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CALONAL

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Calonal Adverse Events Reported to the FDA Over Time

How are Calonal adverse event reports trending over time?

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

Most Common Calonal Adverse Events Reported to the FDA

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

Abnormal Behaviour
45 (3.92%)
Pyrexia
41 (3.57%)
Rash
30 (2.61%)
Stevens-johnson Syndrome
27 (2.35%)
Liver Disorder
17 (1.48%)
Drug Eruption
16 (1.39%)
Hepatic Function Abnormal
16 (1.39%)
Toxic Epidermal Necrolysis
15 (1.31%)
Drug Hypersensitivity
14 (1.22%)
Erythema Multiforme
14 (1.22%)
Pneumonia
13 (1.13%)
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Interstitial Lung Disease
12 (1.05%)
Blood Pressure Decreased
11 (.96%)
Hallucination
11 (.96%)
Delirium
10 (.87%)
Drug Rash With Eosinophilia And Sys...
10 (.87%)
Loss Of Consciousness
10 (.87%)
Aggression
9 (.78%)
Urticaria
9 (.78%)
Generalised Oedema
8 (.7%)
Lymphocyte Stimulation Test Positiv...
8 (.7%)
Malaise
8 (.7%)
Restlessness
8 (.7%)
Vomiting
8 (.7%)
Anaemia
7 (.61%)
Ascites
7 (.61%)
Aspartate Aminotransferase Increase...
7 (.61%)
Diarrhoea
7 (.61%)
Disseminated Intravascular Coagulat...
7 (.61%)
Erythema
7 (.61%)
Jaundice
7 (.61%)
Nasopharyngitis
7 (.61%)
Nausea
7 (.61%)
Sepsis
7 (.61%)
White Blood Cell Count Decreased
7 (.61%)
White Blood Cell Count Increased
7 (.61%)
Convulsion
6 (.52%)
Cough
6 (.52%)
Dyspnoea
6 (.52%)
Headache
6 (.52%)
Nightmare
6 (.52%)
Ocular Hyperaemia
6 (.52%)
Pneumonia Mycoplasmal
6 (.52%)
Pruritus
6 (.52%)
Renal Failure
6 (.52%)
Shock
6 (.52%)
Agitation
5 (.44%)
Altered State Of Consciousness
5 (.44%)
Bacterial Infection
5 (.44%)
Blood Lactate Dehydrogenase Increas...
5 (.44%)
C-reactive Protein Increased
5 (.44%)
Drug Toxicity
5 (.44%)
Generalised Erythema
5 (.44%)
Haemoglobin Decreased
5 (.44%)
Infection
5 (.44%)
Liver Function Test Abnormal
5 (.44%)
Pancytopenia
5 (.44%)
Pleural Effusion
5 (.44%)
Rhabdomyolysis
5 (.44%)
Alanine Aminotransferase Increased
4 (.35%)
Atrioventricular Block
4 (.35%)
Blood Creatine Phosphokinase Increa...
4 (.35%)
Blood Creatinine Increased
4 (.35%)
Cardio-respiratory Arrest
4 (.35%)
Crying
4 (.35%)
Death
4 (.35%)
Depressed Level Of Consciousness
4 (.35%)
Eye Disorder
4 (.35%)
Haematocrit Decreased
4 (.35%)
Heart Rate Decreased
4 (.35%)
Hydronephrosis
4 (.35%)
Hyperhidrosis
4 (.35%)
Hypersensitivity
4 (.35%)
Hypoalbuminaemia
4 (.35%)
Inflammation
4 (.35%)
Multi-organ Failure
4 (.35%)
Oculomucocutaneous Syndrome
4 (.35%)
Oral Herpes
4 (.35%)
Pain In Extremity
4 (.35%)
Pulmonary Congestion
4 (.35%)
Purpura
4 (.35%)
Rash Generalised
4 (.35%)
Sick Sinus Syndrome
4 (.35%)
Stomatitis
4 (.35%)
Tubulointerstitial Nephritis
4 (.35%)
Amnesia
3 (.26%)
Anaphylactic Shock
3 (.26%)
Asthenia
3 (.26%)
Biopsy Skin
3 (.26%)
Blister
3 (.26%)
Blood Alkaline Phosphatase Increase...
3 (.26%)
Blood Urea Increased
3 (.26%)
Body Temperature Increased
3 (.26%)
Brain Natriuretic Peptide Increased
3 (.26%)
Buccal Mucosal Roughening
3 (.26%)
Cardiac Failure Congestive
3 (.26%)
Condition Aggravated
3 (.26%)
Death Neonatal
3 (.26%)
Decreased Appetite
3 (.26%)
Dizziness
3 (.26%)
Dysarthria
3 (.26%)

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

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

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

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

Drug Use For Unknown Indication
193
Pyrexia
149
Antipyresis
79
Influenza
69
Headache
59
Prophylaxis
44
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Pain
42
Analgesic Therapy
31
Cancer Pain
29
Premedication
29
Nasopharyngitis
24
Product Used For Unknown Indication
16
Upper Respiratory Tract Inflammatio...
12
Bronchitis
11
Metastatic Renal Cell Carcinoma
10
Pneumonia
10
Multiple Myeloma
10
Tonsillitis
8
Herpes Zoster
8
Back Pain
7
Pharyngitis
6
Hyperthermia
5
Bone Pain
5
Analgesia
5
Ill-defined Disorder
5
Respiratory Tract Infection
5
Major Depression
4
Post Herpetic Neuralgia
4
Diabetic Neuropathy
4
Toothache
4
Tumour Associated Fever
4
Dental Caries
3
Interstitial Lung Disease
3
Drug Exposure During Pregnancy
3
Subdural Haemorrhage
3
Ovarian Cancer Recurrent
3
Musculoskeletal Stiffness
2
Laryngopharyngitis
2
Pain In Extremity
2
Rheumatoid Arthritis
2
Cough
2
Bronchitis Acute
2
Bronchopneumonia
2
Hepatic Neoplasm Malignant
2
Chest Pain
2
Osteoarthritis
2
Arthralgia
2
Abdominal Pain
2
Otitis Media Acute
2
Acute Myeloid Leukaemia
2
Herpes Virus Infection
2

Calonal Case Reports

What Calonal 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 Calonal. 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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