FDA approved on 25 September 2026

Now Approved

(diclofenac sodium) injection 37.5 mg/mL, for intravenous use

Zueino is a nonsteroidal anti-inflammatory drug (NSAID) approved by the US FDA under NDA 218379, through the 505(b)(2) pathway. It is supplied as a 1 mL single-dose glass vial.

Full Prescribing Information Important Safety Information

Indications and usage ZUEINO is indicated in adults for the:

management of mild to moderate pain
management of moderate to severe pain alone or in combination with opioid analgesics

Warning: risk of serious cardiovascular and gastrointestinal events

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
ZUEINO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

See Important Safety Information below and the full Prescribing Information.

Product at a glance Zueino key facts

Active ingredient: Diclofenac sodium
Strength: 37.5 mg/mL
Presentation: 1 mL fill in a single-dose clear glass vial with a blue tamper-evident top
Route: Intravenous use only
Dosage: 37.5 mg by intravenous bolus injection over 15 seconds every 6 hours as needed; maximum daily dose 150 mg. Patients must be well hydrated before administration. Use for the shortest duration consistent with individual patient treatment goals.
Composition: Each 1 mL contains 37.5 mg diclofenac sodium USP, with monothioglycerol, polysorbate 80, povidone K-12, sodium chloride and water for injection; contains no cyclodextrin
NDC: 88015-101-01 (single-dose vial)
88015-101-02 (carton of 25 vials)
Storage: 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C. Do not freeze. Protect from light.
Shelf life: 24 months from manufacture
Other: Rx only. Not made with natural rubber latex. No REMS.

Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
ZUEINO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Contraindications

Known hypersensitivity to diclofenac or any components of the drug product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
In the setting of CABG surgery
Moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion

Warnings and precautions

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.
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart failure and edema: Avoid use of ZUEINO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZUEINO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
Anaphylactic reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of asthma related to aspirin sensitivity: ZUEINO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious skin reactions: Discontinue ZUEINO at first appearance of skin rash or other signs of hypersensitivity.
Drug reaction with eosinophilia and systemic symptoms (DRESS): Discontinue and evaluate clinically.
Fetal toxicity: Limit use of NSAIDs, including ZUEINO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
Hematologic toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

Adverse reactions

The most common adverse reactions (>5%) in controlled clinical trials include nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia.

Drug interactions

Drugs that interfere with hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ZUEINO with drugs that interfere with hemostasis. Concomitant use of ZUEINO and analgesic doses of aspirin is not generally recommended.
ACE inhibitors, angiotensin receptor blockers (ARB), or beta-blockers: Concomitant use with ZUEINO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
ACE inhibitors and ARBs: Concomitant use with ZUEINO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Digoxin: Concomitant use with ZUEINO can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Use in specific populations

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ZUEINO in women who have difficulties conceiving.

To report SUSPECTED ADVERSE REACTIONS, contact ADVENTAPHARMA DWC LLC at 1-844-238-3682 (1-844-ADVENTA), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, including Boxed Warning.