AMPICILLIN SODIUM

N/A

Manufactured by Armas Pharmaceuticals Inc.

15,856 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMPICILLIN SODIUM

AMPICILLIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Armas Pharmaceuticals Inc.. The most commonly reported adverse reactions for AMPICILLIN SODIUM include DRUG INEFFECTIVE, FOETAL EXPOSURE DURING PREGNANCY, DRUG HYPERSENSITIVITY, MATERNAL EXPOSURE DURING PREGNANCY, PREMATURE BABY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMPICILLIN SODIUM.

Top Adverse Reactions

DRUG INEFFECTIVE820 reports
FOETAL EXPOSURE DURING PREGNANCY650 reports
DRUG HYPERSENSITIVITY603 reports
MATERNAL EXPOSURE DURING PREGNANCY531 reports
PREMATURE BABY511 reports
OFF LABEL USE402 reports
PYREXIA364 reports
PREMATURE DELIVERY336 reports
ACUTE KIDNEY INJURY322 reports
RENAL FAILURE310 reports
CHRONIC KIDNEY DISEASE285 reports
PRODUCT USE IN UNAPPROVED INDICATION276 reports
RASH265 reports
PAIN258 reports
DYSPNOEA244 reports
NAUSEA241 reports
PNEUMONIA238 reports
CONDITION AGGRAVATED236 reports
DIARRHOEA231 reports
SEPSIS217 reports
FATIGUE202 reports
VOMITING194 reports
HYPOTENSION193 reports
EXPOSURE DURING PREGNANCY182 reports
ANAEMIA176 reports
HEADACHE171 reports
URINARY TRACT INFECTION163 reports
ANXIETY161 reports
LOW BIRTH WEIGHT BABY158 reports
ASTHENIA154 reports
ABDOMINAL PAIN145 reports
DIZZINESS142 reports
SEPTIC SHOCK142 reports
THROMBOCYTOPENIA132 reports
INFECTION127 reports
DELIVERY126 reports
DEATH124 reports
OEDEMA123 reports
WEIGHT DECREASED123 reports
NORMAL LABOUR122 reports
RESPIRATORY FAILURE121 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS120 reports
COUGH116 reports
GAIT DISTURBANCE116 reports
ERYTHEMA115 reports
TACHYCARDIA114 reports
PRURITUS113 reports
EMOTIONAL DISTRESS112 reports
ARTHRALGIA111 reports
BACK PAIN110 reports
CHEST PAIN108 reports
DRUG INTERACTION108 reports
CONFUSIONAL STATE107 reports
RASH MACULO PAPULAR107 reports
PLEURAL EFFUSION106 reports
CONSTIPATION104 reports
TUBULOINTERSTITIAL NEPHRITIS103 reports
END STAGE RENAL DISEASE102 reports
NEUTROPENIA102 reports
DRUG RESISTANCE100 reports
HYPERTENSION100 reports
METABOLIC ACIDOSIS100 reports
TYPE IV HYPERSENSITIVITY REACTION100 reports
ANAPHYLACTIC REACTION99 reports
CHILLS94 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME94 reports
URTICARIA94 reports
CANDIDA INFECTION93 reports
DECREASED APPETITE93 reports
DEPRESSION93 reports
FALL93 reports
PATHOGEN RESISTANCE93 reports
LEUKOCYTOSIS89 reports
HYPOKALAEMIA87 reports
GENERAL PHYSICAL HEALTH DETERIORATION85 reports
DYSPHAGIA84 reports
ATRIAL SEPTAL DEFECT82 reports
BLOOD CREATININE INCREASED81 reports
RENAL IMPAIRMENT81 reports
ABDOMINAL DISTENSION80 reports
CARDIAC ARREST78 reports
DEHYDRATION77 reports
TOXICITY TO VARIOUS AGENTS77 reports
BRADYCARDIA76 reports
INJURY76 reports
OEDEMA PERIPHERAL76 reports
CONTUSION75 reports
HYPERSENSITIVITY75 reports
PATENT DUCTUS ARTERIOSUS75 reports
TOXIC EPIDERMAL NECROLYSIS75 reports
GASTROOESOPHAGEAL REFLUX DISEASE74 reports
HYPOAESTHESIA74 reports
NEONATAL RESPIRATORY DISTRESS SYNDROME71 reports
HALLUCINATION69 reports
RESPIRATORY DISTRESS69 reports
DRUG EXPOSURE DURING PREGNANCY67 reports
RENAL INJURY67 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION66 reports
MALAISE65 reports
ANHEDONIA64 reports

Report Outcomes

Out of 8,025 classified reports for AMPICILLIN SODIUM:

Serious 87.0%Non-Serious 13.0%

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

Female4,010 (57.2%)
Male2,973 (42.4%)
Unknown25 (0.4%)

Reports by Age

Age 2149 reports
Age 1145 reports
Age 61137 reports
Age 70103 reports
Age 62102 reports
Age 65101 reports
Age 6998 reports
Age 696 reports
Age 6396 reports
Age 7194 reports
Age 5489 reports
Age 6089 reports
Age 6689 reports
Age 6886 reports
Age 7383 reports
Age 5982 reports
Age 8281 reports
Age 5380 reports
Age 7279 reports
Age 6478 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?

This profile reflects 15,856 FDA FAERS reports that mention AMPICILLIN 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?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FOETAL EXPOSURE DURING PREGNANCY, DRUG HYPERSENSITIVITY, MATERNAL EXPOSURE DURING PREGNANCY, PREMATURE BABY, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMPICILLIN SODIUM?

Labeling and FAERS entries often list Armas Pharmaceuticals Inc. in connection with AMPICILLIN 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.