5 (.34%)
Dizziness
5 (.34%)
Drug Abuse
5 (.34%)
Erythema
5 (.34%)
Face Oedema
5 (.34%)
Hepatitis Toxic
5 (.34%)
Metabolic Encephalopathy
5 (.34%)
Ocular Icterus
5 (.34%)
Oedema
5 (.34%)
Polycythaemia Vera
5 (.34%)
Pulmonary Oedema
5 (.34%)
Purpura
5 (.34%)
Suicide Attempt
5 (.34%)
Thrombocytopenic Purpura
5 (.34%)
Toxic Skin Eruption
5 (.34%)
Tremor
5 (.34%)
Vasculitis
5 (.34%)
Abdominal Discomfort
4 (.28%)
Agranulocytosis
4 (.28%)
Altered State Of Consciousness
4 (.28%)
Angioedema
4 (.28%)
Ascites
4 (.28%)
Blood Creatine Increased
4 (.28%)
C-reactive Protein Increased
4 (.28%)
Drug Eruption
4 (.28%)
Hepatitis Alcoholic
4 (.28%)
Hypersensitivity
4 (.28%)
Hypokalaemia
4 (.28%)
Hyponatraemia
4 (.28%)

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

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

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

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

Diabetes Mellitus
251
Type 2 Diabetes Mellitus
220
Drug Use For Unknown Indication
102
Diabetes Mellitus Non-insulin-depen...
90
Product Used For Unknown Indication
34
Insulin-requiring Type Ii Diabetes ...
33
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Unevaluable Event
6
Insulin-requiring Type 2 Diabetes M...
5
Ill-defined Disorder
5
Drug Abuse
3
Hyperglycaemia
3
Suicide Attempt
3
Medication Error
2
Type 1 Diabetes Mellitus
2
Hypoglycaemia
2
Diabetes Mellitus Inadequate Contro...
1
Acne
1
Mental Disorder
1
Diabetes Mellitus Insulin-dependent
1
Drug Dispensing Error
1
Diabetic Neuropathy
1

Novonorm Case Reports

What Novonorm 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 Novonorm. 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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