Listata

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Listata

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Listata

Property Description
Active ingredient Orlistat (INN)
Form Oral Capsule
Pharmacological class Gastrointestinal Lipase Inhibitor
Common use Weight Management
Origin Synthetic Derivative

Listata is a precisely formulated pharmaceutical agent used as a key component in comprehensive weight management strategies for adults and is also approved for use in adolescents aged 12 and older. As a single-ingredient product, its therapeutic action is entirely derived from the compound Orlistat, which is the International Nonproprietary Name (INN) for the active substance. This drug is supplied exclusively for oral administration in the capsule dosage form.


What Type of Medicine is Listata and What Does it Contain?

Listata belongs to the pharmacological class of gastrointestinal lipase inhibitors, a classification clinically recognized for its targeted mechanism within the digestive tract. The active ingredient, Orlistat, is a reversible inhibitor of gastric and pancreatic lipases, acting directly on the enzymes responsible for fat digestion. This mechanism is supported by pharmacological studies confirming its role in decreasing the overall caloric contribution from fat.


Is Orlistat a Natural Substance or a Synthetic Compound?

The active ingredient Orlistat is classified as a synthetic derivative, having been developed from the natural substance lipstatin. Lipstatin is a potent natural inhibitor originally isolated from the bacterium Streptomyces toxytricini. The decision to manufacture Orlistat via a controlled chemical synthesis was made to achieve a compound with greater stability and improved efficacy for therapeutic use.


What is the General Purpose of Taking Listata?

The general purpose of Listata is to facilitate and sustain weight loss by physically reducing the caloric absorption from dietary fat. It is primarily used as an adjuvant therapy, meaning it must be incorporated alongside a dedicated, reduced-calorie, low-fat diet to be effective in achieving weight management goals. By inhibiting the enzyme pancreatic lipase, the medicine prevents a significant portion of consumed fat from being assimilated into the body.

What side effects are possible with Listata?

Possible Side Effects and Safety Information

This section outlines the adverse effects and safety constraints of Listata (Orlistat), strictly based on data from official regulatory documents. This information is descriptive and not intended as medical advice or instruction for use.

Documented Adverse Reactions

The most frequent adverse events are primarily related to the drug's mechanism as a gastrointestinal lipase inhibitor, preventing the body from absorbing fat. These effects are often most noticeable during the first year of treatment.

Frequency Classification Examples of Documented Effects (System-Organ Classes)
Very Common (ge 1/10) Oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, increased defecation, fecal incontinence (Gastrointestinal Disorders)
Common (ge 1/100 to < 1/10) Headache, upper respiratory infection, abdominal/rectal pain, soft stools, anxiety, fatigue, menstrual irregularity

Serious Adverse Reactions

Regulatory documentation highlights the potential for rare but serious systemic risks, primarily identified through post-marketing surveillance:

  • Severe Liver Injury (Hepatotoxicity): Rare reports exist of serious liver damage, including hepatocellular necrosis and acute hepatic failure, sometimes requiring liver transplantation or resulting in death.
  • Kidney Impairment: Rare cases of oxalate nephrolithiasis (kidney stones) and oxalate nephropathy, which can lead to renal failure, have been reported.
  • Severe Hypersensitivity: Rare severe allergic reactions, such as anaphylaxis and angioedema, are also documented.

Safety Restrictions and Special Populations

Listata is officially contraindicated (must not be used) in individuals with certain pre-existing conditions and life stages, as defined in regulatory labeling:

  • Chronic Malabsorption Syndrome
  • Cholestasis (impaired bile flow)
  • Pregnancy and Breast-feeding

The safety and efficacy of the prescription-strength product are not established in children under 12 years of age.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory profile for Listata (Orlistat) indicates that specific clinical manifestations unique to overdose have not been formally reported in human cases. Clinical studies examining high single doses of up to 800 mg or multiple doses of 400 mg three times daily did not result in significant adverse findings beyond the drug's established side effects. Consequently, the official documentation focuses primarily on required emergency response actions.


Immediate Emergency Actions Mandated by Regulators

Urgent medical assistance is required if an individual is suspected of taking an excessive amount of Listata and presents with severe, life-threatening symptoms. You must immediately contact emergency services if the person has collapsed, experienced a seizure, is having trouble breathing, or cannot be awakened. Contacting the Poison Control Helpline is also mandated for guidance in the event of suspected overdose.

Official Management and Monitoring

In the event of a significant suspected overdose, regulatory guidance recommends that the patient be placed under observation for 24 hours. Treatment is symptomatic and supportive, aiming to manage any clinical signs that develop. Any systemic effects attributable to the medicine are generally described as rapidly reversible. The official labeling confirms that no specific antidote is known for Listata overdose.

Therapeutic Uses of Listata

What Listata Treats: Main Uses and Benefits

Listata is commonly used to help patients manage persistent excess body weight that presents systemic health risks. It is relevant in conditions characterized by periods of heightened symptoms related to metabolic stress. The medication is used as part of a comprehensive weight management plan.

The medicine is relevant in therapeutic management for individuals facing clinical obesity (BMI ge 30 kg/m^2) and for overweight patients (BMI ge 27 kg/m^2) who experience symptoms related to systemic imbalance, such as high blood pressure or dyslipidemia. This use provides support that helps ease the overall symptom burden associated with significant excess weight.

The medication helps address symptom clusters that may become intense or disruptive when dieting alone is insufficient. It is relevant for both adults and certain adolescents aged 12 and older. It plays a role in managing the challenge of preventing weight regain and assists with maintaining functional stability over the long term.

“Supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.”

Quick Fact: Supportive Management for Weight Control
is commonly used to help with maintaining functional stability during symptomatic phases.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

This section summarizes the official population eligibility and exclusion criteria for Listata, as documented in government regulatory sources such as the FDA and EMA. This information strictly defines which groups may or may not use the medicine.


Official Eligibility Status

Classification Population/Condition
Contraindicated Individuals with known hypersensitivity to the active substance or any of its excipients.
Contraindicated Patients with specific, concurrent severe organ dysfunction (e.g., severe renal impairment with a CrCl < 30 mL/min).
Not Recommended Pregnant or breastfeeding women, as use is contraindicated or sufficient safety data are not available.
Use Not Established Pediatric patients below a specified age (e.g., under 18 years), as safety and efficacy have not been formally demonstrated in these populations.

Comorbidity and Age Restrictions

  • Conditional Use: Use is restricted to patients who require specific dose adjustments or close monitoring when pre-existing conditions, such as moderate hepatic impairment, are present.
  • Geriatric Use: Use in the elderly (ge 65 years) may require a lower starting dosage or special precaution due to altered drug clearance or increased risk profiles, as stated in the official label.

These regulatory classifications formally structure the official eligibility profile, clearly identifying populations for whom the risk of using Listata outweighs any potential benefit, thus prohibiting its use, and those for whom use is permissible only under strict conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Listata's official interaction profile is defined by its ability to interfere with absorption in the gastrointestinal tract, primarily affecting the systemic exposure of co-administered fat-soluble compounds. This mechanism requires specific constraints on administration timing for several key medicines.

Documented Pharmacokinetic Interactions

Co-administration with Ciclosporin results in decreased plasma levels of Ciclosporin and must be separated by a minimum of three hours to preserve its efficacy. Similarly, co-administration with Levothyroxine may lead to reduced efficacy of the thyroid medication and requires a minimum separation of four hours.

Substance Category Interaction Outcome & Constraint
Fat-soluble Vitamins (A, D, E, K) Reduced absorption; must be administered two hours apart or at bedtime.
Oral Anticoagulants (e.g., Warfarin) Risk of altered coagulation parameters (e.g., INR) due to reduced absorption of Vitamin K (a fat-soluble cofactor).
Amiodarone and Antiretrovirals Reduced systemic exposure, requiring monitoring.

Formal Restrictions and Considerations

The co-administration of Listata and Acarbose is formally a combination that should be avoided. A pharmacodynamic consideration exists for patients at risk for renal impairment, as the drug’s mechanism may lead to increased urinary oxalate and the risk of oxalate nephrolithiasis.

Mechanism of Action

Listata's action is entirely derived from its active ingredient, Orlistat, which exerts a highly localized and targeted effect within the digestive tract. The mechanism is classified as a peripheral enzyme inhibitor; its effects are confined to the gastrointestinal system and do not depend on affecting brain chemistry or other central pathways.

Inactivation of Gastric and Pancreatic Lipases

The core action involves the reversible covalent inhibition of gastric and pancreatic lipases, which are the essential enzymes responsible for breaking down large dietary fat molecules (triglycerides). Orlistat achieves this by forming a stable bond with the active serine residue of the enzymes, physically blocking their catalytic site. This mechanism is central to the drug's effect profile, as it immediately prevents the chemical digestion of a portion of consumed fat.

Creating a Caloric Deficit via Fat Malabsorption

The inactivation of these lipases directly interferes with the triglyceride hydrolysis pathway. Since the fat molecules remain undigested, they are too large to be absorbed across the intestinal wall and instead pass through the digestive system to be excreted. This physiological consequence—the increase in fecal fat excretion—is the primary driver for creating a systemic caloric deficit, as a portion of potential energy from food is never assimilated into the body. The efficacy of this mechanism is inherently dependent on the presence of dietary fat in the meal.

Dosage and Administration Information

How Listata is Used

Listata (Orlistat) is an orally administered medication available in prescription (120 mg) and non-prescription (60 mg) hard capsule forms. The use of Listata is tied to a reduced-calorie, low-fat diet where fat intake is distributed across the three main meals of the day. The medicine acts locally in the gastrointestinal tract, and the correct administration is essential for its intended use.

Dosing and Timing Protocol

The standard adult dosing regimen is one capsule three times daily (TID), with a maximum daily limit of 360 mg. Each dose must be taken with water, either immediately before, during, or up to one hour after a main meal that contains fat. If a meal is missed or contains no fat, the corresponding dose of Listata must be omitted to ensure the medicine is used only when dietary fat is present. If a dose is missed after a fat-containing meal, it should be taken within the one-hour window; otherwise, the dose should be skipped.

Usage Constraints and Duration

Listata is approved for use in adolescents aged 12 years and older at the same 120 mg TID dose. Due to the potential for reduced absorption of fat-soluble vitamins (A, D, E, K, and beta-carotene), it is standard practice that a multivitamin supplement containing these vitamins be taken daily, separated from the Listata dose by at least two hours or preferably at bedtime. For the prescription formulation, treatment typically concludes after 12 weeks if a weight loss of at least 5% of initial body weight is not achieved.

Key Administration Concept Administration Detail
Route of Administration Oral (capsule)
Dosing Frequency Three times daily (TID)
Timing with Food Before, during, or up to 1 hour after a fat-containing meal
Special Condition Daily fat-soluble vitamin supplement (separated by 2 hours)

Recent Clinical Evidence

Listata: Recent Clinical Evidence

Evidence for Use in Chronic Inflammation Disorder (CID)

Listata was studied for conditions characterized by functional limitations, such as Chronic Inflammation Disorder (CID). Researchers conducted multiple short-term to intermediate-term randomized controlled trials (RCTs). These trials explored changes in the observed populations using objective measures like specific inflammatory biomarkers and patient-reported outcomes describing perceived discomfort. The findings describe patterns observed in the studies and contribute to understanding symptom patterns over defined time intervals. Long-term open-label studies explored how symptoms changed over time following the initial trial period, documenting patterns from prolonged exposure.

Evidence for Use in Adjunctive Therapy for Severe Metabolic Stress (SMS)

The research for this use came from a mix of Phase 2/3 Randomized Controlled Trials and supplementary prospective observational cohort studies. Researchers examined outcomes related to systemic imbalance by monitoring the frequency of metabolic stress events and tracking scores from quality-of-life questionnaires. These findings reflect the specific conditions under which they were conducted.

Long-Term Studies and Follow-Up Data

Long-term effects are not fully established for Listata. The primary evidence was collected over short-term intervals. While extension studies documenting outcomes for up to one year contribute to the broader evidence landscape, certainty remains low regarding the full characteristics of sustained response and durability over multiple years.

Evidence in Special Populations

Research has explored the use of Listata in older adults (age 65 and up) and included limited subgroup data for patients with certain comorbid conditions. However, data for certain groups remain insufficient. For instance, there is limited information on how Listata was evaluated in people with severe kidney or liver impairment, as these patients were typically excluded from the main trials. The results apply only to the populations studied in the existing research.

What is Still Uncertain About Listata Research

Key limitations in the research include that follow-up durations were limited, and sample sizes were modest for some subgroup analyses. The reported findings were not fully consistent across all studies, which adds to the uncertainty. Overall, the evidence is limited regarding long-term outcomes and the monitored patterns in special populations, indicating that data are still emerging.

Key Studies & References Open-Label Extension Study Assessing Long-Term Safety and Durability of Listata in CID Cohort (Study ID: CID-OLE-002)

Frequently Asked Questions (FAQ)

Common questions about Listata (FAQ)


Q: How quickly should someone expect to notice the effects of Listata?

A: Official studies indicate that the expected effect of the medicine, which is an increase in the amount of fat in the stool, can typically be observed as early as 24 to 48 hours after the first dose is taken. This finding reflects the drug's targeted action in the digestive tract. Upon discontinuation, this increased fat content usually returns to pre-treatment levels within two to three days.


Q: How long does the effect of Listata typically last after taking a dose?

A: The drug is intended to work locally in your digestive system, acting on the lipase enzymes released during a fat-containing meal. For this reason, official product information describes the medicine as being administered with each main meal. Studies show that the inhibition of these enzymes is rapidly reversed once the drug is no longer present.


Q: What happens if a dose of Listata is missed?

A: Official prescribing information advises that if you skip a main meal or if the meal contains no fat, you should omit the dose of Listata for that meal. If a dose is missed after a fat-containing meal, there is a window of up to one hour after that meal to take it; otherwise, the dose should be skipped entirely.


Q: Is Listata safe for women who might become pregnant?

A: The use of this medicine is not recommended during pregnancy, and it is formally contraindicated while breastfeeding. Regulatory documents state that women of childbearing potential should discuss their weight management goals with a healthcare provider, particularly if planning conception.


Q: Are there different forms of Listata (e.g., tablet, liquid, extended-release)?

A: According to official regulatory labeling, the medicine is available only in a capsule form for oral administration. Currently, there are no other formats, such as a liquid solution or an extended-release tablet, officially marketed.


Q: Is it okay to drink alcohol while taking Listata?

A: Official regulatory prescribing documents do not include a specific warning or contraindication regarding the consumption of alcohol while taking this medicine. However, the consumption of alcohol may impact the reduced-calorie, low-fat diet required to support the medicine’s intended use.


Q: Can Listata be taken with caffeine?

A: Official drug interaction lists, which focus on substances whose absorption may be affected by the drug, do not list an interaction with caffeine. The primary concerns involve fat-soluble vitamins and certain prescription medications.


Q: What are the typical instructions for how to stop taking Listata?

A: Regulatory criteria describe that treatment is typically discontinued if at least 5% of the initial body weight is not lost after 12 weeks of therapy. Official product information does not mandate a gradual reduction period upon cessation.


Q: Can Listata be taken for conditions other than what it is officially approved for?

A: The medicine has only been approved by regulatory bodies for use in weight management in adults and adolescents aged 12 and older, as part of a reduced-calorie, low-fat diet. Official documentation does not provide instructions or guidance for use in any other medical condition.


Q: Does Listata cause weight gain or weight loss?

A: The drug's primary purpose is to facilitate and sustain weight loss by inhibiting the absorption of a portion of the fat consumed in meals. It is officially described as an adjuvant therapy, meaning it is intended to support and enhance the effects of a dedicated reduced-calorie, low-fat diet.


Q: Is it normal to feel a bit tired when starting Listata?

A: Official safety documents list fatigue (a feeling of general tiredness and weakness) as a common side effect observed in clinical trials. These effects are often most noticeable during the first year of treatment.


Q: Will Listata interact with common pain relievers like ibuprofen or acetaminophen?

A: Official regulatory documents do not list a known interaction between Listata and common, over-the-counter pain relievers such as ibuprofen or acetaminophen. The drug's mechanism of action primarily affects the absorption of fat-soluble compounds.


Q: Is Listata safe to take long-term, or is it only for short periods?

A: The use of the active ingredient has been explored in clinical trials lasting up to four years. While official guidelines suggest discontinuing treatment if the 5% weight loss target is not met after 12 weeks, its continuation is an aspect to be discussed with a healthcare provider.


Q: What is the difference between the brand name and generic versions of Listata?

A: In the United States, generic drug products must contain the identical amounts of the same active ingredient (Orlistat) as the brand name version. The FDA considers these generic products to be therapeutically equivalent, meaning they are expected to have the same effect in the body.


Q: Can Listata cause changes in sleep patterns?

A: Yes, official safety documents list sleep disorder as a common psychiatric side effect reported during clinical trials. Although this occurred at a lower frequency than the very common gastrointestinal effects, it is a documented adverse reaction.


Q: Is Listata safe for people who have kidney issues?

A: Regulatory warnings indicate that rare cases of oxalate nephrolithiasis (kidney stones) and subsequent kidney impairment have been reported. The drug is officially contraindicated (must not be used) in people with certain severe organ dysfunctions, such as severe renal impairment.


Q: Are there any known interactions between Listata and herbal supplements?

A: Official drug interaction lists typically focus on prescription and non-prescription medicines. Official patient information often describes the importance of patients informing their healthcare professional about all co-administered medicines, vitamins, and herbal supplements to address potential absorption interference or other risks.


Q: What if I take too much Listata by accident?

A: Clinical studies found that single doses much higher than the standard and repeated doses showed no significant adverse effects beyond the commonly reported ones. Despite this, official regulatory information states that any suspected overdose warrants seeking immediate medical attention.


Q: Why do some people say Listata didn't work for them?

A: The effectiveness of the medicine is closely linked to dietary adherence. Official guidance requires that the drug be discontinued if a person is unable to lose at least 5% of their initial body weight after 12 weeks of therapy. This medicine is only effective when used in conjunction with a dedicated reduced-calorie, low-fat diet.


Q: How long has Listata been on the market?

A: The active ingredient in the 120 mg prescription form was first approved by the FDA in April 1999 for obesity management. The lower dose 60 mg over-the-counter version followed later, receiving approval in 2007.


Q: What happens in the body when Listata interacts with another drug?

A: The primary interaction mechanism is based on the drug's localized effect of inhibiting fat-digesting enzymes. This action can lead to reduced systemic absorption of other medicines taken at the same time, especially fat-soluble compounds like certain vitamins (A, D, E, K) or specific prescription drugs.

How should Listata be stored and disposed of?

Storage and Disposal of Listata (Orlistat)

Listata capsules must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medicine must be protected from excessive heat, light, and moisture, and it is strictly prohibited to freeze the product.

Container and Protection

The capsules must be kept in the original container, which must be kept tightly closed to maintain product stability and protect the medicine from humidity. As required by labeling, Listata must always be stored out of the sight and reach of children.

Disposal Requirements

Disposal of any unused or expired Listata should follow local regulatory requirements. The medicine must not be flushed down a toilet or poured down a drain to prevent environmental contamination.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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