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NOVORAPID

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Novorapid Adverse Events Reported to the FDA Over Time

How are Novorapid adverse event reports trending over time?

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

Most Common Novorapid Adverse Events Reported to the FDA

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

Hypoglycaemia
499 (6.61%)
Blood Glucose Increased
208 (2.75%)
Drug Exposure During Pregnancy
181 (2.4%)
Diabetes Mellitus Inadequate Contro...
173 (2.29%)
Anti-insulin Antibody Positive
154 (2.04%)
Hyperglycaemia
148 (1.96%)
Blood Glucose Fluctuation
101 (1.34%)
Suicide Attempt
96 (1.27%)
Intentional Overdose
95 (1.26%)
Diabetic Ketoacidosis
89 (1.18%)
Hypoglycaemic Coma
88 (1.17%)
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Anti-insulin Antibody Increased
82 (1.09%)
Hepatic Function Abnormal
81 (1.07%)
Anti-insulin Antibody
74 (.98%)
Loss Of Consciousness
66 (.87%)
Premature Baby
66 (.87%)
Alanine Aminotransferase Increased
57 (.75%)
Aspartate Aminotransferase Increase...
57 (.75%)
Drug Ineffective
56 (.74%)
Hypoglycaemic Unconsciousness
56 (.74%)
Fall
52 (.69%)
Dyspnoea
50 (.66%)
Nausea
50 (.66%)
Blood Glucose Decreased
49 (.65%)
Caesarean Section
49 (.65%)
Vomiting
49 (.65%)
Convulsion
47 (.62%)
Malaise
47 (.62%)
Pregnancy
43 (.57%)
Drug Hypersensitivity
39 (.52%)
Dizziness
37 (.49%)
Hypoglycaemia Neonatal
37 (.49%)
Abortion Spontaneous
36 (.48%)
Death
35 (.46%)
Hypersensitivity
34 (.45%)
Hypoglycaemic Encephalopathy
34 (.45%)
Injection Site Erythema
34 (.45%)
Foetal Distress Syndrome
33 (.44%)
Glycosylated Haemoglobin Increased
33 (.44%)
Injection Site Pruritus
32 (.42%)
Myocardial Infarction
31 (.41%)
Condition Aggravated
30 (.4%)
Headache
30 (.4%)
Coma
29 (.38%)
Pre-eclampsia
29 (.38%)
Oedema Peripheral
28 (.37%)
Blood Glucose Abnormal
27 (.36%)
Intra-uterine Death
27 (.36%)
Maternal Drugs Affecting Foetus
27 (.36%)
Pneumonia
27 (.36%)
Pruritus
27 (.36%)
Weight Increased
27 (.36%)
Dehydration
26 (.34%)
Insulin Resistance
26 (.34%)
Fatigue
25 (.33%)
Overdose
25 (.33%)
Road Traffic Accident
25 (.33%)
Weight Decreased
25 (.33%)
Device Failure
24 (.32%)
Hypoglycaemic Seizure
24 (.32%)
Diarrhoea
23 (.3%)
Hyperhidrosis
23 (.3%)
Neonatal Respiratory Distress Syndr...
23 (.3%)
Syncope
23 (.3%)
Abdominal Pain
22 (.29%)
Hypertension
22 (.29%)
Injection Site Reaction
22 (.29%)
Liver Disorder
22 (.29%)
Urticaria
22 (.29%)
Constipation
21 (.28%)
Gamma-glutamyltransferase Increased
21 (.28%)
Gastroenteritis
21 (.28%)
Oedema
21 (.28%)
Rash
21 (.28%)
Decreased Appetite
20 (.26%)
Erythema
20 (.26%)
Hepatic Enzyme Increased
20 (.26%)
Injection Site Induration
20 (.26%)
Pyrexia
20 (.26%)
Palpitations
19 (.25%)
Injection Site Pain
18 (.24%)
Ascites
17 (.23%)
Injection Site Rash
17 (.23%)
Premature Labour
17 (.23%)
Blood Alkaline Phosphatase Increase...
16 (.21%)
Erythema Multiforme
16 (.21%)
Hypoaesthesia
16 (.21%)
Inguinal Hernia
16 (.21%)
Urinary Tract Infection
16 (.21%)
Autoantibody Positive
15 (.2%)
Blood Ketone Body
15 (.2%)
Cerebrovascular Accident
15 (.2%)
Infection
15 (.2%)
Renal Failure
15 (.2%)
Sepsis
15 (.2%)
Drug Interaction
14 (.19%)
Hepatitis
14 (.19%)
Myalgia
14 (.19%)
Nasopharyngitis
14 (.19%)
Pain In Extremity
14 (.19%)
Pancreatic Carcinoma
14 (.19%)

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

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

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

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

Diabetes Mellitus
1101
Type 1 Diabetes Mellitus
723
Type 2 Diabetes Mellitus
670
Diabetes Mellitus Insulin-dependent
285
Insulin-requiring Type Ii Diabetes ...
239
Drug Use For Unknown Indication
228
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Product Used For Unknown Indication
195
Insulin-requiring Type 2 Diabetes M...
102
Gestational Diabetes
89
Diabetes Mellitus Non-insulin-depen...
32
Drug Exposure During Pregnancy
25
Ill-defined Disorder
18
Hyperglycaemia
15
Latent Autoimmune Diabetes In Adult...
11
Diabetes Mellitus Inadequate Contro...
8
Blood Glucose Abnormal
7
Off Label Use
7
Suicide Attempt
7
Blood Glucose Increased
6
Diabetic Ketoacidosis
4
Pancreatogenous Diabetes
4
Diabetic Nephropathy
3
Blood Glucose Fluctuation
3
Pancreatectomy
3
Ketoacidosis
3
Unevaluable Event
2
Hypoglycaemia
2
Foetal Exposure During Pregnancy
2
Intentional Self-injury
2
Intentional Overdose
2
Diabetes Insipidus
2
Metabolic Disorder
1
Glycosuria
1
Intentional Drug Misuse
1
Maternal Exposure During Pregnancy
1
Homicide
1
Maternal Drugs Affecting Foetus
1
Diabetic Relative
1

Novorapid Case Reports

What Novorapid 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 Novorapid. 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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