Azithromycin Viatris: Uses, Dosage & Side Effects
A macrolide antibiotic used to treat bacterial infections of the respiratory tract, skin, soft tissues, and urogenital tract, including chlamydia
Azithromycin Viatris is a macrolide antibiotic containing azithromycin dihydrate as the active ingredient. It is prescribed for the treatment of bacterial infections affecting the respiratory tract (bronchitis, pneumonia, sinusitis, pharyngitis, tonsillitis, otitis media), skin and soft tissue infections (folliculitis, cellulitis, erysipelas), and chlamydial infections of the urinary tract and cervix. Azithromycin works by inhibiting bacterial protein synthesis, effectively stopping bacteria from multiplying. Its uniquely long tissue half-life allows for convenient short-course treatment regimens of 3 to 5 days, and a single dose for chlamydia. Azithromycin is listed on the WHO Model List of Essential Medicines and is one of the most widely prescribed antibiotics worldwide.
Quick Facts: Azithromycin Viatris
Key Takeaways
- Azithromycin Viatris is a macrolide antibiotic effective against a broad spectrum of bacteria causing respiratory, skin, soft tissue, and sexually transmitted infections, with a uniquely long tissue half-life enabling short treatment courses.
- Standard dosing is a total of 1,500 mg over 3 or 5 days for most infections, or a single 1,000 mg dose for uncomplicated chlamydia – always complete the full course even if symptoms improve to prevent antibiotic resistance.
- The most common side effects are gastrointestinal (diarrhea, nausea, abdominal pain, flatulence); contact your doctor immediately if you experience severe or bloody diarrhea, as this may indicate Clostridioides difficile colitis.
- Azithromycin may prolong the QT interval and should be avoided in patients with pre-existing heart rhythm disorders, low potassium or magnesium levels, or those taking other QT-prolonging medications.
- Important drug interactions include ergotamine derivatives (risk of ergotism), warfarin (increased bleeding risk), digoxin (increased levels), and cyclosporine (increased immunosuppressant levels) – always inform your doctor of all medications you take.
What Is Azithromycin Viatris and What Is It Used For?
Azithromycin Viatris contains the active substance azithromycin dihydrate, which belongs to the macrolide class of antibiotics. Macrolides are among the most commonly used antibiotic classes worldwide and have been a cornerstone of infectious disease treatment since the introduction of erythromycin in the 1950s. Azithromycin, developed as a second-generation macrolide (technically an azalide, a subclass of macrolides), was first approved for clinical use in 1991 and has since become one of the most widely prescribed antibiotics globally due to its broad spectrum of activity, excellent tissue penetration, and convenient dosing schedule.
The mechanism of action of azithromycin involves binding to the 50S ribosomal subunit of susceptible bacteria. By attaching to this critical component of the bacterial protein synthesis machinery, azithromycin inhibits the transpeptidation and translocation steps of protein synthesis. This prevents bacteria from manufacturing the proteins essential for their growth, cell division, and survival. At standard therapeutic concentrations, azithromycin is primarily bacteriostatic (it stops bacteria from multiplying), but at higher concentrations achieved in tissues, it can be bactericidal (directly killing bacteria) against certain susceptible organisms. Additionally, azithromycin has been shown to accumulate within phagocytes (white blood cells), which transport the drug directly to sites of infection, further enhancing its effectiveness.
One of the most distinctive pharmacological properties of azithromycin is its remarkably long tissue half-life, approximately 68 hours. This means that even after a short course of treatment, effective antibiotic concentrations are maintained in infected tissues for several days after the last dose. This pharmacokinetic advantage enables the convenient short-course regimens (3 or 5 days) that have made azithromycin particularly popular with both prescribers and patients. Tissue concentrations typically exceed plasma concentrations by 10 to 100 times, particularly in the lungs, tonsils, prostate, and other sites of common infections.
Azithromycin Viatris is prescribed for the treatment of the following bacterial infections in adults and adolescents:
- Lower respiratory tract infections: Acute bacterial bronchitis and community-acquired pneumonia (CAP). The Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS) include azithromycin as a recommended option for outpatient treatment of CAP, particularly in patients without comorbidities or risk factors for drug-resistant organisms. It is effective against common causative organisms including Streptococcus pneumoniae, Haemophilus influenzae, and atypical pathogens such as Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Legionella pneumophila.
- Upper respiratory tract infections: Acute bacterial sinusitis (in adults and adolescents aged 16 and over), pharyngitis (sore throat), tonsillitis, and otitis media (middle ear infection). While beta-lactam antibiotics such as amoxicillin remain first-line for many of these conditions, azithromycin is an important alternative for patients with penicillin allergy or intolerance.
- Skin and soft tissue infections: Mild to moderate infections including folliculitis (infection of hair follicles), cellulitis (infection of deeper skin layers and subcutaneous tissue), and erysipelas (a superficial form of cellulitis characterized by well-demarcated, raised, red skin). These infections are commonly caused by Staphylococcus aureus and Streptococcus pyogenes, both of which are usually susceptible to azithromycin.
- Sexually transmitted infections: Uncomplicated chlamydial infections of the urethra and cervix caused by Chlamydia trachomatis. A single 1,000 mg dose of azithromycin has been a standard treatment for uncomplicated genital chlamydia, offering the advantage of directly observed therapy in clinical settings, which helps ensure treatment adherence.
It is important to understand that azithromycin, like all antibiotics, is only effective against bacterial infections. It does not treat viral infections such as the common cold, influenza, or most cases of acute bronchitis. The inappropriate use of antibiotics contributes to the growing global crisis of antimicrobial resistance, which the World Health Organization (WHO) has identified as one of the top ten threats to global health. Azithromycin should therefore only be used when a bacterial infection has been diagnosed or is strongly suspected by a healthcare professional.
Azithromycin is included on the WHO Model List of Essential Medicines, which identifies the most important medications needed in a basic health system. This designation reflects its proven efficacy, safety profile, and crucial role in treating common bacterial infections worldwide. The WHO also recommends azithromycin for mass drug administration programs targeting trachoma, the leading infectious cause of blindness globally.
What Should You Know Before Taking Azithromycin Viatris?
Contraindications
There are specific situations in which Azithromycin Viatris must not be used. The most critical absolute contraindication is a known hypersensitivity (allergy) to azithromycin, to any other macrolide antibiotic (such as erythromycin or clarithromycin), to ketolides, or to any of the inactive ingredients in the formulation. An allergic reaction to macrolide antibiotics may manifest as skin rashes, hives, itching, facial swelling, wheezing, or difficulty breathing. If you have previously experienced such reactions to any macrolide antibiotic, you must not take this medication.
If you are uncertain whether you have previously had an allergic reaction to a macrolide antibiotic, consult your doctor or pharmacist before taking Azithromycin Viatris. Your healthcare provider can review your medical history and may recommend allergy testing if necessary.
Warnings and Precautions
Before starting treatment with Azithromycin Viatris, speak with your doctor or pharmacist if any of the following conditions apply to you:
Azithromycin can increase the risk of abnormal heart rhythm by prolonging the QT interval on an electrocardiogram (ECG). In rare cases, this may lead to a potentially life-threatening condition called Torsades de Pointes. This risk is particularly elevated in women, elderly patients, those with pre-existing heart conditions, and those with electrolyte imbalances. Do not take azithromycin if you have long QT syndrome, heart failure, slow or irregular heartbeat, or low potassium or magnesium levels. Inform your doctor immediately if you experience palpitations, fainting, or dizziness during treatment.
- Previous severe allergic reactions: If you have a history of serious allergic reactions involving swelling of the face and throat, difficulty breathing, skin rashes, swollen glands, or elevated eosinophil counts (a type of white blood cell), you may be at increased risk of similar reactions with azithromycin.
- Kidney problems: If you have impaired kidney function, your doctor may need to adjust the dose of azithromycin or monitor your kidney function during treatment.
- Liver problems: If you have liver disease or impaired liver function, your doctor may need to monitor liver enzyme levels and may need to discontinue treatment if liver function deteriorates. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin, although such events are extremely rare.
- Myasthenia gravis: If you have this neuromuscular condition causing muscle weakness, azithromycin may exacerbate symptoms or trigger a myasthenic crisis. Use with caution and close monitoring.
- Neurological or psychiatric conditions: If you have any disease of the brain or nervous system, or if you have mental, emotional, or behavioral health conditions, inform your doctor, as azithromycin has rarely been associated with neuropsychiatric side effects.
- Cardiac conditions: In addition to QT prolongation risk, patients with any form of heart disease should be carefully evaluated before starting azithromycin therapy. The risk of cardiac arrhythmias is increased in patients taking other QT-prolonging medications concurrently.
If you develop severe, persistent, or bloody diarrhea during or after treatment with azithromycin, contact your doctor immediately. This may be a sign of Clostridioides difficile (formerly Clostridium difficile) colitis, a potentially serious bowel condition that can occur with virtually any antibiotic. Do not take anti-diarrheal medications without consulting your doctor first, as they may mask the symptoms of this condition.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking Azithromycin Viatris. Azithromycin should only be used during pregnancy when the clinical benefit clearly outweighs the potential risk to the developing fetus. While animal studies have not demonstrated direct harm, there are limited controlled studies in pregnant women. Your doctor will only prescribe it during pregnancy if it is considered medically necessary.
Azithromycin passes into breast milk. If you are breastfeeding, your doctor will weigh the benefits of antibiotic treatment against the potential risks to your nursing infant, including the possibility of diarrhea and fungal infections of the mucous membranes in the breastfed child. A decision should be made whether to discontinue breastfeeding or to avoid azithromycin treatment, taking into account the benefit of therapy for the mother and the benefit of breastfeeding for the child.
Driving and Using Machines
Azithromycin Viatris may cause side effects that could affect your ability to drive or operate machinery safely. Dizziness, drowsiness (somnolence), visual disturbances, and in rare cases convulsions have been reported. If you experience any of these effects, do not drive a car, ride a bicycle, or operate any tools or machines until the effects have subsided. You are personally responsible for assessing whether you are fit to perform tasks requiring alertness and coordination.
Azithromycin Viatris tablets contain lactose monohydrate as an excipient. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The tablets contain less than 1 mmol (23 mg) sodium per tablet, meaning they are essentially sodium-free.
How Does Azithromycin Viatris Interact with Other Drugs?
Drug interactions are a critical consideration with any medication. Before starting Azithromycin Viatris, inform your doctor or pharmacist about all medications you are currently taking, have recently taken, or may be planning to take. This includes prescription drugs, over-the-counter medications, vitamins, and herbal supplements. Some interactions may require dose adjustments, enhanced monitoring, or avoidance of the combination altogether.
While azithromycin has fewer drug interactions than some other macrolides (such as erythromycin and clarithromycin) because it is a weaker inhibitor of the cytochrome P450 enzyme system, several clinically significant interactions have been identified and should be carefully considered.
Major Interactions
| Drug / Drug Class | Risk | Recommendation |
|---|---|---|
| Ergotamine / Dihydroergotamine | Ergotism (severe vasospasm causing pain, numbness, gangrene of extremities) | Do not combine. Concurrent use is contraindicated. |
| Warfarin and other anticoagulants | Increased anticoagulant effect and higher bleeding risk | Monitor INR closely during and shortly after azithromycin use. |
| Cyclosporine | Increased cyclosporine levels leading to potential toxicity | Monitor cyclosporine blood levels; dose adjustment may be needed. |
| Digoxin | Increased digoxin levels due to altered gut flora metabolism | Monitor digoxin blood levels during concurrent use. |
| QT-prolonging drugs (antiarrhythmics, antipsychotics, certain antibiotics) | Additive QT prolongation increasing risk of Torsades de Pointes | Avoid combination. Includes quinidine, procainamide, amiodarone, sotalol, dofetilide, pimozide, citalopram, moxifloxacin, levofloxacin. |
| Cisapride / Terfenadine | Cardiac arrhythmias due to QT prolongation | Do not combine. These drugs should not be used with azithromycin. |
| Colchicine | Increased colchicine toxicity (potentially fatal) | Use combination with extreme caution; monitor for colchicine toxicity signs. |
Other Interactions
| Drug / Drug Class | Effect | Recommendation |
|---|---|---|
| Antacids (aluminum/magnesium-containing) | Reduced absorption of azithromycin if taken simultaneously | Take azithromycin at least 1 hour before or 2 hours after antacids. |
| Statins (e.g., atorvastatin) | Possible increased risk of myopathy and rhabdomyolysis | Monitor for muscle pain or weakness during concurrent use. |
| Alfentanil | Potentially increased effect of alfentanil | Monitor closely if used together during anesthesia. |
| Hydroxychloroquine | Additive cardiac risk (QT prolongation) | Use with caution; cardiac monitoring recommended. |
This is not an exhaustive list of all possible drug interactions. Always inform your doctor or pharmacist about every medication, supplement, or herbal product you are using before starting Azithromycin Viatris. Some interactions may not be clinically significant for every patient, and your healthcare provider can assess the overall risk-benefit balance of concurrent medications.
What Is the Correct Dosage of Azithromycin Viatris?
Always take Azithromycin Viatris exactly as your doctor or pharmacist has instructed. If you are unsure about anything, consult your doctor or pharmacist. Azithromycin is given as a single daily dose. Swallow the tablets whole with a glass of water. You may take them with or without food, as absorption is not significantly affected by food intake.
Adults (Including Elderly Patients) and Adolescents Weighing Over 45 kg
The recommended total dose for most infections is 1,500 mg, which can be administered over either 3 or 5 days depending on your doctor’s assessment of the infection and your individual clinical situation.
| Indication | Regimen | Total Dose |
|---|---|---|
| Respiratory / Skin / Ear infections (3-day course) | 500 mg once daily for 3 days | 1,500 mg |
| Respiratory / Skin / Ear infections (5-day course) | 500 mg on day 1, then 250 mg once daily on days 2–5 | 1,500 mg |
| Sinusitis (adults and adolescents ≥16 years) | 500 mg once daily for 3 days | 1,500 mg |
| Uncomplicated chlamydia (urethritis / cervicitis) | 1,000 mg as a single dose, one day | 1,000 mg |
Children and Adolescents Weighing 45 kg or Less
The 250 mg film-coated tablets are not recommended for children and adolescents who weigh 45 kg or less. For these patients, other dosage forms of azithromycin are available, such as oral suspensions, which allow for accurate weight-based dosing. The typical pediatric dose is 10 mg/kg once daily for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg on days 2–5. Consult a pediatrician for appropriate dosing.
Elderly Patients
No dose adjustment is required for elderly patients. The same adult dosing regimens apply. However, elderly patients may have an increased baseline risk for cardiac arrhythmias, including QT prolongation, and should be monitored appropriately. If you are an elderly patient with other risk factors for heart rhythm problems, your doctor may consider alternative treatment options.
Patients with Kidney or Liver Problems
If you have mild to moderate kidney impairment, no dose adjustment is generally necessary. However, caution is advised in patients with severe renal impairment (glomerular filtration rate below 10 mL/min), as there is limited clinical data in this population. If you have liver disease, your doctor will carefully assess the risk-benefit ratio, as azithromycin is primarily eliminated via hepatic metabolism and biliary excretion. Liver function tests should be monitored, and the drug should be discontinued if signs of hepatic dysfunction develop.
Missed Dose
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next one at the regular time. Do not take a double dose to compensate for a forgotten dose. If you are unsure, consult your doctor or pharmacist.
Overdose
If you take more Azithromycin Viatris than prescribed, or if a child accidentally ingests the medication, contact your doctor, hospital emergency department, or poison control center immediately. Symptoms of overdose may include temporary hearing loss, severe nausea, vomiting, and diarrhea. Bring the medication packaging and any remaining tablets with you so that healthcare providers can identify what was taken and how much.
Do not stop taking Azithromycin Viatris without consulting your doctor, even if you feel better before the prescribed course is completed. It is critical to complete the full course of antibiotics as directed. Stopping treatment prematurely may allow the infection to return and can contribute to the development of antibiotic-resistant bacteria, making future infections harder to treat.
What Are the Side Effects of Azithromycin Viatris?
Like all medicines, Azithromycin Viatris can cause side effects, although not everybody gets them. Most side effects are mild to moderate and resolve on their own after treatment ends. However, some side effects can be serious and require immediate medical attention.
Stop taking azithromycin and contact your doctor immediately or go to the nearest emergency department if you experience: severe allergic reaction (swelling of lips, face, or throat with breathing difficulties, widespread rash or hives), severe skin reactions (blistering/bleeding on lips, eyes, mouth, or genitals), yellowing of skin or eyes (jaundice), fast or irregular heartbeat, fainting, or severe persistent diarrhea with blood or mucus.
Side Effect Frequency Overview
Very Common
May affect more than 1 in 10 people
- Diarrhea
- Nausea
- Abdominal pain
- Flatulence (gas)
Common
May affect up to 1 in 10 people
- Headache
- Dizziness, drowsiness (somnolence)
- Taste changes (dysgeusia)
- Numbness or tingling (paresthesia)
- Visual disturbances
- Hearing impairment, deafness
- Vomiting, indigestion (dyspepsia)
- Skin rash, itching (pruritus)
- Joint pain (arthralgia)
- Fatigue
- Changes in white blood cell counts
- Low blood bicarbonate levels
Uncommon
May affect up to 1 in 100 people
- Stevens-Johnson syndrome (severe blistering skin reaction)
- Hepatitis (liver inflammation causing jaundice, fatigue, appetite loss)
- Oral or vaginal thrush (fungal infections)
- Decreased sensation (hypoesthesia)
- Allergic reactions of varying severity
- Insomnia, nervousness
- Tinnitus (ringing in ears), vertigo
- Palpitations, hot flushes
- Increased sensitivity to sunlight (photosensitivity)
- Pneumonia, gastroenteritis, pharyngitis
- Nosebleeds, constipation, difficulty swallowing
- Urticaria (hives), dry skin, increased sweating
- Muscle pain, back pain, neck pain
- Chest pain, fever, general weakness
- Abnormal liver function tests
Rare
May affect up to 1 in 1,000 people
- Jaundice (yellowing of skin and eyes)
- Acute generalized exanthematous pustulosis (rapid-onset red skin with small blisters)
- Agitation, irritability
Not Known
Frequency cannot be estimated from available data
- Anaphylaxis (severe allergic reaction with breathing difficulty)
- Toxic epidermal necrolysis, erythema multiforme (severe skin reactions)
- DRESS syndrome (drug rash with fever, swollen glands, eosinophilia)
- QT prolongation, Torsades de Pointes (irregular heart rhythm)
- Hemolytic anemia (destruction of red blood cells)
- Pseudomembranous colitis (prolonged bloody diarrhea)
- Pancreatitis (inflammation of the pancreas)
- Interstitial nephritis (kidney inflammation)
- Hepatic failure (rare, potentially life-threatening)
- Convulsions (seizures)
- Thrombocytopenia (low platelets, easy bruising)
- Aggression, anxiety, delirium, hallucinations
- Syncope (fainting), hyperactivity
- Loss of taste or smell, or altered smell
- Myasthenia gravis exacerbation
- Hypotension (low blood pressure)
- Tongue or tooth discoloration
If you experience any side effects, including those not listed above, talk to your doctor or pharmacist. You can also report suspected side effects directly to your national pharmacovigilance authority. Reporting side effects helps to continuously monitor the benefit-risk balance of this medicine.
Gastrointestinal side effects such as mild diarrhea, nausea, and abdominal discomfort are the most frequently reported effects and usually resolve without treatment. Staying well hydrated and eating small, frequent meals may help. However, if diarrhea is severe, persistent, contains blood, or continues after completing the antibiotic course, contact your doctor promptly as this may indicate Clostridioides difficile infection requiring specific treatment.
How Should You Store Azithromycin Viatris?
Proper storage of medications is essential to ensure they remain safe and effective throughout their shelf life. Azithromycin Viatris 250 mg film-coated tablets do not require any special storage conditions. They can be stored at normal room temperature. However, the following guidelines should be observed:
- Keep out of reach and sight of children. Store the medication in a secure location where children cannot access it. Accidental ingestion by children can cause serious adverse effects.
- Do not use after the expiry date printed on the blister pack and carton after “EXP.” The expiry date refers to the last day of the indicated month. Expired medications may have reduced efficacy and potentially altered safety profiles.
- Keep tablets in the original packaging. Do not transfer the tablets to another container. The original blister packaging protects the tablets from moisture and light degradation.
- Dispose of unused medications properly. Do not dispose of medicines via household waste or down the drain. Return unused or expired medications to your local pharmacy for safe disposal. Proper disposal helps protect the environment and prevents accidental ingestion.
If you notice any change in the appearance of the tablets (such as discoloration, crumbling, or an unusual odor), do not take them. Consult your pharmacist for guidance on safe disposal and a replacement supply.
What Does Azithromycin Viatris Contain?
Understanding the composition of your medication can help you identify potential allergens or ingredients that may not be suitable for you based on dietary restrictions or medical conditions.
Active Ingredient
The active substance is azithromycin dihydrate, equivalent to 250 mg of azithromycin per tablet. Azithromycin dihydrate is the pharmaceutical salt form that provides optimal stability and bioavailability. Once ingested, the dihydrate form releases azithromycin, which is absorbed from the gastrointestinal tract and distributed to tissues throughout the body.
Inactive Ingredients (Excipients)
The inactive ingredients serve various pharmaceutical purposes such as binding, filling, coating, and improving the tablet’s appearance and stability:
- Tablet core: Microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate (type A), anhydrous colloidal silicon dioxide (E551), sodium lauryl sulfate, and magnesium stearate (E470b).
- Film coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), and macrogol 4000.
Appearance and Pack Sizes
Azithromycin Viatris 250 mg tablets are white to off-white, oval-shaped, film-coated tablets that are smooth on both sides. They are available in blister packs containing 4, 6, 12, 24, 50, or 100 tablets, although not all pack sizes may be marketed in every country. The most commonly dispensed pack sizes for standard treatment courses are 4 tablets (for the 5-day regimen, combined with 500 mg tablets for day 1) or 6 tablets (for the 3-day regimen, taking two 250 mg tablets daily).
Frequently Asked Questions
Azithromycin Viatris is a macrolide antibiotic used to treat a range of bacterial infections. These include lower respiratory tract infections (bronchitis, pneumonia), upper respiratory tract infections (sinusitis, pharyngitis, tonsillitis, otitis media), mild to moderate skin and soft tissue infections (folliculitis, cellulitis, erysipelas), and uncomplicated chlamydial infections of the urinary tract and cervix. It is only effective against bacterial infections and should not be used for viral infections such as colds or flu.
Take the tablets as a single daily dose, swallowed whole with a glass of water. You can take them with or without food. For most infections, the standard treatment is either a 3-day course (500 mg daily, which equals two 250 mg tablets per day) or a 5-day course (500 mg on day 1, then 250 mg on days 2 through 5). For chlamydia, a single 1,000 mg dose (four 250 mg tablets taken at once) is typically prescribed. Always complete the full prescribed course, even if you feel better before it is finished.
Antacids containing aluminum or magnesium can reduce the absorption of azithromycin if taken at the same time. To avoid this interaction, take azithromycin at least 1 hour before or 2 hours after taking an antacid. This timing ensures that the antibiotic is fully absorbed before the antacid can interfere with its uptake from the gastrointestinal tract.
Azithromycin can prolong the QT interval on an ECG, which may increase the risk of abnormal heart rhythms in susceptible individuals. While this is uncommon, the risk is higher in people with pre-existing heart conditions (heart failure, slow or irregular heartbeat, long QT syndrome), low potassium or magnesium levels, and in women and elderly patients. If you have any heart condition or are taking medications that affect heart rhythm, discuss this with your doctor before starting azithromycin. Seek immediate medical attention if you experience palpitations, fainting, or dizziness during treatment.
Mild diarrhea is a very common side effect of azithromycin and usually resolves on its own after treatment ends. Stay well hydrated by drinking plenty of fluids. However, if you experience severe diarrhea, diarrhea that lasts a long time, or diarrhea that contains blood or mucus, contact your doctor immediately. These symptoms may indicate Clostridioides difficile colitis, a potentially serious bowel infection that requires specific medical treatment. Do not take anti-diarrheal medicines without your doctor’s advice.
Azithromycin should only be used during pregnancy if your doctor considers it clinically necessary and the benefits outweigh the potential risks. While animal studies have not shown harmful effects on the fetus, there are limited data from controlled studies in pregnant women. Azithromycin passes into breast milk, so breastfeeding mothers should discuss the risks and benefits with their doctor. Your healthcare provider will make an individualized recommendation based on your specific clinical situation.
References
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023. Azithromycin listed as a core essential medicine for bacterial infections.
- European Medicines Agency (EMA). Azithromycin – Summary of Product Characteristics. Last updated 2024. Available from the EMA European public assessment reports database.
- U.S. Food and Drug Administration (FDA). Azithromycin tablets – Prescribing Information. Revised 2024. Silver Spring, MD: FDA.
- Metlay JP, Waterer GW, Long AC, et al. Diagnosis and Treatment of Adults with Community-Acquired Pneumonia: An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7):e45–e67. doi:10.1164/rccm.201908-1581ST.
- British National Formulary (BNF). Azithromycin Monograph. National Institute for Health and Care Excellence (NICE). Last updated 2025.
- Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012;366(20):1881–1890. doi:10.1056/NEJMoa1003833.
- Parnham MJ, Erakovic Haber V, Giamarellos-Bourboulis EJ, et al. Azithromycin: mechanisms of action and their relevance for clinical applications. Pharmacol Ther. 2014;143(2):225–245. doi:10.1016/j.pharmthera.2014.03.003.
- Workowski KA, Bachmann LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1–187. doi:10.15585/mmwr.rr7004a1.
- Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022;399(10325):629–655. doi:10.1016/S0140-6736(21)02724-0.
- Viatris Limited. Azithromycin Viatris 250 mg film-coated tablets – Patient Information Leaflet. Last revised December 2024.
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Last reviewed: | Published: | Content reviewed according to international medical guidelines (WHO, EMA, FDA, IDSA, BNF).