Clarimicina Side effects

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What are the possible side effects of Clarimicina?

Get emergency medical help if you have any of these signs of an allergic reaction to Clarimicina: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Older adults may be more likely to have heart rhythm side effects, including a life-threatening fast heart rate.

Clarimicina may also cause severe liver symptoms. Stop taking Clarimicina and call your doctor at once if you have any of these liver symptoms:

Common Clarimicina side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Clarimicina in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

The most frequent and common adverse reactions related to Clarimicina 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 Clarimicina

The following adverse reactions were observed in clinical trials with Clarimicina 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 Clarimicina

The following adverse reactions were observed in clinical trials with Clarimicina 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

Immume 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 Clarimicina tablets or Clarimicina extended-release tablets; however, patients taking Clarimicina extended-release tablets reported significantly less severe gastrointestinal symptoms compared to patients taking Clarimicina tablets. In addition, patients taking Clarimicina extended-release tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to Clarimicina tablets.

In community-acquired pneumonia studies conducted in adults comparing Clarimicina to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in Clarimicina-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 Clarimicina-treated patients.

In two U.S. studies of acute otitis media comparing Clarimicina to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in Clarimicina-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many Clarimicina-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 Clarimicina. 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 Clarimicina extended release 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 Clarimicina formulation (e.g., suspension) or another antibacterial drug.

Hepatobiliary Disorders

Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with Clarimicina.

Immune System Disorders

Anaphylactic reaction, angioedema

Infections and Infestations

Pseudomembranous colitis


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, Clarimicina was administered concomitantly with statins, fibrates, colchicine or allopurinol.

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 Clarimicina 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


There have been reports of colchicine toxicity with concomitant use of Clarimicina and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.

What is the most important information I should know about Clarimicina?

Clarimicina contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.


Clarimicina is contraindicated in patients with a known hypersensitivity to Clarimicina, erythromycin, or any of the macrolide antibacterial drugs.

Cardiac Arrhythmias

Concomitant administration of Clarimicina with cisapride and pimozide is contraindicated [seeDRUG INTERACTIONS (7)].

There have been postmarketing reports of drug interactions when Clarimicina is coadministered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by Clarimicina. Fatalities have been reported.

Cholestatic Jaundice/Hepatic Dysfunction

Clarimicina is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of Clarimicina.


Concomitant administration of Clarimicina and colchicine is contraindicated in patients with renal or hepatic impairment.

HMG-CoA Reductase Inhibitors

Do not use Clarimicina concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.

Ergot Alkaloids

Concomitant administration of Clarimicina and ergotamine or dihydroergotamine is contraindicated.

Contraindications for Coadministered Drugs

For information about contraindications of other drugs indicated in combination with Clarimicina, refer to their full prescribing information (contraindications section).



  1. DailyMed. "CLARITHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". (accessed September 17, 2018).
  2. DTP/NCI. "clarithromycin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Clarithromycin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". (accessed September 17, 2018).


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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