Drug Safety Information for CEPHALEXIN (Cephalexin)

FDA Safety-related Labeling Changes for KEFLEX (CEPHALEXIN) Rx Drug: Safety Information Link

Adverse Drug Reactions for CEPHALEXIN* (Cephalexin)

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 CEPHALEXIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain988
2Nausea*765
3Anxiety*738
4Dyspnoea721
5Injury612
6Diarrhoea*587
7Vomiting556
8Fatigue*550
9Dizziness*541
10Depression526
11Drug hypersensitivity488
12Pain in extremity481
13Headache*474
14Asthenia469
15Oedema peripheral454
16Chest pain448
17Arthralgia443
18Deep vein thrombosis442
19Abdominal pain435
20Hypertension432

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

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

Reason # of FDA Reports
1Product used for unknown indication4652
2Urinary tract infection*1510
3Infection1215
4Cellulitis*835
5Antibiotic therapy372
6Acne284
7Prophylaxis262
8Antibiotic prophylaxis258
9Bacterial infection243
10Bronchitis*237

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


Types of Adverse Events for CEPHALEXIN

Total Reports Filed with FDA: 80208


Number of FDA Adverse Event Reports by Patient Age for CEPHALEXIN

Total Reports Filed with FDA: 80208*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cephalexin (Panixine disperdose, Palitrex, Keflet, Biocef, Ceporexine, Cephalexin, Keflex)

Charts are based on 80208 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 CEPHALEXIN 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.