Diclofenac AL

Diclofenac

Method of action: Analgesic, Analgesic Local, Analgetic, Anti-Inflammatory, Antiplatelet, Antipyretic, Antirheumatic, Decongestant, Nonsteroidal Anti-Inflammatory, Ophthalmologicals

Treatment option: Ankylosing Spondylitis, Backache, Pain, Bursitis, Headache, Influenza, Dysmenorrhea, Biliary Colic, Toothache, Colic

Medically reviewed

Marina Burgos

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 Diclofenac AL

Diclofenac AL is a preparation whose active component is the substance Diclofenac, a compound primarily classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Its identity is defined by its synthetic origin and its fundamental mechanism, which targets the source of discomfort and swelling.

Quick Facts: Diclofenac AL Identity

Property	Description
Active ingredient	Diclofenac (typically as sodium or potassium salt)
Pharmacological class	Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common form examples	Tablet, Capsule, Gel, Suppository
General purpose	Relief from pain, inflammation, and fever
Origin	Synthetic

What Type of Medicine is Diclofenac AL?

Diclofenac AL is a medicinal preparation whose active ingredient, Diclofenac, belongs to the widely recognized Non-Steroidal Anti-Inflammatory Drug (NSAID) class. It is a synthetically derived substance, specifically a phenylacetic acid derivative, which is clinically recognized for its effectiveness in modifying the body's response to discomfort. Diclofenac is used to reduce swelling and pain, and to lower fever. The "AL" portion often serves as a specific brand designation for a manufacturer, distinguishing it within the global market of Diclofenac preparations. It is a single-ingredient product, focusing exclusively on the pharmacological profile of Diclofenac.

Diclofenac's Action and General Therapeutic Purpose

The general purpose of Diclofenac AL is to provide relief from pain and reduce the swelling and discomfort caused by inflammation, such as that experienced during a musculoskeletal strain. It achieves this by acting as a Cyclooxygenase Inhibitor, which means it limits the production of prostaglandins—key biochemical compounds in the body responsible for signaling pain and regulating inflammatory responses. Diclofenac exhibits anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) activities. These primary general benefits provide symptomatic relief at the site of inflammation.

Available Forms of the Diclofenac Preparation

The substance Diclofenac is formulated into multiple dosage forms to accommodate various routes of administration, including oral, topical, and injectable paths. Common available forms include oral tablets (often with enteric-coated or extended-release properties), capsules, and preparations for localized external use, such as gels and topical patches. This versatility ensures the compound can be delivered effectively, whether for a widespread condition requiring systemic absorption or for a focused issue requiring targeted delivery to a specific area.

Regulatory References

MedlinePlus Drug Information for Diclofenac

What side effects are possible with Diclofenac AL?

Possible Side Effects and Safety Information

The safety profile of this medicine is defined by specific risks and regulatory restrictions documented by authoritative government bodies.

Serious and Clinically Significant Risks

Official regulatory documents emphasize two major risks through warnings that detail the potential for serious adverse events.

Cardiovascular Thrombotic Events: The medicine is associated with an increased risk of serious, potentially fatal cardiovascular thrombotic events, including myocardial infarction (MI) and stroke. This risk may increase with higher doses (such as 150 mg/day) and prolonged use. It is formally contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery and in patients with established severe heart disease (e.g., NYHA Class II-IV heart failure).
Serious Gastrointestinal (GI) Events: The drug can cause serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. This risk can occur at any time during use without warning symptoms.

Common Adverse Reactions

Side effects that are common or uncommon include gastrointestinal disturbances (such as nausea, vomiting, dyspepsia, and abdominal pain), headache, dizziness, and mild skin rash.

Population and Exposure Restrictions

Specific restrictions and contraindications apply to limit use in high-risk groups:

Pregnancy: The medicine is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus.
Dose and Duration: To mitigate the documented cardiovascular and gastrointestinal risks, regulatory guidance specifies using the lowest effective dose for the shortest duration possible.

Other Systemic Adverse Reactions

Other serious, though less frequent, adverse reactions involve systemic toxicity, including severe liver reactions (hepatotoxicity), kidney injury, and severe cutaneous reactions (e.g., Stevens-Johnson syndrome). Use is contraindicated in patients with a history of allergic-type reactions (e.g., asthma, hives) to aspirin or other NSAIDs.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory information emphasizes that a Diclofenac overdose can lead to serious outcomes, and seeking immediate medical help right away is required. The consequences of overdose are documented as generally more serious in the elderly.

Officially Documented Overdose Manifestations

The following clinical presentations are cited in official prescribing information:

System	Manifestations Listed in Labeling
Gastrointestinal	Nausea, Vomiting (potentially with blood), Diarrhea, and Epigastric pain.
Nervous System	Dizziness, Drowsiness, Confusion, Headache, and Seizures or Coma in severe ingestions.
Renal/Urinary	Little or no urine output, indicating Acute Renal Failure.
Cardiovascular	High or low blood pressure, Increased heart rate, and Shock.

Required Emergency Action

Call your local emergency number (such as 911) or Poison Control Center immediately if an overdose is suspected. Urgent medical attention is mandatory for severe or life-threatening symptoms, which include: loss of consciousness, signs of gastrointestinal bleeding (e.g., bloody or tarry stools), acute breathing difficulty, or convulsions.

Management and Antidote Status

There is no specific antidote known for Diclofenac overdose. Management is symptomatic and supportive, and may include procedures like monitoring of vital signs, administration of activated charcoal, and, in severe cases, specialized hospital procedures such as endoscopy or dialysis to manage organ damage.

Therapeutic Uses of Diclofenac AL

Diclofenac AL: Primary Uses

Quick Facts: What Diclofenac AL is used for

Helps relieve signs and symptoms of osteoarthritis.
Aids in managing symptoms of rheumatoid arthritis.
Assists with acute and long-term relief of symptoms associated with ankylosing spondylitis.
May help manage mild to moderate pain and inflammation.

Diclofenac AL is indicated for the management of pain and inflammation related to various conditions. It is commonly used to address the symptoms of inflammatory joint disorders, including both osteoarthritis and rheumatoid arthritis. The medication aims to help reduce the signs and symptoms associated with these chronic conditions, such as joint discomfort, stiffness, and swelling.

The treatment can be utilized for the symptomatic relief of ankylosing spondylitis, a form of arthritis that impacts the spine. Furthermore, Diclofenac AL may be appropriate for addressing a range of general mild to moderate painful and inflammatory states. The specific therapeutic goals and treatment duration are determined by a healthcare provider.

Eligibility and Restrictions for Use

Official Eligibility Rules for Diclofenac

Diclofenac AL (Diclofenac) is governed by strict population eligibility rules as documented in regulatory labeling.

Classification	Population/Condition
Absolute Contraindication	Known hypersensitivity to diclofenac or other NSAIDs/aspirin.
Absolute Contraindication	Active gastrointestinal bleeding, ulceration, or perforation.
Absolute Contraindication	Established ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or congestive heart failure (NYHA Class II–IV).
Absolute Contraindication	In the setting of Coronary Artery Bypass Graft (CABG) surgery.
Absolute Contraindication	Third trimester of pregnancy (after 30 weeks gestation).
Restricted Use	Pregnancy (20–30 weeks gestation): Avoided unless essential, due to risk of fetal renal dysfunction.
Restricted Use	Severe Organ Impairment: Contraindicated in severe hepatic or renal failure; use with caution in mild to moderate impairment.
Age Restriction	Children under 14 years: Use is generally not recommended or not established for systemic formulations.
Age Consideration	Older Adults (Geriatric): Use requires caution due to increased risk of serious gastrointestinal or renal events.

Diclofenac AL is generally intended for use by adults who do not possess any of the contraindicating conditions. The official regulatory guidelines explicitly prohibit its use in individuals with serious established cardiovascular disease or during late-stage pregnancy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Diclofenac is formally documented by regulatory authorities, focusing on pharmacokinetic and pharmacodynamic risks. Co-administration is contraindicated with other systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including aspirin, due to the high risk of severe gastrointestinal adverse events. Use is also prohibited for treating perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Diclofenac co-administration with CYP2C9 inhibitors, such as Voriconazole, may significantly increase Diclofenac's systemic exposure (AUC and Cmax) due to reduced metabolic clearance. Pharmacodynamic interactions can increase serious bleeding risk when combined with Anticoagulants (e.g., Warfarin), Antiplatelet Agents, or Selective Serotonin Reuptake Inhibitors (SSRIs).

Furthermore, Diclofenac may diminish the therapeutic effect of Diuretics and ACE Inhibitors/ARBs and increase the risk of renal function deterioration. It can also elevate the plasma levels of co-administered Lithium and Methotrexate by reducing their renal clearance. Official warnings note that concomitant use with alcohol and tobacco smoking increases the risk of serious gastrointestinal problems. Elderly patients are at an increased risk of serious adverse events from these interactions.

Mechanism of Action

How Diclofenac AL Works: Mechanism of Action

Non-Selective COX Inhibition and Prostaglandin Suppression

Diclofenac AL functions as a non-selective inhibitor of the Cyclooxygenase ( COX-1 and COX-2) enzymes, which catalyze a critical step in the arachidonic acid cascade. By binding reversibly to these enzymes, the drug prevents the conversion of arachidonic acid into eicosanoid mediators, primarily prostaglandins (like PGE2).

Modulation of Nociceptive and Vascular Signaling

The resulting reduction in prostaglandin synthesis decreases the chemical sensitization of peripheral nociceptors and alters local physiological responses such as vasodilation and increased vascular permeability. The mechanism modifies prostaglandin-driven processes that regulate local fluid accumulation and signal transmission in peripheral tissues.

Alteration of Systemic Thermoregulatory Mechanisms

Prostaglandin synthesis is also suppressed within the central nervous system, specifically the hypothalamus. Limiting PGE2 production in this area alters the feedback mechanisms that govern the body's thermoregulatory set point.

Dosage and Administration Information

How to Use Diclofenac AL

Administration of Diclofenac AL is governed by specific instructions concerning route, dosage limits, and timing. The medicine is utilized via multiple approved administration routes, including oral tablets, topical applications (gels), rectal suppositories, and parenteral injections. The choice of route is determined by the specific formulation being used.

The dosing schedule for oral use adheres to a strict maximum limit. The total daily oral intake for adults should generally not exceed 150 mg. Standard oral maintenance dosing often falls in the range of 100 mg to 150 mg per day, typically divided into two or three doses for non-extended-release forms. Extended-release formulations are generally administered once daily.

Procedural Instruction	Administration Principle
Form Integrity	Delayed-release and extended-release tablets must be swallowed whole and not crushed, chewed, or split.
Timing & Water	Oral forms should be taken with a full glass of water, and taking them with food may slow the rate of absorption.
Duration Principle	Treatment involves using the lowest effective dose for the shortest possible duration required to achieve the therapeutic objective.

For older adults, therapy is initiated at the lower end of the established dose range, with close monitoring. If a dose is missed, the standard procedure is to skip the missed dose and take the next scheduled dose at the regular time, without taking a double amount.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Diclofenac AL

The evidence base for Diclofenac focuses on the medicine's role in exploring symptomatic outcomes related to pain and inflammation. This summary outlines the structure of the available research, describing the types of studies conducted and what outcomes they explored, without making any promises about personal results or offering medical advice.

Evidence Base for Inflammatory Joint Conditions

Research into the systemic (oral) forms of Diclofenac for chronic conditions is primarily based on Randomized Controlled Trials (RCTs) and systematic reviews. These studies are conducted during periods when symptom activity is present and examine the measurement of symptoms over time across different patient groups.

Osteoarthritis (OA) Symptom Relief

Diclofenac was studied for exploring outcomes for the symptomatic manifestations of osteoarthritis. Researchers examined outcomes related to physical discomfort (e.g., pain intensity scores) and outcomes reflecting daily functioning or activity level (e.g., WOMAC scores). Findings describe patterns observed in the studies regarding measurements of self-reported pain and physical function scores over the study period. The trials included observation periods for short-term outcomes, but follow-up durations were limited in many core efficacy trials.

Rheumatoid Arthritis (RA) Symptom Relief

The evidence base includes RCTs. Studies explored outcomes related to functional imbalance and outcomes capturing phases of heightened symptom activity. The available research was observed in studies that only tracked the measurement of symptomatic outcomes. The evidence describes observed symptom patterns but do not address whether the medicine has any measurable impact on the underlying course of the disease itself.

Research on Acute Pain and Topical Use

Research involving Diclofenac for sudden or localized pain, such as acute soft-tissue injury or exploring short-term outcomes related to physical discomfort, often uses different study designs.

Topical Use for Osteoarthritis (OA) of Superficial Joints

Topical forms (like gels) was studied for localized joint pain. Studies applied in research contexts involving fluctuating or unstable symptoms and examined pain reduction and functional measures in the local area. Research on topical forms describes the measurement of short-term changes, but long-term effects are not fully established because the trials are often short-to-medium in duration.

Acute Pain (Systemic and Topical)

For general mild-to-moderate acute pain, research examined the very short-term (single-dose) outcomes, monitoring factors like the time until the start of pain measurement and the peak measurement of symptomatic change. For acute musculoskeletal pain, short-term RCTs were observed in patients with conditions associated with acute or disruptive episodes.

Frequently Asked Questions (FAQ)

Common questions about Diclofenac AL (FAQ)

Q: Does Diclofenac AL thin the blood?

Regulatory documents state that Diclofenac is associated with an increased risk of serious bleeding events and may interfere with the body's clotting mechanisms. Because of this, official information often restricts or prohibits its use alongside specific blood-thinning medications (anticoagulants or antiplatelets), as this combination is associated with an increased risk of bleeding.

Q: What is the shelf life of Diclofenac AL?

The official product information specifies that the expiration date is unique to each manufactured lot and is clearly printed on the container. For most forms, the medicine must be stored at Controlled Room Temperature (typically 20 C to 25 C) and kept in its original packaging. The precise shelf life is determined by the manufacturer based on stability testing.

Q: Can I take Diclofenac AL with alcohol?

Official warnings explicitly state that taking Diclofenac concurrently with alcohol consumption is associated with an increased risk of serious gastrointestinal adverse events. This includes the potential for bleeding and ulceration in the stomach or intestines. Awareness of this elevated risk is noted in official documentation.

Q: What pain conditions is Diclofenac AL specifically used to treat?

According to the official product labeling, Diclofenac is typically approved for the relief of signs and symptoms related to specific chronic inflammatory conditions, such as osteoarthritis and rheumatoid arthritis. Diclofenac formulations in general may also be indicated for conditions such as acute pain, primary dysmenorrhea (menstrual cramps), and acute treatment of migraine attacks, depending on the specific product label.

Q: Can I crush or split my Diclofenac AL tablets to make them easier to swallow?

Regulatory instructions emphasize that certain forms, such as delayed-release, enteric-coated, or extended-release tablets, must be swallowed whole. These forms must not be crushed, chewed, or split, as directed by official guidance. The coating is essential for controlled absorption, and damaging it may lead to an improper release of the medicine.

Q: How quickly does Diclofenac AL start working after taking an oral tablet?

Studies and official information indicate that for immediate-release oral tablets, the medicine typically reaches its peak plasma concentration (Tmax) in fasting individuals within approximately one hour after taking the dose. This measured peak concentration is often studied as a point of reference for the onset of effect.

How should Diclofenac AL be stored and disposed of?

Storage and Disposal Instructions for Diclofenac AL

Diclofenac formulations must be stored according to specific regulatory requirements to ensure product stability and safety. The medication is typically required to be stored at Controlled Room Temperature, defined by US regulators as between 20 C and 25 C. Temperatures above 30 C must be avoided. It is essential to keep the medication in its original container and out of the sight and reach of children.

Handling and Disposal

Requirement	Official Instruction
Temperature Restriction	Do not freeze or refrigerate (for most oral forms).
Disposal Compliance	Dispose of unused or expired product and containers in accordance with all local and national regulations for pharmaceutical waste.
Environmental Rule	Do not flush medicine down the sink or toilet, and avoid releasing the substance into the environment.