CEPHALEXIN

N/A

Manufactured by AMELLA PHARMA, LLC

51,762 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CEPHALEXIN

CEPHALEXIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AMELLA PHARMA, LLC. The most commonly reported adverse reactions for CEPHALEXIN include CHRONIC KIDNEY DISEASE, RENAL FAILURE, ACUTE KIDNEY INJURY, PAIN, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CEPHALEXIN.

Top Adverse Reactions

CHRONIC KIDNEY DISEASE2,155 reports
RENAL FAILURE1,554 reports
ACUTE KIDNEY INJURY1,538 reports
PAIN1,364 reports
DIARRHOEA1,351 reports
FATIGUE1,240 reports
NAUSEA1,221 reports
DYSPNOEA1,165 reports
ANXIETY1,132 reports
RASH1,092 reports
HEADACHE1,090 reports
DRUG INEFFECTIVE988 reports
OFF LABEL USE854 reports
VOMITING838 reports
DIZZINESS829 reports
URINARY TRACT INFECTION804 reports
PAIN IN EXTREMITY796 reports
ARTHRALGIA782 reports
FALL752 reports
PRURITUS731 reports
DRUG HYPERSENSITIVITY727 reports
END STAGE RENAL DISEASE707 reports
DEPRESSION695 reports
DEATH687 reports
ASTHENIA630 reports
PNEUMONIA626 reports
MALAISE622 reports
COUGH604 reports
PYREXIA582 reports
HYPERTENSION542 reports
HYPERSENSITIVITY538 reports
ABDOMINAL PAIN537 reports
BACK PAIN520 reports
CONDITION AGGRAVATED516 reports
ABDOMINAL PAIN UPPER509 reports
WEIGHT DECREASED506 reports
RENAL INJURY491 reports
NEPHROGENIC ANAEMIA458 reports
CELLULITIS448 reports
GASTROOESOPHAGEAL REFLUX DISEASE446 reports
EMOTIONAL DISTRESS431 reports
CONSTIPATION424 reports
INJURY413 reports
URTICARIA413 reports
CHEST PAIN393 reports
PULMONARY EMBOLISM384 reports
DECREASED APPETITE373 reports
PERIPHERAL SWELLING373 reports
INSOMNIA368 reports
ABDOMINAL DISCOMFORT358 reports
SWELLING FACE353 reports
HYPOTENSION352 reports
DRUG INTOLERANCE351 reports
ERYTHEMA348 reports
MUSCLE SPASMS340 reports
ANAEMIA337 reports
OEDEMA PERIPHERAL335 reports
ASTHMA334 reports
GAIT DISTURBANCE331 reports
PRODUCT DOSE OMISSION ISSUE330 reports
DEEP VEIN THROMBOSIS328 reports
CARDIAC FAILURE CONGESTIVE327 reports
FEELING ABNORMAL326 reports
INFECTION321 reports
HYPOAESTHESIA319 reports
MYOCARDIAL INFARCTION307 reports
DEHYDRATION305 reports
WEIGHT INCREASED302 reports
WHEEZING302 reports
SINUSITIS297 reports
DYSPHONIA292 reports
CONFUSIONAL STATE290 reports
ANHEDONIA288 reports
BRONCHITIS288 reports
ANGIOEDEMA282 reports
TUBULOINTERSTITIAL NEPHRITIS282 reports
MYALGIA272 reports
ECONOMIC PROBLEM268 reports
HYPERPARATHYROIDISM SECONDARY267 reports
SWOLLEN TONGUE266 reports
SEPSIS264 reports
CEREBROVASCULAR ACCIDENT262 reports
DYSPEPSIA261 reports
PARAESTHESIA254 reports
DRUG INTERACTION253 reports
THROMBOSIS252 reports
PRODUCT USE IN UNAPPROVED INDICATION251 reports
VISION BLURRED248 reports
CONTUSION246 reports
TREMOR238 reports
SOMNOLENCE237 reports
BLOOD PRESSURE INCREASED235 reports
REBOUND ACID HYPERSECRETION234 reports
NASOPHARYNGITIS233 reports
CHEST DISCOMFORT228 reports
HYPERHIDROSIS228 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION227 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES225 reports
LUNG DISORDER225 reports
PRODUCTIVE COUGH224 reports

Report Outcomes

Out of 20,625 classified reports for CEPHALEXIN:

Serious 74.3%Non-Serious 25.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female12,479 (64.1%)
Male6,956 (35.7%)
Unknown32 (0.2%)

Reports by Age

Age 65423 reports
Age 41296 reports
Age 64290 reports
Age 60287 reports
Age 53284 reports
Age 69279 reports
Age 70279 reports
Age 73278 reports
Age 67276 reports
Age 68276 reports
Age 61273 reports
Age 72272 reports
Age 59270 reports
Age 62269 reports
Age 75263 reports
Age 56249 reports
Age 66249 reports
Age 76249 reports
Age 57248 reports
Age 63244 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CEPHALEXIN?

This profile reflects 51,762 FDA FAERS reports that mention CEPHALEXIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CEPHALEXIN?

Frequently reported terms in FAERS include CHRONIC KIDNEY DISEASE, RENAL FAILURE, ACUTE KIDNEY INJURY, PAIN, DIARRHOEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CEPHALEXIN?

Labeling and FAERS entries often list AMELLA PHARMA, LLC in connection with CEPHALEXIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.