Dexonal

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Dexonal

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Treatment option: Pain, Toothache

Medically reviewed

Rosario Oropesa

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 Dexonal

Property Description
Active ingredient Dexketoprofen trometamol
Form Tablet, Oral Solution, Injection/Infusion
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Pain and Inflammation Relief
Origin Synthetic (Chiral Switch product)

What Class of Medicine is Dexonal and What is Its Active Ingredient?

Dexonal is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), with its active chemical substance being Dexketoprofen (specifically the trometamol salt). This synthetic compound belongs to the arylpropionic acid derivative family. This type of compound is clinically recognized for its analgesic efficacy. Dexketoprofen is a distinctive single-isomer product, representing a chiral switch from its parent drug, ketoprofen. It consists solely of the therapeutically effective S-(+) enantiomer, which is isolated to ensure a targeted and potent pharmacological action. This mechanism involves reducing the synthesis of prostaglandins.

General Purpose and Available Preparations

The general purpose of this medicine is to serve as an effective analgesic and anti-inflammatory agent, utilized for the symptomatic relief of various forms of pain in adult patients, such as discomfort following dental procedures or minor injuries. Its mechanism principle is founded on blocking the synthesis of prostaglandins, which are key internal chemicals that transmit pain and cause inflammation. Dexketoprofen is administered as a single-active ingredient product and is available in several pharmaceutical preparations, including the film-coated tablet and the oral solution in a sachet for convenient oral intake. It is also manufactured as a sterile solution for injection/infusion for parenteral administration when an immediate effect is required, offering a distinct and highly flexible means of delivery compared to many standard oral NSAIDs.

What side effects are possible with Dexonal?

Possible Side Effects and Safety Information

The safety profile of Dexonal (dexamethasone) is broadly related to its classification as a potent synthetic glucocorticoid, impacting nearly all body systems. Adverse reactions are frequently dose- and duration-dependent.

Commonly Reported Adverse Reactions

Reactions that are often reported in regulatory documents include alterations in metabolism and fluid balance, such as weight gain, fluid retention (edema), increased blood pressure, and elevated blood sugar levels. Mood and behavioral changes (e.g., euphoria, depression, insomnia) are also commonly cited.

Serious and Clinically Significant Adverse Reactions

Serious risks documented in regulatory sources pertain to: Immunosuppression and Infections (increased susceptibility, masking of signs, reactivation of latent infections); Endocrine Disorders (development of Cushingoid state, adrenal insufficiency after withdrawal); Gastrointestinal Effects (risk of peptic ulcer and perforation, particularly with pre-existing conditions); Musculoskeletal (osteoporosis, muscle weakness, aseptic necrosis); and Ophthalmic Effects (posterior subcapsular cataracts and glaucoma, especially with long-term use). Rare cases of anaphylactoid reactions and venous/arterial thromboembolism have also been reported.

Safety Considerations and Precautions

Specific caution is required in certain populations and contexts. Elderly patients are at a higher risk for more severe consequences of common adverse reactions, such as osteoporosis and hypertension. Pediatric use may be associated with growth suppression; children's growth should be monitored. Corticosteroids may cause fetal harm and appear in breast milk. The drug is generally contraindicated in systemic fungal infections and caution is needed in patients with heart failure, diabetes, and certain gastrointestinal diseases.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information for Dexonal

Overdose with Dexketoprofen, an NSAID, typically presents with non-severe, reversible effects, though severe outcomes are documented. Documented manifestations commonly include nausea, vomiting, epigastric pain, lethargy, drowsiness, headaches, and dizziness.

When to Seek Immediate Medical Help

Urgent medical attention is required upon suspected overdose or the presentation of severe symptoms. Treatment must be immediately discontinued, and professional help sought, at the first signs of severe hypersensitivity reactions (e.g., anaphylactic shock) or gastrointestinal bleeding.

Documented Severe Outcomes and Management

Official labeling describes potential severe outcomes that include acute renal failure, gastrointestinal ulceration or perforation (which may be fatal), and, rarely, seizures or coma. No specific antidote is known for Dexketoprofen overdose. Management is defined as symptomatic and supportive care, with consideration for procedures like activated charcoal or gastric lavage for gastrointestinal decontamination.

Population-Specific Overdose Note

Official documents note that the elderly have an increased frequency of severe adverse reactions to NSAIDs, particularly the risk of gastrointestinal bleeding and perforation.

Therapeutic Uses of Dexonal

Dexonal is commonly used to provide symptomatic relief for symptoms related to physical discomfort and inflammatory states resulting from sudden events or existing conditions. This medication is relevant in clinical settings for easing symptoms of acute pain, musculoskeletal pain, dental pain, and dysmenorrhea. It may provide supportive relief that helps ease the overall symptom burden during episodes of heightened discomfort.


The therapeutic benefit extends to addressing symptoms associated with acute or episodic changes, often used during phases when symptoms become more noticeable. This includes managing intense abdominal cramping linked to painful menstruation and the severe pain of renal colic. It may assist with maintaining a sense of stability when pain symptoms are more disruptive.

“The medication is applied to address symptom clusters that may become intense or disruptive and supports the patient during difficult episodes by easing distress.”

Quick Fact: Relief for Acute Discomfort

This medication is generally applied in contexts where short-term symptomatic assistance is needed, such as managing postoperative discomfort following minor procedures or the pain and swelling from sprains and strains. This support contributes to easing the overall symptom load during symptomatic periods.

Eligibility and Restrictions for Use

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

Dexonal (dexamethasone) use is primarily determined by governmental regulatory labeling, which outlines specific populations who must not use the medicine and others for whom use requires special consideration.


Populations and Conditions for Restricted Use

Classification Eligibility Status Defined by Regulators
Contraindicated Patients with systemic fungal infections, known hypersensitivity to the active substance, uncontrolled psychoses, stomach or duodenal ulcers, and those receiving immunosuppressive doses of corticosteroids who are due to receive live or live attenuated vaccines.
Special Consideration/Cautioned Use Use requires caution and close monitoring in patients with conditions like active or latent peptic ulcers, diverticulitis, severe heart failure, hepatic or renal impairment, and various active infections (e.g., ocular herpes simplex, tuberculosis).

Age, Pregnancy, and Lactation Status

  • Pediatric Use: Safety and efficacy have not been established. Chronic use in children may cause dose-dependent inhibition of growth.
  • Pregnancy: The medicine can cause fetal harm. Females of reproductive potential are advised of the potential risks.
  • Lactation: Systemically administered corticosteroids appear in human milk. Breastfeeding is not recommended during treatment and for a period afterward.

Overall Eligibility Profile: The regulatory profile defines absolute contraindications for life-threatening conditions like systemic fungal infections and restricts use in broad categories of patients with infections, gastrointestinal disorders, and pre-existing psychiatric conditions, requiring careful clinical assessment before administration.

What should I know about interactions with other medicines?

The official regulatory profile for Dexonal (Dexketoprofen) is defined by several interaction classifications based on documented risk. Co-administration with certain products is formally restricted or classified as inadvisable.

Inadvisable Combinations and Exposure Constraints

Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and high-dose Acetylsalicylic acid is inadvisable due to a heightened risk of gastrointestinal adverse events. Use with Lithium and Methotrexate (at doses ge 15mg/week) is also restricted because the medicine can officially lead to elevated plasma concentrations of these agents, increasing the potential for toxicity.

Pharmacodynamic Risk Reinforcement

Other combinations require precaution due to Pharmacodynamic Risk Reinforcement. This includes agents that affect blood clotting, such as Anticoagulants (Warfarin, Heparin) and Anti-platelet agents, due to an increased risk of bleeding. Caution is also noted when co-administered with Oral Corticosteroids (increased GI risk) and Diuretics or ACE Inhibitors, as the regulatory profile notes a potential reduction in the antihypertensive effect of these agents. The risk of nephrotoxicity is officially increased when Dexonal is used with Cyclosporin or Tacrolimus.

Timing and Population Notes

Specific constraints exist for certain populations and administration timing. In elderly patients, the risk and severity of interactions, particularly GI complications with co-administered medicines, are documented as increased. Furthermore, because co-administration with food delays the drug's absorption rate, the official recommendation for the oral solution and granules is to administer the product at least 15 minutes before meals when treating acute pain.

Mechanism of Action

Targeted Inhibition of the Eicosanoid Pathway

The S-(+) enantiomer of Dexketoprofen acts as a reversible inhibitor of the Cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This action directly prevents the conversion of Arachidonic Acid into prostaglandins ( PGE2) and other eicosanoids. This targeted inhibition is the fundamental step in the mechanistic cascade, suppressing the synthesis of prostaglandins and other inflammatory eicosanoids throughout the body.


Modulation of Nociceptive and Systemic Signaling

The resulting reduction in prostaglandin levels causes a decrease in the sensitization of peripheral nerve endings (nociceptors) at the site of injury. Furthermore, this suppression dampens the production of mediators that increase vascular permeability and fluid accumulation. This physiological change, coupled with the inhibition of PGE2 synthesis in the hypothalamus, results in the resetting of the body's thermoregulation set point. The high solubility of the trometamol salt contributes to the rapid rate at which this molecular action commences.

Dosage and Administration Information

The administration of Dexonal is defined by clinical guidelines detailing the route, dose limits, and duration of use. The medicine is authorized for both oral intake as film-coated tablets or granules and parenteral delivery via intramuscular (IM) injection or intravenous (IV) infusion, offering delivery flexibility based on the acute need.


Official Administration Guidelines

Parameter Official Instruction
Route of administration Oral (tablet, granules) and Parenteral (IM injection, IV bolus, or infusion).
Standard Dosing The typical oral dose is 25 mg every eight hours. The parenteral dose is 50 mg, administered every eight to twelve hours.
Maximum Daily Limits The total daily dose is strictly limited to 75 mg for oral use and 150 mg for parenteral use.
Administration Timing Oral forms for acute symptoms are recommended to be taken 15 to 30 minutes before meals to optimize absorption kinetics.
Duration Limitation The drug is intended only for short-term use. Parenteral administration is limited to a maximum of two days of therapy.

Procedural Rules for Specific Populations

Instructions mandate specific dose adjustments for certain patient groups. Individuals classified as older adults or those with mild hepatic or renal impairment are typically started on a reduced total daily dose of 50 mg. Furthermore, the medicine is not established for use in pediatric patients.

When administering the injectable form, an IV bolus must be delivered over no less than 15 seconds, while an IV infusion requires dilution and a slow administration period of 10 to 30 minutes. These guidelines define the protocol for administering the drug correctly according to established standards.

Recent Clinical Evidence

Research evidence / Overview of Studies for Dexonal

Evidence for Use in Acute Pain Models: Dental and Postoperative Settings

Clinical evaluation of Dexonal (Dexketoprofen trometamol) focused on research exploring short-term symptom changes in acute settings. These areas include conditions associated with acute or disruptive episodes, such as pain after minor surgical procedures. Both the oral tablet and the injectable/infusion forms were studied for this indication.

For acute pain models, such as those established after wisdom tooth removal, trials primarily utilize short-term Randomized Controlled Trials (RCTs). These studies examine patient-reported outcomes describing perceived discomfort. Studies report measured patterns of rescue medication usage compared to placebo. However, the results apply only to the populations studied, and long-term effects are not fully established since follow-up durations were limited.

The parenteral (injection/infusion) formulation was studied for use after various general and orthopaedic surgical procedures. Studies monitored the pattern of concomitant opioid medications required in the immediate recovery phase. These findings help contextualize how patients reported their experience during periods of increased symptom activity, but the majority of this evidence is concentrated on the immediate 24 to 48 hours following surgery.

Evidence for Use in Episodic Pain: Menstrual Pain and Musculoskeletal Injury

Research explored conditions characterized by fluctuating or episodic manifestations, particularly those involving periods of heightened symptoms that are temporary or cyclical.

  • Research Focus: Management of Primary Dysmenorrhea

    The oral formulation was evaluated in women experiencing symptoms of primary dysmenorrhea (painful menstruation). Research describes changes in pain intensity measurements observed during the acute symptomatic episode. Evidence for the parenteral (injectable) formulation is limited.

  • Research Focus: Short-Term Musculoskeletal Pain

    For acute conditions associated with functional limitations, such as low back pain or strains, research examined outcomes related to physical discomfort and functional status. Data show measured patterns related to outcomes compared to both placebo and other analgesics. The evidence quality varies across studies, and there is limited information for long-term outcomes.

Research in Specific Patient Groups and Populations

The core research base for Dexonal primarily involves adults. Data for certain groups remain insufficient. For instance, subgroup findings are uncertain or limited for populations such as children and adolescents, and individuals over 75 years of age. The research is ongoing, but studies focusing on these groups are less common, meaning the results apply only to the populations studied and do not determine whether an individual outside the primary research group will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Dexonal (FAQ)

Q: How is Dexonal different from other common treatments for the same condition?

According to official information, Dexonal is manufactured as a single-isomer product, which is based on the therapeutically effective form of the drug.

Studies and official information indicate that this type of formulation may support pain relief using a lower dose, and regulatory studies have examined a potentially different profile of adverse effects compared to the parent drug.


Q: How quickly does the effect of Dexonal begin after taking a dose?

Regulatory documents state that the medicine is formulated for rapid absorption by the body.

Because of this, the onset of the pain-relieving effect may begin rapidly after taking the oral form, with maximum concentrations typically reached within 15 to 30 minutes.


Q: How long does the therapeutic effect of one dose of Dexonal typically last?

According to the official product information, the analgesic (pain-relieving) effect of a single oral dose typically persists for 4 to 6 hours.

This duration is consistent with the drug's short elimination half-life, meaning the drug is cleared from the body relatively quickly.


Q: What does 'contraindicated' actually mean for this specific medicine?

In official documents, 'contraindicated' is defined as the strongest safety warning, and regulatory documents define this as a state in which the medicine should generally not be used in certain circumstances.

It is determined that the risks of using the medicine in those listed situations, such as systemic fungal infections or active stomach ulcers, typically outweigh the potential benefits.


Q: Is it normal to feel unusual fatigue when first starting Dexonal?

Official product information describes drowsiness (also called somnolence) as a common side effect affecting the nervous system.

Fatigue, described as a feeling of unusual tiredness, is listed as a less frequent or uncommon adverse effect in regulatory documents.


Q: Is it safe to consume alcohol while taking Dexonal?

Official information states that consuming alcohol is not recommended while taking this type of medicine (NSAIDs).

Combining alcohol with NSAIDs may increase the risk of serious side effects, most notably gastrointestinal bleeding.


Q: Does Dexonal cause problems with concentration or memory?

Official information notes that trouble concentrating is listed as a less common adverse effect.

Additionally, other changes affecting the nervous system, such as drowsiness and insomnia, are reported as common side effects.


Q: Is there information about Dexonal affecting fertility?

Yes, official regulatory documents provide information about this potential effect.

Dexonal is a prostaglandin synthesis inhibitor, and it is officially recognized that this mechanism may impair female fertility. For this reason, the medicine is generally not advised for use by women who are actively attempting to conceive.


Q: What is the listed information regarding accidental overdose of Dexonal?

Information regarding accidental overdose describes symptoms often focused on the gastrointestinal system, such as nausea, vomiting, or stomach pain, and the central nervous system, including drowsiness or confusion.

The official guidance from regulatory sources is to seek immediate medical assistance or contact a poison control center if an accidental overdose is suspected.


Q: Can the tablets or capsules of Dexonal be split or crushed?

The oral form of Dexonal is manufactured as a film-coated tablet intended to be swallowed with a sufficient amount of fluid.

The official prescribing information details the method of administration but does not include instructions that describe splitting or crushing the tablets.


Q: Does Dexonal have the potential to be habit-forming?

Official regulatory information indicates that no habit-forming tendencies have been reported for this medicine.

It is not listed as a controlled substance in official documents.

How should Dexonal be stored and disposed of?

Storage and Disposal Requirements

Dexonal (dexketoprofen trometamol) must be stored according to its specific preparation. The product must be kept out of the sight and reach of children.


Storage Conditions

Preparation Temperature and Protection
Tablets/Oral Solution Store below 30 C. Protect from light and moisture. Store in original packaging.
Injection/Infusion Store unopened below 25 C in the outer carton. Diluted solution must be used immediately or within 24 hours at 2 C to 8 C.

Disposal

Unused or expired product must be disposed of in accordance with local requirements. The medicine should not be discarded into household waste or wastewater, but through established collection systems for pharmaceutical waste.

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

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