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Isosorbide Side Effects

Common Isosorbide Side Effects


The most commonly reported Isosorbide side effects (click to view or check a box to report):

Product Quality Issue (279)
Dizziness (135)
Chest Pain (85)
Hypotension (80)
Headache (69)
Fall (69)
Myocardial Infarction (65)
Dyspnoea (65)
Asthenia (64)
Blood Pressure Decreased (52)
Syncope (49)
Loss Of Consciousness (42)
Nausea (34)
Fatigue (29)
Diarrhoea (29)
Vomiting (28)
Renal Failure Acute (28)
Incorrect Dose Administered (28)
Cardiac Failure (28)
Cardiac Failure Congestive (27)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Isosorbide Side Effects Reported to FDA

The following Isosorbide reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Isosorbide on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Poisoning, Completed Suicide, Exposure Via Ingestion
This is a report of a 36-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Isosorbide Dinitrate (dosage: NA, start time: NS), combined with:
  • Amlodipine
  • Losartan
  • Metoprolol Extended Release
  • Meclizine
  • Quinine
  • Tamulosin
  • Ethanol
  • Temazepam
and developed a serious reaction and side effect(s). The consumer presented with:
  • Poisoning
  • Completed Suicide
  • Exposure Via Ingestion
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isosorbide Dinitrate treatment in male patients, resulting in poisoning side effect.

Blood Pressure Decreased
This report suggests a potential Isosorbide Dinitrate Blood Pressure Decreased side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: diagnostic procedure and used Isosorbide Dinitrate (dosage: NA) starting Aug 09, 2012. Soon after starting Isosorbide Dinitrate the patient began experiencing various side effects, including:
  • Blood Pressure Decreased
Drugs used concurrently: NA. Although Isosorbide Dinitrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blood pressure decreased, may still occur.

Blood Pressure Decreased
This Blood Pressure Decreased problem was reported by a pharmacist from DE. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diagnostic procedure. On Aug 09, 2012 this consumer started treatment with Isosorbide Dinitrate (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Isosorbide Dinitrate, the patient experienced the following unwanted symptoms/side effects:
  • Blood Pressure Decreased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood pressure decreased, may become evident only after a product is in use by the general population.


This is a report of a 65-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Isosorbide Dinitrate (dosage: NA) starting NS. Concurrently used drugs:
  • Salicylates Nos
Soon after that, the consumer experienced the following side effects:
    This opens a possibility that Isosorbide Dinitrate treatment could cause the above reactions, including death, and some male subjects may be more susceptible.


    Completed Suicide
    A 39-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Isosorbide Dinitrate treatment (dosage: NA) on NS. Soon after starting Isosorbide Dinitrate treatment, the subject experienced various side effects, including:
    • Completed Suicide
    Concurrently used drugs:
    • Metoprolol
    • Amphetamine (Unk Unk, Ingst+inhal)
    This finding indicates that some male patients could be more vulnerable to Isosorbide Dinitrate.

    Completed Suicide
    A 42-year-old male patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Isosorbide Mononitrate(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
    • Completed Suicide
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Isosorbide Mononitrate efficacy:
    • Metoprolol
    • Clopidogrel
    The patient was hospitalized.

    Prostate Cancer, Photosensitivity Reaction, Lip Swelling, Overdose
    In this report, Isosorbide Mononitrate was administered for the following condition: angina pectoris.A 58-year-old male consumer from US (weight: NA) started Isosorbide Mononitrate treatment (dosage: 60 Mg 3 Tablet Once A Day) on Apr 22, 2010.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Prostate Cancer
    • Photosensitivity Reaction
    • Lip Swelling
    • Overdose
    A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Isosorbide Mononitrate treatment could be related to the listed above side effect(s).

    Cyanosis, Pain In Extremity, Peripheral Vascular Disorder
    This is a report of the following Isosorbide Mononitrate side effect(s):
    • Cyanosis
    • Pain In Extremity
    • Peripheral Vascular Disorder
    A 10-year-old female patient from US (weight: NA) presented with the following condition: angina pectoris and received a treatment with Isosorbide Mononitrate (dosage: NA) starting: Jun 07, 2013.The following concurrently used drugs could have generated interactions:
    • Amlodipine
    • Dexamethasone
    • Docusate
    • Effexor
    • Folic Acid
    • Lasix
    • Lisinopril
    • Metoprolol
    This report suggests that a Isosorbide Mononitrate treatment could be associated with the listed above side effect(s).

    Subdural Haematoma
    This Isosorbide Mononitrate report was submitted by a 92-year-old male consumer from GB (weight: NA). The patient was diagnosed with: NA and Isosorbide Mononitrate was administered (dosage: NA) starting: Dec 03, 2010. The consumer developed a set of symptoms:
    • Subdural Haematoma
    Other drugs used simultaneously:
    • Metformin
    • Nicorandil
    The patient was hospitalized.Those unexpected symptoms could be linked to a Isosorbide Mononitrate treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Subdural Haematoma, Vascular Dementia, Delirium, Orthostatic Hypotension
    This is a report of a possible correlation between Isosorbide Mononitrate use and the following symptoms/side effect(s):
    • Subdural Haematoma
    • Vascular Dementia
    • Delirium
    • Orthostatic Hypotension
    which could contribute to an assessment of Isosorbide Mononitrate risk profile.A 82-year-old male consumer from GB (weight: NA) was suffering from NA and was treated with Isosorbide Mononitrate (dosage: NA) starting Jul 25, 2012.Other concurrent medications:
    • Metformin Hydrochloride (2000 Mg)
    • Nicorandil
    The patient was hospitalized.

    Pruritus, Erythema
    A 75-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Isosorbide Mononitrate Er Tablets 60mg (dosage: NA) experienced the following side effect(s):
    • Pruritus
    • Erythema
    The treatment was started on 1999. Isosorbide Mononitrate Er Tablets 60mg was used in combination with the following drugs: NA.This report could alert potential Isosorbide Mononitrate Er Tablets 60mg consumers.

    Chest Pain
    In this report, a 72-year-old male patient from US (weight: NA) was affected by a possible Isosorbide Mononitrate Er Tablets 60mg side effect.The patient was diagnosed with NA. After a treatment with Isosorbide Mononitrate Er Tablets 60mg (dosage: NA, start date: 201108), the patient experienced the following side effect(s):
    • Chest Pain
    The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Isosorbide Mononitrate Er Tablets 60mg treatment.

    Dizziness
    This is a report of a 72-year-old female patient from US (weight: NA), who used Isosorbide Mononitrate Er Tablets 60mg (dosage: NA) for a treatment of myocardial infarction. After starting a treatment on 201205, the patient experienced the following side effect(s):
    • Dizziness
    The following drugs could possibly have interacted with the Isosorbide Mononitrate Er Tablets 60mg treatment NA.Taken together, these observations suggest that a Isosorbide Mononitrate Er Tablets 60mg treatment could be related to side effect(s), such as Dizziness.

    Ammonia Increased, Tinnitus, Dizziness
    This ammonia increased side effect was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight:NA) experienced the following symptoms/conditions: angina pectoris. The patient was prescribed Isosorbide Mononitrate Er Tablets 60mg (dosage: NA), which was started on 201206. Concurrently used drugs:
    • Lisinopril Tablets
    • Plavix
    When starting to take Isosorbide Mononitrate Er Tablets 60mg the consumer reported the following symptoms:
    • Ammonia Increased
    • Tinnitus
    • Dizziness
    These side effects may potentially be related to Isosorbide Mononitrate Er Tablets 60mg.

    Product Label Issue
    This is a Isosorbide Mononitrate side effect report of a 0-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Isosorbide Mononitrate (dosage:NA, start time: Oct 09, 2013), combined with: NA., and developed a serious reaction and a product label issue side effect. The patient presented with:
    • Product Label Issue
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Isosorbide Mononitrate treatment in male patients suffering from NA, resulting in product label issue.

    Gallbladder Non-functioning, Prostate Cancer, Prostatic Specific Antigen Increased, Urinary Incontinence, Spondylitis, Chest Discomfort, Blood Pressure Decreased, Malaise, Somnolence
    This report suggests a potential Isosorbide Mononitrate gallbladder non-functioning side effect(s) that can have serious consequences. A male patient from US (weight:NA) was diagnosed with the following health condition(s): coronary artery dilatation and used Isosorbide Mononitrate (dosage: 30 Mg) starting 2006. Soon after starting Isosorbide Mononitrate the patient began experiencing various side effects, including:
    • Gallbladder Non-functioning
    • Prostate Cancer
    • Prostatic Specific Antigen Increased
    • Urinary Incontinence
    • Spondylitis
    • Chest Discomfort
    • Blood Pressure Decreased
    • Malaise
    • Somnolence
    Drugs used concurrently:NA. The patient was hospitalized. Although Isosorbide Mononitrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gallbladder non-functioning, may still occur.

    Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
    This blood pressure decreased problem was reported by a physician from IT. A 68-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Isosorbide Dinitrate (dosage: 5mg;x1;sl). The following drugs/medications were being taken at the same time:
    • Radioisotope
    When commencing Isosorbide Dinitrate, the patient experienced the following unwanted symptoms /side effects:
    • Blood Pressure Decreased
    • Heart Rate Increased
    • Myocardial Ischaemia
    Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as blood pressure decreased, may become evident only after a product is in use by the general population.

    Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
    This is a Isosorbide Dinitrate side effect report of a 75-year-old male patient (weight: NA) from IT. The patient developed the following symptoms/conditions: NA and was treated with Isosorbide Dinitrate (dosage: 5mg;xl;sl) starting NS. Concurrently used drugs:
    • Radioisotope
    Soon after that, the consumer experienced the following of symptoms:
    • Blood Pressure Decreased
    • Heart Rate Increased
    • Myocardial Ischaemia
    This opens a possibility that Isosorbide Dinitrate could cause blood pressure decreased and that some male patients may be more susceptible.

    Angina Pectoris, Cardiac Failure, Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
    A 60-year-old male patient (weight: NA) from IT with the following symptoms: NA started Isosorbide Dinitrate treatment (dosage: 5mg;x1;sl) on NS. Soon after starting Isosorbide Dinitrate treatment, the consumer experienced several side effects, including:
    • Angina Pectoris
    • Cardiac Failure
    • Blood Pressure Decreased
    • Heart Rate Increased
    • Myocardial Ischaemia
    . Concurrently used drugs:
    • Thallium
    This finding indicates that some patients can be more vulnerable to developing Isosorbide Dinitrate side effects, such as angina pectoris.

    Angina Pectoris, Cardiac Failure, Myocardial Ischaemia, Blood Pressure Decreased, Heart Rate Increased
    This angina pectoris side effect was reported by a physician from US. A 85-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Isosorbide Dinitrate (dosage: 5mg;x1;sl), which was started on NS. Concurrently used drugs:
    • Radioisotope
    .When starting to take Isosorbide Dinitrate the consumer reported symptoms, such as:
    • Angina Pectoris
    • Cardiac Failure
    • Myocardial Ischaemia
    • Blood Pressure Decreased
    • Heart Rate Increased
    These side effects may potentially be related to Isosorbide Dinitrate.

    Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
    This is a report of a 65-year-old male patient (weight: NA) from IT, suffering from the following symptoms/conditions: NA, who was treated with Isosorbide Dinitrate (dosage: 5mg;x1;sl, start time: NS), combined with:
    • Radioisotope
    and developed a serious reaction and side effect(s). The consumer presented with:
    • Blood Pressure Decreased
    • Heart Rate Increased
    • Myocardial Ischaemia
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isosorbide Dinitrate treatment in male patients, resulting in blood pressure decreased side effect.

    Electrocardiogram St Segment Depression, Cardiac Failure, Heart Rate Increased, Blood Pressure Decreased, Myocardial Ischaemia
    This report suggests a potential Isosorbide Dinitrate Electrocardiogram St Segment Depression, Cardiac Failure, Heart Rate Increased, Blood Pressure Decreased, Myocardial Ischaemia side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Isosorbide Dinitrate (dosage: 5mg;x1;sl) starting NS. Soon after starting Isosorbide Dinitrate the patient began experiencing various side effects, including:
    • Electrocardiogram St Segment Depression
    • Cardiac Failure
    • Heart Rate Increased
    • Blood Pressure Decreased
    • Myocardial Ischaemia
    Drugs used concurrently:
    • Radioisotope
    Although Isosorbide Dinitrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as electrocardiogram st segment depression, may still occur.

    Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
    This Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia problem was reported by a physician from IT. A 86-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Isosorbide (dosage: 5mg;x1;sl). The following drugs were being taken at the same time:
    • Radioisotope
    When commencing Isosorbide, the patient experienced the following unwanted symptoms/side effects:
    • Blood Pressure Decreased
    • Heart Rate Increased
    • Myocardial Ischaemia
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood pressure decreased, may become evident only after a product is in use by the general population.

    Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
    This is a report of a 66-year-old male patient (weight: NA) from IT. The patient developed the following symptoms/conditions: NA and was treated with Isosorbide Dinitrate (dosage: 5 Mg;x1;sl) starting NS. Concurrently used drugs:
    • Radioisotope
    Soon after that, the consumer experienced the following side effects:
    • Blood Pressure Decreased
    • Heart Rate Increased
    • Myocardial Ischaemia
    This opens a possibility that Isosorbide Dinitrate treatment could cause the above reactions, including blood pressure decreased, and some male subjects may be more susceptible.

    Myocardial Ischaemia
    A 54-year-old male patient (weight: NA) from IT with the following symptoms/conditions: NA started Isosorbide Dinitrate treatment (dosage: 5mg;x1;sl) on NS. Soon after starting Isosorbide Dinitrate treatment, the subject experienced various side effects, including:
    • Myocardial Ischaemia
    Concurrently used drugs:
    • Raadioisotope
    This finding indicates that some male patients could be more vulnerable to Isosorbide Dinitrate.

    1 of 37 



    Top 10 Isosorbide Side Effects for Women

    Women Side EffectsReports
    Product Quality Issue 135
    Dizziness 65
    Chest Pain 49
    Dyspnoea 39
    Fall 34
    Headache 29
    Myocardial Infarction 27
    Asthenia 26
    Hypotension 26
    Blood Pressure Decreased 23

    Top 10 Isosorbide Side Effects for Men

    Men Side EffectsReports
    Product Quality Issue 142
    Dizziness 69
    Hypotension 53
    Asthenia 38
    Headache 38
    Myocardial Infarction 38
    Fall 35
    Chest Pain 34
    Blood Pressure Decreased 27
    Syncope 27

    Keep Track of Side Effects

    Note Your Observations

    It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

    Why Your Notes are Important

    Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Isosorbide Side Effects

    Did You Have a Isosorbide Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Isosorbide for You?

    Exceeded Expectations
    Effective
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    Isosorbide Safety Alerts, Active Ingredients, Usage Information

    NDC0143-1333
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameIsosorbide Mononitrate
    NameIsosorbide Mononitrate
    Dosage FormTABLET, COATED
    RouteORAL
    On market since20001005
    LabelerWest-ward Pharmaceutical Corp
    Active Ingredient(s)ISOSORBIDE MONONITRATE
    Strength(s)20
    Unit(s)mg/1
    Pharma Class

    Isosorbide Dosage, Warnings, Usage.

    Side Effects reported to FDA: 904

    Isosorbide safety alerts: 2008

    Reported deaths: 148

    Reported hospitalizations: 390

    Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg

    Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg
    Morphine Sulfate Extended Release Tablets 15 mg
    Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg
    Dextroamphetamine Sulfate Tablets 10 mg

    Audience: Pharmacists, other healthcare professionals, patients

    [Posted 11/10/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences. Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall.

    [November 07, 2008 - Press Release - Ethex Corp]

    Previous MedWatch Alert:
    [October 16, 2008]

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