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Ensure Side Effects

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.

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.

Ensure Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Abdominal Pain Upper
  • Headache
  • Arthralgia
  • Myalgia
which developed 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.

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. Soon after starting Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) the patient began experiencing various side effects, including:
  • Vomiting
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.

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 commencing Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos), the patient experienced the following unwanted symptoms/side effects:
  • Vomiting
The 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.

Pyrexia, Loss Of Consciousness
This is a report of a 67-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Ensure (ensure) (dosage: NA) starting Oct 24, 2011. Concurrently used drugs:
  • Bactrim Ds
  • Prilosec
  • Acetaminophen
  • Prednisone Tab
  • Celexa
  • Lenalidomide (5 Mg, X 28 Caps, Po)
  • Metfformin Hydrochloride
Soon after that, the consumer experienced the following side effects:
  • Pyrexia
  • Loss Of Consciousness
The patient was hospitalized. This opens a possibility that Ensure (ensure) treatment could cause the above reactions, including pyrexia, and some female subjects may be more susceptible.


Localised Oedema, Hepatic Neoplasm, Abdominal Distension, Diarrhoea, Flushing, Oedema Peripheral
A female patient (weight: NA) from CANADA with the following symptoms/conditions: NA started Ensure treatment (dosage: NA) on Dec 30, 2008. Soon after starting Ensure treatment, the subject experienced various side effects, including:
  • Localised Oedema
  • Hepatic Neoplasm
  • Abdominal Distension
  • Diarrhoea
  • Flushing
  • Oedema Peripheral
Concurrently used drugs:
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
  • Sandostatin Lar (90 Mg Every 4 Weeks)
This finding indicates that some female patients could be more vulnerable to Ensure.

Hepatic Neoplasm, Abdominal Distension, Oedema Peripheral, Localised Oedema, Flushing, Diarrhoea
A female patient from CANADA (weight: NA) experienced symptoms, such as: NA and was treated with Ensure(dosage: NA). The treatment was initiated on Dec 30, 2008. After that a consumer reported the following side effect(s):
  • Hepatic Neoplasm
  • Abdominal Distension
  • Oedema Peripheral
  • Localised Oedema
  • Flushing
  • Diarrhoea
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Ensure efficacy:
  • Sandostatin Lar (90 Mg Every 4 Weeks)
  • Sandostatin Lar (60 Mg, Every 4 Weeks)


Muscular Weakness, Soft Tissue Infection, Neutrophil Count Decreased, Platelet Count Decreased, Anaemia, Dyspnoea, Chest Pain
In this report, Ensure /06184901/ was administered for the following condition: medical diet.A female consumer from UNITED STATES (weight: NA) started Ensure /06184901/ treatment (dosage: Unk) on Mar 08, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Muscular Weakness
  • Soft Tissue Infection
  • Neutrophil Count Decreased
  • Platelet Count Decreased
  • Anaemia
  • Dyspnoea
  • Chest Pain
A possible interaction with other drugs could have contributed to this reaction:
  • 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)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Ensure /06184901/ treatment could be related to the listed above side effect(s).

Hypotension, Septic Shock, Asthenia, Decreased Appetite
This is a report of the following Ensure Plus side effect(s):
  • Hypotension
  • Septic Shock
  • Asthenia
  • Decreased Appetite
A male patient from UNITED STATES (weight: NA) presented with the following condition: malnutrition and received a treatment with Ensure Plus (dosage: NA) starting: Sep 13, 2011.The following concurrently used drugs could have generated interactions:
  • Ciprofloxacin
  • Thiamine Hcl
  • Folic Acid
  • Remeron (7.5 Milligram)
  • Multi-vitamins
  • Revlimid (10 Milligram)
  • Rilutek
  • Vitamin B-12
The patient was hospitalized and became disabled.This report suggests that a Ensure Plus treatment could be associated with the listed above side effect(s).

Decreased Appetite, Convulsion, Nausea
This Ensure /06184901/ report was submitted by a 83-year-old female consumer from JAPAN (weight: NA). The patient was diagnosed with: NA and Ensure /06184901/ was administered (dosage: Unk) starting: Nov 17, 2011. The consumer developed a set of symptoms:
  • Decreased Appetite
  • Convulsion
  • Nausea
Other drugs used simultaneously:
  • Forteo (Unk)
Those unexpected symptoms could be linked to a Ensure /06184901/ treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Hyponatraemia, Pancytopenia, Vomiting, Neutropenic Sepsis, Hypokalaemia, Hypophagia, Disease Recurrence, Dehydration
This is a report of a possible correlation between Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min use and the following symptoms/side effect(s):
  • Hyponatraemia
  • Pancytopenia
  • Vomiting
  • Neutropenic Sepsis
  • Hypokalaemia
  • Hypophagia
  • Disease Recurrence
  • Dehydration
which could contribute to an assessment of Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min risk profile.A male consumer from UNITED KINGDOM (weight: NA) was suffering from NA and was treated with Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min (dosage: NA) starting Jul 14, 2011.Other concurrent medications:
  • 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.

Stevens-johnson Syndrome
A 85-year-old female patient from UNITED KINGDOM (weight: NA) presented with the following symptoms: NA and after a treatment with Ensure /06184901/ (dosage: NA) experienced the following side effect(s):
  • Stevens-johnson Syndrome
The treatment was started on Jun 29, 2011. Ensure /06184901/ was used in combination with the following drugs:
  • 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
The patient was hospitalized.This report could alert potential Ensure /06184901/ consumers.

Stevens-johnson Syndrome
In this report, a 85-year-old female patient from UNITED KINGDOM (weight: NA) was affected by a possible Ensure side effect.The patient was diagnosed with NA. After a treatment with Ensure (dosage: NA, start date: Jun 29, 2011), the patient experienced the following side effect(s):
  • Stevens-johnson Syndrome
The following simultaneously used drugs could have led to this reaction:
  • Omeprazole
  • Acetaminophen
  • Erythromycin
  • Doxycycline
  • Perindopril Erbumine
  • Levothyroxine Sodium
  • Clarithromycin
  • Gaviscon
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Ensure treatment.

Diarrhoea, Gallbladder Cancer
This is a report of a female patient from UNITED STATES (weight: NA), who used Ensure Plus (dosage: 4 Cans Per Day) for a treatment of NA. After starting a treatment on Jun 10, 2007, the patient experienced the following side effect(s):
  • Diarrhoea
  • Gallbladder Cancer
The following drugs could possibly have interacted with the Ensure Plus treatment
  • Esomeprazole Sodium
  • Zoloft
  • Memantine
  • Zoloft
  • Megestrol Acetate (625mg Per 5ml)
  • Aricept
The patient was hospitalized.Taken together, these observations suggest that a Ensure Plus treatment could be related to side effect(s), such as Diarrhoea, Gallbladder Cancer.

Neoplasm Malignant, Concomitant Disease Progression
This neoplasm malignant side effect was reported by a physician from JAPAN. A 87-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Ensure (dosage: Unk Ukn, Unk), which was started on NS. Concurrently used drugs:
  • Exelon (4.6 Mg, Daily)
When starting to take Ensure the consumer reported the following symptoms:
  • Neoplasm Malignant
  • Concomitant Disease Progression
The patient was hospitalized. These side effects may potentially be related to Ensure.

Hyponatraemia, Lethargy, Vomiting
This is a Ensure (nutrients Nos) side effect report of a male patient (weight:NA) from UNITED KINGDOM, suffering from the following symptoms/conditions: NA, who was treated with Ensure (nutrients Nos) (dosage:NA, start time: Aug 17, 2011), combined with:
  • Dexamethasone
  • Aspirin
  • Bisoprolol Fumarate
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
, and developed a serious reaction and a hyponatraemia side effect. The patient presented with:
  • Hyponatraemia
  • Lethargy
  • Vomiting
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Ensure (nutrients Nos) treatment in male patients suffering from NA, resulting in hyponatraemia.

Decreased Appetite, Hepatic Cirrhosis
This report suggests a potential Ensure decreased appetite side effect(s) that can have serious consequences. A 80-year-old female patient from JAPAN (weight:NA) was diagnosed with the following health condition(s): decreased appetite,musculoskeletal pain and used Ensure (dosage: NA) starting Feb 10, 2006. Soon after starting Ensure the patient began experiencing various side effects, including:
  • Decreased Appetite
  • Hepatic Cirrhosis
Drugs used concurrently:
  • Enbrel
  • Prednisolone
  • Methotrexate
  • Spironolactone
  • Amaryl
  • Januvia
  • Nivadil
The patient was hospitalized. Although Ensure demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as decreased appetite, may still occur.

Oral Candidiasis, Dysphagia, Gastrooesophageal Reflux Disease, Throat Irritation, Oral Discomfort, Oesophageal Candidiasis, Oesophageal Irritation, Blood Thyroid Stimulating Hormone Increased
This oral candidiasis problem was reported by a consumer or non-health professional from UNITED STATES. A 66-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Jan 01, 2000 a consumer started treatment with Ensure (dosage: Unk,). The following drugs/medications were being taken at the same time:
  • Levoxyl (50 Mcg, Qd)
  • Asacol
When commencing Ensure, the patient experienced the following unwanted symptoms /side effects:
  • Oral Candidiasis
  • Dysphagia
  • Gastrooesophageal Reflux Disease
  • Throat Irritation
  • Oral Discomfort
  • Oesophageal Candidiasis
  • Oesophageal Irritation
  • Blood Thyroid Stimulating Hormone Increased
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as oral candidiasis, may become evident only after a product is in use by the general population.

Hepatic Neoplasm, Diarrhoea, Localised Oedema, Oedema Peripheral, Abdominal Distension
This is a Ensure side effect report of a female patient (weight: NA) from CANADA. The patient developed the following symptoms/conditions: NA and was treated with Ensure (dosage: NA) starting Dec 30, 2008. Concurrently used drugs:
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
  • Sandostatin Lar (90 Mg Every 4 Weeks)
Soon after that, the consumer experienced the following of symptoms:
  • Hepatic Neoplasm
  • Diarrhoea
  • Localised Oedema
  • Oedema Peripheral
  • Abdominal Distension
This opens a possibility that Ensure could cause hepatic neoplasm and that some female patients may be more susceptible.

Pancytopenia, Hepatic Enzyme Increased, Catheter Site Inflammation, Diarrhoea, Bacteraemia, Blood Potassium Decreased, Catheter Site Erythema
A 64-year-old male patient (weight: NA) from UNITED STATES with the following symptoms: NA started Ensure treatment (dosage: NA) on Jan 11, 2011. Soon after starting Ensure treatment, the consumer experienced several side effects, including:
  • Pancytopenia
  • Hepatic Enzyme Increased
  • Catheter Site Inflammation
  • Diarrhoea
  • Bacteraemia
  • Blood Potassium Decreased
  • Catheter Site Erythema
. Concurrently used drugs:
  • Tarceva (150 Mg Daily Po)
  • Torisel (5mg Dweekly Iv)
  • Roxicet
  • Oxycodone
  • Fentanyl
  • Magic Mouthwash
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Ensure side effects, such as pancytopenia.

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 (dosage: NA), which was started on Dec 30, 2008. Concurrently used drugs:
  • Sandostatin Lar (90 Mg Every 4 Weeks)
.When starting to take Ensure the consumer reported symptoms, such as:
  • Liver Operation
  • Oedema Peripheral
  • Abdominal Distension
  • Localised Oedema
  • Tricuspid Valve Replacement
  • Hepatic Neoplasm
These side effects may potentially be related to Ensure.



Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Ensure Side Effects

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    How Effective is Ensure for You?

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    Effective
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