NutreStore Side Effects Center

Last updated on RxList: 4/8/2021
NutreStore Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is NutreStore?

NutreStore (L-glutamine powder for oral solution) is indicated for the treatment of Short Bowel Syndrome (SBS) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication.

What Are Side Effects of NutreStore?

Common side effects of NutreStore include:

Dosage for NutreStore

The recommended dosage of NutreStore is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of NutreStore (5g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.

What Drugs, Substances, or Supplements Interact with NutreStore?

NutreStore may interact with other drugs. Tell your doctor all medications and supplements you use.

NutreStore During Pregnancy and Breastfeeding

During pregnancy, NutreStore should be taken only if prescribed. It is unknown if it would affect a fetus. It is unknown if NutreStore passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our NutreStore (L-glutamine powder for oral solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Pancreatitis is inflammation of an organ in the abdomen called the pancreas. See Answer
NutreStore Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pain;
  • hearing problems; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, unusual weakness.

Common side effects may include:

  • nausea, vomiting, stomach pain, gas;
  • swelling in your hands or feet;
  • muscle or joint pain, back pain;
  • headache, dizziness, tired feeling;
  • mild skin rash or itching; or
  • dry mouth, runny nose, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for NutreStore (L-glutamine Powder for Oral Solution)

SLIDESHOW

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NutreStore Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 provides the number of subjects by system-organ class experiencing at least one adverse reaction during the 4-week treatment period of the SBS study. To be listed in Table 1, an adverse reaction must have occurred in more than 10% of subjects in any treatment group.

Table 1. Controlled Trial Adverse Reactions – Initial 4-Week Treatment Period

Adverse Reactions Group A
rhGH + SOD1
N=16
n (%)
Group B
rhGH + SOD [GLN]1
N=16
n (%)
Group C
SOD [GLN]1
N=9
n (%)
Total Number of Subjects with At Least One Adverse Reaction 16 (100) 16 (100) 8 (89)
Body as a Whole: General Disorders 15 (94) 15 (94) 4 (44)
  Edema, Peripheral 11 (69) 13 (81) 1 (11)
  Edema, Facial 8 (50) 7 (44) 0 (0)
  Pain 3 (19) 1 (6) 1 (11)
  Chest Pain 3 (19) 0 (0) 0 (0)
  Fever 0 (0) 1 (6) 2 (22)
  Back Pain 1 (6) 0 (0) 1 (11)
  Flu-like Disorder 0 (0) 1 (6) 1 (11)
  Malaise 2 (13) 0 (0) 0 (0)
  Edema, Generalized 2 (13) 0 (0) 0 (0)
  Abdomen Enlarged 0 (0) 0 (0) 1 (11)
  Allergic Reaction 0 (0) 0 (0) 1 (11)
  Rigors (Chills) 0 (0) 0 (0) 1 (11)
Gastrointestinal System Disorders 12 (75) 12 (75) 6 (67)
  Flatulence 4 (25) 4 (25) 2 (22)
  Abdominal Pain 4 (25) 2 (13) 1 (11)
  Nausea 2 (13) 5 (31) 0 (0)
  Tenesmus 1 (6) 3 (19) 3 (33)
  Vomiting 3 (19) 3 (19) 1 (11)
  Hemorrhoids 1 (6) 0 (0) 1 (11)
  Mouth Dry 1 (6) 0 (0) 1(11)
Musculoskeletal System Disorders 7 (44) 7 (44) 1 (11)
  Arthralgia 7 (44) 5 (31) 0 (0)
  Myalgia 2 (13) 0 (0) 1 (11)
Resistance Mechanism Disorders 6 (38) 3 (19) 4 (44)
  Infection 0 (0) 1 (6) 3 (33)
  Infection Bacterial 3 (19) 0 (0) 1 (11)
  Infection Viral 1 (6) 2 (13) 0 (0)
  Moniliasis 2 (13) 0 (0) 0 (0)
Application Site Disorders 5 (31) 4 (25) 1 (11)
  Injection Site Reaction 3 (19) 4 (25) 1 (11)
  Injection Site Pain 5 (31) 0 (0) 0 (0)
Central and Peripheral Nervous System Disorders 4 (25) 4 (25) 2 (22)
  Dizziness 1 (6) 2 (13) 0 (0)
  Headache 1 (6) 1 (6) 1 (11)
  Hypoasthesia 1 (6) 1 (6) 1 (11)
Skin and Appendages Disorders 4 (25) 4 (25) 2 (22)
  Rash 1 (6) 2 (13) 0 (0)
  Pruritis 0 (0) 1 (6) 1 (11)
  Sweating Increased 2 (13) 0 (0) 0 (0)
  Nail Disorder 0 (0) 0 (0) 1 (11)
Respiratory System Disorders 1 (6) 5 (31) 1 (11)
  Rhinitis 0 (0) 3 (19) 1 (11)
Metabolic and Nutritional Disorders 3 (19) 1 (6) 1 (11)
  Dehydration 3 (19) 0 (0) 1 (11)
  Thirst 0 (0) 0 (0) 1 (11)
Urinary System Disorders 2 (13) 1 (6) 1 (11)
  Pyelonephritis 0 (0) 0 (0) 1 (11)
Psychiatric Disorders 1 (6) 0 (0) 2 (22)
  Depression 0 (0) 0 (0) 2 (22)
Reproductive Disorders, Female 2 (13) 0 (0) 1 (11)
  Breast Pain Female 1 (6) 0 (0) 1 (11)
Hearing and Vestibular Disorders 0 (0) 2 (13) 0 (0)
  Ear or Hearing Symptoms 0 (0) 2 (13) 0 (0)
1 SOD [GLN] = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine
GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks.
GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.
GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.

Table 2 summarizes the number of subjects by system-organ class who experienced an AR during weeks 5 to 18 of the randomized, controlled SBS study. To be listed in Table 2, an AR must have occurred in more than 10% of subjects in any treatment group.

Table 2. Controlled Trial Adverse Reactions –Weeks 5 to 18

Adverse Reactions Group A
rhGH + SOD1
N=15
n (%)
Group B
rhGH + SOD[GLN]1
N=16
n (%)
Group C
SOD [GLN]1
N=9
n (%)
Total Number of Subjects with At Least One Adverse Reaction 12 (80) 13 (81) 7 (78)
Gastrointestinal System Disorders 7 (47) 7 (44) 3 (33)
  Nausea 3 (20) 0 (0) 2 (22)
  Vomiting 2 (13) 3 (19) 0 (0)
  Abdominal Pain 3 (20) 1 (6) 0 (0)
  Tenesmus 0 (0) 3 (19) 1 (11)
  Pancreatitis 0 (0) 1 (6) 1 (11)
  Constipation 0 (0) 0 (0) 1 (11)
  Crohn's Disease Aggravated 0 (0) 0 (0) 1 (11)
  Gastric Ulcer 0 (0) 0 (0) 1 (11)
  Gastrointestinal Fistula 0 (0) 0 (0) 1 (11)
Resistance Mechanism Disorders 6 (40) 5 (31) 5 (56)
  Infection Bacterial 0 (0) 2 (13) 3 (33)
  Infection Viral 3 (20) 1 (6) 1 (11)
  Infection 1 (7) 2 (13) 1 (11)
  Sepsis 3 (20) 1 (6) 0 (0)
Body as a Whole: General Disorders 4 (27) 2 (13) 1 (11)
  Fever 2 (13) 1 (6) 1 (11)
  Fatigue 2 (13) 0 (0) 0 (0)
Respiratory System Disorders 2 (13) 4 (25) 1 (11)
  Rhinitis 1 (7) 3 (19) 0 (0)
  Laryngitis 0 (0) 0 (0) 1 (11)
  Pharyngitis 0 (0) 0 (0) 1 (11)
Reproductive Disorders, Female 0 (0) 4 (25) 1 (11)
  Vaginal Fungal Infection 0 (0) 0 (0) 1 (11)
Skin and Appendages Disorders 2 (13) 2 (13) 1 (11)
  Rash 1 (7) 0 (0) 1 (11)
Musculoskeletal System Disorders 2 (13) 2 (13) 0 (0)
  Arthralgia 2 (13) 2 (13) 0 (0)
Psychiatric Disorders 0 (0) 1 (6) 1 (11)
  Depression 0 (0) 0 (0) 1 (11)
  Insomnia 0 (0) 0 (0) 1 (11)
Urinary System Disorders 0 (0) 0 (0) 2 (22)
  Pyelonephritis 0 (0) 0 (0) 1 (11)
  Renal Calculus 0 (0) 0 (0) 1 (11)
Application Site Disorders 0 (0) 0 (0) 1 (11)
  Injection Site Reaction 0 (0) 0 (0) 1 (11)
Liver and Biliary System Disorders 0 (0) 0 (0) 1 (11)
  Hepatic Function Abnormal 0 (0) 0 (0) 1 (11)
Vascular Extracardiac Disorders 0 (0) 0 (0) 1 (11)
  Vascular Disorder 0 (0) 0 (0) 1 (11)
1 SOD [GLN] = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral
GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks.
GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.
GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.

During the initial 4-week treatment period, 100% of patients receiving growth hormone with and without glutamine reported at least one AR, whereas 89% of patients receiving growth hormone placebo with glutamine reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with glutamine, 80% of patients receiving growth hormone without glutamine and 78% of patients receiving growth hormone placebo with glutamine experienced at least one AR. There were no deaths in this study.

DRUG INTERACTIONS

Formal drug interaction studies have not been conducted.

Read the entire FDA prescribing information for NutreStore (L-glutamine Powder for Oral Solution)

© NutreStore Patient Information is supplied by Cerner Multum, Inc. and NutreStore Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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