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Headache (14)
Neck Pain (8)
Leg Muscle Weakness (7)
Acute Headache (5)
Memory Loss (4)
Weight Gain (3)
Ulcers (2)
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Isosorbide Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 818 

Swelling Face (8372771-3)
on May 14, 2012 Female from UNITED KINGDOM , 72 years of age, weighting 155.2 lb, was treated with Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: swelling face. Isosorbide Mononitrate dosage: 60 Mg Once Daily In Morning.
Associated medications used:
  • Bumetanide (1mg Once Daily In The Morning)
  • Atenolol (25 Mg, 2x/day)
  • Zuclopenthixol Decanoate (300 Mg, 2x/week)
  • Mirtazapine (45mg, Once Daily At Night)
  • Solifenacin (5mg Once Daily In The Morning)
  • Simvastatin (40mg Once Daily At Night)
  • Moviprep (1 Sachet, Twice A Day)
  • Ibuprofen (1 Dose Form Three Times Daily)


Blood Glucose Increased, Pyrexia, Blast Crisis In Myelogenous Leukaemia, Mitral Valve Incompetence, Device Related Infection, Gingival Bleeding, Leukopenia, Platelet Count Decreased, Cardiogenic Shock (8372493-9)
Patient was taking Isosorbide Mononitrate. Patient felt the following Isosorbide side effects: blood glucose increased, pyrexia, blast crisis in myelogenous leukaemia, mitral valve incompetence, device related infection, gingival bleeding, leukopenia, platelet count decreased, cardiogenic shock on May 08, 2012 from UNITED KINGDOM Additional patient health information: Female , weighting 110.2 lb, . Isosorbide Mononitrate dosage: N/A.
Multiple prescriptions taken:
  • Metoprolol Tartrate
  • Red Blood Cells
  • Tasigna (800 Mg, Bid)
Patient was hospitalized.

Carpal Tunnel Syndrome, Impaired Gastric Emptying (8370600-5)
Adverse event was reported on May 11, 2012 by a Female taking Isosorbide Dinitrate (Dosage: N/A) . Location: UNITED STATES , 74 years of age, After Isosorbide was administered, patient encountered several Isosorbide side effects: carpal tunnel syndrome, impaired gastric emptying.
Multiple concurrent drugs taken:
  • Lasix
  • Humira
  • Iron
  • Metformin Hcl
  • Enalapril Maleate
  • Folic Acid
  • Lantus
  • Potassium Chloride
Patient was hospitalized.

Cold Sweat, Chest Pain, Dyspnoea, Angina Pectoris, Obesity, Chest Discomfort (8368152-9)
on May 10, 2012 Male from UNITED KINGDOM , weighting 304.2 lb, was diagnosed with
  • prophylaxis
  • psoriatic arthropathy
and was treated with Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: cold sweat, chest pain, dyspnoea, angina pectoris, obesity, chest discomfort. Isosorbide Mononitrate dosage: N/A.
Associated medications used:
  • Humira
  • Methotrexate
  • Propranolol



Pharyngeal Oedema, Rash, Rash Erythematous, Dermatitis Allergic, Pruritus (8362930-8)
on Apr 23, 2012 Female from UNITED STATES , 79 years of age, was diagnosed with
  • hypertension
and was treated with Isosorbide Mononitrate. Patient felt the following Isosorbide side effects: pharyngeal oedema, rash, rash erythematous, dermatitis allergic, pruritus. Isosorbide Mononitrate dosage: N/A.
Multiple prescriptions taken:
  • Aspirin
  • Pamelor
  • Donepezil Hydrochloride
  • Lasix
  • Donepezil Hydrochloride
  • Atorvastatin Calcium
  • Spironolactone
  • Benicar


Lower Limb Fracture, Upper Limb Fracture, Type 2 Diabetes Mellitus, Cardiac Failure Congestive, Osteoporosis, Rib Fracture, Coronary Artery Disease, Renal Failure Chronic (8351476-9)
Patient was taking Isosorbide Mononitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: lower limb fracture, upper limb fracture, type 2 diabetes mellitus, cardiac failure congestive, osteoporosis, rib fracture, coronary artery disease, renal failure chronic on May 08, 2012 from UNITED STATES Additional patient health information: Female , 61 years of age, . Isosorbide Mononitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Prednisone Tab
  • Azithormycin
  • Warfarin Sodium
  • Enalapril Maleate
  • Cefadroxil
  • Nexium
  • Luspirone Hcl
  • Glimepiride
Patient was hospitalized.

Cardiac Disorder (8349436-7)
Adverse event was reported on May 07, 2012 by a Male taking Isosorbide Mononitrate (Dosage: Unk) was diagnosed with
  • cardiac disorder
  • hypertension
and. Location: BRAZIL , 67 years of age, Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: cardiac disorder.
Associated medications used:
  • Norvasc (5 Mg, 1x/day)
  • Olmesartan Medoxomil And Hydrochlorothizide ([olmesartan Medoxomil 40mg] / [hydrochlorothiazide 12.5mg] (one Tablet), Daily)
Patient was hospitalized.

Deep Vein Thrombosis (8346909-8)
on Apr 30, 2012 Male from UNITED STATES , 63 years of age, weighting 167.6 lb, was diagnosed with
  • atrial fibrillation
and was treated with Isosorbide Mononitrate. Patient felt the following Isosorbide side effects: deep vein thrombosis. Isosorbide Mononitrate dosage: N/A.
Multiple prescriptions taken:
  • Nitroglycerin
  • Metoprolol Tartrate (25 Mg, Bid)
  • Metoprolol Tartrate
  • Danazol


Injection Site Erythema (8345969-8)
on Apr 24, 2012 Female from FRANCE , 76 years of age, was diagnosed with
  • imaging procedure
and was treated with Isosorbide Dinitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: injection site erythema. Isosorbide Dinitrate dosage: 0.3 Mg Once.
Multiple concurrent drugs taken:
  • Heparin Sodium (3000 Iu Once)
  • Diltiazem (25 Mg Once)


Injection Site Erythema, Injection Site Inflammation (8345935-2)
Patient was taking Isosorbide Dinitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: injection site erythema, injection site inflammation on Apr 24, 2012 from FRANCE Additional patient health information: Female , 66 years of age, was diagnosed with
  • imaging procedure
and. Isosorbide Dinitrate dosage: (0.3 Mg 1x Intra-arterial).
Associated medications used:
  • Heparin Sodium ((3000 Iu 1x Intra-arterial))
  • Diltiazem ((25 Mg 1x Intra-arterial))


Staphylococcal Infection, Vomiting, Febrile Neutropenia, Urinary Tract Infection, Malaise, Nausea (8342758-5)
Adverse event was reported on Apr 10, 2012 by a Male taking Isosorbide Mononitrate (Dosage: N/A) . Location: SPAIN , 71 years of age, weighting 167.6 lb, Patient felt the following Isosorbide side effects: staphylococcal infection, vomiting, febrile neutropenia, urinary tract infection, malaise, nausea.
Multiple prescriptions taken:
  • Simvastatin
  • Rituximab (rituximab) (injection) (933mg Per Day)
  • Aspirin
  • Omeprazole
  • Chlorambucil (chlorambucil) (126mg Per Day)
Patient was hospitalized.

Sinus Congestion, Rhinitis Allergic, Application Site Irritation, Dermatitis, Depression, Application Site Pruritus, Application Site Erythema, Blood Pressure Increased (8340652-7)
on Oct 06, 2009 Male from UNITED STATES , 81 years of age, weighting 194.0 lb, was treated with Isosorbide Mononitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: sinus congestion, rhinitis allergic, application site irritation, dermatitis, depression, application site pruritus, application site erythema, blood pressure increased. Isosorbide Mononitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Lisinopril
  • Vitamin Tab
  • Nitroquick (glyceryl Trinitrate)
  • Exelon (4.6 Mg, Qd, Transdermal)
  • Exelon (4.6 Mg, Qd, Transdermal)
  • Novolin 70/30
  • Sinemet Cr
  • Amlodipine


Anaemia, Neutropenia, Bone Marrow Failure (8337605-1)
on Apr 16, 1986 Male from SPAIN , 66 years of age, was treated with Isosorbide Dinitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: anaemia, neutropenia, bone marrow failure. Isosorbide Dinitrate dosage: N/A.
Associated medications used:
  • Elorgan
  • Digoxin
  • Ticlid
  • Amiodarone Hcl
Patient was hospitalized.

Cardiac Failure, Cardio-respiratory Arrest, Alanine Aminotransferase Increased (8329999-8)
Patient was taking Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: cardiac failure, cardio-respiratory arrest, alanine aminotransferase increased on Apr 26, 2012 from CHINA Additional patient health information: Male , 84 years of age, . Isosorbide Dinitrate dosage: N/A.
Multiple prescriptions taken:
  • Lipitor
  • Acetylsalicylic Acid
  • Lipitor (20 Mg, 1x/day)
  • Digoxin
  • Spironolactone
  • Metoprolol Tartrate
  • Furosemide


Embolic Stroke (8329498-3)
Adverse event was reported on Apr 26, 2012 by a Male taking Isosorbide Mononitrate (Dosage: 40 Mg) was diagnosed with
  • angina pectoris
and. Location: JAPAN , 76 years of age, After Isosorbide was administered, patient encountered several Isosorbide side effects: embolic stroke.
Multiple concurrent drugs taken:
  • Urso 250 (1800 Mg)
  • Candesartan Cilexetil And Hydrochlorothiazide
  • Alosenn
  • Mucosta (900 Mg)
  • Pradaxa (300 Mg)


Influenza Like Illness, Pain In Extremity, Angiopathy, Neuralgia, Headache, Rash (8328457-4)
on May 02, 2012 Male from UNITED STATES , 66 years of age, weighting 190.0 lb, was diagnosed with
  • angina pectoris
and was treated with Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: influenza like illness, pain in extremity, angiopathy, neuralgia, headache, rash. Isosorbide Mononitrate dosage: |dosagetext: 1 Tab||strength: 30 Mg||freq: 1 Time A Day||route: Oral|.

Pancreatitis Acute, Cardiac Arrest (8322985-3)
on Apr 23, 2012 Female from TUNISIA , 63 years of age, was diagnosed with
  • coronary artery insufficiency
  • hypertension
and was treated with Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: pancreatitis acute, cardiac arrest. Isosorbide Dinitrate dosage: N/A.
Multiple prescriptions taken:
  • Valsartan
  • Furosemide
  • Amiodarone Hcl


Ocular Ischaemic Syndrome, Eye Haemorrhage (8319292-1)
Patient was taking Isosorbide Mononitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: ocular ischaemic syndrome, eye haemorrhage on Apr 18, 2012 from BRAZIL Additional patient health information: Male , weighting 198.4 lb, . Isosorbide Mononitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Lipitor
  • Levothyroxine Sodium
  • Lyrica
  • Multivitamin
  • Aspirin
  • Insulin
  • Fluoxetine
  • Brilinta


Increased Tendency To Bruise, Bladder Cancer (8315081-2)
Adverse event was reported on Apr 19, 2012 by a Male taking Isosorbide Mononitrate (Dosage: N/A) . Location: UNITED STATES , weighting 165.1 lb, Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: increased tendency to bruise, bladder cancer.
Associated medications used:
  • Blood Thinners
  • Plavix
  • Lisinopril
  • Carvedilol
  • Niaspan
  • Aspirin
  • Pravastatin


Brain Natriuretic Peptide Increased, Acute Sinusitis (8313477-6)
on Apr 20, 2012 Female from JAPAN , weighting 143.3 lb, was treated with Isosorbide Dinitrate. Patient felt the following Isosorbide side effects: brain natriuretic peptide increased, acute sinusitis. Isosorbide Dinitrate dosage: N/A.
Multiple prescriptions taken:
  • Golimumab
  • Warfarin Sodium
  • Digoxin
  • Sulfasalazine
  • Golimumab
  • Tacrolimus


Abasia, Fatigue, Necrotising Fasciitis, Skin Graft (8305742-3)
on Apr 09, 2012 Male from JAPAN , 77 years of age, weighting 104.7 lb, was treated with Isosorbide Dinitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: abasia, fatigue, necrotising fasciitis, skin graft. Isosorbide Dinitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Enbrel (25 Mg, Q4wk, Subcutaneous)
  • Folic Acid
  • Norvasc
  • Rheumatrex (6 Mg, Qwk, Oral)
  • Ecard Combination (candesartan Cilexetil) (hydrochlorothiazide)
  • Voltaren
  • Fosamax
  • Tolterodine Tartrate
Patient was hospitalized.

Polymyositis, Muscular Weakness, Rhabdomyolysis, Myalgia, Chromaturia (8303354-9)
Patient was taking Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: polymyositis, muscular weakness, rhabdomyolysis, myalgia, chromaturia on Feb 23, 2012 from UNITED KINGDOM Additional patient health information: Female , 77 years of age, . Isosorbide Mononitrate dosage: 20 Mg, Bid.
Associated medications used:
  • Aspirin (75 Mg, Unk)
  • Cimetidine (Unk Unk, Qd)
  • Levothyroxine Sodium (100 ?g, Unk)
  • Furosemide Sodium (40 Mg, Unk)
  • Ciprofloxacin Hcl
  • Simvastatin (40 Mg, Unk)
  • Pindolol (2.5 Mg, Qd)
  • Nicorandil (10 Mg, Bid)
Patient was hospitalized.

Occult Blood Positive, Melaena, Anaemia, Haemoptysis, Dyspnoea (8301141-9)
Adverse event was reported on Apr 14, 2012 by a Male taking Isosorbide Dinitrate (Dosage: N/A) . Location: SINGAPORE , 69 years of age, weighting 132.3 lb, Patient felt the following Isosorbide side effects: occult blood positive, melaena, anaemia, haemoptysis, dyspnoea.
Multiple prescriptions taken:
  • Diltiazem Hcl (200 Mg, Unk)
  • Proton Pump Inhibitors
  • Amiodarone Hcl (200 Mg, Unk)
  • Xarelto (15 Mg, Qd)
  • Xarelto (20 Mg, Qd)
  • Digoxin (62.5 ?g, Unk)
  • Atorvastatin (20 Mg, Unk)
  • Enalapril Maleate (5 Mg, Unk)
Patient was hospitalized.

Hypoxia, Pulmonary Oedema, Cardiac Failure Congestive (8296341-0)
on Apr 16, 2012 Male from JAPAN , 86 years of age, was treated with Isosorbide Dinitrate. After Isosorbide was administered, patient encountered several Isosorbide side effects: hypoxia, pulmonary oedema, cardiac failure congestive. Isosorbide Dinitrate dosage: N/A.
Multiple concurrent drugs taken:
  • Zetia (10 Mg, Daily)
  • Crestor
  • Furosemide (40 Mg, Daily)
  • Plavix
  • Allopurinol
  • Candesartan Cilexetil (12 Mg, Daily)
  • Nikoranmart
  • Lantus


Cardiac Disorder, Blood Pressure Increased (8292089-7)
on Jan 03, 2012 Female from UNITED STATES , 78 years of age, weighting 200.0 lb, was diagnosed with
  • blood pressure abnormal
  • gastrooesophageal reflux disease
and was treated with Isosorbide Mononitrate. Directly after, patient experienced the unwanted or unexpected Isosorbide side effects: cardiac disorder, blood pressure increased. Isosorbide Mononitrate dosage: N/A.
Associated medications used:
  • Nexium
  • Lisinopril
  • Crestor
  • Deltiazam
  • Omeprazole


Showing 1-25 of 818 

Isosorbide Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Isosorbide Information

Alternative ISOSORBIDE Names:ISOSORBID

Active Ingredient: ISOSORBID

Isosorbide Dosage, Warnings, Usage.

Side Effects reported to FDA: 818. View Isosorbide Adverse Reports

Isosorbide safety alerts: 2008

Reported deaths: 134

Reported hospitalizations: 351

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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