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CEFACLOR

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Cefaclor Adverse Events Reported to the FDA Over Time

How are Cefaclor adverse event reports trending over time?

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

Most Common Cefaclor Adverse Events Reported to the FDA

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

Pyrexia
26 (2.33%)
Dyspnoea
21 (1.88%)
Anaphylactic Shock
19 (1.7%)
Rash
17 (1.52%)
Alanine Aminotransferase Increased
16 (1.43%)
Toxic Epidermal Necrolysis
15 (1.34%)
Drug Ineffective
14 (1.25%)
Urticaria
14 (1.25%)
Liver Disorder
12 (1.07%)
Anaphylactic Reaction
11 (.98%)
Aspartate Aminotransferase Increase...
11 (.98%)
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Delirium
11 (.98%)
Rhabdomyolysis
11 (.98%)
Blister
10 (.9%)
Diarrhoea
10 (.9%)
Dizziness
10 (.9%)
Haemolytic Anaemia
10 (.9%)
Pruritus
10 (.9%)
Shock
10 (.9%)
Drug Interaction
9 (.81%)
Erythema
9 (.81%)
Hepatitis Fulminant
8 (.72%)
Swelling Face
8 (.72%)
Thrombocytopenia
8 (.72%)
Vomiting
8 (.72%)
Abdominal Pain
7 (.63%)
Autoimmune Hepatitis
7 (.63%)
Body Temperature Increased
7 (.63%)
Dysphagia
7 (.63%)
Fall
7 (.63%)
Hyperhidrosis
7 (.63%)
Malaise
7 (.63%)
Renal Failure Acute
7 (.63%)
Urinary Tract Infection
7 (.63%)
Cough
6 (.54%)
Decreased Appetite
6 (.54%)
Erythema Multiforme
6 (.54%)
Fatigue
6 (.54%)
Hepatic Function Abnormal
6 (.54%)
Hypoxia
6 (.54%)
Increased Tendency To Bruise
6 (.54%)
Linear Iga Disease
6 (.54%)
Nausea
6 (.54%)
Pain
6 (.54%)
Protein Total Decreased
6 (.54%)
Systemic Lupus Erythematosus
6 (.54%)
White Blood Cell Count Increased
6 (.54%)
Abortion Induced
5 (.45%)
Anorexia
5 (.45%)
Autoimmune Thyroiditis
5 (.45%)
Blepharospasm
5 (.45%)
C-reactive Protein Increased
5 (.45%)
Depressed Level Of Consciousness
5 (.45%)
Dermatitis Exfoliative
5 (.45%)
Eczema
5 (.45%)
Gamma-glutamyltransferase Increased
5 (.45%)
Glossitis
5 (.45%)
Haematocrit Decreased
5 (.45%)
Haemoglobin Decreased
5 (.45%)
Hypersensitivity
5 (.45%)
Infection
5 (.45%)
Pallor
5 (.45%)
Rash Generalised
5 (.45%)
Red Blood Cell Count Decreased
5 (.45%)
Respiratory Failure
5 (.45%)
Sepsis
5 (.45%)
Suicide Attempt
5 (.45%)
Angioedema
4 (.36%)
Blood Alkaline Phosphatase Increase...
4 (.36%)
Blood Bilirubin Increased
4 (.36%)
Blood Creatinine Increased
4 (.36%)
Blood Immunoglobulin G Increased
4 (.36%)
Disorientation
4 (.36%)
Drug Hypersensitivity
4 (.36%)
Feeling Abnormal
4 (.36%)
Haematuria
4 (.36%)
Inflammation
4 (.36%)
Joint Swelling
4 (.36%)
Neuroleptic Malignant Syndrome
4 (.36%)
Oedema
4 (.36%)
Oedema Peripheral
4 (.36%)
Pneumonia
4 (.36%)
Pruritus Generalised
4 (.36%)
Pulmonary Oedema
4 (.36%)
Rash Erythematous
4 (.36%)
Stevens-johnson Syndrome
4 (.36%)
Tachycardia
4 (.36%)
Vertigo
4 (.36%)
Acute Myocardial Infarction
3 (.27%)
Anaemia
3 (.27%)
Aspiration
3 (.27%)
Atrial Fibrillation
3 (.27%)
Band Neutrophil Count Increased
3 (.27%)
Bilirubinuria
3 (.27%)
Blood Creatine Phosphokinase Increa...
3 (.27%)
Blood Urea Decreased
3 (.27%)
Chromaturia
3 (.27%)
Coagulopathy
3 (.27%)
Cyanosis
3 (.27%)
Dehydration
3 (.27%)
Depression
3 (.27%)

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

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

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

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

Product Used For Unknown Indication
27
Drug Use For Unknown Indication
24
Upper Respiratory Tract Infection
23
Lower Respiratory Tract Infection
19
Urinary Tract Infection
17
Infection
16
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Bronchitis
16
Infection Prophylaxis
15
Sinusitis
14
Prophylaxis
11
Pneumonia
10
Nasopharyngitis
9
Bacterial Infection
9
Otitis Media
9
Pyrexia
9
Tonsillitis
8
Gastroenteritis
8
Upper Respiratory Tract Inflammatio...
6
Pharyngitis
6
Antibiotic Therapy
6
Cystic Fibrosis
6
Asthma
5
Lung Infection
5
Gingivitis
4
Respiratory Tract Infection
4
Skin Ulcer
4
Postoperative Care
4
Otitis Media Acute
4
Bronchopneumonia
4
Ear Infection
3
Meningitis
3
Scarlet Fever
3
Tooth Infection
3
Tooth Extraction
3
Rhinitis
2
Pyelonephritis
2
Urinary Retention
2
Inflammation
2
Prostatitis
2
Generalised Erythema
2
Skin Infection
2
Impetigo
2
Cystitis
2
Anti-infective Therapy
2
Ill-defined Disorder
2
Analgesic Therapy
2
Monarthritis
2
Arthritis Bacterial
2
Dysuria
1
Tracheobronchitis
1
Pharyngolaryngeal Pain
1

Drug Labels

LabelLabelerEffective
CefaclorWest-ward Pharmaceutical Corp28-SEP-09
CefaclorPD-Rx Pharmaceuticals, Inc.28-SEP-09
Cefaclor bryant ranch prepack06-NOV-09
CefaclorPhysicians Total Care, Inc.08-DEC-10
CefaclorAlvogen, Inc.30-MAR-11
CefaclorRebel Distributors Corp20-JUL-11
CefaclorCarlsbad Technology, Inc.27-MAR-12
CefaclorCarlsbad Technology, Inc.29-JUN-12
CefaclorTeva Pharmaceuticals USA Inc13-AUG-12
CefaclorPack Pharmaceuticals, LLC25-OCT-12

Cefaclor Case Reports

What Cefaclor 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 Cefaclor. 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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