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.
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
- Dyspnoea
Dyspnoea
3,059 reports
- Nausea
Nausea
2,232 reports
- Pain
Pain
2,205 reports
- Pneumonia
Pneumonia
2,085 reports
- Cough
Cough
2,031 reports
- Diarrhoea
Diarrhoea
1,826 reports
- Fatigue
Fatigue
1,754 reports
- Headache
Headache
1,657 reports
- Condition Aggravated
Condition Aggravated
1,628 reports
- Asthma
Asthma
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) 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.
( 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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for azithromycin?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for azithromycin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 37,361.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.71%.
- trandolapril Δ 0.00 pts · 1,978 reports · ACE Inhibitor 9.71%death share
- promethazine Δ 0.05 pts · 17,969 reports · Phenothiazine Antiemetic / Antihistamine 9.76%death share
- nebivolol Δ 0.05 pts · 14,997 reports · Beta-1 Selective Blocker 9.76%death share
- doxycycline Δ 0.05 pts · 64,488 reports · Tetracycline Antibiotic 9.76%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 6, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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