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What the label lists and what reports show

Azithromycin side effects

Azithromycin's FDA label: “Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%).” FAERS holds 59,712 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (4,652 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the azithromycin FDA label on DailyMed (effective December 4, 2025, Bionpharma Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of azithromycin tablets?

Azithromycin tablets can cause serious side effects, including: Serious allergic reactions. Allergic reactions can happen in people taking azithromycin the active ingredient in azithromycin tablets, even after only 1 dose. Stop taking azithromycin tablets and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction: trouble breathing or swallowing swelling of the lips, tongue, face throat tightness, hoarseness rapid heartbeat faintness skin rash (hives) new onset of fever and swollen lymph nodes Stop taking azithromycin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to azithromycin tablets. Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take azithromycin tablets. […]

Source: FDA drug label, Bionpharma Inc., effective December 4, 2025 (SPL set 859bb02c-a4bc-46fa-9fc9-def1219b5dfb), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%).

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions ( 5.3 )] QT Prolongation [see Warnings and Precautions ( 5.4 )] Cardiovascular Death [see Warnings and Precautions ( 5.5 )] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.6 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.7 )] Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious adverse reactions of angioedema and cholestatic jaundice were reported. …

Source: FDA drug label, Bionpharma Inc., effective December 4, 2025 (SPL set 859bb02c-a4bc-46fa-9fc9-def1219b5dfb), via openFDA; the full label on DailyMed

What do FAERS reports show?

59,712 reports list azithromycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,260 are coded as a death and 22,121 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)5,209
  • Drug Ineffective (a use or a product term, not a reaction)5,123
  • Dyspnoea4,652
  • Nausea (named in the label)3,461
  • Pain3,280
  • Pneumonia (a use or a product term, not a reaction)3,225
  • Cough (named in the label)3,120
  • Drug Hypersensitivity2,991
  • Diarrhoea (named in the label)2,951
  • Fatigue (named in the label)2,886
  • Headache (named in the label)2,637
  • Pyrexia2,376
  • Vomiting (named in the label)2,304
  • Anxiety (named in the label)2,247
  • Asthma2,180
  • Condition Aggravated (a use or a product term, not a reaction)2,174
  • Rash (named in the label)2,007
  • Chronic Kidney Disease1,980
  • Malaise (named in the label)1,928
  • Acute Kidney Injury1,800
  • Dizziness (named in the label)1,781
  • Weight Decreased1,706
  • Wheezing1,697
  • Asthenia (named in the label)1,660
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)1,612

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Azithromycin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions