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PROTAPHANE

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Protaphane Adverse Events Reported to the FDA Over Time

How are Protaphane adverse event reports trending over time?

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

Most Common Protaphane Adverse Events Reported to the FDA

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

Hypoglycaemia
43 (6.88%)
Premature Baby
35 (5.6%)
Blood Glucose Increased
25 (4%)
Drug Exposure During Pregnancy
20 (3.2%)
Cerebrovascular Accident
12 (1.92%)
Headache
11 (1.76%)
Diabetes Mellitus Inadequate Contro...
9 (1.44%)
Dyspnoea
9 (1.44%)
Anaphylactic Shock
8 (1.28%)
Cellulitis
8 (1.28%)
Drug Interaction
8 (1.28%)
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Hyperbilirubinaemia
8 (1.28%)
Caesarean Section
7 (1.12%)
Fall
7 (1.12%)
Hyperbilirubinaemia Neonatal
7 (1.12%)
Neonatal Respiratory Distress Syndr...
7 (1.12%)
Atypical Mycobacterial Infection
6 (.96%)
Completed Suicide
6 (.96%)
Dizziness
6 (.96%)
Eczema
6 (.96%)
Injection Site Erythema
6 (.96%)
Injection Site Induration
6 (.96%)
Injection Site Infection
6 (.96%)
Lung Infection
6 (.96%)
Malaise
6 (.96%)
Maternal Drugs Affecting Foetus
6 (.96%)
Product Quality Issue
6 (.96%)
Pseudomonas Infection
6 (.96%)
Abdominal Pain
5 (.8%)
Chest Pain
5 (.8%)
Face Oedema
5 (.8%)
Fatigue
5 (.8%)
Heart Rate Increased
5 (.8%)
Hypoglycaemia Neonatal
5 (.8%)
Injection Site Inflammation
5 (.8%)
Intentional Overdose
5 (.8%)
Sopor
5 (.8%)
Vasculitis
5 (.8%)
Abortion Spontaneous
4 (.64%)
Altered State Of Consciousness
4 (.64%)
Cardiac Disorder
4 (.64%)
Coma
4 (.64%)
Failed Induction Of Labour
4 (.64%)
Infection
4 (.64%)
Palpitations
4 (.64%)
Premature Labour
4 (.64%)
Shoulder Dystocia
4 (.64%)
Tinnitus
4 (.64%)
Astrocytoma, Low Grade
3 (.48%)
Blood Glucose Decreased
3 (.48%)
Blood Insulin
3 (.48%)
Convulsion
3 (.48%)
Death
3 (.48%)
Dermatitis Allergic
3 (.48%)
Gangrene
3 (.48%)
Head Injury
3 (.48%)
Intensive Care
3 (.48%)
Intra-uterine Death
3 (.48%)
Localised Oedema
3 (.48%)
Lower Respiratory Tract Infection
3 (.48%)
Myocardial Infarction
3 (.48%)
Postpartum Haemorrhage
3 (.48%)
Pregnancy
3 (.48%)
Presyncope
3 (.48%)
Sepsis
3 (.48%)
Shock Hypoglycaemic
3 (.48%)
Somnolence
3 (.48%)
Sudden Death
3 (.48%)
Swollen Tongue
3 (.48%)
Anaphylactic Reaction
2 (.32%)
Anxiety
2 (.32%)
Arrhythmia
2 (.32%)
Astrocytoma
2 (.32%)
Blister
2 (.32%)
Blood Glucose Abnormal
2 (.32%)
Blood Glucose Fluctuation
2 (.32%)
Blood Pressure Increased
2 (.32%)
Cardiovascular Insufficiency
2 (.32%)
Cerebral Haemorrhage
2 (.32%)
Diarrhoea
2 (.32%)
Drug Hypersensitivity
2 (.32%)
Dysphagia
2 (.32%)
Erythema
2 (.32%)
Excoriation
2 (.32%)
Foetal Macrosomia
2 (.32%)
Hepatic Steatosis
2 (.32%)
Hypophagia
2 (.32%)
Induced Labour
2 (.32%)
Loss Of Consciousness
2 (.32%)
Medication Error
2 (.32%)
Muscle Spasms
2 (.32%)
Necrobiosis
2 (.32%)
Oedema
2 (.32%)
Panic Attack
2 (.32%)
Paraesthesia
2 (.32%)
Personality Change
2 (.32%)
Phimosis
2 (.32%)
Postoperative Wound Infection
2 (.32%)
Premature Rupture Of Membranes
2 (.32%)
Pruritus
2 (.32%)
Similar Reaction On Previous Exposu...
2 (.32%)

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

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

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

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

Diabetes Mellitus
75
Type 2 Diabetes Mellitus
47
Type 1 Diabetes Mellitus
45
Drug Use For Unknown Indication
42
Gestational Diabetes
39
Product Used For Unknown Indication
31
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Diabetes Mellitus Insulin-dependent
29
Ill-defined Disorder
20
Insulin-requiring Type 2 Diabetes M...
15
Diabetes Mellitus Non-insulin-depen...
5
Insulin-requiring Type Ii Diabetes ...
4
Off Label Use
3
Drug Exposure During Pregnancy
2
Foetal Exposure During Pregnancy
1
Drug Administration Error
1

Protaphane Case Reports

What Protaphane 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 Protaphane. 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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