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NOVOLIN N

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Novolin N Adverse Events Reported to the FDA Over Time

How are Novolin N adverse event reports trending over time?

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

Most Common Novolin N Adverse Events Reported to the FDA

What are the most common Novolin N adverse events reported to the FDA?

Blood Glucose Increased
140 (7.13%)
Hypoglycaemia
103 (5.24%)
Anti-insulin Antibody Positive
54 (2.75%)
Blood Glucose Fluctuation
41 (2.09%)
Blood Glucose Decreased
38 (1.93%)
Hepatic Function Abnormal
38 (1.93%)
Diabetes Mellitus Inadequate Contro...
37 (1.88%)
Hypoglycaemic Unconsciousness
36 (1.83%)
Anti-insulin Antibody
34 (1.73%)
Hyperglycaemia
31 (1.58%)
Headache
27 (1.37%)
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Nausea
26 (1.32%)
Dizziness
24 (1.22%)
Dyspnoea
24 (1.22%)
Alanine Aminotransferase Increased
21 (1.07%)
Aspartate Aminotransferase Increase...
21 (1.07%)
Asthenia
21 (1.07%)
Diabetic Ketoacidosis
21 (1.07%)
Hypoglycaemic Coma
21 (1.07%)
Drug Hypersensitivity
18 (.92%)
Drug Ineffective
18 (.92%)
Product Quality Issue
18 (.92%)
Loss Of Consciousness
17 (.87%)
Syncope
17 (.87%)
Vomiting
17 (.87%)
Hypersensitivity
16 (.81%)
Rash
16 (.81%)
Anti-insulin Antibody Increased
15 (.76%)
Glycosylated Haemoglobin Increased
15 (.76%)
Convulsion
14 (.71%)
Injection Site Pruritus
14 (.71%)
Pain In Extremity
13 (.66%)
Fall
12 (.61%)
Hypoglycaemic Seizure
12 (.61%)
Injection Site Erythema
12 (.61%)
Pneumonia
12 (.61%)
Tremor
12 (.61%)
Hepatic Enzyme Increased
11 (.56%)
Oedema Peripheral
11 (.56%)
Pyrexia
11 (.56%)
Confusional State
10 (.51%)
Diarrhoea
10 (.51%)
Hyperhidrosis
10 (.51%)
Hypoaesthesia Oral
10 (.51%)
Intentional Overdose
10 (.51%)
Drug Exposure During Pregnancy
9 (.46%)
Gamma-glutamyltransferase Increased
9 (.46%)
Alopecia
8 (.41%)
Cerebrovascular Accident
8 (.41%)
Injection Site Reaction
8 (.41%)
Liver Disorder
8 (.41%)
Pregnancy
8 (.41%)
Speech Disorder
8 (.41%)
Suicide Attempt
8 (.41%)
Tachycardia
8 (.41%)
Toe Amputation
8 (.41%)
Urinary Tract Infection
8 (.41%)
Abscess Limb
7 (.36%)
Blood Alkaline Phosphatase Increase...
7 (.36%)
Blood Glucose Abnormal
7 (.36%)
Device Malfunction
7 (.36%)
Erythema
7 (.36%)
Injection Site Induration
7 (.36%)
Malaise
7 (.36%)
Medication Error
7 (.36%)
Pruritus
7 (.36%)
Pulmonary Oedema
7 (.36%)
Urticaria
7 (.36%)
Abdominal Pain Upper
6 (.31%)
Atrial Fibrillation
6 (.31%)
Cardiac Failure Congestive
6 (.31%)
Heart Rate Increased
6 (.31%)
Hepatitis
6 (.31%)
Hypoglycaemic Encephalopathy
6 (.31%)
Injection Site Pain
6 (.31%)
Rash Generalised
6 (.31%)
Abortion Spontaneous
5 (.25%)
Ankle Fracture
5 (.25%)
Cold Sweat
5 (.25%)
Condition Aggravated
5 (.25%)
Gastric Cancer
5 (.25%)
Hyperkalaemia
5 (.25%)
Ketoacidosis
5 (.25%)
Pleural Effusion
5 (.25%)
Road Traffic Accident
5 (.25%)
Skin Test Positive
5 (.25%)
Visual Impairment
5 (.25%)
Wrong Drug Administered
5 (.25%)
Abdominal Pain
4 (.2%)
Blood Lactate Dehydrogenase Increas...
4 (.2%)
Blood Phosphorus Decreased
4 (.2%)
Coma
4 (.2%)
Diabetic Hyperglycaemic Coma
4 (.2%)
Gastrooesophageal Reflux Disease
4 (.2%)
Haemoglobin Decreased
4 (.2%)
Hepatic Steatosis
4 (.2%)
Incorrect Dose Administered
4 (.2%)
Infection
4 (.2%)
Influenza
4 (.2%)
Injection Site Nodule
4 (.2%)
Insomnia
4 (.2%)

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

What are the most common Novolin N adverse events reported to the FDA?

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

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

Diabetes Mellitus
258
Type 2 Diabetes Mellitus
161
Type 1 Diabetes Mellitus
112
Insulin-requiring Type Ii Diabetes ...
102
Diabetes Mellitus Insulin-dependent
67
Insulin-requiring Type 2 Diabetes M...
60
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Drug Use For Unknown Indication
29
Product Used For Unknown Indication
26
Diabetes Mellitus Non-insulin-depen...
10
Gestational Diabetes
4
Blood Glucose Increased
3
Blood Insulin
2
Pancreatogenous Diabetes
2
Ill-defined Disorder
2
Suicide Attempt
2
Off Label Use
1
Blood Glucose Abnormal
1
Diabetes Mellitus Malnutrition-rela...
1

Drug Labels

LabelLabelerEffective
NovolinnNovo Nordisk09-MAR-13

Novolin N Case Reports

What Novolin N 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 Novolin N. 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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