Lertus

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Lertus

What is Lertus? Defining the Medicinal Entity

Property Description
Active ingredient Diclofenac (Sodium/Potassium)
Form Oral tablets, Topical gels/solutions, Injections
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Relief of pain and inflammation
Origin Synthetic (Phenylacetic acid derivative)

What Type of Medicine is Lertus? Classification and Identity

Lertus is a pharmaceutical preparation whose active component is diclofenac, which is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This classification recognizes the agent's ability to interfere with the inflammatory process. Diclofenac is a synthetic compound derived from the phenylacetic acid family, positioning it as a potent non-opioid reliever of discomfort. As a brand, Lertus is typically associated with formulations, such as delayed-release tablets, that are intended for providing sustained relief from discomfort associated with chronic inflammatory conditions, distinguishing its use profile from immediate-release generic preparations.


Composition and Available Forms of Lertus

The core composition of Lertus features the active ingredient diclofenac (as either the Sodium or Potassium salt) combined with specialized excipients. This active agent is formulated into several high-level dosage forms, including oral tablets (often with a proprietary coating), highly concentrated topical gels or solutions, and preparations for injection. This variety in form is particularly useful for the management of localized pain, where the topical route of administration allows for delivery to the site of inflammation, bypassing the systemic absorption required by oral forms. These formulations ensure the active agent can be administered through both oral and topical routes.


How Does Lertus Generally Help? High-Level Purpose

The general purpose of Lertus is to provide anti-inflammatory and analgesic effects that alleviate discomfort and stiffness associated with various inflammatory conditions. It functions as a potent cyclooxygenase inhibitor, effectively reducing the body's synthesis of prostaglandins—the chemical messengers responsible for promoting pain and swelling. The compound's primary benefit is its ability to mitigate the physical signs of inflammation, thereby contributing to improved patient comfort and general mobility.

What side effects are possible with Lertus?

Possible Side Effects and Safety Information

Diclofenac, the active component in Lertus, is classified as an NSAID, and its use is associated with a specific set of officially documented adverse reactions and serious safety concerns, primarily affecting the gastrointestinal and cardiovascular systems. These high-level safety patterns are detailed across regulatory documents and apply regardless of the dosage form used.

Systemic and Serious Adverse Reactions

Official government labeling identifies several serious adverse reactions that can be fatal and may occur without warning symptoms. These systemic risks are a key safety consideration for all NSAID use:

  • Cardiovascular Thrombotic Events: Associated with an increased risk of serious events, including myocardial infarction and stroke. This risk may occur early in treatment and is officially documented to increase with the duration of use.
  • Gastrointestinal Bleeding, Ulceration, and Perforation: Use may cause serious adverse events in the stomach or intestines, including bleeding and perforation. The likelihood of these events increases with longer duration of NSAID therapy.
  • Hepatotoxicity and Renal Injury: Diclofenac may cause elevated liver enzymes, hepatitis, or, rarely, severe liver failure. Long-term administration is also associated with renal papillary necrosis and other forms of renal toxicity.

Common and System-Organ Class Effects

The most frequently reported adverse reactions typically involve the gastrointestinal system and are classified as common in official documents. These effects often include abdominal pain, dyspepsia (indigestion), nausea, vomiting, diarrhea, and constipation. Adverse effects are grouped by System-Organ Classes (SOC) and also include effects on the Nervous System (e.g., headache, dizziness), the Hemic and Lymphatic System, and the development of edema (fluid retention).

Safety Considerations for Specific Populations

Official safety information outlines increased risks for certain groups. Older adults are at a greater risk for serious gastrointestinal events. The medicine is strictly contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Furthermore, diclofenac is contraindicated for the management of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery and in patients with a history of aspirin-sensitive asthma.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The following information details the officially documented overdose presentation and required actions for Lertus (Diclofenac), as described in government regulatory documents.

Element Official Regulatory Statement
Documented Manifestations Symptoms of overdosage may include Epigastric pain, Nausea, Vomiting, Drowsiness, Confusion, Headache, and Gastrointestinal bleeding [FDA/SmPC]. Severe, but rare, outcomes reported are Shock, Coma, and Convulsions [FDA].
Severe Outcomes & Risks Fatal outcomes associated with Gastrointestinal bleeding or perforation are a documented risk. Serious Cardiovascular thrombotic events, including Myocardial Infarction and Stroke, are critical risks that require immediate attention [HPRA/FDA].
Emergency Action Required Seek emergency help immediately if an anaphylactic reaction occurs [FDA]. See a physician immediately in case of signs of serious thrombotic events (e.g., chest pain, shortness of breath, weakness, or slurring of speech) [HPRA/NAFDAC].
Population Note Consequences generally have more serious consequences in the elderly, who are at an increased frequency and risk for fatal GI events [HPRA].

Overdose Management:

Treatment for overdosage is symptomatic and supportive, as no specific antidote is documented as known [FDA]. Supportive measures may include considering gastric lavage or the use of activated charcoal. Close medical surveillance is imperative, particularly regarding the monitoring of hepatic and renal function [HPRA/NAFDAC].

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Therapeutic Uses of Lertus

What Lertus Treats: Main Uses and Benefits

Lertus is applied across domains where additional symptomatic support is needed for symptoms related to inflammatory or irritative states. This medication is used for managing conditions characterized by periods of heightened symptoms. Its therapeutic scope includes easing the discomfort of Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, acute gouty arthritis, and primary dysmenorrhea (menstrual pain).

Lertus is commonly used when short-term symptomatic assistance is needed in clinical settings that involve acute or unstable symptom patterns. It provides supportive relief that helps patients cope more steadily with difficult episodes.

“...supports the patient during difficult episodes by easing distress.”

Quick Fact: Relief for Joint Stiffness and Acute Pain

Lertus is also considered relevant in contexts involving recurrent or episodic manifestations, such as acute migraine headaches, where symptoms may become intense or disruptive. By helping to manage symptom clusters, Lertus contributes to improved day-to-day comfort and assists with maintaining functional stability for the patient.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Lertus — official regulatory information

Category Status (Regulatory Wording)
Populations for whom use is allowed (as stated in label): The adult population is the primary group for established use. Pediatric patients 12 years of age and older may use certain oral formulations, with use in younger children noted for specific conditions in some regions.
Populations for whom use is not recommended (if applicable): Use is not recommended for children under 14 years for many oral forms, and for women who are breastfeeding.
Populations for whom use is contraindicated: Patients with known hypersensitivity to diclofenac, aspirin-sensitive asthma, or other NSAID allergies. Established Congestive Heart Failure (NYHA II-IV), Ischemic/Cerebrovascular Disease, or CABG surgery setting.

Age-related eligibility rules

Older adults require the lowest effective dose for the shortest duration due to increased risk of serious gastrointestinal events. Safety and efficacy are not established for some oral forms in children younger than 12 years.

Condition-specific eligibility rules

Absolute Prohibition: Patients must not use Lertus with active gastrointestinal ulceration, bleeding, or perforation, or with renal failure or hepatic failure. The medicine is contraindicated in those with established cardiovascular disease.

Pregnancy and lactation eligibility status (if explicitly documented)

Use is contraindicated during the last trimester of pregnancy (30 weeks gestation and later) and avoided from 20 weeks gestation. Excretion into human milk means use is not recommended while breastfeeding.


Resulting eligibility structure

Official label statements establish absolute non-eligibility based on hypersensitivity, severe gastrointestinal disease, and established cardiovascular disease. The profile is further defined by conditional use requirements, such as restricting use in patients with mild to moderate organ impairment or major cardiovascular risk factors (e.g., hypertension). Specific age and gestational status rules prohibit use in the late stages of pregnancy and place limitations on pediatric use.

What should I know about interactions with other medicines?

Lertus Interactions with other medicines and products

Lertus, containing diclofenac, is subject to specific regulatory interaction constraints focused on two main risk areas: bleeding and organ function. Formal regulatory documentation outlines several interacting medicinal product categories, often involving pharmacodynamic risk intensification.


Official Interaction Structure

Interaction Scope Details from Regulatory Sources
Medicinal Products Anticoagulants, Anti-platelet Agents, SSRIs, ACE Inhibitors, ARBs, Diuretics, and other NSAIDs.
Mechanistic Basis Pharmacodynamic risk intensification (additive bleeding/nephrotoxicity) and pharmacokinetic inhibition.
Restriction Co-administration with other NSAIDs or analgesic-dose Aspirin is formally restricted due to the increased risk of serious gastrointestinal events.
Timing Rule The specific oral powder/liquid formulations must be taken on an empty stomach to ensure full effectiveness, according to product-specific labeling.

Clinically Significant Interactions

Co-administration with Anticoagulants (like Warfarin) and SSRIs significantly increases the documented risk of gastrointestinal bleeding. Diclofenac may diminish the antihypertensive and natriuretic effects of ACE Inhibitors, ARBs, and Diuretics. This combination, particularly in the elderly or volume-depleted patients, increases the official risk of renal function deterioration.

The use of Voriconazole, a known CYP enzyme inhibitor, is officially documented to increase the systemic exposure (Cmax and AUC) of diclofenac. Furthermore, regulatory documents specify that concomitant ingestion of alcohol increases the risk of gastric irritation and gastrointestinal mucosal bleeding.

Mechanism of Action

Lertus, containing the active ingredient diclofenac, functions primarily as a cyclooxygenase (COX) enzyme inhibitor. The compound preferentially binds to and inhibits both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) isoforms, competing with the physiological substrate, arachidonic acid, for the enzyme's active site. This competitive interaction blocks the initial and rate-limiting step in the eicosanoid cascade. Intracellularly, this inhibition decreases the enzymatic conversion of arachidonic acid into prostaglandin G2 and subsequently into other prostanoids, including prostaglandin E2 and thromboxanes. The reduction in localized prostanoid biosynthesis, particularly prostaglandin E2, modulates cellular responses by decreasing the peripheral sensitization of nociceptors to various stimuli. At the systemic level, this action results in a broad physiological modulation of inflammatory signaling pathways and central nervous system processing of afferent signals.

Dosage and Administration Information

How Lertus Is Used: Administration Guidelines

Lertus, which contains diclofenac, is administered through several routes, including oral tablets, topical applications, and intramuscular (IM) or intravenous (IV) infusion for acute needs. The principle guiding its use is to employ the lowest effective dosage for the shortest duration necessary to manage symptoms.

Oral dosing regimens for chronic conditions like Osteoarthritis and Rheumatoid Arthritis typically range from 100 mg to 200 mg total daily dose, divided into two to four doses, depending on the specific condition and formulation. Extended-release tablets are generally taken once daily. The maximum daily dosage varies by indication and formulation.

Administration requirements are dependent on the dosage form. Delayed-release and extended-release tablets must be swallowed whole and should not be crushed, split, or chewed, as this compromises their controlled release mechanism. The specific oral powder formulation requires mixing with a small amount of water (1 to 2 ounces) and immediate consumption. Intravenous administration requires the drug to be diluted immediately before use, buffered with sodium bicarbonate, and administered as a slow infusion rather than a rapid injection. Furthermore, the IM and IV routes are generally limited to a maximum of two days before transitioning to oral or rectal forms.

For localized use, the topical gel is applied to the affected area, and the treated skin should remain uncovered. Dosing adjustments for older adult patients often follow the rule of initiating treatment with the lowest available effective dose. If a dose is missed, it should be skipped if it is close to the time of the next scheduled dose, and the patient should not take a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action Studies

The drug's mechanism of action is understood to involve inhibiting a specific enzyme pathway. Studies have evaluated whether the drug is associated with improved patient outcomes by targeting this pathway.

  • Pharmacodynamic Research: Early research explored whether this inhibition is associated with a reduction in inflammation and pain, with some studies reporting rapid effects after administration. Further research is examining the full impact on inflammatory markers.

Clinical Trial Data Overview

A number of studies suggest the drug may be a treatment option in the management of chronic conditions. These investigations range from Phase I safety trials to Phase III efficacy trials.

  • Efficacy in Condition A: A randomized controlled trial (RCT) reported a reduction in symptoms that was observed to be sustained over the study period (12 months). A meta-analysis of multiple smaller studies also examined the potential for symptom reduction in a broader patient population. Individual patient responses may vary.

  • Dosing and Administration: The study protocol involved taking the drug twice daily. Studies investigated whether the combination with a specific excipient resulted in increased absorption and examined safety in most adults enrolled in the trials.


Comparative Studies and Future Research

Research compared the drug to older treatments in head-to-head trials. These studies evaluated whether the drug was associated with different outcome measures compared to established therapies.

  • Adverse Event Profile: Overall, the therapeutic profile of the drug suggests a manageable adverse event profile, with the most common events being nausea and headache. Research is continuing to monitor long-term outcomes and safety data.

  • Population Subgroups: Research has explored whether the drug is associated with different outcomes in specific subgroups, such as the elderly or patients with mild renal impairment. Findings were mixed regarding differences in efficacy, and further data collection is necessary to clarify these observations.

Frequently Asked Questions (FAQ)

Common questions about Lertus (FAQ)

Q: Is Lertus generally meant for short-term or long-term use?

A: Official guidance for Lertus, like all Nonsteroidal Anti-inflammatory Drugs (NSAIDs), reflects the general principle of using the lowest effective dosage for the shortest duration necessary to manage symptoms. This regulatory guidance applies whether the medicine is used for acute short-term needs or for chronic conditions.


Q: Why do some people say Lertus made them feel tired?

A: Official regulatory documents that describe side effects often list effects on the nervous system. These documented effects include drowsiness, dizziness, and asthenia (a general lack of energy). While fatigue or tiredness may not be explicitly listed on every label, these are adverse events that can be reported by patients, which may be perceived as tiredness.


Q: Can Lertus be taken at the same time as my daily vitamin or supplement?

A: Official documents detail interactions with specific prescription drug classes and alcohol, but they generally do not list every vitamin or dietary supplement. Regulatory documents recommend reviewing all co-administered products with a healthcare professional.


Q: Is Lertus known to cause any long-term problems?

A: Official regulatory warnings state that the risk of serious side effects, including cardiovascular events, gastrointestinal bleeding, and renal injury (kidney damage), may increase with the duration of use. This regulatory guidance reflects the need to limit duration where feasible.


Q: Are there any specific foods or drinks that should be avoided while taking Lertus?

A: Official regulatory warnings specifically state that alcohol increases the risk of gastrointestinal bleeding and irritation when taken with Lertus. Additionally, specific oral formulations may have product labeling that instructs taking the medicine on an empty stomach.


Q: Can Lertus affect my ability to drive or operate machinery?

A: Regulatory labels state that if side effects such as dizziness, vertigo, drowsiness, or visual disturbances are experienced, activities like driving or operating machinery should be avoided. This is because these effects can temporarily impact the ability to perform tasks requiring focus and quick reaction time.


Q: Do I need to take Lertus with a full meal?

A: Administration requirements for Lertus vary depending on the exact formulation prescribed. Some specific oral formulations may need to be taken on an empty stomach to ensure proper effectiveness. Conversely, other coated tablets may be taken with food to help lessen common stomach upset.


Q: Does Lertus change how my birth control works?

A: Regulatory documents do not state a direct hormonal interaction between Lertus and birth control. However, warnings often contain specific advice regarding potential failure of hormonal contraceptives if severe gastrointestinal side effects, such as vomiting or severe diarrhea, occur.


Q: How long does Lertus stay in my system after the last dose?

A: Official product information includes pharmacokinetic data, which describes how the body processes the medicine. The elimination half-life for the active ingredient is reported in regulatory documents as approximately two hours for the unchanged compound.


Q: Are there different strengths of Lertus available?

A: Regulatory labeling specifies that Lertus is available in multiple strengths and forms to suit various administration needs. These include various doses for immediate-release, delayed-release, and extended-release oral tablets.


Q: Is Lertus a controlled substance or habit-forming?

A: According to official regulatory scheduling systems, the active ingredient in Lertus is not classified as a controlled substance. It is also not considered a medicine that is habit-forming.


Q: Is Lertus available over the counter in some countries?

A: Regulatory agencies in certain regions have reclassified some oral diclofenac tablets from over-the-counter (OTC) status to prescription-only due to cardiovascular risk concerns. However, topical gels for localized use may remain available without a prescription in some locations.


Q: Can Lertus cause any skin reactions or rashes?

A: Official regulatory labeling explicitly warns of a risk for skin reactions and rashes. This includes the potential for rare but serious adverse reactions, such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).


Q: Does Lertus affect blood pressure?

A: Official labeling states that Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including Lertus, can cause new-onset high blood pressure or worsening of existing high blood pressure. Regulatory documents indicate that monitoring of blood pressure may be appropriate during treatment.


Q: Does Lertus have a Pregnancy Category designation?

A: The drug is strictly contraindicated for use during the last trimester of pregnancy (30 weeks gestation and later). Regulatory agencies, such as the Australian TGA, have assigned the drug a Pregnancy Category C.


Q: Are there any warning signs I should look for when starting Lertus?

A: Official regulatory documents describe certain signs of serious adverse reactions, such as symptoms of gastrointestinal bleeding (e.g., bloody or tarry stools) or cardiovascular events (e.g., chest pain, sudden weakness on one side), for which immediate medical attention is necessary.


Q: Why do some people need to have a blood test while on Lertus?

A: Regulatory documents state the drug may cause changes to the liver, kidneys, or blood cells. Monitoring of organ function, such as the liver and kidneys, is outlined in regulatory documents, especially during prolonged administration.


Q: Is Lertus a generic or a brand-name drug?

A: The active ingredient in the medicine, diclofenac, is the generic name. Lertus is a brand name used for a specific product formulation containing the active ingredient diclofenac.


Q: Can Lertus affect my mood or cause nervousness?

A: Adverse event reporting in regulatory documents includes Central Nervous System (CNS) effects. These effects may include anxiety and depression in some formulations, which are related to mood and nervousness.


Q: What kind of evidence is available about the long-term effectiveness of Lertus?

A: Clinical trial data is available from studies that examined the drug's sustained effect in certain patient groups. For example, some Randomized Controlled Trials (RCTs) have reported a reduction in symptoms that was maintained over a study period of up to 12 months.

How should Lertus be stored and disposed of?

Official Storage Requirements

Lertus (Diclofenac) must be stored under Controlled Room Temperature conditions to preserve its chemical stability. The required range is between 20 C and 25 C (68 F and 77 F), with brief deviations permitted between 15 C and 30 C.

  • Environmental Protection: The medicine must be protected from moisture and stored in a tight container. It should be kept in the original packaging and the container must remain tightly closed.
  • Child Safety: It is mandatory to store Lertus out of the sight and reach of children.

Official Disposal Instructions

Unused or expired Lertus must be discarded according to official pharmaceutical waste regulations. Regulatory documents prohibit disposing of the medicine via wastewater (such as flushing down a toilet) or general household trash, as this may pose environmental risks. Patients should return unused medication to a pharmacy or an authorized local drug take-back program.

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

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