- First week on Viberzi and its side effects
- What is Viberzi?
- What Does Viberzi Treat?
- How Does Viberzi Work?
- Precautions to Take Before Using Viberzi
- How You Can Use Viberzi
- The Negative Side Effects of Viberzi
- Mass Torts Against the Viberzi Manufacturer
- How Do Mass Torts Work?
- Find a Viberzi Lawsuit Attorney Near Me
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
First week on Viberzi and its side effects
For a history of my symptoms (and a sob story 😒), see this post.
My gastroenterologist prescribed Viberzi for me, and I’ve been taking 75mg once daily in the evening for 7 days. I did not know this until today, but Viberzi is an opiate, but does not give the user euphoria as experienced with typical opioids. I had a mild flu on days 3 and 4 with no vomiting or diarrhea, but my wife and everyone else we caught it from and spread it to did, and it lasted 5 days for each of them, but I did have a flu shot a month prior.
Viberzi in its smallest dose has done exactly what I needed it to do, and it’s wonderful in that regard.
Solid bowel movements for the first time in at least 7 years, and on a consistent basis
No abdominal pain associated with bowel movements
No more sporadic stabbing-like pain in my abdomen
No more sudden urges for a bowel movement
Far less toilet paper usage (one wipe, in many instances)
I’m not terribly happy with the side effects I’ve been experiencing, and particularly with the last one, I’m undecided if it’s worth it, but I’m going to continue taking it in the meantime. My next appointment with my gastroenterologist is in 4 months.
Severe abdominal pain lasting at least 4 hours on days 1 and 4
Mild to moderate nausea occasionally
Hot flashes and night sweats occasionally
Loss of appetite (I’ve barely been hungry in the last week)
Drowsiness, grogginess, and body feels heavy (just started today)
Hot Flashes and Night Sweats
According to an article published in The Journal of the American Osteopathic Association (JAOA):
Heroin and methadone are also associated with decreased serum testosterone levels in men, potentially causing depression, fatigue, hot flashes, sweating, weight gain, and other symptoms. In fact, a substantial proportion of men treated with sustained-action opioids—previously estimated at 5 million in the United States and Canada—are testosterone deficient.
I find it a little troubling as someone who is biologically male that my testosterone levels could drop. The last time I had them tested, they were right where they should be, but I’ll have them tested once a year and ask my doctor what to do if they drop. My wife and I are trying to conceive at the moment, so hopefully it doesn’t drop too quickly.
Loss of Appetite
Viberzi is an opiate, and according to the website of Allergan, the manufacturer (section 12.1), Viberzi acts on mu-opioid receptors in the gut. Regarding appetite, mu-opioid receptors trigger satiety, as this PubMed article states, and though it seems to be a little more complicated than that, this seems to be how Viberzi suppresses appetite.
My concern here is that I need to take this with food, but I have barely been hungry in the past week, which I thought was due to the flu, but I got over it 3 days ago, and I have to force myself to eat anything. At times, I have an aversion to food. I want to lose weight, but I don’t want my weight to plummet since that can lead to gorging, so this is something I’m going to have to be watchful of.
Drowsiness, Grogginess, and “Heavy” Feeling
I took a pill around 8 PM last night after dinner. This morning, I had a lot of trouble getting out of bed because I was so groggy and felt heavy. I got to work 30 minutes late. I drove there, but probably should not have, but I am fortunate enough to commute 3 miles each way. I left work early to take a nap then work from home, which I am also fortunate enough to do.
I’ve never taken opiates before, but these effects are apparently typical for opiates, except most opiates give a sense of euphoria along with these, which greatly reduces the abuse potential of Viberzi. Someone in the BlueLight forums tried as hard as they could to get high from Viberzi, but to no avail. It’s great that the manufacturer found a way to decrease its potential for abuse, but I would be lying if I said I wasn’t a little disappointed about it. 😅 It’s for the best, though.
For me, these are the most troubling side effects since they interfere with my job. I’m not sure what to do about it other than try to take it in the afternoon with lunch since I experienced these effects 12 hours after I took the pill. At this point, I can’t imagine taking it twice a day. If anyone has a similar experience in this regard, please share how you dealt with it.
Mass torts are emerging as the most efficient tool for seeking compensation if you suffer from negative side effects after using a dangerous drug like Viberzi. If you wish to pursue a product liability suit against the Viberzi manufacturer, there are high chances that your case will be integrated into a mass tort. This way, the court will save resources and time, and you will be compensated much faster. Reach out to Consumer Alert Now if you want to be part of a mass tort against the manufacturer of Viberzi in the United States.
What is Viberzi?
Viberzi is a brand name that is used for marketing the drug Eluxadoline. This medicine was first used in the USA in 2015. Its origin is from Janssen Pharmaceutica, and it was developed by a well-known pharmaceutical company known as Allergan.
Viberzi is administered by mouth. Sometimes, it is also marketed as Truberzi. This drug can cause some interactions with other medications such as cyclosporine, eltrombopag, rifampin, and gemfibrozil.
What Does Viberzi Treat?
The primary reason why most consumers purchase this drug is to find a cure for their digestive tract problems. Viberzi is mainly used to treat irritable bowel syndrome (IBS).
When you take this drug, it will start acting locally on your digestive tract. Viberzi can help in diarrhea prevention, and it can also alleviate any abdominal pain which is brought about by IBS.
IBS can end up being a predominant and chronic condition, and it can cause many recurrent negative symptoms. Some of these symptoms include constipation, abdominal pain, diarrhea, bloating, and gas. Typically, this drug is utilized to relieve IBS patients who cannot respond to traditional and homemade methods of alleviating the condition.
How Does Viberzi Work?
It would be best if you only started using this drug after your doctor has given you the go-ahead. Viberzi is normally taken orally. It is packaged as a coated tablet that comes in two different sizes; 75 ml. and 100 ml.
This drug works by either impeding or activating the opioid receptors present in your digestive system. These opioid receptors are usually involved in intestinal fluids secretion, gut motility, and pain sensation. Viberzi is considered to be unique in that it can stimulate two different types of receptors at the same time and inhibit another one. This way, Viberzi will make you feel relieved without you experiencing constipation.
Unlike other IBS medications such as Lomotil and Imodium, Viberzi can affect the functioning of up to three receptors. Imodium and Lomotil can only stimulate a maximum of two receptors, and they can’t inhibit any of them. If you use these medications, you will probably have some constipation problems before you get cured.
After some clinical trials, the FDA approved Allergan to start distributing and selling Viberzi to consumers in the United States. The FDA concluded that this drug could offer a reasonable improvement in stool consistency, abdominal pain, and the urgency and frequency of bowel movements.
Precautions to Take Before Using Viberzi
It will help if you outweigh the risks vs. the gains of this medicine before you start utilizing it. Make sure you consider the following before you decide to take Viberzi:
Inform your doctor about any allergic condition that you have. Maybe you react negatively to certain medicines, animals, foods, preservatives, and dyes. Please make a point of checking the ingredients used to manufacture Viberzi to gauge whether any of them will be allergic to you.
2. Geriatric and Pediatric
Though medical research hasn’t confirmed it to be true, Viberzi may not be safe for infants and the elderly. If you are an older person, you should refrain from using this drug. Likewise, don’t allow your child who is below five years old to take this medication. Consider other alternative means to cure IBS.
3. Breastfeeding and Pregnant Women
Pregnant women and those who are breastfeeding are customarily advised not to take Viberzi, even if they have abdominal pain problems. This is because they can cause their children to suffer from long term side effects.
4. Drug Interactions
As a general rule, you should not combine Viberzi with any other drug. However, your doctor may advise you to use Viberzi with some other IBS medication to be relieved much faster. In case you take Viberzi together with other medicines, you may experience drug interactions. You should not combine Viberzi with drugs like Tipranavir, Alfentanil, Temsirolimus, Atazanavir, Tacrolimus, and Cyclosporine.
5. Medical Problems
You may be suffering from some medical problems which may aggravate if you start using Viberzi. Talk to your doctor beforehand if you have medical conditions like addiction, a stomach blockage, liver disease, and pancreas problems.
How You Can Use Viberzi
Go through the guide that your pharmacist gives you before you take your first dose of Viberzi. Don’t ignore this guide either when you go for a refill. In case you are unsure about anything, you should contact your doctor.
You should follow a balanced diet when using this drug. Usually, Viberzi should be taken for around two times each day. However, this dosage may vary depending on the specific products you use, how you respond to treatment, and your condition.
Never attempt to increase your dosage, regardless of how bad you are feeling. Most people tend to take more drugs than what their doctor has prescribed for them, believing that they will heal faster. This belief is false. If you don’t follow the recommended dosage, you may end up developing some adverse side effects.
You should utilize this medication frequently so that you can benefit the most from it. You can take Viberzi at the same time each day to avoid forgetting to follow the required dosage. In case you are directed to stop using the drug, you should do so immediately.
Some IBS patients may tend to combine Viberzi with other drugs such as Loperamide. In such instances, you shouldn’t take Viberzi frequently since you may start suffering from constipation. Nevertheless, if you still develop constipation, you should stop taking the IBS medications altogether and urgently seek help from a medical practitioner.
Sometimes, Viberzi can make you addicted; especially if you already have a substance use disorder from taking too much alcohol or drugs. If you don’t follow the dosage, you can quickly become a Viberzi addict!
Don’t panic if you miss any dose. Just skip the missed dosage and resume your regular dosing schedule. Avoid double dosing.
You should store this medication in a cool and dry place, preferably inside a closed container. Do not expose Viberzi to direct light. Moreover, your children should not be able to access this drug, and you shouldn’t freeze it.
If you’ve used Viberzi for a specific period and your condition isn’t improving, you should speak to a doctor right away. Your doctor will help you find another alternative method to make you feel relieved. One way of making sure that the Viberzi medication is helping you out is by visiting your doctor for routine check-ups.
If you stop using this medicine, you should dispose of it properly. Never keep any Viberzi medication that has either expired or you no longer need it.
The Negative Side Effects of Viberzi
Though Viberzi can help cure patients suffering from irritable bowel syndrome, it has many adverse side effects. Recently, the FDA has categorized Viberzi as a dangerous drug since a majority of its users have complained of having harmful side effects after using the medicine. These adverse side effects took a toll on both their physical and mental health.
Viberzi can cause stomach pain, nausea, gallbladder problems, pancreatitis, severe constipation, and Sphincter of Oddi spasm. According to Allergan – Viberzi’s manufacturer, the most common side effects of this drug include stomach pain, constipation, and nausea.
The main ingredient used to manufacture Viberzi is eluxadoline. Eluxadoline can cause you to have some euphoria feelings. Therefore, Viberzi has some abuse potential, and it can lead to addiction and drug dependence. In fact, even if you use the drug normally and as prescribed by the doctor; you will still feel drunk.
As illustrated by the Food and Drug Administration, Viberzi can cause severe adverse reactions. For instance, you may end up suffering from pancreatitis, which may require hospital admission for a long time. You should totally refrain from using this drug if you don’t have a gallbladder. So far, the FDA has reported two incidences of persons who didn’t have a gallbladder who had taken the drug. These people ended up dying of pancreatitis. Below is a quick rundown of the adverse side effects of Viberzi.
Constipation and Other Common Side Effects
During Viberzi’s clinical trials, it was reported that constipation was the most common adverse reaction among patients who used the drug. Viberzi’s safety information usually warns that this constipation can develop into a severe illness, and you may end up being hospitalized. Also, the safety information advises its users to avoid taking the drug if they start experiencing constipation that lasts for an extended period.
As a general rule, you shouldn’t combine Viberzi with other IBS drugs such as Opioids and Loperamide to prevent constipation; unless your doctor advises you otherwise.
In the clinical trials, 8% of people who utilized Viberzi had some constipation symptoms. These people experienced constipation within the first ninety days of using the drug. According to the label of this medication, some patients may develop intestinal obstructions, perforations, and fecal impactions, which may require urgent medical intervention. If you have a history of chronic constipation and gastrointestinal obstruction, you should not use this drug since you have a high risk of developing serious medical complications.
7% of people who took Viberzi during the clinical trials suffered from abdominal pain and nausea. Other common side effects of this medication include the following:
- Viral gastroenteritis
- Infections of the upper respiratory tract like bronchitis
- Malfunctioning of the liver
- Common colds
Furthermore, Viberzi can bring about some allergic reactions. For example, you may experience specific physical symptoms like hives, difficulty in breathing, and swelling of the throat, face, tongue, and lips.
Severe Cases of Pancreatitis and Death
Immediately the FDA approved Viberzi in 2017; it received around 120 reports of severe cases of pancreatitis and death which were caused by the drug. Seventy-six of these patients became hospitalized, and two of them died.
In the same year, the FDA made a safety announcement to warn Americans of the negative side effects of this drug. In particular, this announcement advised IBS patients who didn’t have a gallbladder to avoid using this medication. As highlighted by this U.S. federal agency, such patients have high chances of developing pancreatitis, which could lead to hospitalization for an extended period and even death.
Pancreatitis usually develops when there is an inflammation of the pancreas. When you have pancreatitis, you will feel severe pain in your upper abdomen; and this pain may extend to your back. Also, you may experience vomiting and nausea. Other symptoms of this illness include discolored and oily stools, fever, weight loss, diarrhea, and rapid pulse.
Some patients may develop pancreatitis within one week of using this drug. Others may start experiencing the physical symptoms of this sickness immediately after taking one dosage of the medication.
As per the Alimentary Pharmacology and Therapeutics Journal, 40% of IBS patients who use Viberzi can develop pancreatitis within the first or second dosage of the medication. Typically, 20% of these patients do not have a gallbladder.
In one case reported by the FDA, the patient suffered from vomiting, abdominal pain, and nausea within sixty minutes of taking the first single dose of the Viberzi drug. This patient didn’t have a gallbladder, and he died after three days.
Risk of Suffering from Sphincter of Oddi Spasm
Apart from developing pancreatitis, some patients who took Viberzi suffered from the sphincter of Oddi spasm. As per data from the FDA, one person has already died from this condition.
The sphincter of Oddi muscle coats both the pancreatic duct and the bile duct end. It is fondly referred to as the biliary duct. The primary role of this muscle is to relax automatically when you consume any meal. By relaxing automatically, it will allow the fluids from the bile duct and the pancreatic duct to flow into the small intestine.
The disease of the sphincter of Oddi spasm usually occurs when this muscle fails to relax and contract during meal taking. If you suffer from this disease, you will experience excruciating pain since the bile juice won’t be able to flow normally. This disease can bring about pancreatitis too.
Most IBS patients can develop this disorder within seven days of utilizing the drug. In October 2018, the FDA had received around 74 reported cases of patients who developed a sphincter of Oddi spasm immediately after using the medicine.
The safety information of this medicine instructs consumers who experience symptoms of this condition to stop using it immediately and seek urgent medical attention. People who have ever suffered from this disease before or any bile duct obstruction should not use this medication.
Mass Torts Against the Viberzi Manufacturer
You can join a Viberzi mass tort if you used the drug and suffered from some adverse side effects. Typically, Viberzi lawsuits are filed by patients who developed pancreatitis after using the medicine. Such patients usually do not have a gallbladder.
Gallbladder removal is quite common in the United States. At least 20% of Americans (more than 20 million) have removed their gall bladders. When the FDA approved Viberzi in 2015, its manufacturer launched an excellent advertising strategy that enticed many consumers to purchase the drug. According to a Viberzi TV Commercial, this drug can instantly cure IBS and other uncomfortable abdominal conditions. Due to this misleading advert, many patients suffering from irritable bowel syndrome bought the drug and started using it.
Later in 2015, the FDA issued a warning that Viberzi can cause pancreatitis, which may lead to death, especially to patients who’ve had their gallbladder removed. However, this warning came late since many people had already started using the drug. Up to now, it isn’t clear how many people were negatively affected by the Viberzi medication.
The main argument behind a Viberzi mass tort is that Allergan – Viberzi’s manufacturer, didn’t warn members of the public about the potentially life-threatening consequences of utilizing the drug before it started marketing it. Furthermore, Allergan didn’t conduct the clinical trials properly to assess whether the Viberzi medication is completely safe.
According to the principles of tort law, the manufacturer of Viberzi owes a duty of care to the general public. This duty of care implies that Allergan should take due measures to promote and protect the health and safety of the American population. Allergan breached this duty of care by not alerting the public of the life-altering side effects of the Viberzi medication.
Therefore, IBS patients who suffered from pancreatitis, sphincter of Oddi spasm, and other potentially life-threatening illnesses are entitled to receive compensation from Allergan. This compensation should be in the form of monetary damages.
The amount of compensation which the court will award each plaintiff in a mass tort will depend on the severity of the negative side effects which you endured. You will be compensated for all the expenses you incurred in your medical treatment, loss of consortium and wages, and psychological and physical damage. The compensation amount may range from hundreds of dollars to millions, especially in instances where your loved one died from pancreatitis after using the Viberzi medication.
How Do Mass Torts Work?
Mass torts usually arise when there is a dangerous drug or defective medical device in the market, which has negatively affected many people. Unfortunately, some companies may take shortcuts while manufacturing their products, and it is consumers who end up suffering the consequences. Mass torts are usually brought against such reckless manufacturers.
Some mass torts may be well publicized, while others may not even hit the headlines. Usually, a mass tort will have several plaintiffs and a few defendants. For instance, the Viberzi mass tort can have around 10,000 plaintiffs; and just one defendant who is the manufacturer of Viberzi – Allergan.
Mass torts usually require attorneys who have sophisticated knowledge and extraordinary resources. They are very complex, and you should hire an attorney who can understand the varied subject matter and different theories of damages and liabilities. Moreover, they can take plenty of time since the court will have to process and review many case documents; as well as listen to hundreds of witnesses.
In case you experience any complications after using the Viberzi medication, you are entitled to joining a dangerous drug mass tort to receive monetary compensation. It can be quite challenging to determine whether your claim is feasible. You should reach out to a mass tort attorney so that you can get an accurate and fair evaluation of your case. Here is a summary of the process of a mass tort claim:
- Reviewing records. Your attorney will evaluate whether your claim is feasible by assessing the degree of your suffering and going through your medical records.
- Injury consistency. Your mass tort attorney will check if there are other reported cases of people who used the harmful medical device or drug and suffered from medical
- Court filing. Each case is consolidated, and it becomes part of a mass tort for fast information gathering and processing.
- The defendant can opt to negotiate with the plaintiff to settle all the claims, or the suit will proceed to the trial stage.
Find a Viberzi Lawsuit Attorney Near Me
Currently, many attorneys are filing personal injury claims against the manufacturer of Viberzi – Allergan. Don’t miss out on receiving your deserved monetary compensation if you or your loved one used Viberzi and ended up developing some severe negative side effects such as pancreatitis and sphincter of Oddi spasm. Moreover, you may have a feasible claim if this IBS medication caused you to suffer from economic and emotional distress. The dangerous drugs lawsuit experts at Consumer Alert Now will help you know more about Viberzi Mass Tort issues in the United States. We can also link you up with a reliable law firm for you to get assistance. Get in touch with us at 800-511-0747, and we will be happy to help you.
The following adverse reactions described below and elsewhere in the labeling include:
- Sphincter of Oddi Spasm
- Hypersensitivity Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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.
Over 1700 patients with IBS-D have been treated with 75 or 100 mg of VIBERZI twice daily in controlled trials. Exposures from placebo-controlled clinical trials in adult patients with IBS-D included 1391 exposed for 3 months, 1001 exposed for 6 months and 488 exposed for one year.
Demographic characteristics were comparable between the treatment groups . Data described below represent pooled data compared to placebo across the randomized trials.
Cases of pancreatitis, not associated with sphincter of Oddi spasm, were reported in 2/807 (0.2%) of patients receiving 75 mg and 3/1032 (0.3%) of patients receiving 100 mg VIBERZI twice daily in clinical trials. Of these 5 cases, 3 were associated with excessive alcohol intake, one was associated with biliary sludge, and in one case the patient discontinued VIBERZI 2 weeks prior to the onset of symptoms. All pancreatic events resolved with lipase normalization upon discontinuation of VIBERZI, with 80% (4/5) resolving within 1 week of treatment discontinuation. The case of sphincter of Oddi spasm-induced pancreatitis resolved within 24 hours of discontinuation.
Sphincter Of Oddi Spasm
In clinical trials, sphincter of Oddi spasm occurred in 0.2% (2/807) of patients receiving 75 mg and 0.8% (8/1032) of patients receiving 100 mg VIBERZI twice daily.
- Among patients receiving 75 mg, 1/807 (0.1%) patient experienced a sphincter of Oddi spasm presenting with abdominal pain but with lipase elevation less than 3 times the upper limit of normal (ULN) and 1/ 807 (0.1%) patient experienced a sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain
- Among patients receiving 100 mg, 1/1032 (0.1%) patient experienced a sphincter of Oddi spasm manifested as pancreatitis and 7/1032 (0.7%) patients experienced sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain
Of those patients who experienced a sphincter of Oddi spasm, 80% (8/10) reported their first onset of symptoms within the first week of treatment. The case of sphincter of Oddi spasminduced pancreatitis occurred within minutes of taking the first dose of VIBERZI. No cases of sphincter of Oddi spasm occurred greater than 1 month after treatment onset. All events resolved upon discontinuation of VIBERZI, with symptoms typically improved by the following day.
Common Adverse Reactions
Table 1 provides the incidence of common adverse reactions reported in > 2% of IBS-D patients in either VIBERZI treatment group and at an incidence greater than in the placebo group.
Table 1: Common* Adverse Reactions in the Placebo-Controlled Studies in IBS-D Patients
100 mg twice daily
75 mg twice daily
|Upper Respiratory Tract Infection||5||3||4|
|* Reported in > 2% of VIBERZI-treated patients at either dose and at an incidence greater than in placebo-treated patients
**”Abdominal Pain” term includes: abdominal pain, abdominal pain lower, and abdominal pain upper
*** “Rash” term includes: dermatitis, dermatitis allergic, rash, rash erythematous, rash generalized, rash maculopapular, rash papular, rash pruritic, urticaria, and idiopathic urticaria
Constipation was the most commonly reported adverse reaction in VIBERZI-treated patients in these trials. Approximately 50% of constipation events occurred within the first 2 weeks of treatment while the majority occurred within the first 3 months of therapy. Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg VIBERZI. Similar rates of constipation occurred between the active and placebo arms beyond 3 months of treatment.
Adverse Reactions Leading To Discontinuation
Eight percent of patients treated with 75 mg, 8% of patients treated with 100 mg VIBERZI and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the VIBERZI treatment groups, the most common reasons for discontinuation due to adverse reactions were constipation (1% for 75 mg and 2% for 100 mg) and abdominal pain (1% for both 75 mg and 100 mg). In comparison, less than 1% of patients in the placebo group withdrew due to constipation or abdominal pain.
Less Common Adverse Reactions
Adverse reactions that were reported in ≤ 2% of VIBERZI-treated patients are listed below by body system.
Gastrointestinal: gastroesophageal reflux disease
General Disorders and administration site conditions: feeling drunk
Investigations: increased AST
Nervous system: sedation, somnolence
Psychiatric disorders: euphoric mood
Respiratory: asthma, bronchospasm, respiratory failure, wheezing
The following adverse reactions have been identified during post-approval use of VIBERZI. 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.
Read the entire FDA prescribing information for Viberzi (Eluxadoline Tablets)
How does this medication work? What will it do for me?
Eluxadoline belongs to the class of medications called opioid receptor agonist/antagonists. It works in the bowel to regulate muscle activity and slow the rate that material passes through the digestive system.
This medication is used to treat irritable bowel syndrome with diarrhea in adults (IBS-D).
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each pale-yellow to light tan, capsule-shaped tablet debossed with “FX75” on one side, contains 75 mg of eluxadoline. Nonmedicinal ingredients: colloidal silica, crospovidone, mannitol, magnesium stearate, silicified microcrystalline cellulose and Opadry II (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc, and titanium dioxide).
Each pink-orange to peach, capsule-shaped tablet, debossed with “FX100” on one side contains 100 mg of eluxadoline. Nonmedicinal ingredients: colloidal silica, crospovidone, mannitol, magnesium stearate, silicified microcrystalline cellulose, and Opadry II (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc and titanium dioxide).
How should I use this medication?
The recommended adult dose of this medication is 100 mg taken by mouth 2 times daily. People over the age of 65 years should be started at a dose of 75 mg 2 times daily. Eluxadoline should be taken with food.
Depending on how well the medication is tolerated, your doctor may decrease the dose.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 4 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If it is more than 4 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to eluxadoline or any ingredients of the medication
- have or may have a biliary duct blockage
- do not have a gallbladder
- consume more than 3 alcoholic drinks daily
- are alcoholic, have an alcohol addiction, or abuse alcohol
- have a history of inflammation of the pancreas (pancreatitis)
- have decreased liver function
- have a history of chronic or severe constipation
- have or have had an obstruction of the digestive tract
- are taking certain medications:
- HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir, saquinavir)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- abdominal pain
- nausea and vomiting (accompanied by other symptoms)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- symptoms of pancreatitis (e.g., abdominal pain, nausea, vomiting)
- symptoms of spasm of the Sphincter of Oddi (e.g., new or worsening belly pain, nausea, vomiting, or sudden pain in the upper right abdomen)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Dependence and drug abuse: Although this medication primarily works in the digestive tract, it can cause euphoria (a false sense of extreme well-being). It is possible to develop a psychological need for this medication.
Drowsiness/reduced alertness: Eluxadoline may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Pancreatitis: Eluxadoline can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.
If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this.
Sphincter of Oddi: The sphincter of Oddi is a muscular valve that controls the passage of digestive juices from the pancreas and gall bladder to the small intestine. In uncommon instances, this muscle can spasm, increasing the risk of inflammation of the pancreas or decreased liver function. If you experience symptoms of spasm of the Sphincter of Oddi, such as nausea, vomiting, and sudden pain in the upper right hand side of the abdomen, possibly radiating toward the back, get medical help immediately.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if eluxadoline passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: People over the age of 65 years may experience more side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between eluxadoline and any of the following:
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir, ritonavir)
- HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir, saquinavir)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Viberzi