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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
on Feb 07, 2014 Male from US , 36 years of age, was treated with Isosorbide Dinitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: poisoning, completed suicide, exposure via ingestion. Isosorbide Dinitrate dosage: N/A.
Associated medications used:
  • Amlodipine
  • Losartan
  • Metoprolol Extended Release
  • Meclizine
  • Quinine
  • Tamulosin
  • Ethanol
  • Temazepam


Blood Pressure Decreased
Patient was taking Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: blood pressure decreased on Oct 31, 2013 from DE Additional patient health information: Male , 65 years of age, was diagnosed with and. Isosorbide Dinitrate dosage: N/A.

Blood Pressure Decreased
Adverse event was reported on Oct 31, 2013 by a Male taking Isosorbide Dinitrate (Dosage: N/A) was diagnosed with and. Location: DE , 73 years of age, After Isosorbide was administered, patient encountered several Isosorbide side effects: blood pressure decreased.


on Jan 15, 2014 Male from US , 65 years of age, was treated with Isosorbide Dinitrate. . Isosorbide Dinitrate dosage: N/A.
Associated medications used:
  • Salicylates Nos



Completed Suicide
on Jan 15, 2014 Male from US , 39 years of age, was treated with Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: completed suicide. Isosorbide Dinitrate dosage: N/A.
Multiple prescriptions taken:
  • Metoprolol
  • Amphetamine (Unk Unk, Ingst+inhal)


Completed Suicide
Patient was taking Isosorbide Mononitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: completed suicide on Jan 08, 2014 from US Additional patient health information: Male , 42 years of age, . Isosorbide Mononitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Metoprolol
  • Clopidogrel
Patient was hospitalized.

Prostate Cancer, Photosensitivity Reaction, Lip Swelling, Overdose
Adverse event was reported on Dec 23, 2013 by a Male taking Isosorbide Mononitrate (Dosage: 60 Mg 3 Tablet Once A Day) was diagnosed with and. Location: US , 58 years of age, weighting 205.0 lb, Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: prostate cancer, photosensitivity reaction, lip swelling, overdose.

Cyanosis, Pain In Extremity, Peripheral Vascular Disorder
on Dec 20, 2013 Female from US , child 10 years of age, was diagnosed with and was treated with Isosorbide Mononitrate. Patient felt the following Isosorbide side effects: cyanosis, pain in extremity, peripheral vascular disorder. Isosorbide Mononitrate dosage: N/A.
Multiple prescriptions taken:
  • Amlodipine
  • Dexamethasone
  • Docusate
  • Effexor
  • Folic Acid
  • Lasix
  • Lisinopril
  • Metoprolol


Subdural Haematoma
on Dec 06, 2013 Male from GB , 92 years of age, was treated with Isosorbide Mononitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: subdural haematoma. Isosorbide Mononitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Metformin
  • Nicorandil
Patient was hospitalized.

Subdural Haematoma, Vascular Dementia, Delirium, Orthostatic Hypotension
Patient was taking Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: subdural haematoma, vascular dementia, delirium, orthostatic hypotension on Dec 06, 2013 from GB Additional patient health information: Male , 82 years of age, . Isosorbide Mononitrate dosage: N/A.
Associated medications used:
  • Metformin Hydrochloride (2000 Mg)
  • Nicorandil
Patient was hospitalized.

Pruritus, Erythema
Adverse event was reported on Oct 29, 2013 by a Female taking Isosorbide Mononitrate Er Tablets 60mg (Dosage: N/A) . Location: US , 75 years of age, Patient felt the following Isosorbide side effects: pruritus, erythema.

Chest Pain
on Oct 29, 2013 Male from US , 72 years of age, was treated with Isosorbide Mononitrate Er Tablets 60mg. After Isosorbide was administered, patient encountered several Isosorbide side effects: chest pain. Isosorbide Mononitrate Er Tablets 60mg dosage: N/A.

Dizziness
on Oct 29, 2013 Female from US , 72 years of age, weighting 199.2 lb, was diagnosed with and was treated with Isosorbide Mononitrate Er Tablets 60mg. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: dizziness. Isosorbide Mononitrate Er Tablets 60mg dosage: N/A.

Ammonia Increased, Tinnitus, Dizziness
Patient was taking Isosorbide Mononitrate Er Tablets 60mg. Patient felt the following Isosorbide side effects: ammonia increased, tinnitus, dizziness on Oct 29, 2013 from US Additional patient health information: Female , 77 years of age, weighting 240.2 lb, was diagnosed with and. Isosorbide Mononitrate Er Tablets 60mg dosage: N/A.
Multiple prescriptions taken:
  • Lisinopril Tablets
  • Plavix


Product Label Issue
Adverse event was reported on Oct 10, 2013 by a Male taking Isosorbide Mononitrate (Dosage: N/A) . Location: US , child 0 years of age, After Isosorbide was administered, patient encountered several Isosorbide side effects: product label issue.

Gallbladder Non-functioning, Prostate Cancer, Prostatic Specific Antigen Increased, Urinary Incontinence, Spondylitis, Chest Discomfort, Blood Pressure Decreased, Malaise, Somnolence
on Dec 11, 2013 Male from US , weighting 178.4 lb, was diagnosed with and was treated with Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: gallbladder non-functioning, prostate cancer, prostatic specific antigen increased, urinary incontinence, spondylitis, chest discomfort, blood pressure decreased, malaise, somnolence. Isosorbide Mononitrate dosage: 30 Mg. Patient was hospitalized.

Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
on Aug 28, 2013 Male from IT , 68 years of age, was treated with Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: blood pressure decreased, heart rate increased, myocardial ischaemia. Isosorbide Dinitrate dosage: 5mg;x1;sl.
Multiple prescriptions taken:
  • Radioisotope


Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
Patient was taking Isosorbide Dinitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: blood pressure decreased, heart rate increased, myocardial ischaemia on Aug 28, 2013 from IT Additional patient health information: Male , 75 years of age, . Isosorbide Dinitrate dosage: 5mg;xl;sl.
Multiple concurrent drugs taken:
  • Radioisotope


Angina Pectoris, Cardiac Failure, Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
Adverse event was reported on Aug 28, 2013 by a Male taking Isosorbide Dinitrate (Dosage: 5mg;x1;sl) . Location: IT , 60 years of age, Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: angina pectoris, cardiac failure, blood pressure decreased, heart rate increased, myocardial ischaemia.
Associated medications used:
  • Thallium


Angina Pectoris, Cardiac Failure, Myocardial Ischaemia, Blood Pressure Decreased, Heart Rate Increased
on Aug 28, 2013 Male from US , 85 years of age, was treated with Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: angina pectoris, cardiac failure, myocardial ischaemia, blood pressure decreased, heart rate increased. Isosorbide Dinitrate dosage: 5mg;x1;sl.
Multiple prescriptions taken:
  • Radioisotope


Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
on Aug 28, 2013 Male from IT , 65 years of age, was treated with Isosorbide Dinitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: blood pressure decreased, heart rate increased, myocardial ischaemia. Isosorbide Dinitrate dosage: 5mg;x1;sl.
Multiple concurrent drugs taken:
  • Radioisotope


Electrocardiogram St Segment Depression, Cardiac Failure, Heart Rate Increased, Blood Pressure Decreased, Myocardial Ischaemia
Patient was taking Isosorbide Dinitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: electrocardiogram st segment depression, cardiac failure, heart rate increased, blood pressure decreased, myocardial ischaemia on Aug 28, 2013 from IT Additional patient health information: Male , 77 years of age, . Isosorbide Dinitrate dosage: 5mg;x1;sl.
Associated medications used:
  • Radioisotope


Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
Adverse event was reported on Aug 28, 2013 by a Female taking Isosorbide (Dosage: 5mg;x1;sl) . Location: IT , 86 years of age, Patient felt the following Isosorbide side effects: blood pressure decreased, heart rate increased, myocardial ischaemia.
Multiple prescriptions taken:
  • Radioisotope


Blood Pressure Decreased, Heart Rate Increased, Myocardial Ischaemia
on Aug 28, 2013 Male from IT , 66 years of age, was treated with Isosorbide Dinitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: blood pressure decreased, heart rate increased, myocardial ischaemia. Isosorbide Dinitrate dosage: 5 Mg;x1;sl.
Multiple concurrent drugs taken:
  • Radioisotope


Myocardial Ischaemia
on Aug 28, 2013 Male from IT , 54 years of age, was treated with Isosorbide Dinitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: myocardial ischaemia. Isosorbide Dinitrate dosage: 5mg;x1;sl.
Associated medications used:
  • Raadioisotope


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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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Isosorbide for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative ISOSORBIDE Names:ISOSORBID

    Active Ingredient: ISOSORBID

    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]

    Latest Isosorbide clinical trials