AMOXICILLIN AND CLAVULANATE POTASSIUM

N/A

Manufactured by Allegis Holdings, LLC

50,339 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN AND CLAVULANATE POTASSIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegis Holdings, LLC. The most commonly reported adverse reactions for AMOXICILLIN AND CLAVULANATE POTASSIUM include DIARRHOEA, DRUG HYPERSENSITIVITY, NAUSEA, PYREXIA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMOXICILLIN AND CLAVULANATE POTASSIUM.

Top Adverse Reactions

DIARRHOEA1,832 reports
DRUG HYPERSENSITIVITY1,807 reports
NAUSEA1,404 reports
PYREXIA1,375 reports
DYSPNOEA1,359 reports
FATIGUE1,228 reports
VOMITING1,166 reports
PNEUMONIA1,152 reports
RASH1,015 reports
PAIN962 reports
HEADACHE902 reports
ACUTE KIDNEY INJURY837 reports
PRURITUS837 reports
DRUG INEFFECTIVE836 reports
ASTHENIA813 reports
SINUSITIS813 reports
COUGH771 reports
OFF LABEL USE763 reports
MALAISE713 reports
ANAEMIA687 reports
DIZZINESS656 reports
ABDOMINAL PAIN599 reports
ANXIETY595 reports
HYPOTENSION574 reports
ARTHRALGIA571 reports
DEATH565 reports
WEIGHT DECREASED561 reports
CHOLESTASIS548 reports
CONDITION AGGRAVATED546 reports
ERYTHEMA545 reports
THROMBOCYTOPENIA538 reports
RENAL FAILURE537 reports
URINARY TRACT INFECTION528 reports
FALL519 reports
DRUG INTERACTION492 reports
DECREASED APPETITE488 reports
URTICARIA477 reports
HYPERSENSITIVITY456 reports
NEUTROPENIA450 reports
BRONCHITIS445 reports
BACK PAIN444 reports
PAIN IN EXTREMITY442 reports
CONSTIPATION434 reports
SEPSIS422 reports
RASH MACULO PAPULAR418 reports
ABDOMINAL PAIN UPPER403 reports
INFECTION401 reports
CHRONIC KIDNEY DISEASE396 reports
DEHYDRATION395 reports
PULMONARY EMBOLISM385 reports
CONFUSIONAL STATE380 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS378 reports
INSOMNIA378 reports
CHEST PAIN377 reports
DEPRESSION364 reports
OEDEMA PERIPHERAL362 reports
HEPATOCELLULAR INJURY359 reports
COVID 19346 reports
HYPERTENSION337 reports
ASTHMA336 reports
GENERAL PHYSICAL HEALTH DETERIORATION335 reports
JAUNDICE335 reports
CHILLS325 reports
NASOPHARYNGITIS322 reports
UPPER RESPIRATORY TRACT INFECTION321 reports
FEBRILE NEUTROPENIA307 reports
SOMNOLENCE302 reports
ATRIAL FIBRILLATION301 reports
PRODUCTIVE COUGH295 reports
CELLULITIS284 reports
PANCYTOPENIA284 reports
RENAL FAILURE ACUTE284 reports
MYALGIA281 reports
PRODUCT DOSE OMISSION ISSUE276 reports
GAIT DISTURBANCE272 reports
ABDOMINAL DISCOMFORT271 reports
FEELING ABNORMAL266 reports
INFLUENZA263 reports
NEUROPATHY PERIPHERAL262 reports
OROPHARYNGEAL PAIN261 reports
PARAESTHESIA256 reports
TACHYCARDIA256 reports
MUSCLE SPASMS253 reports
ALANINE AMINOTRANSFERASE INCREASED251 reports
GASTROOESOPHAGEAL REFLUX DISEASE245 reports
DEEP VEIN THROMBOSIS244 reports
HYPOAESTHESIA243 reports
HAEMOGLOBIN DECREASED242 reports
INJURY242 reports
TOXIC SKIN ERUPTION239 reports
EMOTIONAL DISTRESS238 reports
EOSINOPHILIA238 reports
WHEEZING237 reports
LUNG DISORDER235 reports
RESPIRATORY FAILURE231 reports
CHEST DISCOMFORT228 reports
PERIPHERAL SWELLING225 reports
ASPARTATE AMINOTRANSFERASE INCREASED224 reports
ANAPHYLACTIC REACTION223 reports
DYSPHAGIA223 reports

Report Outcomes

Out of 26,342 classified reports for AMOXICILLIN AND CLAVULANATE POTASSIUM:

Serious 77.6%Non-Serious 22.4%

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

Female13,966 (56.6%)
Male10,663 (43.2%)
Unknown53 (0.2%)

Reports by Age

Age 68463 reports
Age 67441 reports
Age 63434 reports
Age 66433 reports
Age 65424 reports
Age 72417 reports
Age 76408 reports
Age 71398 reports
Age 62392 reports
Age 61379 reports
Age 73379 reports
Age 70369 reports
Age 74360 reports
Age 64359 reports
Age 53357 reports
Age 69354 reports
Age 56348 reports
Age 57348 reports
Age 60347 reports
Age 58342 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 AMOXICILLIN AND CLAVULANATE POTASSIUM?

This profile reflects 50,339 FDA FAERS reports that mention AMOXICILLIN AND CLAVULANATE POTASSIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMOXICILLIN AND CLAVULANATE POTASSIUM?

Frequently reported terms in FAERS include DIARRHOEA, DRUG HYPERSENSITIVITY, NAUSEA, PYREXIA, DYSPNOEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMOXICILLIN AND CLAVULANATE POTASSIUM?

Labeling and FAERS entries often list Allegis Holdings, LLC in connection with AMOXICILLIN AND CLAVULANATE POTASSIUM. 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.