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NOVOLOG MIX

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Novolog Mix Adverse Events Reported to the FDA Over Time

How are Novolog Mix adverse event reports trending over time?

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

Most Common Novolog Mix Adverse Events Reported to the FDA

What are the most common Novolog Mix adverse events reported to the FDA?

Blood Glucose Increased
254 (8.19%)
Hypoglycaemia
109 (3.52%)
Loss Of Consciousness
59 (1.9%)
Blood Glucose Decreased
53 (1.71%)
Blood Glucose Fluctuation
44 (1.42%)
Diabetes Mellitus Inadequate Contro...
41 (1.32%)
Dizziness
37 (1.19%)
Dyspnoea
37 (1.19%)
Nausea
37 (1.19%)
Fall
34 (1.1%)
Hypoglycaemic Unconsciousness
32 (1.03%)
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Medication Error
32 (1.03%)
Hypersensitivity
30 (.97%)
Hypoglycaemic Coma
30 (.97%)
Cerebrovascular Accident
29 (.94%)
Hyperhidrosis
28 (.9%)
Weight Increased
27 (.87%)
Headache
26 (.84%)
Vomiting
26 (.84%)
Diarrhoea
25 (.81%)
Vision Blurred
25 (.81%)
Drug Dispensing Error
24 (.77%)
Hypotension
23 (.74%)
Palpitations
23 (.74%)
Wrong Drug Administered
23 (.74%)
Asthenia
22 (.71%)
Chest Pain
22 (.71%)
Malaise
21 (.68%)
Myocardial Infarction
21 (.68%)
Pneumonia
21 (.68%)
Syncope
21 (.68%)
Hypertension
20 (.65%)
Dehydration
19 (.61%)
Urticaria
19 (.61%)
Pain In Extremity
18 (.58%)
Product Quality Issue
18 (.58%)
Rash
18 (.58%)
Death
17 (.55%)
Fatigue
17 (.55%)
Injection Site Urticaria
17 (.55%)
Oedema Peripheral
17 (.55%)
Cold Sweat
16 (.52%)
Diabetic Ketoacidosis
16 (.52%)
Drug Hypersensitivity
16 (.52%)
Hyperglycaemia
16 (.52%)
Lower Limb Fracture
16 (.52%)
Pain
16 (.52%)
Convulsion
15 (.48%)
Pregnancy
15 (.48%)
Condition Aggravated
14 (.45%)
Hypoaesthesia
14 (.45%)
Abdominal Distension
13 (.42%)
Cardiac Failure Congestive
13 (.42%)
Cellulitis
13 (.42%)
Device Failure
13 (.42%)
Hypoglycaemic Seizure
13 (.42%)
Infection
13 (.42%)
Injection Site Erythema
13 (.42%)
Device Malfunction
12 (.39%)
Injection Site Haematoma
12 (.39%)
Injection Site Induration
12 (.39%)
Injection Site Pruritus
12 (.39%)
Oedema
12 (.39%)
Pruritus
12 (.39%)
Rash Pruritic
12 (.39%)
Abdominal Pain
11 (.35%)
Diabetic Retinopathy
11 (.35%)
Drug Ineffective
11 (.35%)
Glycosylated Haemoglobin Increased
11 (.35%)
Hypothermia
11 (.35%)
Injection Site Irritation
11 (.35%)
Paraesthesia
11 (.35%)
Vertigo
11 (.35%)
Erythema
10 (.32%)
Heart Rate Increased
10 (.32%)
Incorrect Dose Administered
10 (.32%)
Injection Site Swelling
10 (.32%)
Premature Baby
10 (.32%)
Road Traffic Accident
10 (.32%)
Urinary Tract Infection
10 (.32%)
Wheezing
10 (.32%)
Back Pain
9 (.29%)
Bronchitis
9 (.29%)
Burning Sensation
9 (.29%)
Muscle Spasms
9 (.29%)
Transient Ischaemic Attack
9 (.29%)
Caesarean Section
8 (.26%)
Chest Discomfort
8 (.26%)
Discomfort
8 (.26%)
Pruritus Generalised
8 (.26%)
Renal Impairment
8 (.26%)
Weight Decreased
8 (.26%)
Angioedema
7 (.23%)
Anti-insulin Antibody
7 (.23%)
Cerebral Infarction
7 (.23%)
Chronic Obstructive Pulmonary Disea...
7 (.23%)
Diabetic Nephropathy
7 (.23%)
Drug Exposure During Pregnancy
7 (.23%)
Expired Drug Administered
7 (.23%)
Fluid Retention
7 (.23%)
Gait Disturbance
7 (.23%)

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

What are the most common Novolog Mix adverse events reported to the FDA?

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

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

Diabetes Mellitus
306
Type 2 Diabetes Mellitus
273
Insulin-requiring Type Ii Diabetes ...
234
Insulin-requiring Type 2 Diabetes M...
133
Drug Use For Unknown Indication
69
Type 1 Diabetes Mellitus
66
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Diabetes Mellitus Insulin-dependent
37
Product Used For Unknown Indication
33
Diabetes Mellitus Non-insulin-depen...
9
Gestational Diabetes
7
Ill-defined Disorder
7
Hypertension
3
Blood Insulin
2
Diabetes Insipidus
2
Peritoneal Dialysis
1
Asthma
1
Blood Glucose Increased
1
Blood Glucose Abnormal
1
Drug Dispensing Error
1
Drug Exposure During Pregnancy
1

Drug Labels

LabelLabelerEffective
Novolog Mix 70/30Physicians Total Care, Inc.08-NOV-10
Novolog Mix 70/30Novo Nordisk18-MAR-13

Novolog Mix Case Reports

What Novolog Mix 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 Novolog Mix. 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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