Diclofenac 0.1%

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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 Diclofenac 0.1%

Quick Facts

Property Description
Active ingredient Diclofenac sodium
Form Sterile ophthalmic solution (Eye Drops)
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General purpose Anti-inflammatory and analgesic
Origin Synthetic, Phenylacetic acid derivative

Diclofenac 0.1%: A Nonsteroidal Anti-Inflammatory Drug (NSAID)

Diclofenac 0.1% is a medicinal preparation whose active ingredient is Diclofenac sodium, which is officially classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). This medication is a synthetic compound derived from phenylacetic acid and is exclusively designed for use as a highly targeted anti-inflammatory agent. Diclofenac works by inhibiting the body's natural production of pro-inflammatory compounds.

As an NSAID, the fundamental purpose of this preparation is to address inflammatory processes at a localized level, a function clinically recognized worldwide. Diclofenac is used topically to relieve inflammation and pain.


Understanding the 0.1% Ophthalmic Solution Form

Diclofenac 0.1% is specifically formulated as a sterile, water-based ophthalmic solution, meaning it is a liquid, single-ingredient product intended solely for topical ocular administration (application to the eye). The 0.1% specifies the precise, low concentration of Diclofenac sodium dissolved within this aqueous vehicle. This form is unique because it ensures the drug is delivered directly to the eye's surface, a crucial differentiating factor from the more common oral NSAID forms.

This preparation contrasts with oral or topical dermal forms of Diclofenac, as its specialized solution base is optimized for focused delivery to the delicate surface of the eye. Its unique composition makes it suitable for managing inflammation, allowing for rapid dispersion and action at the anterior segment of the eye, avoiding the systemic absorption associated with non-ophthalmic forms.

Regulatory References

  1. Diclofenac Ophthalmic: MedlinePlus Drug Information

What side effects are possible with Diclofenac 0.1%?

Possible side effects and safety information

Diclofenac 0.1% Ophthalmic Solution’s safety profile is documented by regulatory authorities, classifying observed adverse reactions by frequency and physiological system. This information helps structure the understanding of the medicine's potential risks.


Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions are associated with the application site.

Classification Examples of Officially Listed Adverse Reactions
Common Transient stinging and burning upon instillation, ocular irritation, ocular pruritus.
Uncommon Corneal edema, elevated intraocular pressure, headache, nausea.
Rare/Very Rare Vomiting, facial edema, asthenia (weakness), blurred vision, hypersensitivity reactions. Severe ocular events like corneal erosion, corneal thinning, or ulcerative keratitis are very rarely documented.

Safety Considerations and Restrictions

Official labeling groups adverse reactions primarily under Eye Disorders, reflecting the medicine's topical administration. However, systemic effects, including Nervous System and Gastrointestinal disorders, have also been documented.

Serious Adverse Reactions: Rare but serious events include severe corneal changes (e.g., thinning, perforation) and systemic hypersensitivity reactions (e.g., asthma exacerbation), particularly with prolonged use or in certain patient populations.

Specific Risk Groups: Individuals with complicated ocular surgery, corneal defects, diabetes mellitus, or rheumatoid arthritis are identified in regulatory documents as potentially having an increased risk for severe corneal adverse events. The medication is formally contraindicated in patients with known hypersensitivity to diclofenac or other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).

Exposure Patterns: The most frequent side effect, stinging, is typically transient. Regulatory information notes that extended use may potentially delay corneal healing.

Overdose and Emergency Response

The official regulatory profile for Diclofenac 0.1% Ophthalmic Solution defines the overdose risk based on the low concentration and topical route of administration. Overdosage resulting from topical ocular over-instillation will not ordinarily cause acute systemic problems, as stated in the official prescribing information. This assessment reflects the minimal systemic absorption achieved following application to the eye, resulting in a very low total amount of drug entering the bloodstream.

The specific overdose scenario addressed under regulatory guidance is the accidental oral ingestion of the sterile ophthalmic solution. Although the total quantity of diclofenac sodium in a typical bottle is extremely small compared to standard oral doses, immediate action is required. If the medication is accidentally swallowed, the official guidance states that fluids should be taken to dilute the medication.

Regulators mandate that any instance of accidental oral ingestion requires immediately seeking emergency medical attention or contacting a Poison Help center. The clinical management of any resulting adverse effects is typically symptomatic and supportive, as no specific antidote for Diclofenac is documented in the product labeling for this scenario. Continuous monitoring requirements following accidental ingestion are determined on a case-by-case basis.

Therapeutic Uses of Diclofenac 0.1%

What Diclofenac 0.1% Treats: Main Uses and Benefits

Diclofenac 0.1% Ophthalmic Solution is primarily applied across therapeutic domains where short-term symptomatic assistance is needed for conditions presenting with acute episodes in the eye. This medication is used to manage ocular pain and inflammation following specific surgeries. This is commonly used across conditions presenting with acute episodes, such as those that follow cataract extraction or corneal refractive surgery.

The medication helps address symptom clusters that may become intense or disruptive, such as sharp pain, redness, swelling, and light sensitivity (photophobia). It provides support that helps ease the overall symptom burden, particularly when symptoms related to inflammatory or irritative states interfere with daily functioning. For the patient, this assists with maintaining functional stability during phases of recovery.

“This medication is commonly used to help with acute pain and inflammation that follow surgical or traumatic events in the eye.”


Supportive Facts: Focus on Symptom Management Symptom Type Example Conditions
Acute Pain Post-Cataract Surgery
Inflammation Post-Refractive Procedures
Associated Distress Non-Infectious Trauma

Regulatory References

  1. DailyMed (NIH) labeling information

Eligibility and Restrictions for Use

Official Eligibility for Diclofenac 0.1% Ophthalmic Solution

Contraindicated Populations

Use is strictly prohibited for patients with a known hypersensitivity to any component of the medication. The drops are also contraindicated for individuals in whom asthma, urticaria, or acute rhinitis are precipitated by aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).


Age-Based Eligibility

Use is established for adults and older adults. Safety and effectiveness in pediatric patients (under 18 years of age) have not been established by regulatory bodies, and use is generally not recommended in this group.


Use Restrictions and Conditional Eligibility

  • Pregnancy and Lactation: The medication must be avoided in late pregnancy (starting at 30 weeks gestation) due to potential risk to the fetal cardiovascular system. Use during earlier pregnancy is restricted to when clearly needed. For nursing women, a decision to discontinue nursing or discontinue the drug is required.
  • Comorbidities: Use requires caution in patients with conditions such as diabetes mellitus or rheumatoid arthritis, as these may elevate the risk of corneal adverse events.
  • Acute Ocular Condition: Patients showing evidence of corneal epithelial breakdown must immediately discontinue the drops. The medication is also to be used with caution in patients with bleeding tendencies or those who have undergone complicated ocular surgeries.

What should I know about interactions with other medicines?

Diclofenac 0.1% Interactions with other medicines and products

The interaction profile for Diclofenac 0.1% Ophthalmic Solution is primarily defined by local pharmacodynamic effects and necessary administration timing rules, reflecting the drug's minimal systemic absorption.

Documented Interaction Patterns

Interacting Substance/Category Official Interaction Outcome Type and Constraint
Topical Ophthalmic Steroids Co-administration may slow or delay corneal wound healing and increase the potential for healing problems. Pharmacodynamic Interaction (Additive Risk)
Medications that prolong bleeding time Theoretical possibility of increased risk of ocular hemorrhage (e.g., hyphemas) in the perioperative context. Pharmacodynamic Interaction (Risk of Bleeding)
Any Other Ophthalmic Medication Requires an administration interval of at least 5 to 10 minutes to prevent washout of the active substance. Timing-based Rule (Mandatory Separation)
Aspirin or Other NSAIDs Contraindicated in patients where these agents precipitate asthma, urticaria, or acute rhinitis due to regulatory cross-sensitivity classification. Formal Restriction (Contraindicated Combination)

The additive risk with topical steroids is documented as being potentially more severe in patients with pre-existing risk factors such as diabetes mellitus or rheumatoid arthritis. Systemic pharmacokinetic interactions involving CYP enzymes or transporters are not established or documented in the ophthalmic product labeling due to the low plasma exposure. Similarly, the regulatory documents state no established interactions with food, alcohol, or herbal products.

Mechanism of Action

Molecular Blockade of Cyclooxygenase (COX) Enzymes

The fundamental action of Diclofenac sodium is its function as a non-selective competitive inhibitor of the Cyclooxygenase (COX) enzyme family, targeting both the constitutive COX-1 and the inducible COX-2 isoforms. This targeted inhibition effectively stops the conversion of arachidonic acid into pro-inflammatory mediators, which is the core molecular action that alters local physiological responses.


Suppression of Prostaglandin Signaling and Cascades

By blocking the COX enzymes, the drug specifically suppresses the synthesis of prostaglandins, particularly PGE2, which are key lipid mediators in the ocular inflammatory cascade. This suppression limits the molecular signaling that drives tissue changes, thereby reducing PGE2-mediated local vasodilation and changes in vascular permeability.


Modulation of Peripheral Pain and Tissue Fluid Dynamics

The reduction in prostaglandin levels alters two physiological functions: it modifies the signaling pathways associated with peripheral nociceptor sensitization, and it reduces the factors that drive capillary fluid extravasation. These alterations modify specific pathways, resulting in a change to the local physiological response to stimuli.

Dosage and Administration Information

The use of Diclofenac 0.1% Ophthalmic Solution involves specific administration and dosing schedules designed to ensure focused delivery to the eye surface.

Administration Scope

Route of administration: The medication is for Topical Ocular Administration only, applied as drops instilled into the conjunctival sac. It must not be injected into the eye (e.g., subconjunctivally or into the anterior chamber).

Dosing schedule: The standard unit of administration is one drop.

  • Post-Cataract Surgery: One drop, four times daily (QID), starting 24 hours after surgery.
  • Corneal Refractive Surgery: One to two drops are applied within the hour prior to surgery, followed by a dose within 15 minutes post-surgery, then continued QID.

Age-group administration rules: No dosage adjustment is required for elderly adults. The safety and effectiveness of the 0.1% ophthalmic solution have not been established in patients under 18 years of age.

Missed-dose rules: If a dose is missed, it is instilled as soon as possible, unless it is nearly time for the next scheduled dose. In such cases, the missed dose is skipped and the regular schedule is resumed, with no extra drops used.

Special procedural conditions: Contact between the dropper tip and the eye or surrounding structures is avoided to maintain sterility. If other eye medications are necessary, an interval of at least five minutes is observed between the applications. To manage systemic absorption, nasolacrimal occlusion or gentle closing of the eyes for several minutes is recommended after instillation. Soft contact lenses are removed before application and not re-inserted for at least 15 minutes.

Instruction Classifications (High-Level)

Administration method type: Topical. Frequency pattern: Fixed-interval daily (typically QID). Use-context constraints: Short-term use, specific to the post-operative period (e.g., up to two weeks).

Connection to the overall use protocol:

These instructions establish a protocol for delivering the drug to the ocular surface via drops. The schedule involves frequent, fixed dosing intervals to maintain drug presence during the acute phase, while procedural steps address sterile application and absorption. The treatment duration is time-bound, reflecting its use for short-term post-operative management.

Recent Clinical Evidence

Evidence for Use Following Cataract Extraction and Corneal Surgery

The evidence base includes Randomized Controlled Trials (RCTs) conducted during periods of increased symptom activity following surgery, comparing the eye drops to an inactive placebo or other topical ophthalmic agents. Studies explored outcomes related to inflammatory states in adults after procedures like cataract removal. Research describes the patterns observed in measured ocular pain scores and levels of inflammation markers, and this evidence contributes to understanding symptom patterns following surgery.

How Pain and Inflammation Were Measured in Trials

To quantify inflammation, researchers used established clinical scales to assess specific markers that reflect temporary physiological imbalance, such as Anterior Chamber Cell and Flare scores. For pain, studies used standardized questionnaires and rating scales to capture patient-reported outcomes related to physical discomfort.

Evidence for Use in Non-Chronic Post-Traumatic Inflammation

Research has explored the use of Diclofenac 0.1% in conditions associated with acute episodes, specifically non-chronic inflammation following non-penetrating wounds. Controlled clinical studies monitored patient-reported outcomes focusing on acute changes, reporting measurements of pain intensity and the frequency of receiving rescue analgesic medication. However, the evidence is limited, primarily derived from smaller clinical study populations focused on very short-term symptom relief.

Long-Term Research and Extended Follow-up

Studies generally focus on short-term changes, but research has also included longer follow-up periods, up to 12 months, to monitor indicators related to complications like Cystoid Macular Edema (CME). Long-term outcomes are not fully established, and evidence for the durability of any observed response remains limited. Research does not determine whether an individual will respond similarly over that duration.

Evidence in Specific Patient Populations

The research has examined specific subgroups within the study population, including patients with co-existing conditions such as diabetic retinopathy who were undergoing cataract surgery. However, data for certain groups, such as children, remain insufficient, and research has not fully established patterns related to usage in patients with more severe underlying eye conditions.

What is Still Uncertain About the Research Base

One key factor is that the sample sizes were modest in some studies, and evidence quality varies across the entire body of available research. Furthermore, the design of many pivotal trials included the simultaneous use of other medications, and this structural limitation must be considered when reviewing the assessment of the NSAID's activity alone. Comparative evidence against every alternative topical treatment is lacking.

Key Studies & References

  1. VOLTAREN OPHTHALMIC (diclofenac sodium ophthalmic solution) 0.1% Prescribing Information

Frequently Asked Questions (FAQ)

Common questions about Diclofenac 0.1% (FAQ)


Q: Is Diclofenac 0.1% the same active ingredient as Diclofenac used for joint pain?

A: The active ingredient in the eye drops is Diclofenac sodium, which is the same chemical compound found in other oral or topical forms of Diclofenac. However, Diclofenac 0.1% is a specialized sterile, low-concentration liquid formulated exclusively for topical application to the eye, ensuring minimal systemic absorption.


Q: Does Diclofenac 0.1% affect the healing process in the eye after surgery?

A: Regulatory documents state that Diclofenac ophthalmic solution, like other non-steroidal anti-inflammatory drugs (NSAIDs), may slow or delay corneal wound healing. This risk is noted to increase, particularly with extended use beyond the recommended short duration.


Q: Can Diclofenac 0.1% cause blurry vision or changes in eyesight?

A: Official labeling reports that blurred vision and abnormal vision have been documented as adverse reactions. Official product information notes that any changes in vision should be discussed with a healthcare provider.


Q: Can Diclofenac 0.1% be used while wearing soft contact lenses?

A: Official administration guidelines indicate that soft contact lenses must be removed prior to application. Official labeling states that an interval of at least 15 minutes should be observed before reinserting the lenses.


Q: How does Diclofenac 0.1% interact with topical corticosteroid eye drops?

A: Official documents note that co-administration with topical ophthalmic steroids may increase the potential for corneal healing problems or slow down the healing process. This combination is described as presenting an additive risk.


Q: Are there specific medical conditions that may slow healing while using Diclofenac 0.1%?

A: Regulatory documents identify patients with certain pre-existing conditions as having an increased risk for severe corneal adverse events and potential healing issues. These conditions include diabetes mellitus and rheumatoid arthritis.


Q: What is the typical duration of treatment with Diclofenac 0.1% after cataract surgery?

A: The treatment duration described in official labeling is typically short-term, intended for the post-operative period. Official documents describe the use after surgery as typically lasting up to two weeks.


Q: What is the role of Diclofenac 0.1% in managing inflammation versus pain?

A: The medicine is officially indicated for the treatment of post-operative inflammation in patients after cataract surgery. It is also indicated for the temporary relief of pain and photophobia following corneal surgery.


Q: Can Diclofenac 0.1% cause a feeling that something is stuck in the eye?

A: Adverse reactions reported in post-marketing experience include a feeling of something in the eye, which is medically referred to as a foreign body sensation. This is in addition to common, transient effects like ocular irritation.


Q: How quickly do patients typically begin to feel pain relief after using Diclofenac 0.1%?

A: Clinical trials for corneal refractive surgery demonstrated that the ophthalmic solution provided temporary relief of pain and photophobia during the six-hour period following surgery.


Q: Are there any systemic side effects, like headache or stomach issues, from Diclofenac 0.1% eye drops?

A: Although systemic absorption is minimal with the ophthalmic solution, some systemic adverse reactions have been reported in clinical studies. These reports include instances of headache, nausea, vomiting, and abdominal pain.


Q: Is it possible to have stomach side effects from eye drops like Diclofenac 0.1%?

A: Yes. Systemic adverse reactions reported in regulatory documents include instances of abdominal pain, nausea, and vomiting.


Q: Is there a risk of increased eye pressure (IOP) associated with Diclofenac 0.1%?

A: Official product information reports that elevated intraocular pressure (IOP) has been documented as an adverse reaction in clinical studies. It was observed in approximately 10% or less of patients.


Q: What is keratitis and is it a possible side effect of Diclofenac 0.1%?

A: Keratitis is a term that refers to inflammation of the cornea, the clear front surface of the eye. Keratitis was reported in some clinical studies, and rare, severe corneal changes like corneal erosion and corneal thinning have been identified during post-marketing use.


Q: What information is available about using Diclofenac 0.1% while breastfeeding?

A: Official guidance notes that because many drugs can be excreted in human milk, a decision is necessary regarding use while breastfeeding. This decision involves weighing the importance of the drug to the mother against the potential for exposure to the nursing infant.


Q: Does using Diclofenac 0.1% affect the use of other non-NSAID eye drops?

A: Yes. Official administration guidelines indicate that if other eye medications are used, an interval of at least five minutes is recommended between applications to prevent the wash-out of the active substance, which would help maintain effectiveness.


Q: Is the drug safe to use during pregnancy, according to regulatory information?

A: Diclofenac 0.1% is not recommended for use during pregnancy, especially during the later part (starting at 30 weeks gestation). This restriction is based on the potential risks described in regulatory documentation, particularly concerning the fetus during the later part of pregnancy.


Q: What are the potential effects if Diclofenac 0.1% is used longer than the prescribed period?

A: Official warnings state that the use of topical NSAIDs, including Diclofenac 0.1%, for more than 14 days may increase the risk or severity of serious corneal adverse events.


Q: Are long-term side effects known for Diclofenac 0.1% when used as directed?

A: The risks of serious corneal adverse events are noted to increase with the duration of use, especially when treatment exceeds two weeks. The official labeling also states that the refractive stability of patients treated with the solution after surgery has not been established.


Q: What research evidence supports the use of Diclofenac 0.1% for corneal refractive surgery?

A: Clinical trials supported the ophthalmic solution’s indication for temporary relief of pain and photophobia during the six-hour period following corneal refractive surgery, such as PRK.


Q: What happens in the body when the effects of Diclofenac 0.1% wear off?

A: Diclofenac's action involves inhibiting an enzyme called cyclooxygenase, which is essential for the biosynthesis of prostaglandins (compounds that drive inflammation). As the drug level in the eye drops, this inhibitory action is naturally reduced.


Q: Why is the concentration 0.1% for the eye drops?

A: The 0.1% concentration reflects the specific formulation that was studied in the pivotal clinical trials. This concentration established the drug's efficacy for treating post-operative inflammation and pain in the authorized indications.


Q: Is Diclofenac 0.1% available over the counter?

A: No. Official regulatory status classifies Diclofenac 0.1% Ophthalmic Solution as a prescription-only drug (Legend status). It is not available for purchase without a prescription.


Q: What are the common brand names for Diclofenac 0.1%?

A: A well-known brand name associated with Diclofenac 0.1% Ophthalmic Solution is Voltaren Ophthalmic.


Q: Do I still need pain medication if I am using Diclofenac 0.1% eye drops?

A: The official claim for the medicine's effect on pain is temporary relief of pain and photophobia. This temporary nature of the relief does not guarantee that all pain management needs will be met solely by the eye drops.


Q: What is the official chemical structure or formula of Diclofenac Sodium 0.1%?

A: The active ingredient, Diclofenac sodium, is chemically designated as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. Its empirical formula is C14 H10 Cl2 NO2 Na.


Q: Why is Diclofenac 0.1% often prescribed alongside a steroid eye drop?

A: Clinical trials for the ophthalmic solution frequently included the simultaneous use of other medications. This co-administration may be intended to achieve a combined anti-inflammatory effect through complementary mechanisms.


Q: What is the longest period Diclofenac 0.1% has been studied for continuous use?

A: The continuous use indicated after surgery is typically up to 14 days. Official warnings state that using the medication for a longer duration may increase the risk or severity of corneal adverse events.


Q: What clinical factors are monitored by doctors while a patient is using Diclofenac 0.1%?

A: Physicians typically monitor patients for documented risks, including signs of corneal epithelial breakdown, changes in intraocular pressure, and signs of ocular hemorrhage, particularly in the post-operative context.


Q: Is Diclofenac 0.1% known to interact with common pain relievers like Tylenol (acetaminophen)?

A: Due to the ophthalmic form's low plasma exposure, no established systemic pharmacokinetic interactions with acetaminophen are documented in the official labeling. The interaction focus is generally on other topical agents and systemic NSAIDs.


Q: Does Diclofenac 0.1% affect wound healing in other parts of the body?

A: The regulatory documents primarily focus on the potential to delay healing in the cornea when applied topically. There is no established information on how the low systemic levels from ophthalmic use affect wound healing elsewhere in the body.


Q: What is the difference between Diclofenac 0.1% and Nepafenac eye drops?

A: Official regulatory documents indicate that comparative evidence against every alternative topical treatment is lacking. No official head-to-head comparison is available in the authorized labeling.


Q: Can the effectiveness of Diclofenac 0.1% be reduced by certain foods or drinks?

A: Regulatory documents state that there are no established interactions with food or alcohol documented in the ophthalmic product labeling.

How should Diclofenac 0.1% be stored and disposed of?

Storage and Disposal of Diclofenac Sodium Ophthalmic Solution 0.1%

Diclofenac 0.1% must be stored at Controlled Room Temperature, defined as 20°C to 25°C (68°F to 77°F), with permitted excursions up to 30°C. The solution must be protected from light and must not be frozen.

Keep the medication in its original container, tightly closed, and stored out of the sight and reach of children.

For stability, multi-dose bottles must be discarded 28 days after first opening. Single-dose units must be discarded immediately after use.

Disposal must not occur via wastewater or household trash. Unused or expired medication should be disposed of by consulting a pharmacist or local waste disposal agency for medicine take-back programs.

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

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