ISOSORBIDE MONONITRATE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

53,965 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ISOSORBIDE MONONITRATE

ISOSORBIDE MONONITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for ISOSORBIDE MONONITRATE include DYSPNOEA, DIZZINESS, DIARRHOEA, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ISOSORBIDE MONONITRATE.

Top Adverse Reactions

DYSPNOEA1,504 reports
DIZZINESS1,397 reports
DIARRHOEA1,248 reports
FATIGUE1,242 reports
NAUSEA1,231 reports
CHEST PAIN1,185 reports
MYOCARDIAL INFARCTION1,018 reports
HEADACHE999 reports
VOMITING942 reports
HYPOTENSION901 reports
MALAISE898 reports
ACUTE KIDNEY INJURY891 reports
OFF LABEL USE856 reports
PAIN843 reports
FALL822 reports
ARTHRALGIA752 reports
PRURITUS722 reports
DRUG INTERACTION708 reports
DEHYDRATION679 reports
DEATH675 reports
ASTHENIA658 reports
RENAL FAILURE652 reports
BACK PAIN645 reports
PYREXIA630 reports
INSOMNIA621 reports
DRUG INEFFECTIVE611 reports
CHRONIC KIDNEY DISEASE606 reports
ANXIETY598 reports
PERIPHERAL SWELLING593 reports
ABDOMINAL PAIN UPPER583 reports
BLOOD GLUCOSE INCREASED583 reports
PNEUMONIA573 reports
FEELING ABNORMAL549 reports
PALPITATIONS545 reports
ABDOMINAL DISCOMFORT518 reports
MUSCULAR WEAKNESS512 reports
HYPERHIDROSIS504 reports
HALLUCINATION502 reports
COVID 19501 reports
MEMORY IMPAIRMENT491 reports
RASH490 reports
CARDIAC FAILURE CONGESTIVE484 reports
ANGINA PECTORIS476 reports
TACHYCARDIA476 reports
VISUAL IMPAIRMENT472 reports
HEART RATE INCREASED471 reports
ATRIAL FIBRILLATION460 reports
ANAEMIA456 reports
ALOPECIA454 reports
CARDIAC FAILURE445 reports
VENTRICULAR TACHYCARDIA439 reports
COUGH436 reports
COGNITIVE DISORDER435 reports
AMNESIA433 reports
DRY SKIN428 reports
TRANSIENT ISCHAEMIC ATTACK426 reports
SYNCOPE425 reports
ANGIOEDEMA424 reports
HYPERTENSION422 reports
LIP SWELLING408 reports
INTENTIONAL PRODUCT MISUSE399 reports
SUBARACHNOID HAEMORRHAGE399 reports
DISTURBANCE IN ATTENTION396 reports
TINNITUS396 reports
PAIN IN EXTREMITY393 reports
CONFUSIONAL STATE387 reports
MIGRAINE384 reports
GASTROINTESTINAL HAEMORRHAGE379 reports
MUSCLE TWITCHING377 reports
DIPLOPIA376 reports
BLINDNESS375 reports
OEDEMA PERIPHERAL369 reports
VASCULITIS368 reports
PERICARDITIS365 reports
WEIGHT DECREASED364 reports
ATRIAL TACHYCARDIA359 reports
EYE PRURITUS356 reports
CARDIOSPASM354 reports
CAROTID ARTERY OCCLUSION354 reports
PAIN OF SKIN351 reports
CONSTIPATION350 reports
FACIAL PAIN350 reports
PRURITUS GENITAL350 reports
PRODUCT QUALITY ISSUE348 reports
SLEEP TERROR348 reports
CONDITION AGGRAVATED347 reports
ANOSMIA346 reports
HYPONATRAEMIA344 reports
TENSION HEADACHE344 reports
PALMOPLANTAR KERATODERMA342 reports
URINARY TRACT INFECTION335 reports
MYALGIA322 reports
INTENTIONAL PRODUCT USE ISSUE315 reports
BRADYCARDIA311 reports
RENAL IMPAIRMENT311 reports
DEPRESSION303 reports
ABDOMINAL PAIN295 reports
DECREASED APPETITE295 reports
CORONARY ARTERY DISEASE281 reports
ACUTE MYOCARDIAL INFARCTION279 reports

Report Outcomes

Out of 19,938 classified reports for ISOSORBIDE MONONITRATE:

Serious 84.4%Non-Serious 15.6%

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

Male9,923 (53.7%)
Female8,527 (46.2%)
Unknown20 (0.1%)

Reports by Age

Age 78553 reports
Age 76546 reports
Age 75537 reports
Age 77500 reports
Age 79495 reports
Age 73494 reports
Age 72490 reports
Age 69482 reports
Age 71477 reports
Age 74475 reports
Age 83472 reports
Age 70422 reports
Age 80397 reports
Age 81388 reports
Age 68383 reports
Age 82381 reports
Age 67379 reports
Age 66348 reports
Age 86329 reports
Age 84327 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 ISOSORBIDE MONONITRATE?

This profile reflects 53,965 FDA FAERS reports that mention ISOSORBIDE MONONITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ISOSORBIDE MONONITRATE?

Frequently reported terms in FAERS include DYSPNOEA, DIZZINESS, DIARRHOEA, FATIGUE, NAUSEA, CHEST PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ISOSORBIDE MONONITRATE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with ISOSORBIDE MONONITRATE. 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.