Drug Safety Information for A/T/S (Erythromycin)

Safety-related Labeling Changes for E.E.S. (ERYTHROMYCIN ETHYLSUCCINATE) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for ERYC (ERYTHROMYCIN) Rx Drug: FDA Link

Safety-related Labeling Changes for PCE (ERYTHROMYCIN) Discontinued Drug: FDA Link

Adverse Drug Reactions for A/T/S* (Erythromycin)

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 A/T/S
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity416
2Drug interaction360
3Dyspnoea336
4Nausea*329
5Vomiting*310
6Rash270
7Diarrhoea*248
8Headache234
9Pain*229
10Dizziness*206
11Pyrexia201
12Anxiety199
13Fatigue*177
14Abdominal pain166
15Depression163
16Malaise162
17Pneumonia160
18Drug ineffective160
19Asthenia159
20Back pain154

* This side effect also appears in "Top 10 Side Effects of A/T/S " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking A/T/S
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication3277
2Acne*901
3Lower respiratory tract infection*596
4Infection440
5Upper respiratory tract infection378
6Pneumonia328
7Rosacea310
8Prophylaxis272
9Bronchitis*263
10Cellulitis231

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


Types of Adverse Events for A/T/S

Total Reports Filed with FDA: 32137


Number of FDA Adverse Event Reports by Patient Age for A/T/S

Total Reports Filed with FDA: 32137*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Erythromycin (R-p mycin, Erythra-derm, Sansac, Erythro-statin, Pce, E-solve 2, Eryc sprinkles, Eryc 125, E-glades, E-base, E.e.s. granules, C-solve-2, Ilotycin, Ery, Erythromycin base, T-stat, Erycette, Staticin, Erythroped a, Theramycin z, Robimycin, Eryderm, Erygel, Akne-mycin, Emgel, A/t/s, E-mycin, Erythromycin, Erymax, Eryc, Ery-tab)

Charts are based on 32137 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 A/T/S 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.