Medicine guide

Balsalazide Disodium

750 mg · Capsule

Prescription only
Aminosalicylate

Active substance: Balsalazide Disodium
Made by: Zydus Pharmaceuticals (USA) Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-06-13

What it is

Aminosalicylate

Used for

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

The label’s usual adult dose

Adults :: the recommended dosage is 2.25 g (three 750 mg capsules) three times daily for 8 weeks.

Full directions ↓

Do not take it if

Balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [see Warnings and…

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

8other products contain Balsalazide Disodium — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

( 1 ) Limitations of Use:

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
Limitations of Use Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in
adults have not been established.
Balsalazide disodium capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in children (ages 5 years to 17 years) and 12 weeks in
adults have not been established.
( 1 )

From the official label · 2025-06-13 · DailyMed

How it works

From this product’s own US prescribing label.

Balsalazide disodium is delivered intact to the colon where it is cleaved by bacterial azoreduction to release equimolar quantities of mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-β-alanine carrier moiety.
The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert.

How the body breaks it down

The 5-ASA is further metabolized to yield N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), a second key metabolite.

With food

Effect of Food The plasma pharmacokinetics of balsalazide and its key metabolites from a crossover study in healthy subjects are summarized in Table 3.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-06-13

Do not take it if

Balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , Description (11) ] .
Known or suspected hypersensitivity to salicylates, aminosalicylates, or any of the components of balsalazide disodium capsules or balsalazide metabolites.
( 4 , 5.3 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Administration Instructions Evaluate renal function before initiating therapy with balsalazide disodium capsules.
( 2.1 ) Swallow capsules whole.
Do not cut, break, crush or chew.
( 2.1 ) For patients who cannot swallow intact capsules, the capsules may be opened and sprinkled on applesauce, then chewed and swallowed immediately.
( 2.1 ) Teeth and/or tongue staining may occur when administered sprinkled on applesauce.
( 2.1 ) Drink an adequate amount of fluids.
( 2.1 , 5.8 ) Take balsalazide disodium capsules with or without food.
( 2.1 ) Dosage
Adults :
The recommended dosage is 2.25 g (three 750 mg capsules) three times daily for 8 weeks.
Some adult patients required treatment for up to 12 weeks in clinical trials.
( 2.2 ) Pediatric Patients 5 Years to 17 Years of Age :
The recommended dosage is either :
2.25 g (three 750 mg capsules) three times for up to 8 weeks.
OR: 750 mg (one capsule) three times daily for up to 8 weeks.
( 2.2 )
2.1 Important Preparation and Administration Instructions Evaluate renal function before initiating therapy with balsalazide disodium capsules [see Warnings and Precaution (5.1) ] .
Swallow balsalazide disodium capsules whole.
Do not cut, break, crush or chew the capsules.
For patients who cannot swallow intact capsules, balsalazide disodium capsules may also be administered by opening the capsule and sprinkling the capsule contents on applesauce.
If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.
Place a small amount (approximately 10 mL) of applesauce into a clean container.
Carefully open the capsules.
Sprinkle the capsule contents on the applesauce.
Mix the capsule contents with the applesauce.
The contents may be chewed, if necessary.
Consume the entire amount of applesauce mixture immediately.
Do not store the applesauce mixture for future use.
Teeth and/or tongue staining may occur in some patients when administered sprinkled on applesauce.
Drink an adequate amount of fluids [see Warnings and Precautions (5.8) ] .
Take balsalazide disodium capsules with or without food [see Clinical Pharmacology (12.3) ].
Recommended Dosage in
Adults and Pediatric Patients 5 Years to 17 Years of Age
Adults The recommended dosage in
adults is 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks.
Some patients in the adult clinical trials required treatment for up to 12 weeks.
Pediatric Patients 5 Years to 17 Years of Age The recommended dosage in pediatric patients 5 years to 17 years of age is either :
2.25 g (three 750 mg capsules) three times daily for up to 8 weeks;
OR : 750 mg (one capsule) three times daily for up to 8 weeks.
Use of balsalazide disodium capsules in the pediatric population for more than 8 weeks has not been evaluated in clinical trials [see Clinical Studies (14) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Renal Impairment:
Assess renal function at the beginning of treatment and periodically during treatment.
Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function.
Discontinue if renal function deteriorates.
( 5.1 , 7.1 , 8.6 ) Mesalamine-Induced Acute Intolerance Syndrome:
Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected.
( 5.2 ) Hypersensitivity Reactions, including Myocarditis and Pericarditis:
Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected.
( 5.3 ) Hepatic Failure:
Evaluate the risks and benefits in patients with known liver impairment.
Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation ( 5.5 ) Upper Gastrointestinal Tract Obstruction :
Avoid in patients with pyloric stenosis or other organic or functional obstruction.
( 5.6 ) Photosensitivity :
( 5.7 ) Nephrolithiasis :
Stones containing mesalamine, the active moiety in balsalazide disodium capsules, are undetectable by standard radiography or computed tomography (CT).
Ensure adequate fluid intake during treatment with balsalazide disodium capsules.
( 5.8 ) Interference with Laboratory Tests :
Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection.
( 5.9 )
5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as balsalazide disodium capsules that release mesalamine into the gastrointestinal tract.
Evaluate renal function prior to initiation of balsalazide disodium capsules and periodically while on therapy.
Evaluate the risks and benefits of using balsalazide disodium capsules in patients with known renal impairment, a history of renal disease or taking nephrotoxic drugs.
Discontinue balsalazide disodium capsules if renal function deteriorates while on therapy [see Drug Interactions (7.1) , Use in Specific Populations (8.6) ] .
5.2 Mesalamine-Induced Acute Intolerance Syndrome Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis.
Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine.
Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash.
Monitor patients for worsening of these symptoms while on treatment.
If acute intolerance syndrome is suspected, promptly discontinue treatment with balsalazide disodium capsules.
5.3 Hypersensitivity Reactions Some patients have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to balsalazide disodium capsules or to other compounds that contain or are converted to mesalamine.
Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities.
Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present.
Discontinue balsalazide disodium capsules if an alternative etiology for the signs and symptoms cannot be established.
5.4 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine.
Because balsalazide is converted to mesalamine, evaluate the risks and benefits of using balsalazide disodium capsules in patients with known liver impairment.
5.5 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine, the active moiety of balsalazide disodium capsules [see Adverse Reactions (6.2)].
Discontinue balsalazide disodium capsules at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
5.6 Upper Gastrointestinal Tract Obstruction Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of balsalazide disodium capsules, which would delay mesalamine release in the colon.
Avoid balsalazide disodium capsules in patients at risk of upper gastrointestinal tract obstruction.
5.7 Photosensitivity Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions.
Advise patients to
5.8 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, the active moiety of balsalazide disodium capsules, including stones with 100% mesalamine content.
Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT).
Ensure adequate fluid intake during treatment with balsalazide disodium capsules.
5.9 Interference with Laboratory Tests Use of balsalazide disodium capsules, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5- ASA).

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide disodium, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .
There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations) .
In animal reproduction studies, there were no adverse developmental effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended human dose (MRHD) (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide disodium, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations.
Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products.
Animal Data Reproduction studies were performed in rats and rabbits following administration of balsalazide during organogenesis at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the MRHD based on body surface area for the rat and rabbit, respectively, and revealed no adverse embryofetal developmental effects due to balsalazide disodium.
IN SPECIFIC POPULATIONS Geriatric Patients :
Increased risk of blood dyscrasias; monitor blood cell counts and platelet counts.
( 8.5 )
8.1 Pregnancy Risk Summary Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide disodium, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .
There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations) .
In animal reproduction studies, there were no adverse developmental effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended human dose (MRHD) (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide disodium, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations.
Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products.
Animal Data Reproduction studies were performed in rats and rabbits following administration of balsalazide during organogenesis at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the MRHD based on body surface area for the rat and rabbit, respectively, and revealed no adverse embryofetal developmental effects due to balsalazide disodium.
8.2 Lactation Risk Summary Data from published literature report the presence of mesalamine and its metabolite, N acetyl-5 aminosalicylic acid, in human milk in small amounts with relative infant doses (RID) of 0.1% or less for mesalamine ( see Data ).
There are case reports of diarrhea in breastfed infants exposed to mesalamine (see Clinical Considerations) .
There is no information on the effects of the drug on milk production.
The lack of clinical data during lactation precludes a clear determination of the risk of balsalazide disodium to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for balsalazide disodium and any potential adverse effects on the breastfed child from balsalazide disodium or from the underlying maternal condition.
Clinical Considerations Advise the caregiver to monitor breastfed infants for diarrhea.
Data In published lactation studies, maternal mesalamine doses from various oral and rectal mesalamine formulations and products ranged from 500 mg to 4.8 g daily.
The average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/L.
The average concentration of N-acetyl-5-aminosalicylic acid in milk ranged from 0.2 mg/L to 9.3 mg/L.
Based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 mg/kg/day to 0.075 mg/kg/day (RID 0 to 0.1%) of mesalamine and 0.03 mg/kg/day to 1.4 mg/kg/day of N-acetyl-5-aminosalicylic acid.
8.4 Pediatric Use The safety and effectiveness of balsalazide disodium has been established for the treatment of mildly to moderately active ulcerative colitis in pediatric and adolescent patients 5 years to 17 years of age.
Use of balsalazide disodium for this indication is supported by evidence from adequate and well-controlled clinical studies in
adults with additional pharmacokinetic and safety data in pediatric patients aged 5 years to 17 years [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.2) ].
Based on the limited data available, dosing can be initiated at either 6.75 g/day or 2.25 g/day [see Dosage and Administration (2.2) ] .
The safety and effectiveness of balsalazide disodium in pediatric patients below the age of 5 years have not been established.
8.5 Geriatric Use Clinical trials of balsalazide disodium did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects.
Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia and pancytopenia, in patients who were 65 years or older compared to younger patients taking mesalamine-containing products.
Balsalazide disodium is converted into mesalamine in the colon.
Monitor complete blood cell counts and platelet counts in elderly patients during treatment with balsalazide disodium.
In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing balsalazide disodium capsules [see Use in Specific Populations ( 8.6 )] .
8.6 Renal Impairment Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to balsalazide disodium, which is converted to mesalamine, may be greater in patients with impaired renal function.
Evaluate renal function in all patients prior to initiation and periodically while on balsalazide disodium capsules therapy.
Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions.
Discontinue balsalazide disodium capsules if renal function deteriorates while on therapy [see Warnings and Precautions ( 5.1 ), Adverse Reactions (6.2), Drug Interactions (7.1)] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Nephrotoxic Agents including NSAIDs:
Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine- related adverse reactions.
( 7.1 ) Azathioprine or 6-Mercaptopurine:
Increased risk of blood disorders; monitor complete blood cell counts and platelet counts.
( 7.2 )
7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of renal reactions.
Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1) ].
7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications.
If concomitant use of balsalazide disodium capsules and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
7.3 Interference with Urinary Normetanephrine Measurements Use of balsalazide disodium capsules, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.9) ] .
Consider an alternative, selective assay for normetanephrine.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Balsalazide disodium capsules are an aminosalicylate, and symptoms of salicylate toxicity include:
nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures).
Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage.
There is no specific antidote for balsalazide overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption.
Proper medical care should be sought immediately with appropriate supportive care, including the possible use of emesis, cathartics, and activated charcoal to prevent further absorption.
Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of balsalazide disodium has been established for the treatment of mildly to moderately active ulcerative colitis in pediatric and adolescent patients 5 years to 17 years of age.
Use of balsalazide disodium for this indication is supported by evidence from adequate and well-controlled clinical studies in
adults with additional pharmacokinetic and safety data in pediatric patients aged 5 years to 17 years [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.2) ].
Based on the limited data available, dosing can be initiated at either 6.75 g/day or 2.25 g/day [see Dosage and Administration (2.2) ] .
The safety and effectiveness of balsalazide disodium in pediatric patients below the age of 5 years have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical trials of balsalazide disodium did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects.
Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia and pancytopenia, in patients who were 65 years or older compared to younger patients taking mesalamine-containing products.
Balsalazide disodium is converted into mesalamine in the colon.
Monitor complete blood cell counts and platelet counts in elderly patients during treatment with balsalazide disodium.
In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing balsalazide disodium capsules [see Use in Specific Populations ( 8.6 )] .

Quoted from the official label, section “Geriatric Use”.

Side effects

The following clinically significant adverse reactions are described elsewhere in labeling:
Renal Impairment [see Warnings and Precautions (5.1) ] Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Failure [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Upper Gastrointestinal Tract Obstruction [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Nephrolithiasis [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥3%) are:
headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia.
Adverse reactions in pediatric patients were similar.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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.
Adult Ulcerative Colitis During clinical development, 259 adult patients with active ulcerative colitis were exposed to 6.75 g/day balsalazide disodium in 4 controlled trials.
In the 4 controlled clinical trials patients receiving a balsalazide disodium dose of 6.75 g/day most frequently reported the following adverse reactions:
headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%).
Withdrawal from therapy due to adverse reactions was comparable among patients on balsalazide disodium and placebo.
Adverse reactions reported by 1% or more of patients who participated in the 4 well-controlled, Phase 3 trials are presented by treatment group (Table 1).
The number of placebo patients (35), however, is too small for valid comparisons.
Some adverse reactions, such as abdominal pain, fatigue, and nausea were reported more frequently in women than in men.
Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.
Table 1:
Adverse Reactions Occurring in ≥1% of Adult balsalazide disodium Patients in Controlled Trials Adverse reactions occurring in at least 1% of balsalazide disodium patients which were less frequent than placebo for the same adverse reaction were not included in the table.
Adverse Reaction balsalazide disodium capsules 6.75 g/day [N=259] Placebo [N=35] Abdominal pain 16 (6%) 1 (3%) Diarrhea 14 (5%) 1 (3%) Arthralgia 9 (4%) 0% Rhinitis 6 (2%) 0% Insomnia 6 (2%) 0% Fatigue 6 (2%) 0% Flatulence 5 (2%) 0% Fever 5 (2%) 0% Dyspepsia 5 (2%) 0% Pharyngitis 4 (2%) 0% Coughing 4 (2%) 0% Anorexia 4 (2%) 0% Urinary tract infection 3 (1%) 0% Myalgia 3 (1%) 0% Flu-like disorder 3 (1%) 0% Dry mouth 3 (1%) 0% Cramps 3 (1%) 0% Constipation 3 (1%) 0% Pediatric Ulcerative Colitis In a clinical trial in 68 pediatric patients aged 5 years to 17 years with mildly to moderately active ulcerative colitis who received 6.75 g/day or 2.25 g/day balsalazide disodium for 8 weeks, the most frequently reported adverse reactions were headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%), and pyrexia (6%) [see Table 2].
One patient who received balsalazide disodium 6.75 g/day and 3 patients who received balsalazide disodium 2.25 g/day discontinued treatment because of adverse reactions.
In addition, 2 patients in each dose group discontinued because of a lack of efficacy.
Adverse reactions reported by 3% or more of pediatric patients within either treatment group in the Phase 3 trial are presented in Table 2.
Table 2:
Treatment-Emergent Adverse Reactions Reported by ≥3% of Patients in Either Treatment Group in a Controlled Study of 68 Pediatric Patients Balsalazide disodium Adverse Reaction 6.75 g/day [N=33] 2.25 g/day [N=35] Total [N=68] Headache 5 (15%) 5 (14%) 10 (15%) Abdominal pain upper 3 (9%) 6 (17%) 9 (13%) Abdominal pain 4 (12%) 4 (11%) 8 (12%) Vomiting 1 (3%) 6 (17%) 7 (10%) Diarrhea 2 (6%) 4 (11%) 6 (9%) Colitis ulcerative 2 (6%) 2 (6%) 4 (6%) Nasopharyngitis 3 (9%) 1 (3%) 4 (6%) Pyrexia 0 (0%) 4 (11%) 4 (6%) Hematochezia 0 (0%) 3 (9%) 3 (4%) Nausea 0 (0%) 3 (9%) 3 (4%) Influenza 1 (3%) 2 (6%) 3 (4%) Fatigue 2 (6%) 1 (3%) 3 (4%) Stomatitis 0 (0%) 2 (6%) 2 (3%) Cough 0 (0%) 2 (6%) 2 (3%) Pharyngolaryngeal pain 2 (6%) 0 (0%) 2 (3%) Dysmenorrhea 2 (6%) 0 (0%) 2 (3%)
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of balsalazide, or other products which contain or are metabolized to mesalamine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular and Vascular :
Myocarditis, pericarditis, vasculitis [see Warnings and Precautions (5.3) ] Respiratory :
pleural effusion, pneumonia (with and without eosinophilia), alveolitis, pleurisy/pleuritis Renal :
renal failure, interstitial nephritis, nephrolithiasis [see Warnings and Precautions ( 5.1 , 5.8 )] Urine discoloration occurring ex-vivo caused by contact of mesalamine, including inactive metabolite, with surfaces or water treated with hypochlorite-containing bleach Gastrointestinal :
pancreatitis Dermatologic :
pruritus, alopecia Hepatic:
hepatotoxicity, elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure, Kawasaki-like syndrome including hepatic dysfunction Skin :
SJS/TEN, DRESS, and AGEP [see Warnings and Precautions (5.5) ]

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Renal Impairment Inform patients that balsalazide disodium capsule may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy.
Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] .
Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions Inform patients of the signs and symptoms of hypersensitivity reactions.
Instruct patients to stop taking balsalazide disodium capsules and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine- induced hypersensitivity [see Warnings and Precautions ( 5.2 , 5.3 )] .
Hepatic Failure Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms [see Warnings and Precautions (5.4) ] .
Severe Cutaneous Adverse Reactions Inform patients of the signs and symptoms of severe cutaneous adverse reactions.
Instruct patients to stop taking balsalazide disodium capsules and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity [see Warnings and Precautions (5.5) ].
Upper Gastrointestinal Tract Obstruction Advise patients to contact their healthcare provider if they experience signs and symptoms of upper gastrointestinal tract obstruction [see Warnings and Precautions (5.6) ] .
Photosensitivity Advise patients with pre-existing skin conditions to
avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see Warnings and Precautions (5.7) ] .
Nephrolithiasis Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [see Warnings and Precautions (5.8) ] .
Blood Disorders Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy.
Advise patients to complete all blood tests ordered by their healthcare provider [see Drug Interactions (7.2) , Use in Specific Populations (8.5) ] .
Administration Instruct patients: Swallow balsalazide disodium capsules whole.
Do not cut, break, crush or chew the capsules.
For patients who cannot swallow intact capsules, balsalazide disodium capsules may also be administered by opening the capsule and sprinkling the capsule contents on applesauce.
If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.
Place a small amount (approximately 10 mL) of applesauce into a clean container.
Carefully open the capsules.
Sprinkle the capsule contents on the applesauce.
Mix the capsule contents with the applesauce.
The contents may be chewed, if necessary.
Consume the entire amount of applesauce mixture immediately.
Do not store the applesauce mixture for future use.
Teeth and/or tongue staining may occur in some patients who use balsalazide disodium capsules in sprinkle form with food.
Drink an adequate amount of fluids.
Take balsalazide disodium capsules without regard to meals [see Clinical Pharmacology (12.3) ].
Urine may become discolored reddish-brown while taking balsalazide disodium capsules when it comes in contact with surfaces or water treated with hypochlorite-containing bleach.
If discolored urine is observed, advise patients to observe their urine flow.
Report to the healthcare provider only if urine is discolored on leaving the body, before contact with any surface or water (e.g., in the toilet).
Manufactured by:
Zydus Lifesciences Ltd., Ahmedabad, India Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534 Rev.: 11/23

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Balsalazide Disodium Capsules, USP containing 750 mg balsalazide disodium are available as yellow colored opaque cap imprinted with "1626" in black ink and white colored opaque body. Capsules:
750 mg

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Balsalazide Disodium Capsules, USP 750 mg are yellow to orange granular powder filled in size "00" empty hard gelatin capsule having a yellow colored opaque cap imprinted with "1626" in black ink and a white colored opaque body.
NDC 70710-1626-1 in bottles of 280 capsules with child resistant closure Storage
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

Each Balsalazide Disodium Capsules, USP contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an aminosalicylate.
Each capsule of balsalazide disodium (750 mg) is equivalent to 267 mg of mesalamine.
Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate.
Its structural formula is: Molecular Weight:
437.31 Molecular Formula:
C 17 H 13 N 3 Na 2 O 6 ·2H 2 O Balsalazide disodium is a yellow to orange crystalline powder.
It is freely soluble in water and isotonic saline and DMSO, sparingly soluble in methanol and ethanol and practically insoluble in all other organic solvents.
Inactive Ingredients:
Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate.
Additionally, the capsule shell contains gelatin, titanium dioxide, iron oxide yellow, iron oxide black, and iron oxide red.
The black ink contains shellac, iron oxide black, and potassium hydroxide.
The sodium content of each capsule is approximately 79 mg.
Sturucture

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

GelatinEach hard gelatin capsule contains colloidal silicon dioxide; the capsule shell contains gelatinAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (9)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 9 of 9

Details

Made by	Zydus Pharmaceuticals (USA) Inc.
Active substance	Balsalazide Disodium
Strength	750 mg
Form	Capsule
Route	Oral
Packs	280 CAPSULE in 1 BOTTLE
NDC	70710-1626

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

9 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Capsule9 products
- 750 mg9
  750 mg · 9 companies
  +1 more

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Balsalazide Disodium750 mgPrescription onlyCapsule Hikma Pharmaceuticals USA Inc. · Balsalazide Disodium Balsalazide Disodium750 mgPrescription onlyCapsule AvPAK · Balsalazide Disodium Balsalazide Disodium750 mgPrescription onlyCapsule Golden State Medical Supply, Inc. · Balsalazide Disodium Balsalazide Disodium750 mgPrescription onlyCapsule Apotex Corp. · Balsalazide Disodium Balsalazide Disodium750 mgPrescription onlyCapsule Zydus Lifesciences Limited · Balsalazide Disodium Balsalazide Disodium750 mgPrescription onlyCapsule Bryant Ranch Prepack · Balsalazide Disodium

See every product with Balsalazide Disodium