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Actrapid Adverse Events Reported to the FDA Over Time

How are Actrapid adverse event reports trending over time?

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

Most Common Actrapid Adverse Events Reported to the FDA

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

Hypoglycaemia
138 (6.17%)
Drug Exposure During Pregnancy
65 (2.9%)
Hypoglycaemia Neonatal
48 (2.14%)
Caesarean Section
38 (1.7%)
Drug Interaction
36 (1.61%)
Premature Baby
31 (1.39%)
Blood Glucose Increased
29 (1.3%)
Diabetes Mellitus Inadequate Contro...
25 (1.12%)
Dyspnoea
25 (1.12%)
Fall
25 (1.12%)
Hyperglycaemia
24 (1.07%)
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Hypoglycaemic Coma
22 (.98%)
Shock Hypoglycaemic
22 (.98%)
Stevens-johnson Syndrome
21 (.94%)
Pregnancy
20 (.89%)
Toxic Epidermal Necrolysis
20 (.89%)
Coma
19 (.85%)
Pleural Effusion
18 (.8%)
Pre-eclampsia
18 (.8%)
Death
16 (.71%)
Hyperhidrosis
16 (.71%)
Hypertension
16 (.71%)
Renal Failure
16 (.71%)
Cardiac Failure
15 (.67%)
Glycosylated Haemoglobin Increased
15 (.67%)
Septic Shock
15 (.67%)
Angioedema
14 (.63%)
Anuria
13 (.58%)
Blood Glucose Fluctuation
13 (.58%)
Cardiac Arrest
13 (.58%)
Completed Suicide
13 (.58%)
Maternal Drugs Affecting Foetus
13 (.58%)
Premature Labour
13 (.58%)
Loss Of Consciousness
12 (.54%)
Oedema
12 (.54%)
Polyhydramnios
12 (.54%)
Abortion Induced
11 (.49%)
Congenital Diaphragmatic Hernia
11 (.49%)
Thrombocytopenia
11 (.49%)
Cellulitis
10 (.45%)
Hypokalaemia
10 (.45%)
Malaise
10 (.45%)
Toxic Skin Eruption
10 (.45%)
Atrial Septal Defect
9 (.4%)
Blood Glucose Decreased
9 (.4%)
Cardio-respiratory Arrest
9 (.4%)
Convulsion
9 (.4%)
Dehydration
9 (.4%)
Dizziness
9 (.4%)
Drug Ineffective
9 (.4%)
Dysphagia
9 (.4%)
Head Injury
9 (.4%)
Hypothermia
9 (.4%)
Medication Error
9 (.4%)
Myocardial Infarction
9 (.4%)
Proteinuria
9 (.4%)
Suicide Attempt
9 (.4%)
Vomiting
9 (.4%)
Condition Aggravated
8 (.36%)
Fatigue
8 (.36%)
Foetal Distress Syndrome
8 (.36%)
Haemoglobin Decreased
8 (.36%)
Headache
8 (.36%)
Neonatal Respiratory Distress Syndr...
8 (.36%)
Product Quality Issue
8 (.36%)
Respiratory Distress
8 (.36%)
Syncope
8 (.36%)
Transient Ischaemic Attack
8 (.36%)
Acute Respiratory Distress Syndrome
7 (.31%)
Anaphylactic Shock
7 (.31%)
Blood Pressure Increased
7 (.31%)
Confusional State
7 (.31%)
Diarrhoea
7 (.31%)
Injection Site Inflammation
7 (.31%)
Metabolic Disorder
7 (.31%)
Pseudomonas Infection
7 (.31%)
Pyrexia
7 (.31%)
Sepsis
7 (.31%)
Somnolence
7 (.31%)
Sopor
7 (.31%)
Sudden Death
7 (.31%)
Urticaria
7 (.31%)
Abortion Spontaneous
6 (.27%)
Agranulocytosis
6 (.27%)
Anaemia
6 (.27%)
Anorexia
6 (.27%)
Bradycardia
6 (.27%)
Cholestasis
6 (.27%)
Depressed Level Of Consciousness
6 (.27%)
Diabetic Ketoacidosis
6 (.27%)
Expired Drug Administered
6 (.27%)
Foetal Growth Retardation
6 (.27%)
Hypotension
6 (.27%)
Injection Site Erythema
6 (.27%)
Intentional Overdose
6 (.27%)
Lung Infection
6 (.27%)
Mental Disorder
6 (.27%)
Muscle Spasms
6 (.27%)
Neonatal Disorder
6 (.27%)
Neuroglycopenia
6 (.27%)
Oedema Peripheral
6 (.27%)

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

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

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

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

Diabetes Mellitus
398
Type 2 Diabetes Mellitus
221
Drug Use For Unknown Indication
186
Diabetes Mellitus Insulin-dependent
148
Type 1 Diabetes Mellitus
83
Product Used For Unknown Indication
55
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Hyperglycaemia
51
Insulin-requiring Type 2 Diabetes M...
35
Insulin-requiring Type Ii Diabetes ...
27
Ill-defined Disorder
21
Diabetes Mellitus Non-insulin-depen...
18
Gestational Diabetes
13
Off Label Use
10
Hyperkalaemia
8
Blood Glucose Abnormal
6
Pancreatogenous Diabetes
6
Blood Glucose Increased
5
Drug Exposure During Pregnancy
4
Diabetic Ketoacidosis
3
Maternal Drugs Affecting Foetus
3
Insulin Tolerance Test
3
Hypoglycaemia
3
Pneumonia
3
Diabetes Mellitus Inadequate Contro...
2
Metabolic Disorder
2
Blood Glucose Fluctuation
1
Foetal Exposure During Pregnancy
1
Toxic Epidermal Necrolysis
1
Medication Error
1
Resuscitation
1
Suicide Attempt
1
Ulcer
1
Sepsis
1
Blood Insulin
1
Cardiac Failure
1
Blood Glucose
1
Blood Potassium Increased
1

Actrapid Case Reports

What Actrapid 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 Actrapid. 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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