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POLARAMINE

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Polaramine Adverse Events Reported to the FDA Over Time

How are Polaramine adverse event reports trending over time?

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

Most Common Polaramine Adverse Events Reported to the FDA

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

Malaise
50 (2.75%)
Erythema
35 (1.93%)
Loss Of Consciousness
31 (1.71%)
Pruritus
31 (1.71%)
Hypotension
29 (1.6%)
Pyrexia
29 (1.6%)
Dyspnoea
28 (1.54%)
Neutropenia
24 (1.32%)
Thrombocytopenia
23 (1.27%)
Anaphylactic Shock
22 (1.21%)
Hepatic Function Abnormal
21 (1.16%)
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Hypersensitivity
20 (1.1%)
Vomiting
17 (.94%)
Convulsion
16 (.88%)
Febrile Bone Marrow Aplasia
15 (.83%)
Rash
15 (.83%)
Abdominal Pain
14 (.77%)
Chills
14 (.77%)
Oxygen Saturation Decreased
14 (.77%)
Sepsis
14 (.77%)
Anaemia
13 (.72%)
Diarrhoea
13 (.72%)
Ileitis
13 (.72%)
Leukopenia
13 (.72%)
Somnolence
13 (.72%)
Tachycardia
12 (.66%)
Drug Hypersensitivity
11 (.61%)
Drug Interaction
11 (.61%)
Hyperhidrosis
11 (.61%)
Hypertension
11 (.61%)
Renal Impairment
11 (.61%)
Condition Aggravated
10 (.55%)
Hypothyroidism
10 (.55%)
Intestinal Obstruction
10 (.55%)
Nausea
10 (.55%)
Urticaria
10 (.55%)
Back Pain
9 (.5%)
Confusional State
9 (.5%)
Depressed Level Of Consciousness
9 (.5%)
Dizziness
9 (.5%)
Fall
9 (.5%)
Hot Flush
9 (.5%)
Liver Disorder
9 (.5%)
Platelet Count Decreased
9 (.5%)
Renal Failure
9 (.5%)
Amaurosis
8 (.44%)
Cough
8 (.44%)
Cyanosis
8 (.44%)
Decreased Appetite
8 (.44%)
Drug Ineffective
8 (.44%)
Glare
8 (.44%)
Haemolytic Uraemic Syndrome
8 (.44%)
Infusion Related Reaction
8 (.44%)
Interstitial Lung Disease
8 (.44%)
Respiratory Disorder
8 (.44%)
Shock
8 (.44%)
Arrhythmia
7 (.39%)
Blood Lactate Dehydrogenase Increas...
7 (.39%)
Blood Pressure Increased
7 (.39%)
Bronchospasm
7 (.39%)
Cardiac Arrest
7 (.39%)
Headache
7 (.39%)
Purpura
7 (.39%)
Rash Erythematous
7 (.39%)
Stevens-johnson Syndrome
7 (.39%)
Syncope
7 (.39%)
Tremor
7 (.39%)
Agranulocytosis
6 (.33%)
Cardiac Failure
6 (.33%)
Cytolytic Hepatitis
6 (.33%)
Dermatitis Exfoliative
6 (.33%)
Disorientation
6 (.33%)
Haemolysis
6 (.33%)
Hallucination
6 (.33%)
Hyperthermia
6 (.33%)
Myositis
6 (.33%)
Pain
6 (.33%)
Paraesthesia
6 (.33%)
Abnormal Behaviour
5 (.28%)
Alanine Aminotransferase Increased
5 (.28%)
Anxiety
5 (.28%)
Asthenia
5 (.28%)
Burning Sensation
5 (.28%)
Chest Discomfort
5 (.28%)
Chest Pain
5 (.28%)
Dehydration
5 (.28%)
Drug Intolerance
5 (.28%)
Dry Mouth
5 (.28%)
Generalised Erythema
5 (.28%)
Gynaecomastia
5 (.28%)
Haematuria
5 (.28%)
Heart Rate Increased
5 (.28%)
Hypogonadism
5 (.28%)
Hypothermia
5 (.28%)
Inflammation
5 (.28%)
Infusion Site Extravasation
5 (.28%)
Melaena
5 (.28%)
Oedema Peripheral
5 (.28%)
Pallor
5 (.28%)
Pulmonary Oedema
5 (.28%)
Renal Failure Acute
5 (.28%)

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

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

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

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

Premedication
634
Prophylaxis
203
Drug Use For Unknown Indication
111
Product Used For Unknown Indication
70
Pruritus
64
Hypersensitivity
43
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Allergy Prophylaxis
36
Urticaria
34
Rash
21
Ill-defined Disorder
17
Drug Eruption
16
Rhinitis Allergic
15
Influenza
13
Rhinorrhoea
8
Nasopharyngitis
7
Bronchitis
6
Aplastic Anaemia
6
Bone Marrow Conditioning Regimen
6
Scratch
5
Antiallergic Therapy
5
Dermatitis Atopic
5
Pruritus Generalised
5
Rhinitis
5
Ovarian Cancer
5
Chemotherapy
5
Nausea
5
Upper Respiratory Tract Inflammatio...
5
Erysipelas
4
Sinusitis
4
Varicella
4
Colorectal Cancer Recurrent
4
Conjunctivitis Allergic
4
Psoriasis
4
Bone Marrow Failure
4
Pharyngitis
4
Dermatitis Allergic
4
Renal Transplant
3
Nasal Congestion
3
Swelling Face
3
Otitis Media
3
Asthma
3
Multiple Myeloma
3
Cough
3
Drug Exposure During Pregnancy
3
Bronchitis Acute
2
Non-hodgkins Lymphoma
2
Large Intestine Carcinoma
2
Infusion Related Reaction
2
Palmar-plantar Erythrodysaesthesia ...
2
Tonsillitis
2
Graft Versus Host Disease
2

Polaramine Case Reports

What Polaramine 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 Polaramine. 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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