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NOVOLIN R

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Novolin R Adverse Events Reported to the FDA Over Time

How are Novolin R adverse event reports trending over time?

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

Most Common Novolin R Adverse Events Reported to the FDA

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

Blood Glucose Increased
175 (7.07%)
Hypoglycaemia
154 (6.22%)
Diabetes Mellitus Inadequate Contro...
68 (2.75%)
Anti-insulin Antibody Positive
64 (2.59%)
Hyperglycaemia
53 (2.14%)
Anti-insulin Antibody
47 (1.9%)
Hepatic Function Abnormal
42 (1.7%)
Intentional Overdose
40 (1.62%)
Blood Glucose Fluctuation
35 (1.41%)
Alanine Aminotransferase Increased
33 (1.33%)
Aspartate Aminotransferase Increase...
32 (1.29%)
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Vomiting
31 (1.25%)
Blood Glucose Decreased
30 (1.21%)
Diabetic Ketoacidosis
30 (1.21%)
Dyspnoea
29 (1.17%)
Nausea
28 (1.13%)
Anti-insulin Antibody Increased
27 (1.09%)
Product Quality Issue
27 (1.09%)
Suicide Attempt
26 (1.05%)
Dizziness
25 (1.01%)
Hypoglycaemic Unconsciousness
25 (1.01%)
Drug Ineffective
22 (.89%)
Hypoglycaemic Coma
22 (.89%)
Fall
20 (.81%)
Medication Error
20 (.81%)
Blood Glucose Abnormal
19 (.77%)
Drug Hypersensitivity
19 (.77%)
Loss Of Consciousness
19 (.77%)
Pain In Extremity
18 (.73%)
Glycosylated Haemoglobin Increased
17 (.69%)
Rash
17 (.69%)
Urinary Tract Infection
17 (.69%)
Asthenia
15 (.61%)
Headache
15 (.61%)
Ketoacidosis
15 (.61%)
Pyrexia
15 (.61%)
Injection Site Pruritus
14 (.57%)
Convulsion
13 (.53%)
Pneumonia
13 (.53%)
Anaemia
12 (.48%)
Malaise
12 (.48%)
Urticaria
12 (.48%)
Dehydration
11 (.44%)
Hypersensitivity
11 (.44%)
Liquid Product Physical Issue
11 (.44%)
Chest Pain
10 (.4%)
Chills
10 (.4%)
Erythema
10 (.4%)
Hyperkalaemia
10 (.4%)
Hypoglycaemic Seizure
10 (.4%)
Injection Site Erythema
10 (.4%)
Oedema Peripheral
10 (.4%)
Device Malfunction
9 (.36%)
Dry Mouth
9 (.36%)
Incorrect Dose Administered
9 (.36%)
Injection Site Induration
9 (.36%)
Liver Disorder
9 (.36%)
Fatigue
8 (.32%)
Hepatitis
8 (.32%)
Hepatomegaly
8 (.32%)
Hypoglycaemic Encephalopathy
8 (.32%)
Incorrect Product Storage
8 (.32%)
Product Counterfeit
8 (.32%)
Pruritus
8 (.32%)
Rash Generalised
8 (.32%)
Syncope
8 (.32%)
Blood Alkaline Phosphatase Increase...
7 (.28%)
Blood Pressure Decreased
7 (.28%)
Cardiac Arrest
7 (.28%)
Device Failure
7 (.28%)
Diarrhoea
7 (.28%)
Gamma-glutamyltransferase Increased
7 (.28%)
Haemoptysis
7 (.28%)
Hyperhidrosis
7 (.28%)
Hypertension
7 (.28%)
Injection Site Haemorrhage
7 (.28%)
Injection Site Reaction
7 (.28%)
Renal Impairment
7 (.28%)
Sepsis
7 (.28%)
Altered State Of Consciousness
6 (.24%)
Arrhythmia
6 (.24%)
Cardiac Disorder
6 (.24%)
Cerebrovascular Accident
6 (.24%)
Cough
6 (.24%)
Device Leakage
6 (.24%)
Electrolyte Imbalance
6 (.24%)
Expired Drug Administered
6 (.24%)
Hepatic Enzyme Increased
6 (.24%)
Injection Site Pain
6 (.24%)
Memory Impairment
6 (.24%)
Paraesthesia
6 (.24%)
Product Colour Issue
6 (.24%)
Pruritus Generalised
6 (.24%)
Pulmonary Oedema
6 (.24%)
Skin Ulcer
6 (.24%)
Throat Irritation
6 (.24%)
Urine Ketone Body Present
6 (.24%)
Visual Impairment
6 (.24%)
Wrong Drug Administered
6 (.24%)
Arthralgia
5 (.2%)
Ascites
5 (.2%)

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

What are the most common Novolin R 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 R, 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 R 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 R According to Those Reporting Adverse Events

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

Diabetes Mellitus
328
Type 2 Diabetes Mellitus
188
Type 1 Diabetes Mellitus
126
Insulin-requiring Type Ii Diabetes ...
91
Drug Use For Unknown Indication
62
Product Used For Unknown Indication
59
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Diabetes Mellitus Insulin-dependent
52
Insulin-requiring Type 2 Diabetes M...
33
Hyperglycaemia
19
Diabetes Mellitus Non-insulin-depen...
13
Blood Insulin
7
Ill-defined Disorder
7
Blood Glucose
6
Diabetes Mellitus Inadequate Contro...
5
Suicide Attempt
5
Blood Glucose Increased
4
Gestational Diabetes
4
Blood Glucose Abnormal
4
Ketosis
3
Ketoacidosis
3
Hyperkalaemia
3
Diabetic Ketoacidosis
3
Off Label Use
3
Prophylaxis
3
Somnolence
2
Intentional Drug Misuse
2
Post Procedural Complication
1
Medication Error
1
Diabetic Nephropathy
1
Blood Pressure
1
Blood Bicarbonate Decreased
1
Latent Autoimmune Diabetes In Adult...
1
Diabetes Mellitus Malnutrition-rela...
1

Drug Labels

LabelLabelerEffective
NovolinrNovo Nordisk09-MAR-13

Novolin R Case Reports

What Novolin R 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 R. 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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