Drug Safety Information for ZITHROMAX (Azithromycin)

Safety-related Labeling Changes for ZITHROMAX (AZITHROMYCIN DIHYDRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZMAX (AZITHROMYCIN) Rx Drug: FDA Link

Adverse Drug Reactions for ZITHROMAX* (Azithromycin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ZITHROMAX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*1495
2Dyspnoea1458
3Nausea*1390
4Diarrhoea*1230
5Vomiting1149
6Anxiety*1106
7Pneumonia996
8Pyrexia986
9Fatigue917
10Injury912
11Headache*869
12Drug ineffective856
13Dizziness*840
14Cough800
15Abdominal pain778
16Asthenia755
17Pulmonary embolism750
18Drug hypersensitivity750
19Rash728
20Chest pain702

* This side effect also appears in "Top 10 Side Effects of ZITHROMAX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ZITHROMAX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication8172
2Bronchitis*3299
3Pneumonia*2668
4Sinusitis*2351
5Upper respiratory tract infection*1926
6Infection*1186
7Pharyngitis*1047
8Ill-defined disorder837
9Oropharyngeal pain798
10Prophylaxis795

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ZITHROMAX

Total Reports Filed with FDA: 122993


Number of FDA Adverse Event Reports by Patient Age for ZITHROMAX

Total Reports Filed with FDA: 122993*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Azithromycin (Zpak, Ultreon, Sumamed, Azasite, Azitrocin, Zithromax, Azithromycin, Zitromax, Azadose, Zmax)

Charts are based on 122993 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ZITHROMAX Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.