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Pharmaranks rates Acular 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Acular (Ketorolac Tromethamine) is a nonsteroidal anti-inflammatory drug used to treat Allergic Conjunctivitis, Inflammation, Pain, Photophobia.
Ketorolac Tromethamine · by Abbvie
Available as a generic: Ketorolac Tromethamine
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ketorolac Tromethamine
- Drug class
- Nonsteroidal Anti-Inflammatory Drug
- Form
- Drops
- Strength
- Ketorolac Tromethamine 0.5%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- allergic conjunctivitis, inflammation, pain
- Manufacturer
- Abbvie
- Half-life
- about 5 to 6 hours (how long it stays in your system)
- FDA application
- NDA019700
What is Acular?
From the FDA label:ACULAR (ketorolac tromethamine ophthalmic solution) 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: ACULAR ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ACULAR ophthalmic solution is 290 mOsmol/kg. Each mL of ACULAR ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative : benzalkonium chloride 0.01%. Inactives : edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH. Chemical Structure
How to use
For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ACULAR to the affected eye(s) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, apply one drop of ACULAR to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. ( 2.1 ) 2.1 Recommended Dosage Temporary Relief o f Ocular Itching D ue t o Seasonal Allergic Conjunctivitis The recommended dosage of ACULAR is one drop four times a day to the affected eye(s) for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Treatment o f Postoperative Inflammation i n Patients Who Have Undergone Cataract Extraction Apply one drop of ACULAR to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period for the treatment of postoperative inflammation in patients who have undergone cataract extraction. 2.2 Use with Other Topical Ophthalmic Medications ACULAR has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.
Side effects
The following serious adverse reactions are described elsewhere in the labeling: Delayed Healing [see Warnings and Precautions ( 5.1 )] Cross-Sensitivity or Hypersensitivity [see Warnings and Precautions ( 5.2 )] Increased Bleeding Time [see Warnings and Precautions ( 5.3 )] Corneal Effects [see Warnings and Precautions ( 5.4 )] The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials. Other adverse reactions occurring approximately 1% to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritus), corneal…
Warnings
Important safety information
Delayed healing ( 5.1 ) Cross-sensitivity or hypersensitivity ( 5.2 ) Increased bleeding time due to interference with thrombocyte aggregation ( 5.3 ) Corneal effects including keratitis ( 5.4 ) 5.1 Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.2 Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine ophthalmic solution in patients who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.3 Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ACULAR be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time. 5.4 Corneal Effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. 5.5 Risk of Contamination Avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. 5.6 Contact Lens Wear ACULAR should not be administered while wearing contact lenses.
Who should not take Acular
ACULAR solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions ( 6.1 )] . Hypersensitivity to any component of this product. ( 4 )
How long does Ketorolac Tromethamine stay in your body?
The elimination half-life of ketorolac tromethamine is about 5 to 6 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. FDA label mean terminal elimination half-life is 5.6 hours (range 4.0-7.9) in healthy young adults (24-35 yrs). It lengthens with age (about 7 hours in the elderly, 65-78 yrs) and, most importantly, with reduced kidney function: in renally impaired patients the mean half-life ranges from 6 to 19 hours depending on severity, since ketorolac is largely eliminated renally. Ketorolac has no long-lasting active metabolite and is not a prodrug. Half-life is not the same as a drug-test detection window — how long it stays measurable can exceed the time the drug is clinically active.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: KETOROLAC TROMETHAMINE tablet — FDA label (DailyMed).
Drug class
How this class works, per Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Acular ranks — best-rated nonsteroidal anti-inflammatory drug for:
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Acular treat?
- Acular (Ketorolac Tromethamine) may be used to treat allergic conjunctivitis, inflammation, pain, photophobia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Acular work?
- Acular is a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature.
- How is Acular rated?
- pharmaranks gives Acular a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Acular?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Acular. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Acular?
- Acular is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Acular a brand-name or generic drug?
- Acular is a brand-name product with the active ingredient Ketorolac Tromethamine. Lower-cost generic equivalents containing Ketorolac Tromethamine are available — ask your pharmacist.
- Is Acular available over the counter?
- No. Acular is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Acular come in?
- Acular is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Acular?
- Acular is classified as cyclooxygenase inhibitor, nonsteroidal anti-inflammatory drug, per the FDA's Established Pharmacologic Class.
- Is Acular FDA-registered?
- Acular is on record with the U.S. FDA under application number NDA019700. You can verify this on its official FDA label.
- Has Acular been recalled by the FDA?
- Acular has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Acular safe?
- There's no single safe-or-not verdict. pharmaranks gives Acular a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Acular?
- Acular's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described elsewhere in the labeling: Delayed Healing [see Warnings and Precautions ( 5.1 )] Cross-Sensitivity or Hypersensitivity [see Warnings and Precautions ( 5.2 )] Increased Bleeding Time [see Warnings and Precautions ( 5.3 )] Corneal Effects [see War… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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72/100