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Novomix Adverse Events Reported to the FDA Over Time

How are Novomix adverse event reports trending over time?

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

Most Common Novomix Adverse Events Reported to the FDA

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

Hypoglycaemia
126 (7.2%)
Blood Glucose Increased
50 (2.86%)
Hypoglycaemic Coma
39 (2.23%)
Loss Of Consciousness
30 (1.71%)
Fall
29 (1.66%)
Death
27 (1.54%)
Intentional Overdose
24 (1.37%)
Vomiting
24 (1.37%)
Nausea
23 (1.31%)
Dizziness
22 (1.26%)
Suicide Attempt
22 (1.26%)
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Syncope
21 (1.2%)
Hyperglycaemia
20 (1.14%)
Product Quality Issue
20 (1.14%)
Malaise
18 (1.03%)
Diabetes Mellitus Inadequate Contro...
17 (.97%)
Abdominal Pain
16 (.91%)
Blood Glucose Decreased
16 (.91%)
Diabetic Ketoacidosis
16 (.91%)
Hyperhidrosis
16 (.91%)
Pneumonia
15 (.86%)
Tachycardia
15 (.86%)
Drug Interaction
14 (.8%)
Dyspnoea
14 (.8%)
Pruritus
14 (.8%)
Drug Exposure During Pregnancy
13 (.74%)
Myocardial Infarction
13 (.74%)
Device Malfunction
12 (.69%)
Urinary Tract Infection
12 (.69%)
Abdominal Pain Upper
11 (.63%)
Blood Glucose Abnormal
11 (.63%)
Cerebrovascular Accident
11 (.63%)
Oedema Peripheral
11 (.63%)
Pregnancy
11 (.63%)
Drug Ineffective
10 (.57%)
Hypoglycaemic Unconsciousness
10 (.57%)
Hypothermia
10 (.57%)
Pain
10 (.57%)
Asthenia
9 (.51%)
Blood Glucose Fluctuation
9 (.51%)
Glycosylated Haemoglobin Increased
9 (.51%)
Headache
9 (.51%)
Hypersensitivity
9 (.51%)
Pyrexia
9 (.51%)
Renal Failure
9 (.51%)
Blood Ketone Body
8 (.46%)
Depressed Level Of Consciousness
8 (.46%)
Head Injury
8 (.46%)
Hypoglycaemic Seizure
8 (.46%)
Injection Site Erythema
8 (.46%)
Overdose
8 (.46%)
Premature Baby
8 (.46%)
Swelling Face
8 (.46%)
Anaemia
7 (.4%)
Cardiac Failure
7 (.4%)
Diarrhoea
7 (.4%)
Fatigue
7 (.4%)
Injection Site Pruritus
7 (.4%)
Intentional Drug Misuse
7 (.4%)
Multi-organ Failure
7 (.4%)
Rash
7 (.4%)
Thrombocytopenia
7 (.4%)
Tremor
7 (.4%)
Urticaria
7 (.4%)
Dehydration
6 (.34%)
Diabetic Retinopathy
6 (.34%)
Drug Hypersensitivity
6 (.34%)
Electrolyte Imbalance
6 (.34%)
Feeling Abnormal
6 (.34%)
Hemiparesis
6 (.34%)
Influenza Like Illness
6 (.34%)
Injection Site Pain
6 (.34%)
Injection Site Rash
6 (.34%)
Lower Limb Fracture
6 (.34%)
Unresponsive To Stimuli
6 (.34%)
Bladder Cancer
5 (.29%)
Convulsion
5 (.29%)
Dermatitis Allergic
5 (.29%)
Device Breakage
5 (.29%)
Device Failure
5 (.29%)
Face Oedema
5 (.29%)
Hot Flush
5 (.29%)
Hypotension
5 (.29%)
Lung Disorder
5 (.29%)
Mental Disorder
5 (.29%)
Palpitations
5 (.29%)
Rash Erythematous
5 (.29%)
Renal Failure Acute
5 (.29%)
Somnolence
5 (.29%)
Sopor
5 (.29%)
Tinnitus
5 (.29%)
Treatment Noncompliance
5 (.29%)
Weight Increased
5 (.29%)
Angina Pectoris
4 (.23%)
Ankle Fracture
4 (.23%)
Blood Lactate Dehydrogenase Increas...
4 (.23%)
Caesarean Section
4 (.23%)
Cardiac Disorder
4 (.23%)
Chest Pain
4 (.23%)
Circulatory Collapse
4 (.23%)
Cold Sweat
4 (.23%)

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

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

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

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

Diabetes Mellitus
231
Type 2 Diabetes Mellitus
189
Drug Use For Unknown Indication
93
Product Used For Unknown Indication
70
Insulin-requiring Type Ii Diabetes ...
60
Type 1 Diabetes Mellitus
52
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Diabetes Mellitus Insulin-dependent
34
Insulin-requiring Type 2 Diabetes M...
30
Gestational Diabetes
15
Diabetes Mellitus Non-insulin-depen...
14
Ill-defined Disorder
13
Hyperglycaemia
5
Diabetes Insipidus
1
Drug Exposure During Pregnancy
1
Acne
1
Hypoglycaemia
1
Nystagmus
1

Novomix Case Reports

What Novomix 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 Novomix. 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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