balsalazide
Balsalazide disodium, also known by the brand name Colazal, is an aminosalicylate. It's a first-choice treatment option for treating mild-to-moderate ulcerative colitis (UC) in people age 5 years and older. Balsalazide (Colazal) is available as 750 mg capsules. The typical dosage for adults is 3 capsules by mouth three times per day. Children can take either 1 or 3 capsules by mouth three times per day. Side effects include stomach pain and diarrhea.
What is Balsalazide (Colazal)?
What is Balsalazide (Colazal) used for?
- Mild-to-moderate ulcerative colitis (UC) in people age 5 years and older
How Balsalazide (Colazal) works
Balsalazide (Colazal) is an aminosalicylate. Once swallowed, the medication reaches the colon. It blocks the body from making inflammatory proteins and chemicals in the gut. This is thought to lessen inflammation in the gut.
Drug facts
Side effects of Balsalazide (Colazal)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Stomach pain (6%)
- Diarrhea (5%)
- Joint pain (4%)
Less Common Side Effects
- Passing gas
- Indigestion
- Loss of appetite
- Stuffy, runny, or itchy nose
- Sore throat
- Cough
- Trouble sleeping
- Tiredness
- Fever
Note: Side effect data for adults. Side effects might differ in children.
Balsalazide (Colazal) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Kidney damage: urinating less often than usual; dry and itchy skin; muscle cramps; swelling in your feet, ankles, or hands
- Kidney stones: trouble urinating, bloody urine, fever, chills, back or side pain
- Liver problems: yellowing of your skin or the whites of your eyes, stomach bloating, right-sided stomach pain, dark urine
- Serious skin reactions: hives, blisters, peeling skin, skin reddening, fever, sore throat, swollen lymph nodes
- Serious allergic reaction: hives, swelling of the lips or tongue, trouble breathing
The following Balsalazide (Colazal) side effects have also been reported
Along with its needed effects, a medicine 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:
More common
Agitation
bloody diarrhea
blood in the urine
coma
confusion
dark-colored urine
decreased urine output
dizziness
headache
hostility
increased sensitivity of the skin to sunlight
irritability
itching, skin rash
lethargy
light-colored stools
muscle twitching
pain in the groin or genitals
rapid weight gain
redness or other discoloration of the skin
seizures
severe sunburn
sharp back pain just below ribs
stomach pain
swelling of the face, ankles, or hands
unusual tiredness or weakness
vomiting
yellow eyes or skin
Less common
Bladder pain
cloudy urine
difficult, burning, or painful urination
frequent urge to urinate
lower back or side pain
pale skin
trouble breathing
unusual bleeding or bruising
Rare
Tightness in the chest
Incidence not known
Chills
clay colored stools
decreased appetite
dizziness
increased blood pressure
increased thirst
joint pain
loss of appetite
swelling of the ,fingers, feet, or lower legs
unpleasant breath odor
vomiting of blood
Some side effects 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:
Less common
Acid or sour stomach
belching
bloated or full feeling
body aches or pain
bone pain
congestion
cramps
difficulty with moving
dryness of the throat
excess air or gas in the stomach or bowels
general feeling of discomfort or illness
hoarseness
indigestion
muscle pain or stiffness
passing of gas
shivering
stomach discomfort or upset
sweating
swelling or inflammation of the mouth
swollen joints
tender, swollen glands in the neck
trouble with sleeping
trouble with swallowing
unable to sleep
voice changes
Rare
Back pain
ear congestion
loss of voice
pain in the ankles or knees
painful, red lumps under the skin, mostly on the legs
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
Hair loss or thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Balsalazide (Colazal)
Pros
- Can start to provide symptom relief after 2 weeks of treatment
- Can sprinkle the pill contents onto applesauce if you have trouble swallowing it whole
Cons
- Need to take three times per day
- Can't take if you're allergic to salicylates, such as aspirin
Pharmacist tips for Balsalazide (Colazal)
- Take balsalazide (Colazal) with or without food at any time of day. If it hurts your stomach, try taking the medication with food to help lessen stomach upset.
- Swallow balsalazide (Colazal) capsules whole. Don't crush, chew, or break them.
- If you're having trouble swallowing balsalazide (Colazal) capsules whole, you can open them and sprinkle the contents over 2 teaspoonfuls of applesauce. Mix the medication into the applesauce and then eat all of the mixture right away. Don't save it for later. Your teeth or tongue might get stained since the powder inside the capsules is orange to yellow.
- While you're taking balsalazide (Colazal), it's normal if you notice that your urine looks reddish-brown if it hits surfaces or water that's been bleached. But if your urine is a reddish-brown color when it comes out of your body, contact your prescriber because this can be a sign that something else is going on.
- Make sure to drink plenty of fluids while you're taking balsalazide (Colazal). Staying hydrated helps lessen your risk for kidney stones from the medication.
- Your skin might become more sensitive to the sun and be easier to burn while you're taking balsalazide (Colazal). To protect your skin, make sure to wear sunscreen, wear sun-protective clothing, and find shade when you're outside.
- Share your most up-to-date medication list with your care team so they can check that all your medications are safe to take together. Certain medications can interact with balsalazide (Colazal). For example, taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil), with balsalazide (Colazal) can raise your risk for kidney problems because they both can harm the kidneys.
Common questions about Balsalazide (Colazal)
No, balsalazide (Colazal) isn't a steroid. It's an aminosalicylate. Steroids and aminosalicylates both are types of medications that help treat UC. But they work differently to lessen inflammation in the gut. In general, treatment guidelines for mild UC typically prefer trying aminosalicylates first because steroids are known for their short- and long-term side effects. Speak with your prescriber about your treatment plan.
Balsalazide (Colazal) isn't the same as mesalamine. But the two different medications are related. They're both aminosalicylates that are approved for treating mild-to-moderate ulcerative colitis (UC). Of note, after you swallow balsalazide (Colazal), the body turns balsalazide into mesalamine. Balsalazide (Colazal) is only available as a capsule that's taken three times a day. But there are many forms of mesalamine, including pills, enemas, and suppositories. And each form of mesalamine can have different instructions on how to take it. Studies suggest that balsalazide (Colazal) might work better and faster than mesalamine pills. Compare between balsalazide (Colazal) and mesalamine, and talk to your gastroenterologist if you have more questions about the two medications.
Hair loss wasn't a side effect balsalazide (Colazal) that people who took the medication reported having during clinical trials. But some people reported hair loss after the medication became available on the market. It's not completely clear whether balsalazide (Colazal) directly caused the hair loss or whether it was from something else. Contact your prescriber if you notice unusual hair loss while you're taking balsalazide (Colazal). They can examine what's causing this hair loss.
Weight gain wasn't a typical side effect reported in people who took balsalazide (Colazal) during clinical trials. Keep in mind that severe gut-related symptoms of UC can lead to low appetite and weight loss. So it's possible that you might slowly get your appetite back and gain a little weight if balsalazide (Colazal) is working to treat your UC. Discuss with your care team about ways to incorporate balanced, nutritious meals and regular exercise into your daily routine to manage your weight.
It's recommended for adults and children age 5 and older to take balsalazide (Colazal) for up to 8 weeks. Some adults needed to take the medication for up to 12 weeks during clinical trials. Discuss with your prescriber about how long you should take balsalazide (Colazal) based on your condition and how the medication is working for you.
Because balsalazide (Colazal) gets broken down in the body into many chemicals, it's not completely clear how long the medication stays in your system. We do know that balsalazide gets broken down in the body into mesalamine, which is the main component of the medication that works to lessen inflammation in the gut. Mesalamine can stay in your body for about 5 days. This time frame is estimated based on the half-life of mesalamine. Even though it might stay in the body for several days, it's recommended to take balsalazide (Colazal) three times every day. This helps keep the levels of the medication in your body high enough so it can work well.
No, balsalazide (Colazal) doesn't contain any sulfa. This means that balsalazide (Colazal) is safe for people who have a sulfa allergy.
Let a member of your healthcare team know if you're breastfeeding. They can discuss the risks and benefits of taking balsalazide (Colazal) with you. It's considered generally safe to breastfeed while you're taking this medication. But be aware that your baby might get diarrhea. Ask a healthcare professional if you have more questions about breastfeeding while you're taking balsalazide (Colazal).
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Risks and warnings for Balsalazide (Colazal)
Balsalazide (Colazal) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Kidney damage
- Risk factors: History of kidney problems | Taking medications that are harmful to the kidneys
Some people who take balsalazide (Colazal) have had kidney damage. Your risk for kidney damage is higher if you have kidney problems or if you take medications that can harm the kidneys, like nonsteroidal anti-inflammatory drugs (NSAIDs) and diuretics (water pills).
You might need blood work or urine tests done every so often during treatment so your prescriber can check your kidney function. Tell your care team if you have any signs or symptoms of kidney problems while you're taking balsalazide (Colazal), including changes in your need to urinate, tiredness, low appetite, and muscle cramps.
Kidney stones
Some people who take balsalazide (Colazal) can get kidney stones. Make sure to stay hydrated each day while you're taking this medication to prevent kidney stones. Let your prescriber know if you have trouble urinating, notice a change in how much you urinate, have blood in the urine, or feel back or side pain. These can be signs of a kidney stone.
Acute intolerance syndrome
Although rare, some people who take balsalazide (Colazal) can have a reaction to the medication called acute intolerance syndrome. It typically happens 1 to 3 weeks after starting balsalazide (Colazal). And it usually goes away within a few days after stopping the medication or after starting corticosteroid treatment.
Symptoms of acute intolerance syndrome can be hard to tell apart from a flare-up of UC. Let your care team know if you have symptoms like stomach cramping or pain, bloody diarrhea, fever, headache, and rash. You might need to stop taking balsalazide (Colazal) to help these symptoms go away.
Allergic reactions
- Risk factors: Allergy to sulfasalazine (Azulfidine) | Allergy to other aminosalicylates or salicylates (e.g., aspirin)
Severe allergic reactions to balsalazide (Colazal) are possible. They can include life-threatening reactions like facial swelling, shock, and anaphylaxis (e.g., closing of the throat). Get emergency medical help right away if you notice hives, rash, swelling of the lips or tongue, or difficulty breathing after you take balsalazide (Colazal).
Severe skin reactions
Balsalazide (Colazal) can cause rare but serious skin reactions. These skin reactions can include Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.
Stop taking balsalazide (Colazal) and get medical attention right away at the first sign of any unusual changes in your skin, like rash, blisters, peeling skin, or skin reddening. These skin reactions can sometimes happen with fever, sore throat, fatigue, and swollen lymph nodes, so watch out for these symptoms as well.
Liver problems
- Risk factors: History of liver problems
Although rare, some people with liver problems had liver failure after they took mesalamine, a similar medication to balsalazide (Colazal). Let your prescriber know if you have a history of liver problems before you start taking balsalazide (Colazal). They can weigh the risks and benefits of treatment.
Get medical help as soon as possible if you notice severe nausea, vomiting, right-sided stomach pain, fatigue, low or no appetite, or yellowing of the skin or eyes while you're taking balsalazide (Colazal). These can be signs of liver damage.
Skin that's sensitive to the sun
- Risk factors: Skin conditions (e.g., eczema)
People with skin conditions like eczema who take balsalazide (Colazal) are at higher risk that their skin gets more sensitive to the sun. This means that they can get sunburns more easily than usual.
To lower your risk for sunburn, wear sunscreen and long-sleeved clothing to protect your skin when you're outside, even during the winter and on overcast days. Also try to find shade as much as possible.
Caution in people with gut blockage
People who have or are at risk of a bowel obstruction should avoid taking balsalazide (Colazal). Gut blockages can make it take longer for the medication to reach your colon and help treat your UC. Let your prescriber know right away if you notice symptoms of a bowel obstruction, like severe stomach cramping, severe stomach pain, vomiting, constipation, or a hard or swollen belly.
Balsalazide (Colazal) dosage
Capsule| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 750mg | 270 capsules | $88.77 | $0.33 |
Typical dosage for Balsalazide (Colazal)
Each capsule contains 750 mg of balsalazide.
- Age 18 years and older: The typical dose is 3 capsules by mouth three times per day for up 8 to 12 weeks.
- Age 5 to under 18 years: The typical dose is either 1 capsule or 3 capsules by mouth three times per day for up to 8 weeks.
Interactions between Balsalazide (Colazal) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aceclofenac
- Acemetacin
- Amtolmetin Guacil
- Bismuth Subsalicylate
- Bromfenac
- Bufexamac
- Celecoxib
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Clonixin
- Dexibuprofen
- Dexketoprofen
- Diflunisal
- Dipyrone
- Droxicam
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Ibuprofen
- Ketoprofen
- Lornoxicam
- Loxoprofen
- Lumiracoxib
- Magnesium Salicylate
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Mesalamine
- Morniflumate
- Nabumetone
- Naproxen
- Nepafenac
- Niflumic Acid
- Nimesulide
- Nimesulide Beta Cyclodextrin
- Olsalazine
- Oxaprozin
- Oxyphenbutazone
- Parecoxib
- Phenylbutazone
- Phenyl Salicylate
- Piketoprofen
- Piroxicam
- Proglumetacin
- Propyphenazone
- Proquazone
- Rofecoxib
- Salicylamide
- Salicylic Acid
- Salsalate
- Sodium Salicylate
- Sulfasalazine
- Sulindac
- Tenoxicam
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolmetin
- Trolamine Salicylate
- Valdecoxib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tamarind
- Warfarin
How much does Balsalazide (Colazal) cost?
Balsalazide (Colazal) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Balsalazide (Colazal) will not be safe for you to take.
- Allergy to aspirin or other salicylates, like mesalamine and sulfasalazine (Azulfidine)
What are alternatives to Balsalazide (Colazal)?
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