PENICILLIN V POTASSIUM

N/A

Manufactured by Aurobindo Pharma Limited

7,202 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PENICILLIN V POTASSIUM

PENICILLIN V POTASSIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for PENICILLIN V POTASSIUM include DRUG HYPERSENSITIVITY, DYSPNOEA, ANXIETY, HYPERSENSITIVITY, ASTHMA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PENICILLIN V POTASSIUM.

Top Adverse Reactions

DRUG HYPERSENSITIVITY457 reports
DYSPNOEA211 reports
ANXIETY178 reports
HYPERSENSITIVITY149 reports
ASTHMA145 reports
CONDITION AGGRAVATED143 reports
FATIGUE135 reports
RASH130 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE123 reports
PAIN IN EXTREMITY122 reports
WHEEZING119 reports
HYPOTHYROIDISM116 reports
OBSTRUCTIVE AIRWAYS DISORDER116 reports
OFF LABEL USE114 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION110 reports
PAIN106 reports
FULL BLOOD COUNT ABNORMAL103 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES103 reports
NAUSEA98 reports
PULMONARY EMBOLISM98 reports
LUNG DISORDER96 reports
DRUG INEFFECTIVE94 reports
DIARRHOEA92 reports
HAEMOPTYSIS90 reports
PULMONARY FIBROSIS90 reports
PULMONARY ALVEOLAR HAEMORRHAGE89 reports
URTICARIA89 reports
NEURITIS88 reports
NEUROLOGICAL SYMPTOM88 reports
PULMONARY VASCULITIS88 reports
PNEUMONIA86 reports
VASCULITIS86 reports
DEATH85 reports
RESPIRATORY SYMPTOM85 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS81 reports
HEADACHE81 reports
PRODUCTIVE COUGH81 reports
PYREXIA77 reports
THROMBOSIS77 reports
PRURITUS76 reports
HYPOXIA71 reports
ARTERIOSCLEROSIS68 reports
NODULE68 reports
ARTERIOSCLEROSIS CORONARY ARTERY67 reports
CONJUNCTIVITIS ALLERGIC67 reports
NORMOCHROMIC NORMOCYTIC ANAEMIA67 reports
VOMITING67 reports
ARTHRALGIA64 reports
DUST ALLERGY64 reports
FORCED EXPIRATORY VOLUME DECREASED64 reports
MITE ALLERGY64 reports
MYCOTIC ALLERGY64 reports
ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE62 reports
SPIROMETRY ABNORMAL62 reports
TOTAL LUNG CAPACITY ABNORMAL60 reports
ACUTE KIDNEY INJURY56 reports
COUGH54 reports
ASTHENIA49 reports
CHRONIC KIDNEY DISEASE49 reports
DIZZINESS49 reports
RENAL FAILURE47 reports
HYPERTENSION45 reports
HYPOTENSION45 reports
ABDOMINAL PAIN44 reports
MALAISE44 reports
PRODUCT DOSE OMISSION ISSUE44 reports
URINARY TRACT INFECTION43 reports
CONSTIPATION42 reports
SWELLING42 reports
COVID 1941 reports
EMOTIONAL DISTRESS41 reports
NASOPHARYNGITIS39 reports
WEIGHT DECREASED39 reports
ANAEMIA38 reports
BACK PAIN36 reports
CAPILLARITIS35 reports
DEPRESSION35 reports
ANAPHYLACTIC REACTION34 reports
DEHYDRATION33 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION33 reports
GAIT DISTURBANCE32 reports
SEPSIS32 reports
INSOMNIA31 reports
MUSCLE SPASMS31 reports
NEUROPATHY PERIPHERAL31 reports
FALL30 reports
INFECTION30 reports
SLEEP DISORDER30 reports
ABDOMINAL PAIN UPPER29 reports
INJURY29 reports
SKIN EXFOLIATION29 reports
HAEMOGLOBIN DECREASED28 reports
PLATELET COUNT DECREASED28 reports
THROMBOCYTOPENIA28 reports
MYALGIA27 reports
SINUSITIS27 reports
CHEST PAIN25 reports
ILLNESS25 reports
MYOCARDIAL INFARCTION25 reports
ALOPECIA24 reports

Report Outcomes

Out of 2,398 classified reports for PENICILLIN V POTASSIUM:

Serious 55.4%Non-Serious 44.6%

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

Female1,315 (61.2%)
Male818 (38.1%)
Unknown16 (0.7%)

Reports by Age

Age 6588 reports
Age 4231 reports
Age 6230 reports
Age 7230 reports
Age 6329 reports
Age 7129 reports
Age 5928 reports
Age 5625 reports
Age 5825 reports
Age 5724 reports
Age 6924 reports
Age 6423 reports
Age 6122 reports
Age 6622 reports
Age 6822 reports
Age 4921 reports
Age 4720 reports
Age 6020 reports
Age 8020 reports
Age 5019 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 PENICILLIN V POTASSIUM?

This profile reflects 7,202 FDA FAERS reports that mention PENICILLIN V POTASSIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PENICILLIN V POTASSIUM?

Frequently reported terms in FAERS include DRUG HYPERSENSITIVITY, DYSPNOEA, ANXIETY, HYPERSENSITIVITY, ASTHMA, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PENICILLIN V POTASSIUM?

Labeling and FAERS entries often list Aurobindo Pharma Limited in connection with PENICILLIN V 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.