AMPICILLIN SODIUM AND SULBACTAM SODIUM

N/A

Manufactured by Roerig

4,969 FDA adverse event reports analyzed

Last updated: 2026-04-15

About AMPICILLIN SODIUM AND SULBACTAM SODIUM

AMPICILLIN SODIUM AND SULBACTAM SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Roerig. The most commonly reported adverse reactions for AMPICILLIN SODIUM AND SULBACTAM SODIUM include PYREXIA, PNEUMONIA, DRUG INEFFECTIVE, DYSPNOEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMPICILLIN SODIUM AND SULBACTAM SODIUM.

Top Adverse Reactions

PYREXIA200 reports
PNEUMONIA186 reports
DRUG INEFFECTIVE137 reports
DYSPNOEA116 reports
DIARRHOEA107 reports
RASH102 reports
SEPSIS92 reports
PAIN83 reports
NAUSEA79 reports
VOMITING78 reports
ANAEMIA73 reports
HYPOTENSION72 reports
OFF LABEL USE69 reports
RESPIRATORY FAILURE67 reports
CONDITION AGGRAVATED65 reports
FATIGUE65 reports
INTERSTITIAL LUNG DISEASE64 reports
ERYTHEMA63 reports
HEPATIC FUNCTION ABNORMAL63 reports
PRURITUS63 reports
RENAL FAILURE63 reports
THROMBOCYTOPENIA59 reports
ALANINE AMINOTRANSFERASE INCREASED58 reports
ANXIETY58 reports
PLATELET COUNT DECREASED58 reports
PNEUMONIA ASPIRATION57 reports
ASTHENIA55 reports
DRUG HYPERSENSITIVITY55 reports
ASPARTATE AMINOTRANSFERASE INCREASED54 reports
CELLULITIS54 reports
DEATH54 reports
GENERAL PHYSICAL HEALTH DETERIORATION54 reports
SEPTIC SHOCK54 reports
URINARY TRACT INFECTION51 reports
ACUTE KIDNEY INJURY50 reports
ABDOMINAL PAIN49 reports
PLEURAL EFFUSION49 reports
RENAL FAILURE ACUTE48 reports
RENAL IMPAIRMENT48 reports
DRUG INTERACTION47 reports
INJURY47 reports
ARTHRALGIA46 reports
DRUG ERUPTION46 reports
DIZZINESS45 reports
HYPERTENSION45 reports
C REACTIVE PROTEIN INCREASED44 reports
CHEST PAIN44 reports
HEADACHE44 reports
WHITE BLOOD CELL COUNT DECREASED44 reports
DECREASED APPETITE43 reports
FALL40 reports
HYPOKALAEMIA39 reports
OEDEMA PERIPHERAL39 reports
BLOOD CREATININE INCREASED38 reports
INFECTION38 reports
DEPRESSED LEVEL OF CONSCIOUSNESS37 reports
NEUTROPENIA37 reports
BLOOD PRESSURE DECREASED36 reports
OSTEONECROSIS OF JAW36 reports
URTICARIA36 reports
CONSTIPATION35 reports
EMOTIONAL DISTRESS35 reports
ACUTE RESPIRATORY DISTRESS SYNDROME34 reports
CARDIAC FAILURE34 reports
HAEMOGLOBIN DECREASED34 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME34 reports
PANCYTOPENIA34 reports
SOMNOLENCE34 reports
BRONCHITIS33 reports
TOXIC EPIDERMAL NECROLYSIS33 reports
WEIGHT DECREASED33 reports
CARDIAC FAILURE CONGESTIVE32 reports
COUGH32 reports
DISSEMINATED INTRAVASCULAR COAGULATION32 reports
HYPOXIA32 reports
LIVER DISORDER32 reports
LOSS OF CONSCIOUSNESS32 reports
DEEP VEIN THROMBOSIS31 reports
MALIGNANT NEOPLASM PROGRESSION31 reports
NEUTROPHIL COUNT DECREASED31 reports
PRODUCT USE IN UNAPPROVED INDICATION31 reports
ANAPHYLACTIC SHOCK30 reports
DEHYDRATION30 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED30 reports
INSOMNIA30 reports
STAPHYLOCOCCAL INFECTION30 reports
CARDIAC ARREST29 reports
CHILLS29 reports
DYSPHAGIA29 reports
GAIT DISTURBANCE29 reports
DEPRESSION28 reports
HYPERSENSITIVITY28 reports
BLOOD BILIRUBIN INCREASED27 reports
BLOOD LACTATE DEHYDROGENASE INCREASED27 reports
FEBRILE NEUTROPENIA27 reports
GASTROINTESTINAL HAEMORRHAGE27 reports
OXYGEN SATURATION DECREASED27 reports
TACHYCARDIA27 reports
WHITE BLOOD CELL COUNT INCREASED27 reports
COVID 1926 reports

Report Outcomes

Out of 2,510 classified reports for AMPICILLIN SODIUM AND SULBACTAM SODIUM:

Serious 93.9%Non-Serious 6.1%

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

Male1,201 (51.7%)
Female1,112 (47.9%)
Unknown8 (0.3%)

Reports by Age

Age 6653 reports
Age 7049 reports
Age 7449 reports
Age 8046 reports
Age 6244 reports
Age 6043 reports
Age 7342 reports
Age 7542 reports
Age 6741 reports
Age 6941 reports
Age 7841 reports
Age 7140 reports
Age 6539 reports
Age 7739 reports
Age 7637 reports
Age 7935 reports
Age 3534 reports
Age 5833 reports
Age 5932 reports
Age 7232 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 AMPICILLIN SODIUM AND SULBACTAM SODIUM?

This profile reflects 4,969 FDA FAERS reports that mention AMPICILLIN SODIUM AND SULBACTAM SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMPICILLIN SODIUM AND SULBACTAM SODIUM?

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

Who manufactures AMPICILLIN SODIUM AND SULBACTAM SODIUM?

Labeling and FAERS entries often list Roerig in connection with AMPICILLIN SODIUM AND SULBACTAM SODIUM. 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.