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

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Vomiting (8577053-2)
on Nov 30, 2009 Female from UNITED STATES , 70 years of age, was treated with Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos). Directly after, patient experienced the unwanted or unexpected Ensure side effects: vomiting. Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) dosage: N/A.
Associated medications used:
  • Travatan
  • Tears Naturale (dextran 70, Hypromellose)
  • Furosemide
  • Potassium Chloride
  • Zyrtec
  • Nitroglycerin
  • Tetracycline
  • Aspirin
Patient was hospitalized.

Vomiting (8575205-9)
Patient was taking Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos). Patient felt the following Ensure side effects: vomiting on Nov 30, 2009 from UNITED STATES Additional patient health information: Female , 70 years of age, . Ensure (amino Acids Nos, Minerals Nos, Vitamins Nos) dosage: N/A.
Multiple prescriptions taken:
  • Warfarin Sodium
  • Folic Acid (folic Acid) Table
  • Tetracycline (tetracycline) Capsule
  • Aspirin
  • Furosemide (furosemide) Tablet
  • Potassium Chloride
  • Zyrtec
  • Travatan
Patient was hospitalized.

Pyrexia, Loss Of Consciousness (8462931-5)
Adverse event was reported on Nov 07, 2011 by a Female taking Ensure (ensure) (Dosage: N/A) . Location: UNITED STATES , 67 years of age, After Ensure was administered, patient encountered several Ensure side effects: pyrexia, loss of consciousness.
Multiple concurrent drugs taken:
  • Bactrim Ds
  • Prilosec
  • Acetaminophen
  • Prednisone Tab
  • Celexa
  • Lenalidomide (5 Mg, X 28 Caps, Po)
  • Metfformin Hydrochloride
Patient was hospitalized.

Localised Oedema, Hepatic Neoplasm, Abdominal Distension, Diarrhoea, Flushing, Oedema Peripheral (8353359-7)
on May 07, 2012 Female from CANADA , weighting 134.5 lb, was treated with Ensure. Directly after, patient experienced the unwanted or unexpected Ensure side effects: localised oedema, hepatic neoplasm, abdominal distension, diarrhoea, flushing, oedema peripheral. Ensure dosage: N/A.
Associated medications used:
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
  • Sandostatin Lar (90 Mg Every 4 Weeks)



Hepatic Neoplasm, Abdominal Distension, Oedema Peripheral, Localised Oedema, Flushing, Diarrhoea (8289232-2)
on Apr 09, 2012 Female from CANADA , weighting 134.5 lb, was treated with Ensure. Patient felt the following Ensure side effects: hepatic neoplasm, abdominal distension, oedema peripheral, localised oedema, flushing, diarrhoea. Ensure dosage: N/A.
Multiple prescriptions taken:
  • 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 (8287874-1)
Patient was taking Ensure /06184901/. After Ensure was administered, patient encountered several Ensure side effects: muscular weakness, soft tissue infection, neutrophil count decreased, platelet count decreased, anaemia, dyspnoea, chest pain on Apr 05, 2012 from UNITED STATES Additional patient health information: Female , weighting 124.8 lb, was diagnosed with
  • medical diet
and. Ensure /06184901/ dosage: Unk.
Multiple concurrent drugs taken:
  • 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)
Patient was hospitalized.

Hypotension, Septic Shock, Asthenia, Decreased Appetite (8031669-0)
Adverse event was reported on Jan 05, 2012 by a Male taking Ensure Plus (Dosage: N/A) was diagnosed with
  • malnutrition
and. Location: UNITED STATES , weighting 132.1 lb, Directly after, patient experienced the unwanted or unexpected Ensure side effects: hypotension, septic shock, asthenia, decreased appetite.
Associated medications used:
  • Ciprofloxacin
  • Thiamine Hcl
  • Folic Acid
  • Remeron (7.5 Milligram)
  • Multi-vitamins
  • Revlimid (10 Milligram)
  • Rilutek
  • Vitamin B-12
Patient was hospitalized and became disabled.

Decreased Appetite, Convulsion, Nausea (7984456-3)
on Dec 04, 2011 Female from JAPAN , 83 years of age, was treated with Ensure /06184901/. Patient felt the following Ensure side effects: decreased appetite, convulsion, nausea. Ensure /06184901/ dosage: Unk.
Multiple prescriptions taken:
  • Forteo (Unk)


Hyponatraemia, Pancytopenia, Vomiting, Neutropenic Sepsis, Hypokalaemia, Hypophagia, Disease Recurrence, Dehydration (7957042-9)
on Nov 15, 2011 Male from UNITED KINGDOM , weighting 202.8 lb, was treated with Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min. After Ensure was administered, patient encountered several Ensure side effects: hyponatraemia, pancytopenia, vomiting, neutropenic sepsis, hypokalaemia, hypophagia, disease recurrence, dehydration. Ensure Plus (carbohydrates Nos, Electrolytes Nos, Fatty Acids Nos, Min dosage: N/A.
Multiple concurrent drugs taken:
  • 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)
Patient was hospitalized.

Stevens-johnson Syndrome (7903060-6)
Patient was taking Ensure /06184901/. Directly after, patient experienced the unwanted or unexpected Ensure side effects: stevens-johnson syndrome on Oct 27, 2011 from UNITED KINGDOM Additional patient health information: Female , 85 years of age, weighting 92.59 lb, . Ensure /06184901/ dosage: N/A.
Associated medications used:
  • 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
Patient was hospitalized.

Stevens-johnson Syndrome (7867246-1)
Adverse event was reported on Oct 27, 2011 by a Female taking Ensure (Dosage: N/A) . Location: UNITED KINGDOM , 85 years of age, weighting 92.59 lb, Patient felt the following Ensure side effects: stevens-johnson syndrome.
Multiple prescriptions taken:
  • Omeprazole
  • Acetaminophen
  • Erythromycin
  • Doxycycline
  • Perindopril Erbumine
  • Levothyroxine Sodium
  • Clarithromycin
  • Gaviscon
Patient was hospitalized.

Diarrhoea, Gallbladder Cancer (7784623-8)
on Sep 23, 2011 Female from UNITED STATES , weighting 147.9 lb, was treated with Ensure Plus. After Ensure was administered, patient encountered several Ensure side effects: diarrhoea, gallbladder cancer. Ensure Plus dosage: 4 Cans Per Day.
Multiple concurrent drugs taken:
  • Esomeprazole Sodium
  • Zoloft
  • Memantine
  • Zoloft
  • Megestrol Acetate (625mg Per 5ml)
  • Aricept
Patient was hospitalized.

Neoplasm Malignant, Concomitant Disease Progression (7781132-7)
on Sep 22, 2011 Male from JAPAN , 87 years of age, was treated with Ensure. Directly after, patient experienced the unwanted or unexpected Ensure side effects: neoplasm malignant, concomitant disease progression. Ensure dosage: Unk Ukn, Unk.
Associated medications used:
  • Exelon (4.6 Mg, Daily)
Patient was hospitalized.

Hyponatraemia, Lethargy, Vomiting (7745205-7)
Patient was taking Ensure (nutrients Nos). Patient felt the following Ensure side effects: hyponatraemia, lethargy, vomiting on Aug 23, 2011 from UNITED KINGDOM Additional patient health information: Male , weighting 202.8 lb, . Ensure (nutrients Nos) dosage: N/A.
Multiple prescriptions taken:
  • Dexamethasone
  • Aspirin
  • Bisoprolol Fumarate
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
  • Samsca (See Image)
Patient was hospitalized.

Decreased Appetite, Hepatic Cirrhosis (7642030-2)
Adverse event was reported on Jul 19, 2011 by a Female taking Ensure (Dosage: N/A) was diagnosed with
  • decreased appetite
  • musculoskeletal pain
and. Location: JAPAN , 80 years of age, After Ensure was administered, patient encountered several Ensure side effects: decreased appetite, hepatic cirrhosis.
Multiple concurrent drugs taken:
  • Enbrel
  • Prednisolone
  • Methotrexate
  • Spironolactone
  • Amaryl
  • Januvia
  • Nivadil
Patient was hospitalized.

Oral Candidiasis, Dysphagia, Gastrooesophageal Reflux Disease, Throat Irritation, Oral Discomfort, Oesophageal Candidiasis, Oesophageal Irritation, Blood Thyroid Stimulating Hormone Increased (7621057-0)
on Nov 16, 2010 Female from UNITED STATES , 66 years of age, was treated with Ensure. Directly after, patient experienced the unwanted or unexpected Ensure side effects: oral candidiasis, dysphagia, gastrooesophageal reflux disease, throat irritation, oral discomfort, oesophageal candidiasis, oesophageal irritation, blood thyroid stimulating hormone increased. Ensure dosage: Unk,.
Associated medications used:
  • Levoxyl (50 Mcg, Qd)
  • Asacol


Hepatic Neoplasm, Diarrhoea, Localised Oedema, Oedema Peripheral, Abdominal Distension (7617985-2)
on Jul 05, 2011 Female from CANADA , weighting 134.5 lb, was treated with Ensure. Patient felt the following Ensure side effects: hepatic neoplasm, diarrhoea, localised oedema, oedema peripheral, abdominal distension. Ensure dosage: N/A.
Multiple prescriptions taken:
  • Sandostatin Lar (60 Mg, Every 4 Weeks)
  • Sandostatin Lar (90 Mg Every 4 Weeks)


Pancytopenia, Hepatic Enzyme Increased, Catheter Site Inflammation, Diarrhoea, Bacteraemia, Blood Potassium Decreased, Catheter Site Erythema (7274551-9)
Patient was taking Ensure. After Ensure was administered, patient encountered several Ensure side effects: pancytopenia, hepatic enzyme increased, catheter site inflammation, diarrhoea, bacteraemia, blood potassium decreased, catheter site erythema on Feb 01, 2011 from UNITED STATES Additional patient health information: Male , 64 years of age, weighting 136.7 lb, . Ensure dosage: N/A.
Multiple concurrent drugs taken:
  • Tarceva (150 Mg Daily Po)
  • Torisel (5mg Dweekly Iv)
  • Roxicet
  • Oxycodone
  • Fentanyl
  • Magic Mouthwash
Patient was hospitalized.

Liver Operation, Oedema Peripheral, Abdominal Distension, Localised Oedema, Tricuspid Valve Replacement, Hepatic Neoplasm (7212553-9)
Adverse event was reported on Dec 28, 2010 by a Female taking Ensure (Dosage: N/A) . Location: CANADA , weighting 134.5 lb, Directly after, patient experienced the unwanted or unexpected Ensure side effects: liver operation, oedema peripheral, abdominal distension, localised oedema, tricuspid valve replacement, hepatic neoplasm.
Associated medications used:
  • Sandostatin Lar (90 Mg Every 4 Weeks)


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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.

Ensure Information

More About Ensure

Side Effects reported to FDA: 19. View Ensure Adverse Reports

Ensure safety alerts: No

Reported deaths: 3

Reported hospitalizations: 4

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