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SOLU CORTEF

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Solu Cortef Adverse Events Reported to the FDA Over Time

How are Solu Cortef adverse event reports trending over time?

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

Most Common Solu Cortef Adverse Events Reported to the FDA

What are the most common Solu Cortef adverse events reported to the FDA?

Dyspnoea
45 (1.93%)
Shock
42 (1.8%)
Anaphylactic Shock
33 (1.42%)
Pyrexia
32 (1.37%)
Pneumonia
27 (1.16%)
Drug Ineffective
24 (1.03%)
Nausea
24 (1.03%)
Urticaria
24 (1.03%)
Hypotension
22 (.94%)
Hypersensitivity
21 (.9%)
Respiratory Failure
21 (.9%)
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Reversible Posterior Leukoencephalo...
21 (.9%)
Convulsion
20 (.86%)
Infusion Related Reaction
20 (.86%)
Blood Glucose Increased
19 (.82%)
Flushing
18 (.77%)
Loss Of Consciousness
18 (.77%)
Vomiting
18 (.77%)
Blood Pressure Decreased
17 (.73%)
Blood Pressure Increased
17 (.73%)
Septic Shock
17 (.73%)
Anaemia
16 (.69%)
Condition Aggravated
16 (.69%)
Diarrhoea
16 (.69%)
Platelet Count Decreased
16 (.69%)
Anaphylactic Reaction
15 (.64%)
Asthma
15 (.64%)
Malaise
13 (.56%)
Abdominal Pain
12 (.51%)
Disorientation
12 (.51%)
Hyperglycaemia
12 (.51%)
Hyperhidrosis
12 (.51%)
Osteonecrosis
12 (.51%)
Pleural Effusion
12 (.51%)
Stevens-johnson Syndrome
12 (.51%)
Acute Respiratory Distress Syndrome
11 (.47%)
Agitation
11 (.47%)
Deep Vein Thrombosis
11 (.47%)
Erythema
11 (.47%)
Pulmonary Oedema
11 (.47%)
Tachycardia
11 (.47%)
Thrombocytopenia
11 (.47%)
Cough
10 (.43%)
Febrile Neutropenia
10 (.43%)
Hypertension
10 (.43%)
Infection
10 (.43%)
Paraesthesia
10 (.43%)
Renal Failure Acute
10 (.43%)
Sepsis
10 (.43%)
Adrenocortical Insufficiency Acute
9 (.39%)
Dysphagia
9 (.39%)
Heparin-induced Thrombocytopenia
9 (.39%)
Hepatic Function Abnormal
9 (.39%)
Histiocytosis Haematophagic
9 (.39%)
Hypokalaemia
9 (.39%)
Oedema
9 (.39%)
Pruritus
9 (.39%)
Ventricular Extrasystoles
9 (.39%)
Anaphylactoid Reaction
8 (.34%)
Aspartate Aminotransferase Increase...
8 (.34%)
Blood Lactic Acid Decreased
8 (.34%)
Blood Pressure Systolic Increased
8 (.34%)
Dehydration
8 (.34%)
Gastrointestinal Haemorrhage
8 (.34%)
Hepatosplenomegaly
8 (.34%)
Hypoaesthesia
8 (.34%)
Leukopenia
8 (.34%)
Medication Error
8 (.34%)
Multi-organ Failure
8 (.34%)
Muscular Weakness
8 (.34%)
Pain
8 (.34%)
Pancytopenia
8 (.34%)
Alanine Aminotransferase Increased
7 (.3%)
Breath Sounds Abnormal
7 (.3%)
Cardiomegaly
7 (.3%)
Chest Discomfort
7 (.3%)
Delirium
7 (.3%)
Depressed Level Of Consciousness
7 (.3%)
Disseminated Intravascular Coagulat...
7 (.3%)
Epstein-barr Virus Infection
7 (.3%)
Erythema Multiforme
7 (.3%)
Gastroenteritis
7 (.3%)
Grand Mal Convulsion
7 (.3%)
Headache
7 (.3%)
Hypophagia
7 (.3%)
Klebsiella Infection
7 (.3%)
Liver Function Test Abnormal
7 (.3%)
Lung Infiltration
7 (.3%)
Mental Status Changes
7 (.3%)
Myalgia
7 (.3%)
Neutropenia
7 (.3%)
Pharyngeal Oedema
7 (.3%)
Rash
7 (.3%)
Respiratory Distress
7 (.3%)
Rhabdomyolysis
7 (.3%)
Sinus Bradycardia
7 (.3%)
Syncope
7 (.3%)
Tremor
7 (.3%)
Tuberculosis
7 (.3%)
Upper Respiratory Tract Infection
7 (.3%)
Vision Blurred
7 (.3%)

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

What are the most common Solu Cortef adverse events reported to the FDA?

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

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

Premedication
763
Prophylaxis
112
Drug Use For Unknown Indication
86
Asthma
69
Product Used For Unknown Indication
65
Prophylaxis Of Nausea And Vomiting
23
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Ill-defined Disorder
22
Hypersensitivity
18
Adrenal Insufficiency
18
Allergy Prophylaxis
17
Crohns Disease
16
Acute Myeloid Leukaemia
15
Septic Shock
15
Pyrexia
14
Acute Lymphocytic Leukaemia
14
Urticaria
13
Sepsis
13
Rash
11
Infection
8
Steroid Therapy
8
Shock
7
Facial Palsy
7
Anaphylactic Reaction
7
Drug Hypersensitivity
7
Respiratory Disorder
7
Prophylaxis Against Graft Versus Ho...
7
Burkitts Lymphoma
6
Pain
6
Graft Versus Host Disease
6
Interstitial Lung Disease
6
Respiratory Therapy
6
Multiple Myeloma
6
Metastases To Bone
6
Renal Failure Chronic
6
Colitis Ulcerative
6
Rheumatoid Arthritis
6
Adrenocortical Insufficiency Acute
6
Prostate Cancer
6
Anaphylaxis Prophylaxis
6
Anaphylactic Shock
5
Isolated Adrenocorticotropic Hormon...
5
Myelodysplastic Syndrome
5
Infection Prophylaxis
5
Laryngeal Oedema
5
Stem Cell Transplant
5
Lung Infection
5
Infusion Related Reaction
5
Prophylactic Chemotherapy
5
Exanthem
4
Temporal Arteritis
4
Abdominal Pain
4

Drug Labels

LabelLabelerEffective
Solu-cortefCardinal Health16-MAY-12
Solu-cortefPharmacia and Upjohn Company25-JUL-12
Solu-cortefPharmacia and Upjohn Company14-AUG-12
Solu-cortefCardinal Health15-MAR-13
Solu-cortefCardinal Health23-APR-13

Solu Cortef Case Reports

What Solu Cortef 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 Solu Cortef. 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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