MAGNESIUM SULFATE HEPTAHYDRATE

N/A

Manufactured by Baxter Healthcare Corporation

30,255 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MAGNESIUM SULFATE HEPTAHYDRATE

MAGNESIUM SULFATE HEPTAHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Corporation. The most commonly reported adverse reactions for MAGNESIUM SULFATE HEPTAHYDRATE include DRUG INEFFECTIVE, OFF LABEL USE, NAUSEA, PYREXIA, MATERNAL EXPOSURE DURING PREGNANCY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MAGNESIUM SULFATE HEPTAHYDRATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,177 reports
OFF LABEL USE811 reports
NAUSEA809 reports
PYREXIA776 reports
MATERNAL EXPOSURE DURING PREGNANCY741 reports
PAIN695 reports
FOETAL EXPOSURE DURING PREGNANCY674 reports
PREMATURE BABY658 reports
DIARRHOEA618 reports
DYSPNOEA579 reports
HYPOTENSION547 reports
ANAEMIA545 reports
VOMITING504 reports
PNEUMONIA475 reports
MACULAR DEGENERATION456 reports
ABDOMINAL PAIN455 reports
MALAISE448 reports
FATIGUE447 reports
HEADACHE429 reports
EXPOSURE DURING PREGNANCY418 reports
PREMATURE DELIVERY416 reports
SEPSIS401 reports
RENAL FAILURE394 reports
DEATH385 reports
ACUTE KIDNEY INJURY384 reports
FEBRILE NEUTROPENIA382 reports
CONSTIPATION376 reports
WEIGHT DECREASED375 reports
ANXIETY354 reports
ASTHENIA352 reports
RESPIRATORY FAILURE342 reports
ERYTHEMA299 reports
THROMBOCYTOPENIA299 reports
PRODUCT USE IN UNAPPROVED INDICATION292 reports
CONDITION AGGRAVATED287 reports
DIZZINESS286 reports
RASH284 reports
HYPOKALAEMIA282 reports
INFUSION RELATED REACTION275 reports
CARDIAC ARREST256 reports
DEHYDRATION256 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE256 reports
DYSPEPSIA249 reports
NEUTROPENIA242 reports
RENAL IMPAIRMENT240 reports
LOW BIRTH WEIGHT BABY239 reports
HYPERTENSION238 reports
COLITIS236 reports
PLATELET COUNT DECREASED231 reports
BACK PAIN228 reports
DRUG INTERACTION227 reports
PARAESTHESIA ORAL227 reports
FALL225 reports
DECREASED APPETITE221 reports
TACHYCARDIA218 reports
ATRIAL FIBRILLATION210 reports
PULMONARY OEDEMA210 reports
CYTOKINE RELEASE SYNDROME209 reports
HYPOMAGNESAEMIA209 reports
CHRONIC SINUSITIS205 reports
RECTAL HAEMORRHAGE204 reports
INJURY202 reports
CHEST PAIN199 reports
HAEMATOCHEZIA198 reports
PROCEDURAL PAIN196 reports
URINARY TRACT INFECTION194 reports
ELECTROCARDIOGRAM QT PROLONGED190 reports
OEDEMA PERIPHERAL185 reports
COUGH181 reports
EMOTIONAL DISTRESS178 reports
PLEURAL EFFUSION178 reports
CONFUSIONAL STATE177 reports
SEPTIC SHOCK177 reports
DEPRESSION175 reports
UNEVALUABLE EVENT175 reports
FREQUENT BOWEL MOVEMENTS168 reports
ORAL CANDIDIASIS165 reports
COLITIS ULCERATIVE164 reports
RADICULOPATHY164 reports
FEMALE GENITAL TRACT FISTULA162 reports
PANCYTOPENIA162 reports
RENAL FAILURE ACUTE159 reports
SOMNOLENCE159 reports
ARTHRALGIA158 reports
CHILLS158 reports
MULTI ORGAN FAILURE157 reports
DRUG EXPOSURE DURING PREGNANCY156 reports
VAGINAL DISCHARGE156 reports
PRURITUS155 reports
FEAR154 reports
HAEMOGLOBIN DECREASED154 reports
BLOOD CREATININE INCREASED153 reports
HYPOCALCAEMIA153 reports
VAGINAL FLATULENCE153 reports
PROCTITIS152 reports
HYPOXIA147 reports
ALANINE AMINOTRANSFERASE INCREASED146 reports
ASPARTATE AMINOTRANSFERASE INCREASED144 reports
ENCEPHALOPATHY144 reports
WHITE BLOOD CELL COUNT DECREASED144 reports

Report Outcomes

Out of 12,565 classified reports for MAGNESIUM SULFATE HEPTAHYDRATE:

Serious 90.4%Non-Serious 9.6%

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

Female6,818 (59.3%)
Male4,647 (40.4%)
Unknown36 (0.3%)

Reports by Age

Age 71317 reports
Age 65263 reports
Age 69240 reports
Age 67223 reports
Age 70208 reports
Age 68203 reports
Age 74196 reports
Age 59191 reports
Age 66184 reports
Age 60174 reports
Age 64172 reports
Age 75172 reports
Age 73170 reports
Age 62168 reports
Age 63166 reports
Age 61165 reports
Age 54162 reports
Age 72157 reports
Age 31155 reports
Age 58153 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 MAGNESIUM SULFATE HEPTAHYDRATE?

This profile reflects 30,255 FDA FAERS reports that mention MAGNESIUM SULFATE HEPTAHYDRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MAGNESIUM SULFATE HEPTAHYDRATE?

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

Who manufactures MAGNESIUM SULFATE HEPTAHYDRATE?

Labeling and FAERS entries often list Baxter Healthcare Corporation in connection with MAGNESIUM SULFATE HEPTAHYDRATE. 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.