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Magne Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 5323 

Tongue Pruritus, Ear Pruritus (8450266-6)
on Jun 18, 2012 Female from UNITED STATES , 41 years of age, was diagnosed with
  • nuclear magnetic resonance imaging brain
  • pituitary tumour
and was treated with Magnevist. Directly after, patient experienced the unwanted or unexpected Magne side effects: tongue pruritus, ear pruritus. Magnevist dosage: 20 Ml, Unk.

Blood Culture Positive, Encephalitis, Listeriosis, Epilepsy, Sepsis (8449169-2)
Patient was taking Magnesium. Patient felt the following Magne side effects: blood culture positive, encephalitis, listeriosis, epilepsy, sepsis on Jun 05, 2012 from SWITZERLAND Additional patient health information: Female , weighting 114.6 lb, . Magnesium dosage: Unk.
Multiple prescriptions taken:
  • Aspirin (Unk)
  • Inc424 (20 Mg, Bid)
Patient was hospitalized.

Respiratory Arrest, Loss Of Consciousness, Cardiac Arrest, Hypersensitivity, Unresponsive To Stimuli (8448989-8)
Adverse event was reported on Jun 08, 2012 by a Female taking Magnevist (Dosage: 9 Ml, Once) was diagnosed with
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , 58 years of age, After Magne was administered, patient encountered several Magne side effects: respiratory arrest, loss of consciousness, cardiac arrest, hypersensitivity, unresponsive to stimuli.

Cardiac Failure, Protein Total Increased (8448147-7)
on May 22, 2012 Female from UNITED STATES , 68 years of age, was treated with Magnesium (magnesiuim). Directly after, patient experienced the unwanted or unexpected Magne side effects: cardiac failure, protein total increased. Magnesium (magnesiuim) dosage: N/A.
Associated medications used:
  • Aspirin
  • Prednisone Tab
  • Centrum Silver (centrum Silver)
  • Metoprolol Tartrate
  • Bactrim
  • Hizentra
  • Lidocaine
  • Lipitor



Pyrexia, Renal Failure Acute, Renal Function Test Abnormal, Dizziness, Cholecystitis Acute, Back Pain, Abdominal Pain (8446989-5)
on Jun 14, 2012 Male from JAPAN , 64 years of age, weighting 130.1 lb, was treated with Magnevist. Patient felt the following Magne side effects: pyrexia, renal failure acute, renal function test abnormal, dizziness, cholecystitis acute, back pain, abdominal pain. Magnevist dosage: N/A.
Multiple prescriptions taken:
  • Pursennid (Daily Dose 24 Mg)
  • Selbex (Daily Dose 150 Mg)
Patient was hospitalized.

Neck Mass (8446370-9)
Patient was taking Magnesium Chloride. After Magne was administered, patient encountered several Magne side effects: neck mass on Jun 14, 2012 from ARGENTINA Additional patient health information: Female , 78 years of age, . Magnesium Chloride dosage: 0.495 Mg, Qd.
Multiple concurrent drugs taken:
  • Diurex (12.5 Mg, Unk)
  • Aspirin (Unk)
  • Levothyroxine Sodium (25 Mug, Qd)
  • Atorvastatin Calcium (10 Mg, Qod)
  • Denosumab (60 Mg, Q6mo)
  • Amoxicillin (1 G, Q12h)


Hip Fracture, Fall, Cerebrovascular Accident (8444467-0)
Adverse event was reported on Jun 11, 2012 by a Female taking Magnesium (Dosage: Unk, 2x/day) . Location: UNITED STATES , weighting 172.0 lb, Directly after, patient experienced the unwanted or unexpected Magne side effects: hip fracture, fall, cerebrovascular accident.
Associated medications used:
  • Acetylsalicylic Acid (81 Mg, Unk)
  • Zovirax (Unk)
  • Calcium (Unk)
  • Toviaz (Unk)
  • Linagliptin (Unk)
  • Zoloft (Unk)
  • Vesicare (Unk)
  • Coreg (Unk)


Induration, Skin Discolouration, Muscular Weakness, Joint Stiffness, Fibrosis, Post Thrombotic Syndrome, Nephrogenic Systemic Fibrosis, Hemiparesis, Skin Hyperpigmentation (8443810-6)
on Jun 12, 2012 Male from UNITED STATES , 59 years of age, was treated with Magnevist. Patient felt the following Magne side effects: induration, skin discolouration, muscular weakness, joint stiffness, fibrosis, post thrombotic syndrome, nephrogenic systemic fibrosis, hemiparesis, skin hyperpigmentation. Magnevist dosage: N/A.
Multiple prescriptions taken:
  • Omniscan
  • Albuterol


Muscular Weakness, Cerebrovascular Accident (8441691-8)
on Jun 08, 2012 Male from GERMANY , weighting 172.0 lb, was diagnosed with
  • muscle spasms
  • varicose vein
  • coronary artery disease
  • depression
  • hypertension
and was treated with Magnesium. After Magne was administered, patient encountered several Magne side effects: muscular weakness, cerebrovascular accident. Magnesium dosage: Max 300 Mg.
Multiple concurrent drugs taken:
  • Venostasin (1 Anz)
  • Clopidogrel
  • Mictonorm (As Required)
  • Bisoprolol Fumarate (2 Anz)
  • Micardis Hct (1 Anz)
  • Pantoprazole (1 Anz)
  • Ramipril (2 Anz)
  • Clopidogrel


Toothache, Tooth Fracture, Procedural Pain, Pain In Jaw, Gingival Swelling (8437886-X)
Patient was taking Magnesium. Directly after, patient experienced the unwanted or unexpected Magne side effects: toothache, tooth fracture, procedural pain, pain in jaw, gingival swelling on May 15, 2012 from UNITED STATES Additional patient health information: Female , 51 years of age, . Magnesium dosage: Unk Unk, Qd.
Associated medications used:
  • Calcium (Unk, Qd)
  • Ascorbic Acid (Unk Unk, Qd)
  • Benazepril Hydrochloride (Unk Unk, Qd)
  • Niacin
  • Pristiq (Unk Unk, Qd)
  • Multi-vitamin
  • Aspirin (Unk Unk, Qd)
  • Fish Oil (Unk Unk, Qd)


Urticaria, Dyspnoea, Heart Rate Abnormal, Ocular Hyperaemia, Hypersensitivity, Cyanosis (8436841-3)
Adverse event was reported on Jun 13, 2012 by a Male taking Magnevist (Dosage: Unk) was diagnosed with
  • nuclear magnetic resonance imaging brain
and. Location: UNITED STATES , 59 years of age, Patient felt the following Magne side effects: urticaria, dyspnoea, heart rate abnormal, ocular hyperaemia, hypersensitivity, cyanosis.

Maternal Exposure During Pregnancy, Coagulopathy, Hypersensitivity, Anaemia, Foetal Growth Restriction, Thrombocytopenia, Haematoma (8435907-1)
on Jun 06, 2012 Female from GERMANY , 28 years of age, weighting 113.5 lb, was treated with Magnesium. After Magne was administered, patient encountered several Magne side effects: maternal exposure during pregnancy, coagulopathy, hypersensitivity, anaemia, foetal growth restriction, thrombocytopenia, haematoma. Magnesium dosage: N/A.
Multiple concurrent drugs taken:
  • Enoxaparin Sodium
  • Folic Acid/iodine/minerals Nos/vitamins Nos
  • Haemoprotect
  • Leucovorin Calcium
  • Fresh Frozen Plasma
  • Fibrinogen
  • Ampicillin W/sulbactam
  • Ferrous Sulfate Tab


Emotional Distress, Injury, Mobility Decreased, Musculoskeletal Stiffness, Abasia, Fibrosis, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Pain (8435663-7)
on Jun 08, 2012 Male from UNITED STATES , 54 years of age, was treated with Magnevist. Directly after, patient experienced the unwanted or unexpected Magne side effects: emotional distress, injury, mobility decreased, musculoskeletal stiffness, abasia, fibrosis, nephrogenic systemic fibrosis, skin hypertrophy, pain. Magnevist dosage: N/A.

Nausea, Diarrhoea, Headache (8434897-5)
Patient was taking Magnevist. Patient felt the following Magne side effects: nausea, diarrhoea, headache on Jun 08, 2012 from UNITED STATES Additional patient health information: Female , 60 years of age, weighting 145.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and. Magnevist dosage: Once Iv.

Vomiting, Nausea (8433753-6)
Adverse event was reported on Jun 12, 2012 by a Female taking Magnevist (Dosage: 20 Ml, Once) was diagnosed with
  • arteriogram carotid
  • convulsion
and. Location: UNITED STATES , 48 years of age, After Magne was administered, patient encountered several Magne side effects: vomiting, nausea.

Hypersensitivity, Infusion Site Pain, Tremor, Hypoaesthesia (8433592-6)
on Jun 12, 2012 Female from UNITED STATES , 40 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Magnevist. Directly after, patient experienced the unwanted or unexpected Magne side effects: hypersensitivity, infusion site pain, tremor, hypoaesthesia. Magnevist dosage: 5 Ml, Once.

Urticaria, Presyncope, Pruritus (8433591-4)
on Jun 11, 2012 Female from UNITED STATES , 51 years of age, was treated with Magnevist. Patient felt the following Magne side effects: urticaria, presyncope, pruritus. Magnevist dosage: 12 Ml, Once. Patient was hospitalized.

Injection Site Extravasation, Injection Site Swelling, Injection Site Pain (8433540-9)
Patient was taking Magnevist. After Magne was administered, patient encountered several Magne side effects: injection site extravasation, injection site swelling, injection site pain on Jun 11, 2012 from UNITED STATES Additional patient health information: Male , 31 years of age, weighting 140.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging brain
and. Magnevist dosage: 15 Ml, Once.

Hepatic Failure, Renal Failure, White Blood Cell Count Decreased (8433234-X)
Adverse event was reported on Jun 04, 2012 by a Male taking Magnesium Hydroxide Tab (Dosage: N/A) was diagnosed with
  • duodenal ulcer
and. Location: JAPAN , 60 years of age, Directly after, patient experienced the unwanted or unexpected Magne side effects: hepatic failure, renal failure, white blood cell count decreased.
Associated medications used:
  • Lansoprazole
  • Thrombin
  • Omeprazole
  • Selbex
  • Rabeprazole Sodium
  • Norvasc
  • Candesartan Cilexetil
Patient was hospitalized.

Optic Ischaemic Neuropathy, Myopathy, Papilloedema (8430902-0)
on Jun 05, 2012 Female from BELGIUM , 83 years of age, was diagnosed with
  • muscle spasms
  • depression
  • hypertension
  • post procedural diarrhoea
and was treated with Magnepamyl. Patient felt the following Magne side effects: optic ischaemic neuropathy, myopathy, papilloedema. Magnepamyl dosage: 1xday.
Multiple prescriptions taken:
  • Escitalopram Oxalate (5 Mg, 1x/day)
  • Lercanidipine (20 Mg, 1x/day)
  • Loperamide (4 Mg, 1x/day)
  • Provera
  • Celiprolol (400 Mg, 1x/day)
  • Fluticasone Propionate/salmeterol (Unk)
  • Escitalopram Oxalate
  • Moxonidine (0.4 Mg, 1x/day)
Patient was hospitalized and became disabled.

Dermatitis Contact (8430020-1)
on Jun 06, 2012 Male from JAPAN , 30 years of age, was treated with Magnesium Oxide. After Magne was administered, patient encountered several Magne side effects: dermatitis contact. Magnesium Oxide dosage: N/A.
Multiple concurrent drugs taken:
  • Rohypnol


Respiratory Arrest, Loss Of Consciousness, Unresponsive To Stimuli, Hypersensitivity, Cardiac Arrest (8428841-4)
Patient was taking Magnevist. Directly after, patient experienced the unwanted or unexpected Magne side effects: respiratory arrest, loss of consciousness, unresponsive to stimuli, hypersensitivity, cardiac arrest on Jun 08, 2012 from UNITED STATES Additional patient health information: Female , 58 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and. Magnevist dosage: 9 Ml, Once.

Ear Congestion, Paraesthesia Oral, Urticaria (8428831-1)
Adverse event was reported on Jun 08, 2012 by a Female taking Magnevist (Dosage: 15 Ml, Once) . Location: UNITED STATES , 45 years of age, Patient felt the following Magne side effects: ear congestion, paraesthesia oral, urticaria.

Asthenia, Dysphagia, Pneumonia (8426849-6)
on Jun 04, 2012 Female from JAPAN , 85 years of age, was treated with Magnesium Oxide. After Magne was administered, patient encountered several Magne side effects: asthenia, dysphagia, pneumonia. Magnesium Oxide dosage: N/A.
Multiple concurrent drugs taken:
  • Torsemide
  • Alosenn
  • Pradaxa (220 Mg)
  • Digoxin
  • Candesartan Cilexetil
Patient was hospitalized.

Anaphylactic Reaction (8425755-0)
on Jun 08, 2012 Male from UNITED STATES , 33 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Magnevist. Directly after, patient experienced the unwanted or unexpected Magne side effects: anaphylactic reaction. Magnevist dosage: Unk.

Showing 1-25 of 5323 

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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.

Magne Information

CHOLINE M CITRATE O CITROMA M GADOPENTE MILK OF M OMEPRAZOL PHILLIPS

Active Ingredient: ACETAMINO ADENINE; AESCULUS ALMASILAT ALUMINUM AMBERGRIS ANHYDROUS BLACK COH CAUSTICUM CHOLINE M DIMETHICO GADOPENTE LACTIC AC MAGNESIUM OMEPRAZOL

More About Magne

Side Effects reported to FDA: 5323. View Magne Adverse Reports

Magne safety alerts: 2013 2011 2008 2007 2006 2005 2000

Reported deaths: 401

Reported hospitalizations: 594

Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use

Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), AcipHex (rabeprazole sodium), and Vimovo (a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen).

Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).

 

[Posted 03/02/2011]

AUDIENCE: Consumer, Gastroenterology, Family Practice

ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[03/02/2011 - Drug Safety Communication - FDA]

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