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Milk Side Effects

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Common Milk Side Effects


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

Haematochezia (16)
Constipation (15)
Rectal Haemorrhage (11)
Dyspnoea (9)
Abdominal Pain Upper (9)
Vomiting (8)
Diarrhoea (7)
Blood Potassium Decreased (7)
Abdominal Pain (6)
Blood Sodium Decreased (6)
Palpitations (5)
Heart Rate Increased (5)
Dizziness (5)
Back Pain (5)
Hypersensitivity (4)
Gastrooesophageal Reflux Disease (4)
Hypertension (4)
Pain In Extremity (4)
Nausea (4)
Muscle Spasms (4)

➢ 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.

Milk Side Effects Reported to FDA



Milk Side Effect Report#8461814-4
Hypoxia, Fluid Overload
This is a report of a 69-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: constipation,nausea,pain, who was treated with Milk Of Magnesia Tab (dosage: NA, start time:
May 07, 2012), combined with:
  • Ondansetron (Prn)
  • Morphine Sulfate
  • Magnesium Sulfate (Inj. 6 G, 4 G Every 4 Hr)
  • Oxycodone Hcl (Liquid. 5ml Every 4 Hours, 10 Ml At Bedtime)
  • Ipratropium Bromide (Neb Prn)
  • Albuterol (2.5 Ned Inhalation, Prn)
  • Salmeterol + Fluticasone (1 Df: 1 Puff. 500 Mcg+50mcg/puff)
  • Docusate (Solution 100 Mg/25 Ml)
and developed a serious reaction and side effect(s): Hypoxia, Fluid Overload after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in female patients, resulting in Hypoxia side effect. The patient was hospitalized.
Milk Side Effect Report#8437185-6
Weight Increased, Muscle Spasms, Joint Swelling, Stress, Gait Disturbance
This report suggests a potential Milk Of Magnesia Tab Weight Increased side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Milk Of Magnesia Tab (dosage: 1 Ml, Qd) starting
Sep 24, 2011. After starting Milk Of Magnesia Tab the patient began experiencing various side effects, including: Weight Increased, Muscle Spasms, Joint Swelling, Stress, Gait DisturbanceAdditional drugs used concurrently:
  • Motrin
  • Prolia (60 Mg, Q6mo)
Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Weight Increased, may still occur.
Milk Side Effect Report#8416694-X
Anxiety, Palpitations, Dyspnoea
This Anxiety problem was reported by a physician from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 20, 2011 this consumer started treatment with Milk Of Magnesia Tab (dosage: NA). The following drugs were being taken at the same time:
  • Dulcolax
  • Gilenya (5 Mg, Qd)
  • Colace
  • Zofran
  • Cephalexin
  • Rebif
  • Lotrel
  • Toprol-xl
When using Milk Of Magnesia Tab, the patient experienced the following unwanted symptoms/side effects: Anxiety, Palpitations, DyspnoeaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anxiety, may become evident only after a product is in use by the general population.
Milk Side Effect Report#8397501-0
Subdural Haemorrhage, Dysphagia, Cerebral Haematoma, Rectal Haemorrhage, Loss Of Consciousness, Grand Mal Convulsion, Haemorrhagic Stroke, Unresponsive To Stimuli, Ischaemic Stroke
This Subdural Haemorrhage side effect was reported by a pharmacist from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Milk Of Magnesia Tab (drug dosage: NA), which was initiated on
Dec 01, 2011. Concurrently used drugs:
  • Hydralazine Hcl
  • Acetaminophen
  • Ciprofloxacin Hcl
  • Magnesium Hydroxide Tab
  • Tekturna
  • Xarelto (15 Mg Daily Po)
  • Levemir
  • Protonix
.After starting to take Milk Of Magnesia Tab the consumer reported adverse symptoms, such as: Subdural Haemorrhage, Dysphagia, Cerebral Haematoma, Rectal Haemorrhage, Loss Of Consciousness, Grand Mal Convulsion, Haemorrhagic Stroke, Unresponsive To Stimuli, Ischaemic StrokeThese side effects may potentially be related to Milk Of Magnesia Tab.
Milk Side Effect Report#8390766-0
Deep Vein Thrombosis, Pain In Extremity, Chest Pain, Dyspnoea, Pulmonary Embolism
This is a report of a 40-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: constipation, who was treated with Milk Of Magnesia Tab (dosage: Unk, start time:
Jun 14, 2007), combined with:
  • Aspirin
  • Ibuprofen
  • Bentyl (20 Mg, Unk)
  • Yaz (Unk)
and developed a serious reaction and side effect(s): Deep Vein Thrombosis, Pain In Extremity, Chest Pain, Dyspnoea, Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in female patients, resulting in Deep Vein Thrombosis side effect. The patient was hospitalized.
Milk Side Effect Report#8381013-4
Therapeutic Response Unexpected, Overdose, Off Label Use
This report suggests a potential Milk Of Magnesia Tab Therapeutic Response Unexpected side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Milk Of Magnesia Tab (dosage: 3 Tsp, At Night) starting
Jun 01, 2011. After starting Milk Of Magnesia Tab the patient began experiencing various side effects, including: Therapeutic Response Unexpected, Overdose, Off Label UseAdditional drugs used concurrently:
  • Benefiber W/ Wheat Dextrin (3 Tsp, Tid)
  • Benefiber W/ Wheat Dextrin (9 Tsp, Tid)
Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Therapeutic Response Unexpected, may still occur.
Milk Side Effect Report#8345458-0
Gastric Ulcer
This Gastric Ulcer problem was reported by a consumer or non-health professional from United States. A 32-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: abdominal discomfort. On
Apr 29, 2012 this consumer started treatment with Milk Of Magnesia Tab (dosage: 2 Df, Once, Bottle Size 12 Oz). The following drugs were being taken at the same time: NA. When using Milk Of Magnesia Tab, the patient experienced the following unwanted symptoms/side effects: Gastric UlcerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastric Ulcer, may become evident only after a product is in use by the general population.
Milk Side Effect Report#8329800-2
Dyspnoea, Abdominal Distension, Constipation, Abdominal Discomfort
This Dyspnoea side effect was reported by a consumer or non-health professional from United States. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: constipation.The patient was prescribed Milk Of Magnesia Tab (drug dosage: 3 Df (tbsp) Once), which was initiated on
Apr 22, 2012. Concurrently used drugs: NA..After starting to take Milk Of Magnesia Tab the consumer reported adverse symptoms, such as: Dyspnoea, Abdominal Distension, Constipation, Abdominal DiscomfortThese side effects may potentially be related to Milk Of Magnesia Tab.
Milk Side Effect Report#8296325-2
Change Of Bowel Habit, Diarrhoea, Proctalgia, Anal Haemorrhage
This is a report of a 68-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: constipation, who was treated with Milk Of Magnesia Tab (dosage: Unk, start time:
Apr 09, 2012), combined with:
  • Multi-vitamin
  • Complex B
  • Ascorbic Acid
  • Neurontin
  • Colace
  • Vitamin D
  • Aspirin
  • Vicodin
and developed a serious reaction and side effect(s): Change Of Bowel Habit, Diarrhoea, Proctalgia, Anal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in female patients, resulting in Change Of Bowel Habit side effect.
Milk Side Effect Report#8286651-5
Nausea, Abdominal Pain Upper, Dizziness, Urine Output Decreased
This report suggests a potential Milk Of Magnesia Tab Nausea side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: constipation and used Milk Of Magnesia Tab (dosage: NA) starting NS. After starting Milk Of Magnesia Tab the patient began experiencing various side effects, including: Nausea, Abdominal Pain Upper, Dizziness, Urine Output DecreasedAdditional drugs used concurrently: NA. Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Milk Side Effect Report#8270854-X
Neutrophil Count Decreased, White Blood Cell Count Decreased
This Neutrophil Count Decreased problem was reported by a pharmacist from United States. A 28-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 26, 2012 this consumer started treatment with Milk Of Magnesia Tab (dosage: NA). The following drugs were being taken at the same time:
  • Acetaminophen
  • Olanzapine
  • Clozapine (100.0 Mg)
  • Multi-vitamins
  • Docusate
  • Levothyroxine Sodium
  • Fluphenazine
  • Clozapine (125 Mg)
When using Milk Of Magnesia Tab, the patient experienced the following unwanted symptoms/side effects: Neutrophil Count Decreased, White Blood Cell Count DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neutrophil Count Decreased, may become evident only after a product is in use by the general population.
Milk Side Effect Report#8270300-6
Dizziness, Nausea, Abdominal Pain Upper, Urine Output Decreased
This Dizziness side effect was reported by a consumer or non-health professional from United States. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: constipation.The patient was prescribed Milk Of Magnesia Tab (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Milk Of Magnesia Tab the consumer reported adverse symptoms, such as: Dizziness, Nausea, Abdominal Pain Upper, Urine Output DecreasedThese side effects may potentially be related to Milk Of Magnesia Tab.
Milk Side Effect Report#8269736-9
Heart Rate Irregular, Dyspnoea, Constipation, Product Quality Issue, Overdose
This is a report of a 93-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: constipation, who was treated with Milk Of Magnesia Tab (dosage: , Oral, start time: NS), combined with:
  • Miralax
and developed a serious reaction and side effect(s): Heart Rate Irregular, Dyspnoea, Constipation, Product Quality Issue, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in male patients, resulting in Heart Rate Irregular side effect. The patient was hospitalized.
Milk Side Effect Report#8222019-5
Atrial Fibrillation, Osteoarthritis, Myalgia, Atrial Tachycardia, Pneumonitis, Confusional State, Lethargy, Tremor, Cerebral Ventricle Dilatation
This report suggests a potential Milk Of Magnesium Atrial Fibrillation side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Milk Of Magnesium (dosage: NA) starting
Jul 07, 2006. After starting Milk Of Magnesium the patient began experiencing various side effects, including: Atrial Fibrillation, Osteoarthritis, Myalgia, Atrial Tachycardia, Pneumonitis, Confusional State, Lethargy, Tremor, Cerebral Ventricle DilatationAdditional drugs used concurrently:
  • Klonopin
  • Toprol-xl
  • Coreg
  • Vitamin B Complex Cap
  • Digoxin (0.25mg;unk;po)
  • Furosemide
  • Singulair
  • Celexa
The patient was hospitalized. Although Milk Of Magnesium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atrial Fibrillation, may still occur.
Milk Side Effect Report#8175580-3
Supraventricular Tachycardia, Staphylococcal Sepsis, Colitis Ischaemic
This Supraventricular Tachycardia problem was reported by a physician from United States. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 11, 2009 this consumer started treatment with Milk Of Magnesia Tab (dosage: NA). The following drugs were being taken at the same time:
  • Atenolol
  • Cymbalta
  • Rozerem
  • Potassium Chloride
  • Topamax
  • Lithium Carbonate
  • Protonix
  • Dulcolax
When using Milk Of Magnesia Tab, the patient experienced the following unwanted symptoms/side effects: Supraventricular Tachycardia, Staphylococcal Sepsis, Colitis IschaemicThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Supraventricular Tachycardia, may become evident only after a product is in use by the general population.
Milk Side Effect Report#8173965-2
Lip Disorder, Abdominal Pain Upper, Haemorrhage, Lip Swelling
This Lip Disorder side effect was reported by a consumer or non-health professional from United States. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation.The patient was prescribed Milk Of Magnesia Tab (drug dosage: 1 Df, Qd), which was initiated on
Feb 19, 2012. Concurrently used drugs: NA..After starting to take Milk Of Magnesia Tab the consumer reported adverse symptoms, such as: Lip Disorder, Abdominal Pain Upper, Haemorrhage, Lip SwellingThese side effects may potentially be related to Milk Of Magnesia Tab.
Milk Side Effect Report#8154188-X
Food Allergy, Pruritus
This is a report of a 83-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Milk Thistle (dosage: NA, start time:
Dec 01, 2011), combined with:
  • Omeprazole
  • Cetirizine
  • Letairis (Letairis 5 Mg Daily)
  • Amlodipine
and developed a serious reaction and side effect(s): Food Allergy, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Thistle treatment in female patients, resulting in Food Allergy side effect.
Milk Side Effect Report#8093419-1
Injection Site Haemorrhage, Musculoskeletal Pain, Blood Disorder, Contusion, Injection Site Pain, Pain In Extremity
This report suggests a potential Milk Thistle Injection Site Haemorrhage side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Milk Thistle (dosage: NA) starting
Jul 01, 2011. After starting Milk Thistle the patient began experiencing various side effects, including: Injection Site Haemorrhage, Musculoskeletal Pain, Blood Disorder, Contusion, Injection Site Pain, Pain In ExtremityAdditional drugs used concurrently:
  • Humira
  • Vitamin D
  • Citalopram
  • Acidophilus
  • Vitamin E
  • Azathioprine
  • Amitriptyline Hcl
Although Milk Thistle demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Haemorrhage, may still occur.
Milk Side Effect Report#8068719-1
Joint Swelling, Gait Disturbance, Weight Increased, Stress, Muscle Spasms
This Joint Swelling problem was reported by a physician from United States. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 01, 2011 this consumer started treatment with Milk Of Magnesia Tab (dosage: 1 Ml, Qd). The following drugs were being taken at the same time:
  • Motrin
  • Prolia (60 Mg, Q6mo)
When using Milk Of Magnesia Tab, the patient experienced the following unwanted symptoms/side effects: Joint Swelling, Gait Disturbance, Weight Increased, Stress, Muscle SpasmsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Joint Swelling, may become evident only after a product is in use by the general population.
Milk Side Effect Report#8049001-5
Dysgeusia
This Dysgeusia side effect was reported by a health professional from United States. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Milk Thistle (drug dosage: NA), which was initiated on
Aug 31, 2011. Concurrently used drugs:
  • Fish Oil
  • Pegasys
  • Procrit
  • Hydroxychloroquine Sulfate
  • Victrelis (800 Mg;tid; Po)
  • Alpha-lipoic Acid
  • Ribavirin
  • Neupogen
.After starting to take Milk Thistle the consumer reported adverse symptoms, such as: DysgeusiaThese side effects may potentially be related to Milk Thistle.
Milk Side Effect Report#7952856-3
Bronchitis, Anaemia, Fatigue, Gingival Bleeding
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Milk Thistle (dosage: NA, start time:
Dec 08, 2008), combined with:
  • Uroxatral
  • Coq10
  • Decadron
  • Nexium
  • Cat's Claw
  • Iron
  • Avodart
  • Gluco/chon
and developed a serious reaction and side effect(s): Bronchitis, Anaemia, Fatigue, Gingival Bleeding after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Thistle treatment in male patients, resulting in Bronchitis side effect.
Milk Side Effect Report#7890032-3
Chest Discomfort, Gastrointestinal Haemorrhage, Duodenal Ulcer, Anxiety, Non-cardiac Chest Pain, Gastrooesophageal Reflux Disease, Renal Failure Chronic, Abdominal Pain Lower, Pyrexia
This report suggests a potential Milk Of Magnesia Tab Chest Discomfort side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Milk Of Magnesia Tab (dosage: NA) starting
Mar 05, 2008. After starting Milk Of Magnesia Tab the patient began experiencing various side effects, including: Chest Discomfort, Gastrointestinal Haemorrhage, Duodenal Ulcer, Anxiety, Non-cardiac Chest Pain, Gastrooesophageal Reflux Disease, Renal Failure Chronic, Abdominal Pain Lower, PyrexiaAdditional drugs used concurrently:
  • Aldactone
  • Tasigna (400 Mg, Bid)
  • Actos (Unk)
  • Glimepiride
  • Protonix
The patient was hospitalized. Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chest Discomfort, may still occur.
Milk Side Effect Report#7885557-0
Tremor
This Tremor problem was reported by a consumer or non-health professional from United States. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Milk Thistle (dosage: NA). The following drugs were being taken at the same time:
  • Enbrel (50 Mg, Qwk)
  • Asa Arthritis Strength Aspirin (81 Mg, Unk)
  • Multivitamin /00097801/
  • Norco (325 Mg, Unk)
  • Vitamin D (1000 Unit, Unk)
  • Levothyroxine Sodium (112 Mci/mug, Unk)
  • Flaxseed Oil
  • Vitamin E /00110501/ (1000 Unit, Unk)
When using Milk Thistle, the patient experienced the following unwanted symptoms/side effects: TremorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tremor, may become evident only after a product is in use by the general population.
Milk Side Effect Report#7855067-5
Hepatic Failure, Renal Failure, Heparin-induced Thrombocytopenia, Mobility Decreased, Hyperhidrosis, Convulsion, Vomiting, Aphasia
This Hepatic Failure side effect was reported by a consumer or non-health professional from United States. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Milk Of Magnesia Tab (drug dosage: NA), which was initiated on
Mar 20, 2008. Concurrently used drugs:
  • Prochlorperazine
  • Acetaminophen
  • Insulin Glargine
  • Metformin Hcl
  • Aspirin
  • Ondansetron
  • Phenytoin
  • Lantus
.After starting to take Milk Of Magnesia Tab the consumer reported adverse symptoms, such as: Hepatic Failure, Renal Failure, Heparin-induced Thrombocytopenia, Mobility Decreased, Hyperhidrosis, Convulsion, Vomiting, AphasiaThese side effects may potentially be related to Milk Of Magnesia Tab.
Milk Side Effect Report#7846692-6
Pulmonary Function Test Decreased, Infection, Pallor, Abdominal Pain, Vomiting, Blood Pressure Decreased, Helicobacter Infection, Nausea, Renal Failure
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Milk Of Magnesia Tab (dosage: 30 Ml, Tid, start time:
May 01, 2011), combined with:
  • Peri-colace (2 Df, Bid)
  • Advair Diskus 100/50
  • Amoxicillin (1000 Mg, Bid)
  • Norco (1 Df, Every 6 Hours)
  • Reglan (10 Mg, Unk)
  • Protonix (40 Mg, Daily)
  • Albuterol (2.5 Mg, Per 3 Ml)
  • Klor-con (20 Meq, Bid)
and developed a serious reaction and side effect(s): Pulmonary Function Test Decreased, Infection, Pallor, Abdominal Pain, Vomiting, Blood Pressure Decreased, Helicobacter Infection, Nausea, Renal Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in female patients, resulting in Pulmonary Function Test Decreased side effect. The patient was hospitalized.


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The appearance of Milk 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.

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Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    Milk 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.

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    Discuss Milk Side Effects

    Did You Have a Milk Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Milk for You?

    Exceeded Expectations
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    Milk Safety Alerts, Active Ingredients, Usage Information

    NDC0054-3567
    TypeHUMAN OTC DRUG
    Proprietary NameMilk of Magnesia
    NameMilk of Magnesia
    Dosage FormCONCENTRATE
    RouteORAL
    On market since20010312
    LabelerRoxane Laboratories, Inc.
    Active Ingredient(s)MAGNESIUM HYDROXIDE
    Strength(s)2400
    Unit(s)mg/10mL
    Pharma Class

    More About Milk

    Side Effects reported to FDA: 128

    Milk safety alerts: 2014 2013 2002

    Reported deaths: 6

    Reported hospitalizations: 33

    Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk

     

    [Posted 02/04/2013]

    AUDIENCE: Consumer, Patient, Surgery

    ISSUE: R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens which are not declared on the labels of individual packets of the product. People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume these products.

    BACKGROUND: Z PRO HIGH PROTEIN SUPPLEMENT was distributed nationwide between January 1, 2006 and January 24, 2013, to bariatric centers and bariatric physicians who dispense the product to patients who have undergone bariatric surgery. This recall was initiated after an FDA inspection noted that these allergens were not disclosed on the inner packets of the product. Product shipped after January 24, 2013 contains the allergen disclosure on both the outer box packaging and the individual inner packets of the product. No illnesses have been reported to date.

    RECOMMENDATION: Additional information on what consumers should do with the product maybe be obtained by calling Robert Kaskey, 1-856-663-0644 (M–F 10 AM to 4:00 PM EST).

    Healthcare professionals and patients are encouraged to report adverse events or side effects 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


    [01/30/2013 - Press Release - R-Kane Products, Inc.]

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