Prescription medication · Macrolide Antibiotic
azithromycin
Also sold as Zithromax, Z-Pack. Azithromycin treats mild to moderate infections caused by certain bacteria.
Data updated 2026-05-15
- 37,361
- FDA reportsModerately reported
- 9
- InteractionsFew interactions
- In shortage
- FDA status
What the data shows
azithromycin (Zithromax) is a prescription Macrolide Antibiotic, reported at a middle-of-the-pack volume (37,361 FDA reports), with 9 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
azithromycin (Zithromax) is a prescription Macrolide Antibiotic. Azithromycin treats mild to moderate infections caused by certain bacteria.
Azithromycin is an antibiotic that fights bacteria. It is used to treat many different types of infections.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
azithromycin is currently listed as to be discontinued by the FDA. Affected manufacturer: Hospira, Inc., a Pfizer Company.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$2.07/unit
Generic Price
$17.41/unit
Generic Available
Yes (36 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Azithromycin treats mild to moderate infections caused by certain bacteria.
Common side effects
Diarrhea (5-14%), Nausea (3-18%), Abdominal pain (3-7%)
Key warnings
This drug can cause serious allergic reactions, liver problems, and heart rhythm changes.
The sections below are summarized in plain English from azithromycin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Azithromycin belongs to a class of drugs called macrolide antibiotics. It works by stopping the growth of bacteria. This helps your body fight off the infection.
How to Take It
Take azithromycin tablets with or without food. The dose and how long you take it depends on the infection. Follow your doctor's instructions carefully. For some infections, you may take it for just 1-5 days, while others may require longer treatment.
This is a plain-language summary of azithromycin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Studies haven't shown major risks to the baby during pregnancy. Talk to your doctor if you are pregnant or breastfeeding before taking this medicine.
This is a plain-language summary of azithromycin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of azithromycin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store azithromycin tablets at room temperature (68° to 77°F).
Side Effects (from patient reports)
Based on 37,361 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for azithromycin, by number of reports
- Difficulty breathing
Difficulty breathing
3,058 reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,232 reports
- Ache or discomfort
Ache or discomfort
2,204 reports
- Lung infection
Lung infection
2,085 reports
- Forceful expulsion of air from the lungs
Forceful expulsion of air from the lungs
2,031 reports
- Loose or watery stools
Loose or watery stools
1,826 reports
- Feeling tired
Feeling tired
1,754 reports
- Pain in the head
Pain in the head
1,657 reports
- The illness is getting worse
The illness is getting worse
1,628 reports
- Lung disease that causes difficulty breathing
Lung disease that causes difficulty breathing
1,592 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for azithromycin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where azithromycin sits
azithromycin has more FDA adverse-event reports than 68% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is azithromycin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 37,361 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
37,361
Reports Mentioning Death
3,628
9.7% of reports — not proof of cause
Hospitalization Reports
14,840
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | DYSPNOEA | 3,059 |
| 4 | NAUSEA | 2,232 |
| 5 | PAIN | 2,205 |
| 6 | PNEUMONIA | 2,085 |
| 7 | COUGH | 2,031 |
| 8 | DIARRHOEA | 1,826 |
| 9 | FATIGUE | 1,754 |
| 10 | HEADACHE | 1,657 |
| 11 | CONDITION AGGRAVATED | 1,628 |
| 12 | ASTHMA | 1,592 |
| 13 | PYREXIA | 1,531 |
| 14 | ANXIETY | 1,458 |
| 15 | VOMITING | 1,373 |
| 16 | CHRONIC KIDNEY DISEASE | 1,368 |
| 17 | ACUTE KIDNEY INJURY | 1,294 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This drug can cause serious allergic reactions, liver problems, and heart rhythm changes. Tell your doctor right away if you have signs of an allergic reaction, like rash or swelling. Also, tell your doctor if you have liver problems, heart problems, or muscle weakness.
Known Drug Interactions
albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline,...
Mechanism: Azithromycin does not significantly change the levels of theophylline in your body.
What to do: You can take these two drugs together safely without extra blood tests.
( 7.1 ) • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. [see Adverse Reactions (6) ] 7.2 Warfarin Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin.
Mechanism: Azithromycin may increase the effects of warfarin, which can make your blood take longer to clot.
What to do: Your doctor should closely monitor your blood clotting tests while you are taking both of these medications.
7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
Mechanism: It is not yet fully known how these drugs interact, but azithromycin might change how your body handles digoxin.
What to do: Your doctor should monitor you carefully for any side effects while you are using these two drugs together.
7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
Mechanism: It is not yet known exactly how these drugs interact, but azithromycin may potentially change the levels of colchicine in your body.
What to do: Your doctor should monitor you closely for any side effects if you take these two medicines together.
7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
Mechanism: While not proven in clinical trials, azithromycin might interfere with how your body handles phenytoin.
What to do: You should be monitored carefully by your healthcare provider while using both of these medications.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take azithromycin with food?
How long will I need to take azithromycin?
What should I do if I feel sick to my stomach?
Can azithromycin cause an allergic reaction?
Can I drink alcohol while taking azithromycin?
What if my symptoms don't improve?
Can azithromycin interact with other medications?
Is it safe for children?
Can azithromycin cause diarrhea?
What if I miss more than one dose?
What are the common side effects of azithromycin?
Does azithromycin interact with other medications?
What drug class is azithromycin?
Is azithromycin safe during pregnancy?
Is azithromycin currently in shortage?
Related Medications in Macrolide Antibiotic
Other drugs grouped near azithromycin - same-class peers and common alternatives.
amikacin
Amikin
Amikacin is an antibiotic medicine.
Compare with azithromycin →
amoxicillin
Amoxil
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections.
Compare with azithromycin →
amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
Compare with azithromycin →
ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
Compare with azithromycin →
cefazolin
Ancef, Kefzol
Cefazolin is an antibiotic medicine.
Compare with azithromycin →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for azithromycin
The FDA label for azithromycin (sold under brand names such as Zithromax, Z-Pack) classifies it as a prescription-only medication in the Macrolide Antibiotic class. Azithromycin treats mild to moderate infections caused by certain bacteria. Official labeling lists 4 commonly reported side effects, including Diarrhea (5-14%), Nausea (3-18%), Abdominal pain (3-7%).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 37,361 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $17.41 versus $2.07 for the brand.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 6, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages