Imdur (Isosorbide Mononitrate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate as IMDUR Tablets once daily. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate in the three placebo-controlled North American studies discontinued treatment because of adverse events. Most of these discontinued because of headache. Dizziness was rarely associated with withdrawal from these studies. Since headache appears to be a dose-related adverse effect and tends to disappear with continued treatment, it is recommended that IMDUR treatment be initiated at low doses for several days before being increased to desired levels.

FREQUENCY AND ADVERSE EVENTS (DISCONTINUED) ¹

Three Controlled North American Studies
Dose	Placebo	30 mg	60 mg	120 mg 2	240 mg
Patients	96	60	102	65	65
Headache	15% (0%)	38% (5%)	51% (8%)	42% (5%)	57% (8%)
Dizziness	4% (0%)	8% (0%)	11% (1%)	9% (2%)	9% (2%)

In addition, the three North American trials were pooled with 11 controlled trials conducted in Europe. Among the 14 controlled trials, a total of 711 patients were randomized to IMDUR Tablets. When the pooled data were reviewed, headache and dizziness were the only adverse events that were reported by >5% of patients. Other adverse events, each reported by ≤5% of exposed patients, and in many cases of uncertain relation to drug treatment, were:

Autonomic Nervous System Disorders: Dry mouth, hot flushes.

Body as a Whole: Asthenia, back pain, chest pain, edema, fatigue, fever, flu-like symptoms, malaise, rigors.

Cardiovascular Disorders, General: Cardiac failure, hypertension, hypotension.

Central and Peripheral Nervous System Disorders: Dizziness, headache, hypoesthesia, migraine, neuritis, paresis, paresthesia, ptosis, tremor, vertigo.

Gastrointestinal System Disorders: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting.

Hearing and Vestibular Disorders: Earache, tinnitus, tympanic membrane perforation.

Heart Rate and Rhythm Disorders: Arrhythmia, arrhythmia atrial, atrial fibrillation, bradycardia, bundle branch block, extrasystole, palpitation, tachycardia, ventricular tachycardia.

Liver and Biliary System Disorders: SGOT increase, SGPT increase.

Metabolic and Nutritional Disorders: Hyperuricemia, hypokalemia.

Musculoskeletal System Disorders: Arthralgia, frozen shoulder, muscle weakness, musculoskeletal pain, myalgia, myositis, tendon disorder, torticollis.

Myo-, Endo-, Pericardial and Valve Disorders: Angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q wave abnormality.

Platelet, Bleeding and Clotting Disorders: Purpura, thrombocytopenia.

Psychiatric Disorders: Anxiety, concentration impaired, confusion, decreased libido, depression, impotence, insomnia, nervousness, paroniria, somnolence.

Red Blood Cell Disorder: Hypochromic anemia.

Reproductive Disorders, Female: Atrophic vaginitis, breast pain.

Resistance Mechanism Disorders: Bacterial infection, moniliasis, viral infection.

Respiratory System Disorders: Bronchitis, bronchospasm, coughing, dyspnea, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, rhinitis, sinusitis.

Skin and Appendages Disorders: Acne, hair texture abnormal, increased sweating, pruritus, rash, skin nodule.

Urinary System Disorders: Polyuria, renal calculus, urinary tract infection.

Vascular (Extracardiac) Disorders: Flushing, intermittent claudication, leg ulcer, varicose vein.

Vision Disorders: Conjunctivitis, photophobia, vision abnormal.

In addition, the following spontaneous adverse event has been reported during the marketing of isosorbide mononitrate: syncope.

REPORTS OF SUSPECTED IMDUR SIDE EFFECTS / ADVERSE REACTIONS

Possible Imdur side effects / adverse reactions in 57 year old female

Reported by a pharmacist from United States on 2011-11-07

Patient: 57 year old female

Reactions: Confusional State

Suspect drug(s):
Klor-CON
    Dosage: unk

Lipitor
    Dosage: 40 mg, unk

Bystolic
    Dosage: unk

Lasix
    Dosage: unk

Nexium
    Dosage: unk

Vivelle
    Dosage: unk

Paxil
    Dosage: unk

Flexeril
    Dosage: unk

Xanax
    Dosage: unk

Imdur
    Dosage: unk

Actonel
    Dosage: unk

Possible Imdur side effects / adverse reactions in 67 year old male

Reported by a consumer/non-health professional from United States on 2011-12-28

Patient: 67 year old male weighing 75.8 kg (166.7 pounds)

Reactions: Miosis, Headache, Eye Disorder, LID LAG

Adverse event resulted in: disablity

Suspect drug(s):
Imdur
    Dosage: one pill daily (less one month)
    Indication: Angina Pectoris
    Start date: 2011-07-11

Imdur
    Dosage: one pill daily (less one month)
    Indication: Prophylaxis
    Start date: 2011-07-11

Possible Imdur side effects / adverse reactions in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: 61 year old male weighing 88.5 kg (194.7 pounds)

Reactions: White Blood Cell Count Decreased, Fatigue, Meningitis Cryptococcal, Malignant Pleural Effusion, Cardiac Failure Congestive

Adverse event resulted in: death

Suspect drug(s):
Lisinopril
    Dosage: 2.5 day
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Mental Status Changes
    Start date: 2010-01-01

Imdur
    Administration route: Oral

Symbicort
    Dosage: 160/4.5 mcg bid 1 puff

Other drugs received by patient: Sublinqual B12; Continuous Oxygen; Prevacid; Levemir; Metform 500; Astelin; Naproxen (Aleve); Prednisone; Excedrin PM Caplets; Magnesium Oxide; Caltrate + Vitamin D; Norco; Ultracet; Cymbalta; Humalog; Aspirin; Lopressor; Furosemide; L-Lysine; Xopenex; Provastin; Albutelor Nebulizer; Potassium Chloride; Amiodarone HCL; Antivert