NutreStore

Name: NutreStore

Dosing & Uses

Dosage Forms & Strengths

powder for oral administration

  • 5g/packet (as L-glutamine)

Sickle Cell Disease

Endari: Indicated to reduce acute complications of sickle cell disease

<30 kg (<66 lb): 5 g PO BID

30-65 kg (66-143 lb): 10 g PO BID

≥65 kg (≥143 lb): 15 g PO BID

Also see Administration regarding mixing oral powder with beverage or food

Short Bowel Syndrome

NutreStore: Indicated for short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with recombinant human growth hormone

30 g/day PO in divided doses (ie, 5 g taken 6 times each day) for up to 16 weeks

Also see Administration regarding mixing oral powder with water

Dosage Forms & Strengths

powder for oral administration

  • 5g/packet (as L-glutamine)

Sickle Cell Disease

Endari: Indicated to reduce acute complications of sickle cell disease in adults and children aged ≥5 yr

<5 years: Safety and efficacy not established

≥5 years

  • <30 kg (<66 lb): 5 g PO BID
  • 30-65 kg (66-143 lb): 10 g PO BID
  • ≥65 kg (≥143 lb): 15 g PO BID
  • Also see Administration regarding mixing oral powder with beverage or food

Short Bowel Syndrome

NutreStore: Safety and efficacy not established

Adverse Effects

>10%

Endari

  • Constipation (21%)
  • Nausea (19%)
  • Headache (18%)
  • Abdominal pain (17%)
  • Cough (16%)
  • Pain in extremity (13%)
  • Back pain (12%)
  • Chest pain (12%)

NutreStore

  • Adverse effects listed below are those reported that exceed growth hormone without glutamine supplementation
  • Peripheral edema (81%)
  • Nausea (31%)
  • Tenesmus (19%)
  • Rhinitis (19%)
  • Dizziness (13%)
  • Rash (13%)
  • Ear or hearing symptoms (13%)

1-10%

NutreStore

  • Pruritus (6%)

Pregnancy & Lactation

Pregnancy

No available data regarding use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

NutreStore Overview

NutreStore is a brand name medication included in a group of medications called Amino acids and derivatives. For more information about NutreStore see its generic Glutamine

Adverse Reactions

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 clinical 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 Group B Group C
rhGH+SOD*
N=16
n (%)
rhGH+SOD[GLN]*
N=16
n (%)
SOD[GLN]*
N=9
n (%)
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.
* 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
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 (16) 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)

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 Group B Group C
rhGH+SOD*
N=15
n (%)
rhGH+SOD[GLN]*
N=16
n (%)
SOD[GLN]*
N=9
n (%)
GROUP A: rhCH + 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.
* SOD [GLNJ = Specialized Oral Diet supplemented with Glutamine; rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral
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 FistuIa 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)

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.

Nutrestore Description

Nutrestore (L-glutamine powder for oral solution) for oral administration is formulated as a white crystalline powder in a paper-foil-plastic laminate packet. Each packet of Nutrestore contains 5 g of L-glutamine. The amino acid glutamine is also known as (S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, (S)-2,5-diamino-5-oxopentanoic acid, or L-glutamine. The molecular formula of glutamine is C5H10N2O3, and the molecular weight is 146.15 d. Glutamine has the following structural formula:

Clinical Studies

Short Bowel Syndrome

A randomized, controlled, 3-arm, double-blind, parallel-group clinical study evaluated the efficacy and safety of oral glutamine as a cotherapy with rhGH in subjects with SBS who were dependent on intravenous parenteral nutrition (IPN) for nutritional support. The primary endpoint was the change in weekly total IPN volume defined as the sum of the volumes of lPN, supplemental lipid emulsion (SLE), and intravenous hydration fluid. The secondary endpoints were the change in weekly IPN caloric content and the change in the frequency of IPN administration per week.

All subjects received a specialized oral diet (SOD) for the duration of the study. Following a two-week equilibration period, treatment was administered in a double blind manner. Group A (N=16) received rhGH for four weeks plus oral glutamine placebo for 16 weeks, Group B (N=16) received rhGH for four weeks plus oral glutamine for 16 weeks, and Group C (N=9), received rhGH placebo for four weeks plus oral glutamine for 16 weeks. The efficacy of glutamine was assessed by comparing the cotherapy (rhGH and oral glutamine) to rhGH alone.

After 4 weeks of treatment with subcutaneous rhGH (0.1 mg/kg/d) and oral glutamine (30 g/ d) (Group B), subjects with SBS reduced their requirement for IPN volume (-7.7 L/wk), IPN caloric content (-5751 kcal/wk), and weekly frequency of IPN administration (-4.2 d/wk).

Table 3 Results for Endpoints after 4 weeks of Treatment
Group A Group B Group C
rhGH + SOD * rhGH + SOD[GLN] * SOD[GLN] *
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
* 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 † p= 0.023, treatment comparison between rhGH + SOD[GLN] versus rhGH+SOD
 
Total IPN volume (L/wk)
  Mean at Baseline 10.3 10.5 13.5
  Mean Change -5.9 -7.7† -3.8
 
Total IPN Calories (kcal/wk)
  Mean at Baseline 7634.7 7895.0 8570.4
  Mean Change -4338.3 -5751.2 -2633.3
 
Frequency of IPN or SLE (days/week)
  Mean at Baseline 5.1 5.4 5.9
  Mean Change -3.0 -4.2 -2.0
 

IPN volume requirements were Significantly reduced in subjects receiving subcutaneous rhGH and oral glutamine (Group B) when compared with IPN volume requirements in subjects receiving either treatment alone.

Table 4 Persistence of Treatment Effect
Change in lPN* Volume, Calories, and Frequency
Week 2 to Week 18
lTT Population
Endpoint Group A
[n = 16]
Group B
[n = 16]
Group C
[n = 9]
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 yv SOD[GLN] for 12 weeks.
* IPN is Total lPN excluding supplemental lipid emulsion (SLE) and hydration fluid.
Change in weekly IPN Volume (L/wk) -5.9 -7.2 -4.7
Change in weekly IPN Calories (kcal/wk) -3522.2 -5347.3 -2254.0
Change in weekly IPN frequency (days/wk) -2.9 -3.9 -1.9

The change in weekly IPN volume, calories and frequency was assessed from Week 2 to Week 18. The data support that the treatment effect is maintained for 16 weeks. The efficacy of oral glutamine beyond 16 weeks of treatment has not been adequately studied.

Patient Counseling Information

[See FDA-approved patient labeling]

Dosing Instructions

Nutrestore should be taken with meals or snacks at 2- to 3-hour intervals while awake. The volume of water may be varied according to the patient's preference. In the event of a patient's transient intolerance to oral intake, a dose may be delayed for up to 2 hours.

For additional information concerning Nutrestore, contact:

Manufactured for:
Emmaus
MEDICAL, INC.

20725 S. Western Ave., Suite 136
Torrance, CA 90501-1884
Tel: 1-877-420-6493
www.Nutrestore.com

© 2013 Emmaus Medical, Inc.

FDA-Approved Patient Labeling

Patient Information

Nutrestore® (NOO-tre-stor)
[L-glutamine powder for oral solution] (GLOO-tah-min)

Please read this leaflet carefully before you start to use Nutrestore® and each time your prescription is refilled since there may be new information. The information in this leaflet does not take the place of regularly talking with your doctor or health care professional.

What is Nutrestore®?

Nutrestore® is the amino acid L-glutamine, identical to the L-glutamine that your body produces. Nutrestore® is used together with a human growth hormone, approved for treating short bowel syndrome [SBS], in patients receiving a specialized diet tailored to meet their individual needs.

Why has my doctor prescribed Nutrestore®?

Your doctor prescribed Nutrestore® initially in combination with human growth hormone to help decrease your need for intravenous feedings. After treatment in combination with human growth hormone, you will continue to take Nutrestore® alone to maintain the treatment effect. During your treatment with Nutrestore® you will be taking up to 6 packets of Nutrestore® a day. You will also receive instructions from your doctor or a dietitian on the proper diet you should follow during this treatment period as well as after your treatment is over. Please refer to the patient package leaflet available for human growth hormone for more information on how to take human growth hormone.

What should I tell my doctor before taking Nutrestore®?

Tell your doctor about all of your conditions including if you:

  • are pregnant or planning to become pregnant. It is not known if Nutrestore® can harm your unborn baby.
  • are breast feeding. It is not known if Nutrestore® passes into your milk and if it can harm your baby. You should talk to your doctor about breastfeeding while taking Nutrestore®.
  • have liver or kidney problems. Your doctor may do blood tests to check your liver and kidney function while you are taking Nutrestore®.
  • are older than 65 years of age. Your dose of Nutrestore® may need to be adjusted.

Tell your doctor about all the medicines you take including prescription medicines, non-prescription medicines, vitamins, or herbal supplements. It is not known if Nutrestore® and other medicines can affect each other.

What should I avoid while taking Nutrestore®?

  • Pregnancy. You should talk to your doctor if you are planning to become pregnant while taking Nutrestore®. It is not known whether Nutrestore® can affect the ability of a woman to become pregnant. It is also not known whether Nutrestore® can cause harm to a fetus when taken by a pregnant woman or if Nutrestore® has an effect on labor and delivery.
  • Breastfeeding. You should talk to your doctor before breastfeeding an infant while taking Nutrestore®. It is not known whether the glutamine in Nutrestore® can be passed to an infant in mother's milk, and it is not clear whether the drug could harm the infant if it is passed in mother's milk.

What are the possible side effects of Nutrestore®?

Many patients taking Nutrestore® and human growth hormone for the treatment of SBS experience side effects.

Whether or not you experience side effects, you and your doctor should periodically talk about your general health.

  • Your doctor may want to monitor you more closely and ask you to have blood tests done more frequently.

Digestive system.

The possible side effects you may experience while taking Nutrestore® include vomiting, hemorrhoids, pancreatitis, aggravation of Crohn's disease, gastric ulcer, and gastrointestinal fistula (opening between stomach and intestine).

The possible related symptoms you may experience while taking Nutrestore® include urge to empty bowel, gas, abdominal pain, nausea, dry mouth and constipation.

These side effects and related symptoms may be similar to those you have experienced while being treated for SBS. You should talk to your doctor about these problems before starting an over-the-counter medication to treat these symptoms. It is important for you to follow your doctor's or dietitian's instructions on the type of diet best for you.

Please refer also to the patient package leaflet available for human growth hormone for more information on the possible benefits and side effects of human growth hormone.

Tell your doctor about any side effects that bother you or that do not go away.

These are not all the side effects with Nutrestore®. For more information, ask your doctor or pharmacist.

How should I take Nutrestore®?

Nutrestore® should be taken up to 6 times a day (every 2 to 3 hours during the day) with a meal or snack. This should be continued every day for as long as your doctor prescribes. Each dose of Nutrestore® should be prepared by pouring the contents of one packet into an 8-oz glass of water and stirring for approximately 1 minute. After stirring, you should drink the Nutrestore® within 2 hours. If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Do not take more than 6 packets each day.

What kind of food should I eat during my treatment with Nutrestore®?

Your doctor or dietitian will prescribe for you the types and quantities of foods you should eat during your treatment with Nutrestore®. These foods are not special and can be purchased from your local market. Your likes and dislikes should be taken into consideration when your meal plan is created.

Your doctor or dietitian will advise you on how many times a day you should eat. Your doctor or dietitian will adjust your diet as needed during your treatment with Nutrestore®. It is important that you carefully follow the eating plan your doctor or dietitian gives you.

Storage conditions for Nutrestore®

Packets of Nutrestore® should be stored at room temperature (25°C / 77°F). Expiration dates are stated on product labels. Do not use any damaged packets of Nutrestore®. Keep Nutrestore® and all medicines out of the reach of children.

General information about prescription medicines

This medication has been prescribed for a particular medical condition. Do not use it for another condition or give this drug to anyone else. If you have any questions, you should speak with your doctor or health care professional. You may also ask your doctor or pharmacist for a copy of the information provided to them with the product. Keep this and all drugs out of the reach of children.

For additional information, you may call the Nutrestore® patient hotline at 1-877-420-6493.

PRINCIPAL DISPLAY PANEL - 84 Packet Carton

Nutrestore®
[L-glutamine powder for oral solution]

Nutrestore 
glutamine powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42457-001
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glutamine (glutamine) glutamine 5 g
Packaging
# Item Code Package Description
1 NDC:42457-001-84 84 PACKET in 1 BOX
1 NDC:42457-001-01 1 POWDER, FOR SOLUTION in 1 PACKET
2 NDC:42457-001-18 18 PACKET in 1 BOX
2 NDC:42457-001-11 1 POWDER, FOR SOLUTION in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021667 06/04/2008
Labeler - Emmaus Medical, Inc. (784073434)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc. 053217022 PACK(42457-001)
Establishment
Name Address ID/FEI Operations
Kyowa Hakko Bio Co., Ltd. 690598751 API MANUFACTURE(42457-001)
Revised: 07/2014   Emmaus Medical, Inc.

For the Consumer

Applies to glutamine: oral capsule, oral packet, oral powder, oral powder for solution, oral powder for suspension, oral tablet

Along with its needed effects, glutamine (the active ingredient contained in NutreStore) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking glutamine:

Less common
  • Blood in urine
  • changes in skin color
  • chills
  • cold hands and feet
  • confusion
  • cough
  • difficulty swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • fever
  • frequent and painful urination
  • headache
  • hives, itching, skin rash
  • lightheadedness
  • lower back or side pain
  • pain, redness, or swelling in the arm or leg
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, shallow breathing
  • stomach pain
  • sudden decrease in amount of urine
  • tightness in the chest
  • unusual tiredness or weakness

Some side effects of glutamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cough or hoarseness
  • frequent urge to have a bowel movement
  • straining while passing stool
Less common
  • Abnormal or decreased touch sensation
  • back pain
  • bacterial infection
  • bleeding after having a bowel movement
  • body aches or pain
  • breast pain in females
  • chest pain
  • change in the color, amount, or odor of vaginal discharge
  • congestion
  • constipation
  • dark urine
  • decreased urination
  • diarrhea
  • difficulty having a bowel movement
  • difficulty in moving
  • discoloration of the fingernails or toenails
  • discouragement
  • dry mouth
  • dryness or soreness of the throat
  • ear or hearing symptoms
  • excess air or gas in the stomach or intestines
  • feeling sad or empty
  • feeling unusually cold, shivering
  • full or bloated feeling
  • general feeling of discomfort or illness
  • increased heart rate
  • indigestion
  • irritability
  • joint pain
  • lack of appetite
  • light-colored stools
  • loss of appetite
  • loss of interest or pleasure
  • muscle aches and pains
  • muscle pain or stiffness
  • nausea
  • pain or burning feeling while urinating
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • passing gas
  • pressure in the stomach
  • rectal bleeding
  • runny nose
  • sneezing
  • stomach bloating, burning, cramping, or pain
  • stuffy nose
  • sunken eyes
  • sweating
  • swelling of the face
  • swelling of the hands, ankles, feet, or lower legs
  • swelling of the stomach area
  • swollen joints
  • tender, swollen glands in the neck
  • thirst
  • trouble concentrating
  • trouble sleeping
  • trouble in swallowing
  • uncomfortable swelling around the anus
  • unpleasant breath odor
  • unusual tiredness or weakness
  • voice changes
  • vomiting
  • vomiting of blood
  • weight loss
  • wrinkled skin
  • yellow eyes or skin

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