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Flurbiprofen Sodium Ophthalmic Solution USP 0.03%

NAFDAC Reg. No. B4-5397 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Flurbiprofen Sodium Ophthalmic Solution USP 0.03%
NAFDAC number
B4-5397
Active ingredient
Flurbiprofen sodium
Strength
0.03%
Form
Solution/Drops
Manufacturer
Not listed
Applicant (holder)
Lin-Kabs Pharmaceutical Limited
Approved
28 Sep 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
27 Sep 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Flurbiprofen Sodium Ophthalmic Solution USP 0.03% is on the NAFDAC register with an active registration (B4-5397). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Flurbiprofen Sodium Ophthalmic Solution USP 0.03% is used for

From the official U.S. FDA label for flurbiprofen sodium, the active ingredient registered with NAFDAC.

Boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. …
What it is used for

Flurbiprofen tablets are indicated: For relief of the signs and symptoms of rheumatoid arthritis. For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of rheumatoid arthritis ( 1 ) Relief of the signs and symptoms of osteoarthritis ( 1 )

Possible side effects

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2) ] Hepatotoxicity [ see Warnings and Precautions (5.3) ] Hypertension [ see Warnings and Precautions (5.4) ] Heart Failure and Edema [ see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ] Anaphylactic Reactions [ see Warnings and Precautions (5.7) ] Serious Skin Reactions [ see Warnings and Precautions (5.9) ] Hematologic Toxicity [ see Warnings and Precautions (5.12) ] Most common adverse react …

Do not use if

Flurbiprofen tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to flurbiprofen or any components of the drug product [ see Warnings and Precautions (5.7 , 5.9) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. …

Warnings

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of flurbiprofen in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Use of NSAIDs, including flurbiprofen tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. …

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Flurbiprofen Sodium Ophthalmic Solution USP 0.03%

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Flurbiprofen Sodium Ophthalmic Solution USP 0.03%

What is in Flurbiprofen Sodium Ophthalmic Solution USP 0.03%?

Flurbiprofen Sodium Ophthalmic Solution USP 0.03% contains Flurbiprofen sodium (0.03%), as solution/drops, according to its NAFDAC registration record.

Is Flurbiprofen Sodium Ophthalmic Solution USP 0.03% registered with NAFDAC?

Yes. Flurbiprofen Sodium Ophthalmic Solution USP 0.03% is listed on the NAFDAC register under registration number B4-5397, and its registration is active as of 5 November 2026.

Has Flurbiprofen Sodium Ophthalmic Solution USP 0.03% been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Flurbiprofen Sodium Ophthalmic Solution USP 0.03% in our automatically synced alert list.

How can I check that my pack of Flurbiprofen Sodium Ophthalmic Solution USP 0.03% is genuine?

Run a free authenticity scan with the NAFDAC number B4-5397, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Flurbiprofen Sodium Ophthalmic Solution USP 0.03% used for?

Flurbiprofen tablets are indicated: For relief of the signs and symptoms of rheumatoid arthritis. For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of rheumatoid arthritis ( 1 ) Relief of the signs and symptoms of osteoarthritis ( 1 ) (Summarised from the official U.S. FDA label for flurbiprofen sodium. Always follow your doctor or pharmacist.)

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