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Ensure Side Effects

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Common Ensure Side Effects


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

Diarrhoea (5)
Oedema Peripheral (4)
Vomiting (4)
Localised Oedema (4)
Hepatic Neoplasm (4)
Abdominal Distension (4)
Decreased Appetite (3)
Flushing (2)
Hyponatraemia (2)
Pancytopenia (2)
Stevens-johnson Syndrome (2)
Liver Operation (1)
Hypotension (1)
Loss Of Consciousness (1)
Lethargy (1)
Myalgia (1)
Neutropenic Sepsis (1)
Neoplasm Malignant (1)
Nausea (1)
Muscular Weakness (1)

➢ 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.

Ensure Side Effects Reported to FDA



Ensure Side Effect Report#9092751
Abdominal Pain Upper, Headache, Arthralgia, Myalgia
This is a report of a 24-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Ensure (dosage: NA, start time:
May 20, 2012), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Pain Upper, Headache, Arthralgia, Myalgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ensure treatment in female patients, resulting in Abdominal Pain Upper side effect.
Ensure Side Effect Report#8577053-2
Vomiting
This report suggests a potential Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) Vomiting side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) (dosage: NA) starting
Jul 31, 2009. After starting Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) the patient began experiencing various side effects, including: VomitingAdditional drugs used concurrently:
  • Travatan
  • Tears Naturale (dextran 70, Hypromellose)
  • Furosemide
  • Potassium Chloride
  • Zyrtec
  • Nitroglycerin
  • Tetracycline
  • Aspirin
The patient was hospitalized. Although Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vomiting, may still occur.
Ensure Side Effect Report#8575205-9
Vomiting
This Vomiting problem was reported by a health professional from United States. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 20, 2009 this consumer started treatment with Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) (dosage: NA). The following drugs were being taken at the same time:
  • Warfarin Sodium
  • Folic Acid (folic Acid) Table
  • Tetracycline (tetracycline) Capsule
  • Aspirin
  • Furosemide (furosemide) Tablet
  • Potassium Chloride
  • Zyrtec
  • Travatan
When using Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos), the patient experienced the following unwanted symptoms/side effects: VomitingThe 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 Vomiting, may become evident only after a product is in use by the general population.
Ensure Side Effect Report#8462931-5
Pyrexia, Loss Of Consciousness
This Pyrexia side effect was reported by a health professional from United States. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ensure (ensure) (drug dosage: NA), which was initiated on
Oct 24, 2011. Concurrently used drugs:
  • Bactrim Ds
  • Prilosec
  • Acetaminophen
  • Prednisone Tab
  • Celexa
  • Lenalidomide (5 Mg, X 28 Caps, Po)
  • Metfformin Hydrochloride
.After starting to take Ensure (ensure) the consumer reported adverse symptoms, such as: Pyrexia, Loss Of ConsciousnessThese side effects may potentially be related to Ensure (ensure). The patient was hospitalized.
Ensure Side Effect Report#8353359-7
Localised Oedema, Hepatic Neoplasm, Abdominal Distension, Diarrhoea, Flushing, Oedema Peripheral
This is a report of a female patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Ensure (dosage: NA, start time:
Dec 30, 2008), combined with:
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
  • Sandostatin Lar (90 Mg Every 4 Weeks)
and developed a serious reaction and side effect(s): Localised Oedema, Hepatic Neoplasm, Abdominal Distension, Diarrhoea, Flushing, Oedema Peripheral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ensure treatment in female patients, resulting in Localised Oedema side effect.
Ensure Side Effect Report#8289232-2
Hepatic Neoplasm, Abdominal Distension, Oedema Peripheral, Localised Oedema, Flushing, Diarrhoea
This report suggests a potential Ensure Hepatic Neoplasm side effect(s) that can have serious consequences. A female patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: NA and used Ensure (dosage: NA) starting
Dec 30, 2008. After starting Ensure the patient began experiencing various side effects, including: Hepatic Neoplasm, Abdominal Distension, Oedema Peripheral, Localised Oedema, Flushing, DiarrhoeaAdditional drugs used concurrently:
  • Sandostatin Lar (90 Mg Every 4 Weeks)
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
Although Ensure demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Neoplasm, may still occur.
Ensure Side Effect Report#8287874-1
Muscular Weakness, Soft Tissue Infection, Neutrophil Count Decreased, Platelet Count Decreased, Anaemia, Dyspnoea, Chest Pain
This Muscular Weakness problem was reported by a physician from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: medical diet. On
Mar 08, 2012 this consumer started treatment with Ensure /06184901/ (dosage: Unk). The following drugs were being taken at the same time:
  • Carboplatin (3.75 Auc, Every 21 Days)
  • Vitamin B-12 (Unk)
  • Pantenol (Unk)
  • Cetuximab (400 Mg/m2, Loading Dose Day 1 Every 21 Days)
  • Pemetrexed (375 Mg/m2, Every 21 Days)
  • Cetuximab (400 Mg/m2, Every 21 Days)
  • Carboplatin (75 Mg/m2, Day 1 Every 21 Days)
  • Folic Acid (Unk)
When using Ensure /06184901/, the patient experienced the following unwanted symptoms/side effects: Muscular Weakness, Soft Tissue Infection, Neutrophil Count Decreased, Platelet Count Decreased, Anaemia, Dyspnoea, Chest PainThe 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 Muscular Weakness, may become evident only after a product is in use by the general population.
Ensure Side Effect Report#8031669-0
Hypotension, Septic Shock, Asthenia, Decreased Appetite
This Hypotension side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: malnutrition.The patient was prescribed Ensure Plus (drug dosage: NA), which was initiated on
Sep 13, 2011. Concurrently used drugs:
  • Ciprofloxacin
  • Thiamine Hcl
  • Folic Acid
  • Remeron (7.5 Milligram)
  • Multi-vitamins
  • Revlimid (10 Milligram)
  • Rilutek
  • Vitamin B-12
.After starting to take Ensure Plus the consumer reported adverse symptoms, such as: Hypotension, Septic Shock, Asthenia, Decreased AppetiteThese side effects may potentially be related to Ensure Plus. The patient was hospitalized and became disabled.
Ensure Side Effect Report#7984456-3
Decreased Appetite, Convulsion, Nausea
This is a report of a 83-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Ensure /06184901/ (dosage: Unk, start time:
Nov 17, 2011), combined with:
  • Forteo (Unk)
and developed a serious reaction and side effect(s): Decreased Appetite, Convulsion, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ensure /06184901/ treatment in female patients, resulting in Decreased Appetite side effect.
Ensure Side Effect Report#7957042-9
Hyponatraemia, Pancytopenia, Vomiting, Neutropenic Sepsis, Hypokalaemia, Hypophagia, Disease Recurrence, Dehydration
This report suggests a potential Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min Hyponatraemia side effect(s) that can have serious consequences. A male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min (dosage: NA) starting
Jul 14, 2011. After starting Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min the patient began experiencing various side effects, including: Hyponatraemia, Pancytopenia, Vomiting, Neutropenic Sepsis, Hypokalaemia, Hypophagia, Disease Recurrence, DehydrationAdditional drugs used concurrently:
  • Acetaminophen
  • Topotecan (4.25 Mg Milligram(s), Daily Dose, Oral)
  • Dexamethasone
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
The patient was hospitalized. Although Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.
Ensure Side Effect Report#7903060-6
Stevens-johnson Syndrome
This Stevens-johnson Syndrome problem was reported by a health professional from United Kingdom. A 85-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 29, 2011 this consumer started treatment with Ensure /06184901/ (dosage: NA). The following drugs were being taken at the same time:
  • Doxycycline
  • Perindopril Erbumine
  • Erythromycin ((2000 Mg (500 Mg, 4 In 1 D) Oral))
  • Levothyroxine Sodium
  • Clarithromycin ((500 Mg) Intravenous (not Otherwise Specified)))
  • Gaviscon /00237601/
  • Citalopram Hydrobromide
  • Acetaminophen
When using Ensure /06184901/, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson SyndromeThe 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 Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Ensure Side Effect Report#7867246-1
Stevens-johnson Syndrome
This Stevens-johnson Syndrome side effect was reported by a physician from United Kingdom. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ensure (drug dosage: NA), which was initiated on
Jun 29, 2011. Concurrently used drugs:
  • Omeprazole
  • Acetaminophen
  • Erythromycin
  • Doxycycline
  • Perindopril Erbumine
  • Levothyroxine Sodium
  • Clarithromycin
  • Gaviscon
.After starting to take Ensure the consumer reported adverse symptoms, such as: Stevens-johnson SyndromeThese side effects may potentially be related to Ensure. The patient was hospitalized.
Ensure Side Effect Report#7784623-8
Diarrhoea, Gallbladder Cancer
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 Ensure Plus (dosage: 4 Cans Per Day, start time:
Jun 10, 2007), combined with:
  • Esomeprazole Sodium
  • Zoloft
  • Memantine
  • Zoloft
  • Megestrol Acetate (625mg Per 5ml)
  • Aricept
and developed a serious reaction and side effect(s): Diarrhoea, Gallbladder Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ensure Plus treatment in female patients, resulting in Diarrhoea side effect. The patient was hospitalized.
Ensure Side Effect Report#7781132-7
Neoplasm Malignant, Concomitant Disease Progression
This report suggests a potential Ensure Neoplasm Malignant side effect(s) that can have serious consequences. A 87-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Ensure (dosage: Unk Ukn, Unk) starting NS. After starting Ensure the patient began experiencing various side effects, including: Neoplasm Malignant, Concomitant Disease ProgressionAdditional drugs used concurrently:
  • Exelon (4.6 Mg, Daily)
The patient was hospitalized. Although Ensure demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neoplasm Malignant, may still occur.
Ensure Side Effect Report#7745205-7
Hyponatraemia, Lethargy, Vomiting
This Hyponatraemia problem was reported by a health professional from United Kingdom. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 17, 2011 this consumer started treatment with Ensure (nutrients Nos) (dosage: NA). The following drugs were being taken at the same time:
  • Dexamethasone
  • Aspirin
  • Bisoprolol Fumarate
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
When using Ensure (nutrients Nos), the patient experienced the following unwanted symptoms/side effects: Hyponatraemia, Lethargy, VomitingThe 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 Hyponatraemia, may become evident only after a product is in use by the general population.
Ensure Side Effect Report#7642030-2
Decreased Appetite, Hepatic Cirrhosis
This Decreased Appetite side effect was reported by a physician from Japan. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: decreased appetite,musculoskeletal pain.The patient was prescribed Ensure (drug dosage: NA), which was initiated on
Feb 10, 2006. Concurrently used drugs:
  • Enbrel
  • Prednisolone
  • Methotrexate
  • Spironolactone
  • Amaryl
  • Januvia
  • Nivadil
.After starting to take Ensure the consumer reported adverse symptoms, such as: Decreased Appetite, Hepatic CirrhosisThese side effects may potentially be related to Ensure. The patient was hospitalized.
Ensure Side Effect Report#7621057-0
Oral Candidiasis, Dysphagia, Gastrooesophageal Reflux Disease, Throat Irritation, Oral Discomfort, Oesophageal Candidiasis, Oesophageal Irritation, Blood Thyroid Stimulating Hormone Increased
This is a report of a 66-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Ensure (dosage: Unk, start time:
Jan 01, 2000), combined with:
  • Levoxyl (50 Mcg, Qd)
  • Asacol
and developed a serious reaction and side effect(s): Oral Candidiasis, Dysphagia, Gastrooesophageal Reflux Disease, Throat Irritation, Oral Discomfort, Oesophageal Candidiasis, Oesophageal Irritation, Blood Thyroid Stimulating Hormone Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ensure treatment in female patients, resulting in Oral Candidiasis side effect.
Ensure Side Effect Report#7617985-2
Hepatic Neoplasm, Diarrhoea, Localised Oedema, Oedema Peripheral, Abdominal Distension
This report suggests a potential Ensure Hepatic Neoplasm side effect(s) that can have serious consequences. A female patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: NA and used Ensure (dosage: NA) starting
Dec 30, 2008. After starting Ensure the patient began experiencing various side effects, including: Hepatic Neoplasm, Diarrhoea, Localised Oedema, Oedema Peripheral, Abdominal DistensionAdditional drugs used concurrently:
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
  • Sandostatin Lar (90 Mg Every 4 Weeks)
Although Ensure demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Neoplasm, may still occur.
Ensure Side Effect Report#7274551-9
Pancytopenia, Hepatic Enzyme Increased, Catheter Site Inflammation, Diarrhoea, Bacteraemia, Blood Potassium Decreased, Catheter Site Erythema
This Pancytopenia problem was reported by a health professional from United States. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 11, 2011 this consumer started treatment with Ensure (dosage: NA). The following drugs were being taken at the same time:
  • Tarceva (150 Mg Daily Po)
  • Torisel (5mg Dweekly Iv)
  • Roxicet
  • Oxycodone
  • Fentanyl
  • Magic Mouthwash
When using Ensure, the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Hepatic Enzyme Increased, Catheter Site Inflammation, Diarrhoea, Bacteraemia, Blood Potassium Decreased, Catheter Site ErythemaThe 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 Pancytopenia, may become evident only after a product is in use by the general population.
Ensure Side Effect Report#7212553-9
Liver Operation, Oedema Peripheral, Abdominal Distension, Localised Oedema, Tricuspid Valve Replacement, Hepatic Neoplasm
This Liver Operation side effect was reported by a physician from Canada. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ensure (drug dosage: NA), which was initiated on
Dec 30, 2008. Concurrently used drugs:
  • Sandostatin Lar (90 Mg Every 4 Weeks)
.After starting to take Ensure the consumer reported adverse symptoms, such as: Liver Operation, Oedema Peripheral, Abdominal Distension, Localised Oedema, Tricuspid Valve Replacement, Hepatic NeoplasmThese side effects may potentially be related to Ensure.



The appearance of Ensure 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.

    Ensure 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 Ensure Side Effects

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