MIDODRINE HYDROCHLORIDE

N/A

Manufactured by Advagen Pharma Limited

9,858 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MIDODRINE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Limited. The most commonly reported adverse reactions for MIDODRINE HYDROCHLORIDE include NAUSEA, HYPOTENSION, DYSPNOEA, HEADACHE, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MIDODRINE HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA331 reports
HYPOTENSION323 reports
DYSPNOEA315 reports
HEADACHE310 reports
DEATH294 reports
DIARRHOEA278 reports
FATIGUE276 reports
DIZZINESS269 reports
FALL254 reports
VOMITING191 reports
DRUG INEFFECTIVE180 reports
COUGH173 reports
PNEUMONIA173 reports
PAIN170 reports
ASTHENIA168 reports
OFF LABEL USE167 reports
WEIGHT DECREASED162 reports
PRODUCT DOSE OMISSION ISSUE143 reports
INFUSION SITE PAIN124 reports
MALAISE120 reports
DECREASED APPETITE119 reports
URINARY TRACT INFECTION115 reports
PAIN IN EXTREMITY112 reports
SOMNOLENCE109 reports
BLOOD PRESSURE DECREASED106 reports
COVID 19105 reports
CHEST PAIN103 reports
LOSS OF CONSCIOUSNESS102 reports
ANXIETY101 reports
CONFUSIONAL STATE101 reports
ARTHRALGIA95 reports
SYNCOPE90 reports
DEHYDRATION88 reports
HYPERTENSION88 reports
PYREXIA87 reports
HALLUCINATION85 reports
ILLNESS84 reports
RASH83 reports
PRURITUS81 reports
FEELING ABNORMAL80 reports
ABDOMINAL PAIN79 reports
DEPRESSION79 reports
SEPSIS79 reports
CONDITION AGGRAVATED77 reports
OEDEMA PERIPHERAL76 reports
INSOMNIA75 reports
INFUSION SITE ERYTHEMA74 reports
CONSTIPATION73 reports
HOSPITALISATION73 reports
BACK PAIN72 reports
FLUID RETENTION71 reports
OXYGEN SATURATION DECREASED71 reports
PERIPHERAL SWELLING70 reports
GENERAL PHYSICAL HEALTH DETERIORATION69 reports
TREMOR69 reports
NASOPHARYNGITIS68 reports
ABDOMINAL PAIN UPPER67 reports
GAIT DISTURBANCE66 reports
INFECTION65 reports
INFUSION SITE SWELLING65 reports
EPISTAXIS64 reports
WEIGHT INCREASED64 reports
BLOOD PRESSURE INCREASED60 reports
ORTHOSTATIC HYPOTENSION60 reports
DRUG HYPERSENSITIVITY59 reports
SEASONAL ALLERGY59 reports
ATRIAL FIBRILLATION58 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION58 reports
ACUTE KIDNEY INJURY57 reports
PRODUCT USE IN UNAPPROVED INDICATION57 reports
ANAEMIA56 reports
ABDOMINAL DISTENSION55 reports
RENAL FAILURE55 reports
PALPITATIONS54 reports
ABDOMINAL DISCOMFORT53 reports
DRUG INTERACTION53 reports
HEART RATE INCREASED53 reports
CARDIAC FAILURE CONGESTIVE52 reports
DYSPNOEA EXERTIONAL52 reports
INCORRECT DOSE ADMINISTERED52 reports
MOBILITY DECREASED52 reports
BALANCE DISORDER51 reports
PLEURAL EFFUSION51 reports
PRODUCT USE ISSUE51 reports
SINUSITIS49 reports
HYPOAESTHESIA48 reports
MIGRAINE48 reports
MUSCLE SPASMS48 reports
HYPERVOLAEMIA47 reports
MUSCULAR WEAKNESS47 reports
CARDIAC FAILURE46 reports
DYSPHAGIA46 reports
CEREBROVASCULAR ACCIDENT45 reports
FLUSHING45 reports
CHEST DISCOMFORT44 reports
CHILLS44 reports
ERYTHEMA44 reports
INFLUENZA43 reports
TACHYCARDIA43 reports
SEIZURE42 reports

Report Outcomes

Out of 3,678 classified reports for MIDODRINE HYDROCHLORIDE:

Serious 71.7%Non-Serious 28.3%

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

Female2,098 (61.1%)
Male1,333 (38.9%)

Reports by Age

Age 7571 reports
Age 6570 reports
Age 7264 reports
Age 7759 reports
Age 6358 reports
Age 6857 reports
Age 7057 reports
Age 7457 reports
Age 7155 reports
Age 7355 reports
Age 7652 reports
Age 6750 reports
Age 6949 reports
Age 6646 reports
Age 7845 reports
Age 7945 reports
Age 8043 reports
Age 5742 reports
Age 6442 reports
Age 8142 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 MIDODRINE HYDROCHLORIDE?

This profile reflects 9,858 FDA FAERS reports that mention MIDODRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MIDODRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include NAUSEA, HYPOTENSION, DYSPNOEA, HEADACHE, DEATH, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MIDODRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Advagen Pharma Limited in connection with MIDODRINE 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.