Mounjaro for Fatty Liver (MASH): Clinical Evidence

Last updated: April 2026

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Quick Answer

Mounjaro's active ingredient, tirzepatide, activates both GIP and GLP-1 receptors to manage blood sugar and reduce appetite, leading to an average weight loss of 20.9% at the 15 mg dose over 72 weeks.
Clinical trials show tirzepatide can lead to an average weight loss of 20.9% at the 15 mg dose over 72 weeks.
Mounjaro is FDA-approved for treating type 2 diabetes, while Zepbound, also tirzepatide, is approved for chronic weight management and sleep apnea.
Common side effects include nausea (12-22% of patients), diarrhea (12-16%), vomiting (6-13%), and constipation (6-9%).

Mounjaro, an injectable prescription medication, contains the active ingredient tirzepatide, a compound that has shown significant promise in managing both blood sugar and body weight. This medication works by mimicking two crucial gut hormones, GLP-1 and GIP, which play a vital role in the body's metabolic processes. By activating receptors for both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), tirzepatide helps to improve glycemic control in adults with type 2 diabetes. Furthermore, it contributes to substantial weight reduction, with clinical trials demonstrating an average weight loss of 20.9% of body weight for patients on a 15mg dose over 72 weeks, a stark contrast to the 3.1% weight loss observed in placebo groups during the same period Mounjaro and Zepbound Comparison. While Mounjaro is specifically approved for type 2 diabetes, its identical active ingredient, tirzepatide, is also found in Zepbound, which holds FDA approval for chronic weight management and the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity. This dual action and impressive weight loss efficacy highlight tirzepatide's potential impact on various health conditions, including those often linked to obesity and metabolic dysfunction. We compare how GLP-1s perform across specific patient subgroups, including NAFLD and MASH.

What is Mounjaro and How Does it Work?

Mounjaro is an injectable prescription medication containing tirzepatide as its active ingredient. This medication is primarily FDA-approved for the treatment of type 2 diabetes in adults, intended for use alongside diet and exercise to help improve blood sugar control. The way Mounjaro works is by activating two specific gut hormone receptors: glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). This dual agonism allows it to address multiple metabolic pathways, leading to its observed benefits in managing blood sugar and promoting satiety.

The Role of Tirzepatide as a Dual Agonist

Tirzepatide's unique mechanism lies in its ability to mimic both GLP-1 and GIP hormones. These naturally occurring incretin hormones are released by the gut in response to food intake and play critical roles in glucose metabolism. By acting on both receptors, tirzepatide offers a comprehensive approach to metabolic regulation. Dr. Eleanor Yusupov, D.O., an assistant professor at New York Institute of Technology’s medical school, explains that "Zepbound is different from Ozempic and other GLP-1s. That’s because it [mimics] two gut hormones — GLP-1 and GIP — to control blood sugar, increase insulin, decrease glucagon (a hormone that raises blood sugar), slow down food leaving the stomach, and regulate appetite." This dual action is central to its effectiveness.

Stimulating Insulin Release and Improving Sensitivity

One of the primary ways tirzepatide works is by stimulating the pancreas to release insulin, but only when blood glucose levels are elevated. This glucose-dependent action helps to prevent hypoglycemia, or dangerously low blood sugar, which can be a concern with some other diabetes medications. By improving insulin sensitivity, tirzepatide helps the body's cells respond more effectively to the insulin that is produced, further aiding in blood sugar control. This means that the body can use its own insulin more efficiently, which is crucial for individuals with type 2 diabetes who often experience insulin resistance. The medication essentially helps the body to better manage the sugar it takes in from food.

Slowing Gastric Emptying and Reducing Glucagon

Tirzepatide also slows down gastric emptying, the process by which food moves from the stomach into the small intestine. This slower emptying has several benefits. First, it leads to increased satiety, meaning patients feel full for longer after meals. This can naturally reduce overall food intake and contribute to weight management. Second, by slowing gastric emptying, it helps to control post-meal sugar spikes, preventing rapid increases in blood glucose that can be detrimental for individuals with type 2 diabetes. Additionally, tirzepatide reduces glucagon production from the liver. Glucagon is a hormone that raises blood sugar levels, so by decreasing its production, tirzepatide further contributes to lower blood glucose. Dr. Andrew Shapiro, M.D., a board-certified general surgery specialist, notes that "Like Zepbound, Mounjaro mimics the GLP-1 and GIP hormones to help regulate blood sugar, improve insulin production, and promote satiety." This combined effect on appetite and glucose regulation is a hallmark of tirzepatide's mechanism.

Appetite Reduction Through Central Nervous System Effects

Beyond its direct effects on insulin and glucagon, tirzepatide also influences appetite through central nervous system effects. It sends signals to the brain that tell it the body is feeling full, making it easier to eat less. This mechanism contributes significantly to the weight loss observed in patients using tirzepatide. By reducing appetite, individuals are less likely to consume excess calories, supporting a reduced-calorie diet and increased physical activity, which are often recommended alongside the medication. The feeling of fullness can make adherence to dietary changes more manageable, leading to more consistent weight loss results. This comprehensive action on appetite, gastric emptying, insulin, and glucagon makes tirzepatide a powerful tool in managing both type 2 diabetes and conditions related to obesity.

How Does Mounjaro Compare to Zepbound?

Mounjaro and Zepbound are, in essence, two brand names for the exact same active ingredient: tirzepatide. Despite sharing the identical compound and working through the same biological mechanisms, they have distinct FDA approvals, which dictates their primary indications for use and often influences insurance coverage. Understanding these differences is crucial for patients and healthcare providers when making treatment decisions. Both medications are injectable and administered once a week subcutaneously.

Shared Active Ingredient and Mechanism

Both Mounjaro and Zepbound contain tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. This means they both function by mimicking these two gut hormones to manage blood sugar, stimulate insulin release when glucose levels are high, slow gastric emptying, reduce glucagon production, improve insulin sensitivity, and decrease appetite through central nervous system effects. The core pharmacological action is identical for both drugs. As Dr. Andrew Shapiro highlights, "Like Zepbound, Mounjaro mimics the GLP-1 and GIP hormones to help regulate blood sugar, improve insulin production, and promote satiety." This shared mechanism ensures that both medications have the potential for similar effects on the body's metabolism.

Mounjaro's FDA Approval: Type 2 Diabetes

Mounjaro received its FDA approval in 2022. Its primary indication is for the treatment of type 2 diabetes in adults. It is prescribed alongside diet and exercise to help improve blood sugar control in this patient population. This approval means that Mounjaro is recognized as a safe and effective treatment specifically for managing the high blood sugar levels characteristic of type 2 diabetes. For individuals with this condition, Mounjaro can be a critical part of their treatment plan, helping them to achieve better glycemic control and potentially reduce the risk of diabetes-related complications. Insurance coverage for Mounjaro typically falls under diabetes benefits, making it more accessible for those with a type 2 diabetes diagnosis.

Zepbound's FDA Approval: Chronic Weight Management

Zepbound, also a brand name for tirzepatide, received its FDA approval for chronic weight management in adults. This approval covers individuals with obesity (defined as a Body Mass Index, or BMI, of ≥30 kg/m²) or those who are overweight (BMI ≥27 kg/m²) and have at least one weight-related condition. Such weight-related conditions can include high blood pressure, dyslipidemia (unhealthy levels of fats in the blood), or sleep apnea. Zepbound is intended for use in combination with a reduced-calorie diet and increased physical activity. This distinct approval positions Zepbound as a dedicated weight loss medication, addressing the growing global burden of obesity. In our analysis, we see how this specific indication can influence patient populations, as Zepbound is targeted at individuals primarily seeking help with weight loss.

Zepbound's Additional FDA Approval: Obstructive Sleep Apnea

In 2024, Zepbound received an additional FDA approval to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. This expands its utility beyond general weight management, offering a therapeutic option for a common and serious comorbidity of obesity. Obstructive sleep apnea can lead to significant health issues, and by addressing it through weight reduction facilitated by tirzepatide, Zepbound offers a comprehensive benefit to patients. This further differentiates Zepbound's approved uses from Mounjaro's. Typical insurance coverage for Zepbound may include weight management benefits and sleep apnea benefits, but it can still face more restrictions compared to Mounjaro's diabetes coverage, making diagnosis and treatment goals key to prescribing decisions. While both medications share the same active ingredient and similar safety profiles, their differing FDA approvals mean they serve distinct, though often overlapping, patient needs.

What Are the Weight Loss Results with Tirzepatide?

Tirzepatide, the active ingredient in Mounjaro and Zepbound, has demonstrated significant efficacy in promoting weight loss, as evidenced by the SURMOUNT clinical trials. These trials have provided robust data on the extent of weight reduction achievable with tirzepatide, particularly at higher doses, showcasing its potential as a powerful tool in chronic weight management. The results are compelling when compared to placebo, indicating a substantial physiological impact of the medication. The SURMOUNT trials, such as the SURMOUNT-4 Randomized Clinical Trial, have been pivotal in understanding the long-term effects and maintenance of weight reduction in adults with obesity Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial.

Average Weight Loss at 15mg Dose

One of the most notable findings from the SURMOUNT trials is the average weight loss achieved with the highest dose of tirzepatide. Patients receiving the 15mg dose experienced an average weight loss of 20.9% of their body weight over a period of 72 weeks Mounjaro and Zepbound Comparison. This figure represents a substantial reduction in body weight, which can have profound benefits for overall health, including improvements in metabolic markers, reduced risk of cardiovascular disease, and alleviation of weight-related comorbidities like sleep apnea. The consistency of this average across multiple sources underscores the reliability of this outcome. This level of weight loss is often associated with clinical improvements in various health parameters, making it a significant achievement in the field of obesity treatment.

Placebo Comparison: A Clear Difference

To put the efficacy of tirzepatide into perspective, it is crucial to compare its effects against a placebo. During the same 72-week period, patients in the placebo group achieved an average weight loss of only 3.1% of their body weight Mounjaro and Zepbound Comparison. This stark difference highlights that the weight loss observed with tirzepatide is not merely due to lifestyle changes or other external factors but is a direct result of the medication's pharmacological action. The placebo group serves as a baseline, demonstrating the natural progression of weight management efforts without the active drug. The nearly seven-fold difference in average weight loss between the tirzepatide 15mg group and the placebo group underscores the powerful impact of tirzepatide.

Achieving Significant Weight Loss (≥5%)

Beyond average weight loss, it is important to consider the proportion of patients who achieve clinically meaningful weight reduction. The SURMOUNT trials showed that a remarkable 91% of patients treated with tirzepatide achieved significant weight loss, defined as losing 5% or more of their body weight Mounjaro and Zepbound Comparison. Losing 5% of body weight is often considered a clinical benchmark for improving health outcomes, such as blood pressure, cholesterol levels, and blood sugar control. This high percentage indicates that the vast majority of individuals who use tirzepatide can expect to experience a health-relevant amount of weight loss, which can lead to tangible improvements in their health status. This widespread success across a large patient population demonstrates the broad applicability and effectiveness of tirzepatide.

Achieving Substantial Weight Loss (≥20%)

Even more impressive is the proportion of patients who achieved substantial weight loss. The research indicates that 55% of patients treated with tirzepatide achieved a weight loss of 20% or more of their body weight Mounjaro and Zepbound Comparison. This level of weight loss is often comparable to that seen with bariatric surgery and can lead to significant improvements in obesity-related complications, potentially even leading to remission of conditions like type 2 diabetes. Achieving 20% or more weight loss can dramatically transform a patient's health and quality of life, offering benefits that extend far beyond aesthetics. This statistic truly highlights the profound impact tirzepatide can have on individuals struggling with obesity, offering a non-surgical option with powerful outcomes. The efficacy and safety of tirzepatide in people with obesity are well-documented Understanding Tirzepatide in Clinical Trials.

What Are the Common Side Effects of Tirzepatide?

Like all medications, tirzepatide, found in both Mounjaro and Zepbound, can cause side effects. Most of these are gastrointestinal in nature and tend to be mild to moderate, especially during the initial phases of treatment as the body adjusts to the medication. Understanding these common side effects and how to manage them can help patients adhere to their treatment plan and minimize discomfort. These side effects are generally consistent across both brand names of tirzepatide due to their shared active ingredient and mechanism of action.

Nausea

Nausea is one of the most frequently reported side effects when taking tirzepatide. Clinical data indicates that nausea affects between 12% and 22% of patients Mounjaro and Zepbound Comparison. This sensation of feeling sick to the stomach can range from mild discomfort to a more pronounced feeling that can impact daily activities. It often occurs more frequently when starting the medication or when increasing the dose. To manage nausea, healthcare providers often recommend starting with small, frequent meals and avoiding high-fat, greasy foods, which can exacerbate the feeling. Staying well-hydrated is also crucial, and taking the medication with food might help alleviate some symptoms for certain individuals. In cases of severe nausea, anti-nausea medications might be considered under a doctor's guidance.

Diarrhea

Diarrhea is another common gastrointestinal side effect associated with tirzepatide, reported by 12% to 16% of patients (for how the newer triple agonist stacks up, see our retatrutide side effects breakdown by system and dose) Mounjaro and Zepbound Comparison. This can manifest as loose or watery stools and, if persistent, can lead to dehydration. Similar to nausea, it is often more prevalent during the initial stages of treatment. Management strategies include ensuring adequate fluid intake to prevent dehydration and potentially adjusting dietary choices to include more binding foods. Avoiding excessively spicy or high-fiber foods that might irritate the digestive system could also be beneficial. It is important for patients to monitor their hydration status closely and report persistent or severe diarrhea to their healthcare provider.

Vomiting

Vomiting is experienced by a smaller percentage of patients compared to nausea and diarrhea, affecting 6% to 13% of individuals taking tirzepatide Mounjaro and Zepbound Comparison. While less common, vomiting can be more distressing and can lead to fluid and electrolyte imbalances if severe or prolonged. If vomiting occurs, it's important to try to stay hydrated by sipping small amounts of clear fluids. Avoiding solid foods for a short period and gradually reintroducing bland foods may help. If vomiting is persistent and prevents fluid intake, immediate medical attention is necessary to prevent dehydration and other complications.

Constipation

On the opposite end of the spectrum from diarrhea, constipation is also a reported side effect, affecting 6% to 9% of patients Mounjaro and Zepbound Comparison. This can involve infrequent bowel movements, hard stools, or difficulty passing stool. Constipation can be uncomfortable and, in some cases, lead to other digestive issues. To manage constipation, increasing fiber intake through diet, ensuring sufficient fluid intake, and engaging in regular physical activity are often recommended. Over-the-counter laxatives or stool softeners might be considered under the guidance of a healthcare professional if lifestyle changes are not sufficient. For more details, see Weight Loss Outcomes with Tirzepatide.

Stomach Pain and Decreased Appetite

Stomach pain, also known as abdominal pain, is another common complaint, affecting 8% to 11% of patients Mounjaro and Zepbound Comparison. This pain can vary in intensity and location. It's important to differentiate this from severe abdominal pain, which could indicate a more serious condition like pancreatitis. For mild stomach pain, simple measures like avoiding irritating foods and taking over-the-counter pain relievers (if approved by a doctor) might help.

Finally, decreased appetite is reported by 5% to 11% of patients using tirzepatide Mounjaro and Zepbound Comparison. While this is often a desired effect for those taking the medication for weight management, it can sometimes be so pronounced that it affects nutritional intake. Patients should ensure they are still consuming enough nutrients through smaller, nutrient-dense meals. If decreased appetite leads to insufficient food intake or significant fatigue, it should be discussed with a healthcare provider. Effective management of these common side effects often involves dietary adjustments, hydration, and communication with a healthcare professional to ensure treatment continues safely and comfortably.

What Serious Side Effects Should You Watch For?

While common side effects of tirzepatide are usually manageable, it is critical for patients and healthcare providers to be aware of the potential for serious adverse events. These serious side effects are rare but require immediate medical attention. The FDA has issued specific warnings and contraindications for tirzepatide, underscoring the importance of careful patient selection and monitoring during treatment. These warnings are in place to ensure patient safety and prevent severe health complications.

Black Box Warning: Thyroid C-cell Tumors

Tirzepatide carries a black box warning, the most serious type of warning issued by the FDA, regarding the risk of thyroid C-cell tumors Mounjaro and Zepbound Comparison. This warning is based on studies in rodents that showed tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). While it is unknown whether tirzepatide causes thyroid C-cell tumors, including MTC, in humans, the risk cannot be ruled out. Therefore, Mounjaro and Zepbound are contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a genetic condition that predisposes individuals to MTC. Patients should be informed of the potential risk and symptoms of thyroid tumors.

Acute Pancreatitis

Another serious side effect is acute pancreatitis, which is inflammation of the pancreas. Patients with a history of pancreatitis should use tirzepatide with caution Mounjaro and Zepbound Comparison. Symptoms of acute pancreatitis can include severe, persistent abdominal pain that may radiate to the back, often accompanied by vomiting. If such symptoms occur, immediate medical evaluation is necessary. The precise mechanism by which GLP-1 and GIP receptor agonists might lead to pancreatitis is still under investigation, but prompt recognition and treatment are vital to prevent severe complications.

Acute Gallbladder Disease

Acute gallbladder disease, including cholelithiasis (gallstones) and cholecystitis (inflammation of the gallbladder), is another potential serious side effect. Rapid weight loss, which can occur with tirzepatide, is a known risk factor for gallstone formation. Symptoms might include severe pain in the upper right abdomen, nausea, vomiting, fever, or jaundice (yellowing of the skin or eyes). Patients experiencing these symptoms should seek medical attention promptly. Regular monitoring may be recommended during treatment, especially for those at higher risk.

Diabetic Retinopathy Complications

For patients with type 2 diabetes, there is a risk of diabetic retinopathy complications. This is particularly relevant in patients with a history of diabetic retinopathy who experience rapid improvement in glycemic control. While improving blood sugar is generally beneficial for retinopathy, very rapid changes can sometimes paradoxically worsen pre-existing retinopathy in the short term. Regular eye examinations are recommended for diabetic patients using tirzepatide, especially if they have a history of retinopathy, to monitor for any changes.

Acute Kidney Injury

Acute kidney injury is another serious concern. Patients treated with GLP-1 receptor agonists have reported acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who experienced nausea, vomiting, or diarrhea leading to dehydration. Therefore, patients should be advised of the potential risk of dehydration and to take precautions to avoid fluid loss. Regular monitoring of kidney function may be recommended, particularly in patients with pre-existing kidney impairment. Tirzepatide is not recommended for type 1 diabetes, and caution is advised for patients with a history of pancreatitis. These contraindications and warnings are crucial for safe prescribing and patient management.

When Should You Contact Your Doctor About Tirzepatide Side Effects?

Knowing when to seek medical attention for side effects is crucial for anyone taking tirzepatide. While many common side effects are mild and manageable, certain symptoms can indicate a serious underlying condition that requires immediate professional assessment. Prompt communication with your healthcare provider can prevent complications and ensure your safety during treatment with Mounjaro or Zepbound. It is important to distinguish between typical, expected side effects and those that warrant urgent medical advice.

Severe Abdominal Pain

One of the most critical symptoms to watch for is severe abdominal pain that does not go away. This pain may be a sign of acute pancreatitis, a serious inflammation of the pancreas. The pain associated with pancreatitis can often be described as intense and persistent, sometimes radiating to the back. If you experience such pain, especially if it is accompanied by vomiting, you should seek immediate medical attention Mounjaro and Zepbound Comparison. Do not wait for the pain to subside, as pancreatitis can be a rapidly progressing and potentially life-threatening condition. Your doctor will need to perform tests to diagnose or rule out this condition.

Persistent Vomiting Preventing Fluid Intake

While some vomiting can be a common side effect, persistent vomiting that prevents you from keeping fluids down is a cause for serious concern. This can quickly lead to dehydration, which can be dangerous and worsen other health conditions, including the risk of acute kidney injury. If you find yourself unable to tolerate any fluids due to continuous vomiting, you need to contact your doctor or seek emergency medical care right away Mounjaro and Zepbound Comparison. Dehydration can lead to electrolyte imbalances, dizziness, confusion, and can put a strain on your kidneys.

Symptoms of Thyroid Tumors

Given the black box warning for thyroid C-cell tumors, it is essential to be vigilant for any symptoms that might suggest a thyroid issue. These symptoms include a lump in the neck, hoarseness that does not go away, or difficulty swallowing Mounjaro and Zepbound Comparison. If you notice any of these signs, you should contact your doctor immediately for further evaluation. Early detection is important for conditions like medullary thyroid carcinoma. Your doctor may perform physical examinations, blood tests, or imaging studies to investigate these symptoms.

Signs of a Severe Allergic Reaction

Although rare, severe allergic reactions to tirzepatide are possible and require immediate medical attention. Symptoms of a severe allergic reaction can include swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing, severe rash or itching, dizziness, or a very rapid heartbeat. If you experience any of these symptoms, call emergency services or go to the nearest emergency room without delay. Anaphylaxis is a life-threatening condition that requires prompt medical intervention.

Other Important Safety Information

It is important to remember that tirzepatide is not recommended for individuals with type 1 diabetes. Additionally, patients with a history of pancreatitis should use tirzepatide with caution. Regular monitoring is recommended during treatment to assess for adverse reactions and ensure the medication remains appropriate for your health status. Always discuss any new or worsening symptoms with your healthcare provider. They are the best resource for determining whether a side effect is common and manageable or if it warrants more serious intervention. The goal is to maximize the benefits of tirzepatide while minimizing any risks to your health.

Frequently Asked Questions

Is Mounjaro FDA-approved for weight loss?

No, Mounjaro is not FDA-approved for weight loss. Its primary FDA approval is for improving glycemic control in adults with type 2 diabetes, used alongside diet and exercise. However, its active ingredient, tirzepatide, is FDA-approved under the brand name Zepbound for chronic weight management in adults with obesity or those who are overweight with at least one weight-related condition. Clinical trials for tirzepatide have shown significant weight loss, with an average of 20.9% body weight lost at the 15mg dose over 72 weeks.

How often do you take Mounjaro?

Mounjaro is administered as a subcutaneous injection once a week. It is designed for weekly dosing, which can make it a convenient option for patients managing their type 2 diabetes. The consistent weekly schedule helps maintain steady levels of tirzepatide in the body, which is crucial for its effectiveness in managing blood sugar and promoting satiety. Patients should follow their healthcare provider's instructions regarding the exact day and time of administration.

What is the main difference between Mounjaro and Zepbound?

The main difference between Mounjaro and Zepbound lies in their FDA-approved indications, despite both containing the same active ingredient, tirzepatide. Mounjaro is approved for treating type 2 diabetes, while Zepbound is approved for chronic weight management in adults with obesity or overweight and at least one weight-related condition, and also for moderate to severe obstructive sleep apnea in adults with obesity. This distinction impacts patient populations and insurance coverage, with Mounjaro typically covered under diabetes benefits and Zepbound under weight management or sleep apnea benefits.

Can Mounjaro cause thyroid problems?

Yes, Mounjaro carries a black box warning for the risk of thyroid C-cell tumors. Studies in rodents showed an increased incidence of these tumors, including medullary thyroid carcinoma (MTC). While it's unknown if this risk applies to humans, Mounjaro is contraindicated in individuals with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2. Patients should be alert for symptoms like a lump in the neck, hoarseness, or difficulty swallowing and report them to their doctor immediately.

Who should not use Mounjaro?

Mounjaro should not be used by individuals with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. It is also contraindicated in patients with hypersensitivity to tirzepatide or any of its components. Furthermore, Mounjaro is not recommended for individuals with type 1 diabetes. Caution is advised for patients with a history of pancreatitis or diabetic retinopathy, and regular monitoring is recommended during treatment.