Delfos

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Delfos

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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 Delfos

Property Description
Active ingredient Nimesulide
Form Tablet, Capsule, Granules, Topical Gel, Suppository
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Pain relief, inflammation reduction, fever reduction
Origin Synthetic organic compound (Sulfonanilide class)

What Type of Medicine is Delfos?

Delfos is the commercial designation for the active substance Nimesulide, which is broadly classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Nimesulide is a synthetic organic compound with a sulfonanilide structure, chemically distinguishing it from many older NSAIDs. Its pharmacological function is that of a Cyclooxygenase-2 (COX-2) selective inhibitor, meaning it preferentially targets the enzyme responsible for initiating acute pain and inflammatory signals. Delfos is a monotherapy, containing only this single active component.


Active Ingredient and Available Forms

The sole active ingredient in Delfos is Nimesulide, supplied in various pharmaceutical preparations to ensure flexible routes of administration. These forms include oral options such as tablets and powdered granules for oral suspension, as well as specialized formulations like topical gel for localized application, and suppositories for rectal administration. The availability of multiple forms allows the drug to be used either systemically or locally to target a specific area of discomfort.


What is the General Purpose of Nimesulide?

The core purpose of Nimesulide is to offer reliable symptomatic relief by modulating the body's inflammatory response. The drug achieves this by inhibiting the synthesis of prostaglandins, the chemical mediators that are responsible for signaling pain and inducing fever. This action translates directly into three essential physiological actions: it functions as a pain reliever (analgesic), a swelling reducer (anti-inflammatory), and a fever reducer (antipyretic). It is typically employed in scenarios where immediate relief from acute, inflammation-driven discomfort is necessary.

Regulatory References

  1. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - StatPearls - NCBI Bookshelf
  2. COX Inhibitors - StatPearls - NCBI Bookshelf
  3. Nimesulide - referral | European Medicines Agency (EMA)
  4. Pain Management Medications - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Delfos?

Serious and Clinically Significant Safety Information (Boxed Warning)

As a fluoroquinolone antimicrobial, Delfos carries a Boxed Warning—the strongest safety warning required by the FDA—due to the risk of serious, disabling, and potentially permanent adverse reactions affecting multiple body systems. These serious adverse reactions can occur together in the same patient and include:

  • Tendinitis and Tendon Rupture: Risk of swelling or tearing of the tendons, most commonly the Achilles tendon. This risk is elevated in patients over 60, those taking corticosteroids, or those with solid-organ transplants.
  • Peripheral Neuropathy: Nerve damage (peripheral neuropathy) leading to symptoms such as pain, burning, tingling, numbness, or weakness in the arms or legs.
  • Central Nervous System (CNS) Effects: Reactions including hallucinations, anxiety, depression, insomnia, severe confusion, and, rarely, suicidal thoughts or acts.
  • Exacerbation of Myasthenia Gravis: Use is contraindicated in patients with a history of Myasthenia Gravis due to the potential for worsening muscle weakness.

Regulatory Limitations on Use

Due to the risks of these serious adverse reactions, regulatory authorities advise reserving Delfos for use in patients who have no other available treatment options for certain uncomplicated infections (e.g., acute bacterial sinusitis or uncomplicated urinary tract infections).

Other Documented Adverse Reactions

In clinical trials, the most common (ge 1/100 to <1/10) adverse reactions reported were within the Gastrointestinal disorders system-organ class, including Nausea and Diarrhea.

Uncommon side effects (including lab abnormalities) include increased liver enzymes (ALT/AST) and Creatinine Phosphokinase, which may indicate potential hepatic or muscle damage. Other documented risks for the class include Aortic Aneurysm and Dissection in high-risk populations, QT interval prolongation (a risk for abnormal heart rhythm), and blood glucose disturbances (hypoglycemia and hyperglycemia).

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Delfos (Nimesulide)

Overdose manifestations of Nimesulide are documented in official regulatory labeling. Symptoms following acute ingestion are typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain. These acute presentations involving the gastrointestinal and central nervous systems are generally reversible with medical attention.


Immediate Actions and Severe Outcomes

The regulatory documents for Nimesulide state explicitly that no specific antidotes are known for overdose. Management is therefore restricted to symptomatic and supportive care aimed at managing the manifestations and stabilizing the patient. Urgent medical help is required for any ingestion beyond the recommended dose, especially if symptoms progress. Although rare, overdose may lead to serious systemic and organ outcomes, including gastrointestinal bleeding, acute renal failure, hypertension, respiratory depression, and coma.


Regulatory Trigger for Help

Medical attention must be sought immediately if any symptoms compatible with hepatic injury develop, such as anorexia, abdominal pain, fatigue, or dark urine. Official guidance mandates that treatment be discontinued instantly if signs of liver toxicity or abnormal liver function tests appear, as the official protocol prohibits re-challenging the patient with the medicine. This immediate cessation is an explicitly required emergency action.

Therapeutic Uses of Delfos

Delfos (Nimesulide) is commonly used across domains where additional symptomatic support is needed, relevant in clinical settings marked by increased discomfort or tension. This medication is applicable within clinical settings that involve acute or disruptive symptom patterns.

It is relevant for the management of symptoms related to acute pain, painful osteoarthritis, and primary dysmenorrhoea. It is used for managing symptom clusters that may become intense or disruptive, including symptoms related to inflammatory or irritative states such as swelling following soft tissue injuries (like sprains or strains), and heightened discomfort from menstrual cramping. It is often used during phases when symptoms become more noticeable, contributing to easing the overall symptom load.


Quick Fact: Symptomatic Relief Domains

Delfos is applied in addressing symptoms related to heightened physiological activity, supporting patients during difficult episodes by providing supportive relief. It is relevant in contexts involving heightened systemic burden, such as those that present with both pain and fever, and may assist with managing pronounced symptom manifestations.

Regulatory References

  1. European Medicines Agency (EMA) on Nimesulide

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Delfos, which contains the active ingredient Nimesulide, has eligibility strictly defined by regulatory authorities due to specific risks, primarily concerning the liver. The medicine is primarily allowed for use in adolescents and adults aged 12 years and older.


Populations Absolutely Prohibited (Contraindicated)

Official labeling mandates that Delfos must not be used in the following groups:

  • Age Restriction: Children under 12 years of age.
  • Hepatic Risk: Patients with any form of hepatic impairment (liver disease) or a history of liver reactions to nimesulide.
  • Gastrointestinal/Bleeding: Individuals with an active ulcer, gastrointestinal bleeding, severe coagulation disorders, or active bleeding (e.g., cerebrovascular bleeding).
  • Allergy: Patients with a known allergy to nimesulide or a history of reactions (like asthma or hives) to aspirin or other NSAIDs.
  • Cardio/Renal: Patients with severe heart failure or severe renal impairment (creatinine clearance < 30 ml/min).
  • Reproductive Status: Women in the third trimester of pregnancy or who are breastfeeding.

Conditional and Restricted Use

  • Pregnancy: Use is not recommended during the first two trimesters of pregnancy or for women attempting to conceive.
  • Older Adults: Appropriate clinical monitoring is advised for older adults due to susceptibility to adverse effects.
  • Mild Impairment: Patients with mild to moderate renal impairment are generally allowed use without dosage adjustment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory profile for Delfos (Nimesulide) interactions is defined by documented pharmacokinetic and pharmacodynamic effects, leading to specific regulatory constraints on co-administration.

Restrictions and Contraindicated Combinations

Interacting Substance/Class Official Regulatory Constraint
Oral Anticoagulants (e.g., Warfarin) and Aspirin Not recommended due to documented additive risk of bleeding complications.
Other NSAIDs Simultaneous use is generally not recommended.
Alcohol / Hepatotoxic Substances Must be avoided due to heightened risk of serious hepatic reactions.

Pharmacokinetic and Exposure Interactions

Delfos is officially documented as a moderate inhibitor of the CYP2C9 enzyme. This mechanism can lead to an increase in the plasma concentrations of co-administered drugs metabolized by this pathway.

  • Lithium: Co-administration reduces the renal clearance of Lithium, potentially causing elevated plasma Lithium levels and increased toxicity.
  • Methotrexate: The risk of increased serum levels is noted if Delfos is administered less than 24 hours before or after Methotrexate treatment.

Pharmacodynamic Effects

  • Diuretics (e.g., Furosemide): Nimesulide reduces the diuretic response. This combination requires specific caution in patients with renal or cardiac impairment due to the risk of renal function deterioration.

Mechanism of Action

The mechanism of action for Delfos (Nimesulide) operates through precise molecular targeting to modulate specific physiological responses involving eicosanoid and cellular inflammatory signaling.


Targeted Inhibition of Prostaglandin Synthesis

This domain covers the drug’s primary action: the preferential inhibition of the Cyclooxygenase-2 (COX-2) enzyme. By blocking this key molecular target, the drug significantly limits the synthesis of Prostaglandins, which are chemical mediators mediating inflammatory and nociceptive signaling.


Modulation of Nociceptive and Thermoregulatory Pathways

The reduction of Prostaglandins has a dual effect on key systems. Peripherally, it decreases the sensitization of nociceptors (pain-sensing neurons); centrally, it allows for the chemical resetting of a pathologically elevated core body temperature. This process leads to the reduction of signal transmission intensity within nociceptive pathways and the adjustment of the central thermoregulatory set-point.


Complementary Cellular and Oxidative Modulation

Beyond the primary target, the drug engages secondary, non-Prostaglandin mechanisms that contribute to the drug's overall pharmacodynamic profile. This involves the modulation of the Myeloperoxidase enzyme and a reduction in the migration of immune cells into affected tissue. These complementary actions reduce the generation of reactive oxygen species and inhibit the migration of leukocytes into the tissue.

Dosage and Administration Information

The use of Delfos (Nimesulide) is governed by administration guidelines that specify the correct route, dosage, frequency, and duration of the short-term systemic course.

The medicine is available for systemic use via oral forms (tablets, granules) or rectal suppositories, and for local use as a topical gel. The standard systemic dose for adults is 100 mg, administered twice daily. The maximum recommended systemic daily dose is 200 mg.

For proper administration, oral forms must be taken after meals. The systemic treatment duration is strictly limited to the shortest possible time, with a maximum limit of 15 consecutive days. The treatment must be discontinued immediately if no benefit is observed. Topical gel is applied two to three times daily and massaged into the skin; the gel must never be taken by mouth.

Dosing is generally uniform across certain populations; no dose adjustment is required for adolescents (12–18 years) or older adults. Additionally, no adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance 30–80 ml/min).

Recent Clinical Evidence

Research evidence / Overview of Studies for Delfos

Delfos (Nimesulide) was evaluated in numerous clinical trials, particularly Randomized Controlled Trials (RCTs), to understand the outcomes measured in relation to different types of short-term pain and inflammatory conditions. The research helps contextualize how patients reported their experience and provides insight into short-term changes in symptoms.


Evidence for Use in Acute Pain

Research was studied for clinical contexts involving acute or disruptive episodes of pain, such as pain following orthopedic or dental surgery, and discomfort from soft tissue injuries. The primary study designs used in research exploring how symptoms change over time are short-term RCTs, which compare the medicine against a placebo or other standard pain relievers.

Research monitored outcomes related to physical discomfort and measures of daily functioning. Findings describe patterns observed in the studied populations, which typically included adults and adolescents (age 12 and above). These studies reported how symptoms evolved in the observed populations and tracked measurements of pain intensity changes using standardized tools, indicating that measurements of physical discomfort were a key focus of the research.


Evidence for Primary Dysmenorrhoea

The medicine was studied for outcomes related to primary dysmenorrhoea (menstrual pain) in multiple Randomized Controlled Trials and subsequent systematic reviews. These studies examined outcomes describing episodic or acute changes in pain intensity that are characteristic of this condition. The study populations primarily included adult and adolescent women experiencing this type of pain.

Research focused on episodes where symptoms become more noticeable, specifically monitoring patient-reported outcomes describing perceived discomfort during the menstrual cycle. Findings describe patterns observed in the studies, where research highlights changes measured during the study period within the short-term treatment window.


Research Structure for Painful Osteoarthritis Episodes

Research has explored the role of the medicine in the symptomatic management of painful osteoarthritis episodes, a condition characterized by functional limitations and periods of heightened symptom activity. The studies included in the regulatory review, which focused on monitoring symptomatic outcomes, primarily involved adult populations.

Research examined outcomes related to daily functioning or activity level and changes in pain scores. Findings describe patterns observed in the studies related to outcomes reflecting daily functioning. Current evidence applies strictly to short-term symptomatic relief only.


Uncertainty and Research Gaps in the Evidence

Information regarding long-term outcomes remains insufficient or not fully established by the existing controlled trial structure, as the research base is strictly limited to short-term findings. The research base does not contain studies evaluating use as a maintenance therapy for chronic conditions. Furthermore, the research structure does not contain extensive comparative evidence across all short-term uses. The results apply only to the populations studied, and evidence quality varies across studies when evaluating certain subgroups.

Key Studies & References Nonsteroidal anti-inflammatory drugs for primary dysmenorrhoea (Cochrane Review/Meta-analysis)

Frequently Asked Questions (FAQ)

Common questions about Delfos (FAQ)


Q: How quickly should someone expect Delfos to start working?

A: Studies and official product information indicate that Nimesulide, the active ingredient in Delfos, has a relatively rapid onset of action. Studies have observed pain reductions within 15 minutes following oral administration of the medicine.


Q: What is the total duration of effect for a typical dose of Delfos?

A: Regulatory information in the pharmacokinetics section describes how the medicine is processed by the body. The elimination half-life of Nimesulide is noted to be approximately 1.8 to 4.7 hours. This measure indicates the time it takes for the concentration of the substance in the body to decrease by half.


Q: Does Delfos have a generic version available?

A: Nimesulide is the active substance in Delfos, and it is available under various trade names, including generic medicines, in countries where it is authorized. Official registries show that the active ingredient itself is widely used.


Q: Is Delfos considered a high-risk medication?

A: Regulatory authorities have mandated restrictions on the use and duration of Nimesulide due to the risk of serious side effects, particularly concerning the liver. Due to these risks, regulatory mandates exist to ensure the medicine is only used for a limited time and at appropriate levels to minimize potential harm.


Q: Is it common for Delfos to cause drowsiness or fatigue?

A: Regulatory documents list side effects such as drowsiness, somnolence (sleepiness), and fatigue as potential adverse reactions associated with the use of Nimesulide. While these effects are documented, their frequency may be uncommon or linked to higher doses.


Q: If I miss a dose of Delfos, what is the usual recommendation?

A: Official patient information often contains specific instructions regarding what to do in the event of a missed dose. These instructions typically advise against taking a double dose to compensate for one that was missed, focusing instead on returning to the regular dosing schedule.


Q: What happens if someone accidentally takes too much Delfos?

A: In cases of acute overdose with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), symptoms described often include lethargy, drowsiness, nausea, vomiting, and stomach pain. Official overdose sections indicate these effects are generally reversible with supportive care.


Q: Is Delfos a scheduled or controlled substance?

A: Delfos is a Non-Steroidal Anti-Inflammatory Drug (NSAID) and is classified as a prescription-only medicine (Rx) in countries where it is approved. It is not generally categorized as a controlled or scheduled substance.


Q: Where can I find the official prescribing information for Delfos?

A: The comprehensive official prescribing information for Nimesulide (Delfos) is contained in documents like the Summary of Product Characteristics (SmPC). This information is published by regulatory bodies such as the European Medicines Agency (EMA) and similar national health authorities.


Q: Is it normal to feel a change in appetite while using Delfos?

A: Regulatory documents list a symptom called anorexia (loss of appetite) as a potential adverse reaction. Official documentation notes that this symptom may be associated with the risk of serious hepatic reactions.


Q: Why do official documents emphasize the importance of using Delfos exactly as described?

A: The official documentation emphasizes using the medicine according to specific rules for duration and amount. This restriction exists because adhering to short-term use is associated with a reduced risk of undesirable effects, particularly serious reactions to the liver.


Q: Can Delfos be crushed or split if someone has trouble swallowing pills?

A: Official patient information describes the tablet form as needing to be swallowed whole; crushing, breaking, or chewing is not indicated. If difficulty swallowing is a concern, other available forms of the medicine, such as granules for oral suspension, may be considered.


Q: Why is Delfos sometimes referred to by a different name in other countries?

A: Nimesulide is the chemical name for the active substance in Delfos. Because the name 'Delfos' is a commercial brand, the medicine is marketed under many different and unique brand names in various international markets.


Q: How soon after stopping Delfos can I take interacting medications?

A: Regulatory documents provide specific guidance for highly interacting drugs. For example, regarding Methotrexate, there is a known risk if Nimesulide is given less than 24 hours before or after the interacting medicine. This time frame relates to preventing increased levels of Methotrexate in the blood.


Q: How does Delfos fit into the overall treatment guidelines for the condition it addresses?

A: Due to its safety profile, regulatory authorities have restricted the use of Nimesulide (Delfos) to be a second-line treatment. This means it is generally reserved for use only when at least one other medicine for the approved condition has proven ineffective.


Q: Are there any special warnings about driving or operating machinery while on Delfos?

A: Official product information includes a warning that if patients experience side effects such as dizziness, vertigo, or somnolence (drowsiness), caution should be exercised regarding driving or operating machinery. This precaution is related to the potential effects on the nervous system.


Q: Is Delfos a new medication or has it been used for many years?

A: The active substance, Nimesulide, is not a new compound. The first marketing authorization for Nimesulide was approved in Italy in 1985, indicating it has been available for clinical use for many years.

How should Delfos be stored and disposed of?

Storage Conditions

Official regulatory documents require that Delfos (Nimesulide) be stored at a temperature not exceeding 30 C in a cool and dry place. The medicine must be protected from direct light and moisture to ensure stability throughout its labeled shelf life. It is mandatory to store the product in its original container with the closure kept tightly closed.

Child Safety and Disposal

In line with official labeling, Delfos must be stored out of the reach and sight of children to prevent accidental exposure. When discarding unused or expired product, disposal must be done in accordance with local requirements for pharmaceutical waste. Regulators advise that the product should not be released into the environment and that disposal should avoid sewers and public waters.

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

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