Common Zithromycin Side Effects


The most commonly reported Zithromycin side effects (click to view or check a box to report):

Tachycardia (2)
Blood Alkaline Phosphatase Increased (1)
Anaemia (1)
Alanine Aminotransferase Increased (1)
Blood Bilirubin Increased (1)
Cardiac Failure Congestive (1)
Dystonia (1)
Diabetes Mellitus (1)
Cholelithiasis (1)
Hepatitis C (1)
Thrombocytopenia (1)
Protrusion Tongue (1)
Oedema (1)
Liver Injury (1)
Rash Maculo-papular (1)
Renal Failure (1)
Tardive Dyskinesia (1)
Syncope (1)
Sepsis (1)
Hepatomegaly (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Zithromycin Side Effects Reported to FDA


Zithromycin Side Effect Report#8160263-6
Dystonia, Tardive Dyskinesia, Protrusion Tongue
This is a report of a 34-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Zithromycin (dosage: NA, start time:
Feb 21, 2012), combined with:
  • Compazine
and developed a serious reaction and side effect(s): Dystonia, Tardive Dyskinesia, Protrusion Tongue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zithromycin treatment in female patients, resulting in Dystonia side effect.
Zithromycin Side Effect Report#7415007-X
Tachycardia, Sepsis, Renal Failure, Oedema, Cardiac Failure Congestive, Anaemia, Hepatitis C, Diabetes Mellitus
This report suggests a potential Zithromycin Tachycardia side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: bronchitis and used Zithromycin (dosage: NA) starting
Oct 14, 2010. After starting Zithromycin the patient began experiencing various side effects, including: Tachycardia, Sepsis, Renal Failure, Oedema, Cardiac Failure Congestive, Anaemia, Hepatitis C, Diabetes MellitusAdditional drugs used concurrently:
  • Tamiflu
  • Amoxicillin
  • Phenergan Vc W/ Codeine
Although Zithromycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tachycardia, may still occur.
Zithromycin Side Effect Report#7327778-1
Blood Alkaline Phosphatase Increased, Liver Injury, Hepatomegaly, Blood Bilirubin Increased, Rash Maculo-papular, Toxicity To Various Agents, Alanine Aminotransferase Increased, Cholelithiasis, Thrombocytopenia
This Blood Alkaline Phosphatase Increased problem was reported by a physician from United States. A 30-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 24, 2009 this consumer started treatment with Zithromycin (dosage: NA). The following drugs were being taken at the same time:
  • Ceftriaxone
  • Vancomycin
  • Clindamycin
When using Zithromycin, the patient experienced the following unwanted symptoms/side effects: Blood Alkaline Phosphatase Increased, Liver Injury, Hepatomegaly, Blood Bilirubin Increased, Rash Maculo-papular, Toxicity To Various Agents, Alanine Aminotransferase Increased, Cholelithiasis, ThrombocytopeniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Alkaline Phosphatase Increased, may become evident only after a product is in use by the general population.
Zithromycin Side Effect Report#4595397-6
Electrocardiogram Qt Corrected Interval Prolonged, Syncope, Tachycardia
This Electrocardiogram Qt Corrected Interval Prolonged side effect was reported by a physician from . A female patient (weight:NA) experienced the following symptoms/conditions: cough,upper respiratory tract infection.The patient was prescribed Zithromycin (z Pack) (drug dosage: 500 Mg 1st Day 250 Mg 2,3,4, 5th Day), which was initiated on
Oct 02, 2004. Concurrently used drugs: NA..After starting to take Zithromycin (z Pack) the consumer reported adverse symptoms, such as: Electrocardiogram Qt Corrected Interval Prolonged, Syncope, TachycardiaThese side effects may potentially be related to Zithromycin (z Pack). The patient was hospitalized.



The appearance of Zithromycin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Zithromycin Side Effects for Women?

Women Side Effects Reports
Dystonia 1
Electrocardiogram Qt Corrected Interval Prolonged 1
Protrusion Tongue 1
Syncope 1
Tachycardia 1
Tardive Dyskinesia 1

What are common Zithromycin Side Effects for Men?

Men Side Effects Reports
Alanine Aminotransferase Increased 1
Anaemia 1
Blood Alkaline Phosphatase Increased 1
Blood Bilirubin Increased 1
Cardiac Failure Congestive 1
Cholelithiasis 1
Diabetes Mellitus 1
Hepatitis C 1
Hepatomegaly 1
Liver Injury 1

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Zithromycin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Zithromycin Safety Alerts, Active Ingredients, Usage Information

    NDC 0093-2026
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Azithromycin
    Name Azithromycin
    Dosage Form POWDER, FOR SUSPENSION
    Route ORAL
    On market since 20101217
    Labeler Teva Pharmaceuticals USA Inc
    Active Ingredient(s) AZITHROMYCIN MONOHYDRATE
    Strength(s) 200
    Unit(s) mg/5mL
    Pharma Class Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]

    More About Zithromycin

    Side Effects reported to FDA: 4

    Zithromycin safety alerts: 2014

    Reported hospitalizations: 1

    Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms

     

    [Posted 03/12/2013]

    AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional

    ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.  FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.

    FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.

    BACKGROUND: Azithromycin is marketed under the brand names Zithromax and Zmax. FDA-approved indications for azithromycin include: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease.

    RECOMMENDATION: Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.  FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [03/12/2013 -Drug Safety Communication - FDA]
    [05/17/2013 - Statement - FDA]  

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