PYRIDOXINE HYDROCHLORIDE

N/A

Manufactured by Fresenius Kabi USA, LLC

14,601 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PYRIDOXINE HYDROCHLORIDE

PYRIDOXINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for PYRIDOXINE HYDROCHLORIDE include OFF LABEL USE, NAUSEA, VOMITING, PAIN, GENERAL PHYSICAL HEALTH DETERIORATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PYRIDOXINE HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE403 reports
NAUSEA389 reports
VOMITING357 reports
PAIN306 reports
GENERAL PHYSICAL HEALTH DETERIORATION286 reports
ABDOMINAL PAIN276 reports
ABDOMINAL DISTENSION269 reports
CONDITION AGGRAVATED262 reports
DRUG INEFFECTIVE257 reports
CONSTIPATION255 reports
HEADACHE255 reports
FATIGUE253 reports
SOMNOLENCE253 reports
SEPSIS223 reports
ASCITES221 reports
DIARRHOEA220 reports
HYPONATRAEMIA216 reports
APPENDICITIS211 reports
APPENDICOLITH210 reports
CARDIOGENIC SHOCK202 reports
GASTROOESOPHAGEAL REFLUX DISEASE200 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME198 reports
STRESS197 reports
DYSPNOEA195 reports
DRUG INTOLERANCE192 reports
DRY MOUTH191 reports
SWELLING189 reports
DRUG HYPERSENSITIVITY183 reports
ANAEMIA176 reports
ASTHENIA172 reports
VENTRICULAR FIBRILLATION172 reports
BLOOD CHOLESTEROL INCREASED170 reports
DIZZINESS170 reports
PRODUCT USE IN UNAPPROVED INDICATION169 reports
SLEEP DISORDER151 reports
ABDOMINAL PAIN UPPER150 reports
ARTHRALGIA148 reports
BLOOD PHOSPHORUS INCREASED145 reports
HYPOAESTHESIA140 reports
DEATH138 reports
MIGRAINE136 reports
HYPERTENSION135 reports
MEMORY IMPAIRMENT133 reports
PYREXIA128 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION127 reports
PNEUMONIA124 reports
PARAESTHESIA123 reports
THROMBOSIS116 reports
DIABETES MELLITUS112 reports
ANXIETY111 reports
BACK PAIN111 reports
BLOOD URIC ACID INCREASED109 reports
INTENTIONAL PRODUCT MISUSE107 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE106 reports
NECK PAIN106 reports
RASH106 reports
BACTERIAL INFECTION105 reports
LOWER RESPIRATORY TRACT INFECTION105 reports
PERIPHERAL SWELLING105 reports
PULMONARY EMBOLISM105 reports
DECREASED APPETITE103 reports
HYPERSENSITIVITY103 reports
MYASTHENIA GRAVIS103 reports
OSTEOARTHRITIS103 reports
RHEUMATOID ARTHRITIS102 reports
NEURALGIA100 reports
INSOMNIA99 reports
URTICARIA98 reports
COMA97 reports
HYPERPHOSPHATAEMIA96 reports
PNEUMONIA ASPIRATION96 reports
NASOPHARYNGITIS95 reports
CONFUSIONAL STATE94 reports
PAIN IN EXTREMITY94 reports
MUSCULOSKELETAL STIFFNESS93 reports
HYPOPHOSPHATAEMIA92 reports
MALAISE92 reports
EPILEPSY91 reports
FALL88 reports
PRURITUS88 reports
STOMATITIS88 reports
MUSCLE SPASMS87 reports
INFUSION RELATED REACTION86 reports
WHEEZING84 reports
ALOPECIA83 reports
IRON DEFICIENCY82 reports
MATERNAL EXPOSURE DURING PREGNANCY82 reports
BLOOD CREATININE INCREASED81 reports
OEDEMA PERIPHERAL81 reports
ABDOMINAL DISCOMFORT80 reports
JOINT SWELLING80 reports
ARTHROPATHY79 reports
TASTE DISORDER79 reports
DEPRESSION76 reports
PRODUCT DOSE OMISSION ISSUE76 reports
HAEMOGLOBIN DECREASED75 reports
PERICARDITIS75 reports
WEIGHT INCREASED74 reports
BLEPHAROSPASM73 reports
MOBILITY DECREASED73 reports

Report Outcomes

Out of 2,440 classified reports for PYRIDOXINE HYDROCHLORIDE:

Serious 82.8%Non-Serious 17.2%

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

Female1,275 (57.5%)
Male942 (42.5%)
Unknown2 (0.1%)

Reports by Age

Age 80237 reports
Age 43131 reports
Age 6490 reports
Age 7578 reports
Age 2952 reports
Age 6547 reports
Age 5241 reports
Age 6241 reports
Age 6139 reports
Age 7039 reports
Age 7237 reports
Age 6735 reports
Age 6332 reports
Age 6932 reports
Age 7331 reports
Age 7129 reports
Age 7627 reports
Age 6626 reports
Age 7926 reports
Age 5125 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 PYRIDOXINE HYDROCHLORIDE?

This profile reflects 14,601 FDA FAERS reports that mention PYRIDOXINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PYRIDOXINE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, NAUSEA, VOMITING, PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, ABDOMINAL PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PYRIDOXINE HYDROCHLORIDE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with PYRIDOXINE HYDROCHLORIDE. 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.