Clarithromycin adverse reactions

# Adverse Reactions
The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. These adverse reactions are consistent with the known safety profile of macrolide antibiotics.
There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.

## Adverse Reactions Observed During Clinical Trials of Clarithromycin
The following adverse reactions were observed in clinical trials with clarithromycin at a rate greater than or equal to 1%:

### Gastrointestinal Disorders
Diarrhea, vomiting, dyspepsia, nausea, abdominal pain

### Hepatobiliary Disorders
Liver function test abnormal

### Immune System Disorders
Anaphylactoid reaction

### Infection and Infestations
Candidiasis

### Nervous System Disorders
Dysgeusia, headache

### Psychiatric Disorders
Insomnia

### Skin and Subcutaneous Tissue Disorders
Rash

### Other Adverse Reactions Observed During Clinical Trials of Clarithromycin
The following adverse reactions were observed in clinical trials with clarithromycin at a rate less than 1%:

### Blood and Lymphatic System Disorders
Leukopenia, neutropenia, thrombocythemia, eosinophilia

### Cardiac Disorders
Electrocardiogram QT prolonged, cardiac arrest, atrial fibrillation,extrasystoles, palpitations

### Ear and Labyrinth Disorders
Vertigo, tinnitus, hearing impaired

### Gastrointestinal Disorders
Stomatitis,glossitis, esophagitis, gastrooesophageal reflux disease, gastritis, proctalgia, abdominal distension, constipation, dry mouth, eructation, flatulence

### General Disorders and Administration Site Conditions
Malaise, pyrexia, asthenia, chest pain, chills, fatigue

### Hepatobiliary Disorders
Cholestasis, hepatitis

### Immune System Disorders
Hypersensitivity

### Infections and Infestations
Cellulitis, gastroenteritis, infection, vaginal infection

### Investigations
Blood bilirubin increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, albumin globulin ratio abnormal

### Metabolism and Nutrition Disorders
Anorexia, decreased appetite

### Musculoskeletal and Connective Tissue Disorders
Myalgia, muscle spasms, nuchal rigidity

### Nervous System Disorders
Dizziness, tremor, loss of consciousness, dyskinesia, somnolence

### Psychiatric Disorders
Anxiety, nervousness

### Renal and Urinary Disorders
Blood creatinine increased, blood urea increased

### Respiratory, Thoracic and Mediastinal Disorders
Asthma, epistaxis, pulmonary embolism

### Skin and Subcutaneous Tissue Disorders
Urticaria, dermatitis bullous, pruritus, hyperhidrosis, rash maculo-papular
In the acute exacerbation of chronic bronchitis and acute maxillary sinusitis studies overall gastrointestinal adverse events were reported by a similar proportion of patients taking either BIAXIN tablets or BIAXIN XL tablets; however, patients taking BIAXIN XL tablets reported significantly less severe gastrointestinal symptoms compared to patients taking BIAXIN tablets. In addition, patients taking BIAXIN XL tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to BIAXIN tablets.
In community-acquired pneumonia studies conducted in adults comparing clarithromycin to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to erythromycin-treated patients (13% vs 32%; p < 0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of clarithromycin-treated patients.
In two U.S. studies of acute otitis media comparing clarithromycin to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many clarithromycin-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.

## Post-Marketing Experience
The following adverse reactions have been identified during post approval use of clarithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

### Blood and Lymphatic System Disorders
Thrombocytopenia, agranulocytosis

### Cardiac Disorders
Torsades de pointes, ventricular tachycardia, ventricular arrhythmia

### Ear and Labyrinth Disorders
Deafness was reported chiefly in elderly women and was usually reversible.

### Gastrointestinal Disorders
Pancreatitis acute, tongue discoloration, tooth discoloration was reported and was usually reversible with professional cleaning upon discontinuation of the drug. There have been reports of BIAXIN XL tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times. In several reports, tablet residues have occurred in the context of diarrhea. It is recommended that patients who experience tablet residue in the stool and no improvement in their condition should be switched to a different clarithromycin formulation (e.g. suspension) or another antibacterial drug.

### Hepatobiliary Disorders
Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with clarithromycin (see WARNINGS - Hepatotoxicity).

### Immune System Disorders
Anaphylactic reaction

### Infections and Infestations
Pseudomembranous colitis

### Investigations
Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased. Abnormal urine color has been reported, associated with hepatic failure.

### Metabolism and Nutrition Disorders
Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin.

### Musculoskeletal and Connective Tissue Disorders
Myopathy, rhabdomyolysis was reported and in some of the reports, clarithromycin was administered concomitantly with statins, fibrates, colchicine or allopurinol (see Contraindications And WarningS).

### Nervous System Disorders
Convulsion, ageusia, parosmia, anosmia, paraesthesia

### Psychiatric Disorders
Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams. These disorders usually resolve upon discontinuation of the drug.
There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

### Renal and Urinary Disorders
Nephritis interstitial, renal failure

### Skin and Subcutaneous Tissue Disorders
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne

### Vascular Disorders
Hemorrhage
There have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see warnings and precautions).