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Ibuprofen Lysine: uses, dosing, side effects & brands

Ibuprofen Lysine is a medicine sold in the U.S. under one brand, for juvenile arthritis, rheumatoid arthritis and bursitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Juvenile Arthritis, Rheumatoid Arthritis and Bursitis
Available as
Solution
Sold as
Neoprofen
Prescription?
Prescription only
Generic available?
Not in our catalog
Half-life
about 1.8 to 2.0 hours

How ibuprofen lysine is dosed

From the FDA label for Neoprofen (application NDA021903). Other ibuprofen lysine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

A course of therapy is three doses administered I.V. (2.1) An initial dose of 10 mg/kg (based on birth weight) is followed by two doses of 5 mg/kg each, after 24 and 48 hours (2.1) Do not administer if anuria or marked oliguria (<0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose (2.1) 2.1 Recommended Dose A course of therapy is three doses of Ibuprofen Lysine administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Ibuprofen Lysine, no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of Ibuprofen Lysine, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Ibuprofen Lysine, alternative pharmacological therapy, or surgery may be necessary. 2.2 Directions for Use For intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and…

Ibuprofen Lysine side effects

Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure. (6) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The most frequently reported adverse events with Ibuprofen Lysine were as shown in Table 1. Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study Within 30 days of therapy, with an event rate greater on Ibuprofen Lysine than on placebo, and greater than 2 events on Ibuprofen Lysine. % Incidence Adverse Event Ibuprofen Lysine Placebo Sepsis 43 37 Anemia 32 25 Total Bleeding A given subject may have experienced more than one specific event within these adverse event categories. Only the most severe grade of IVH counted for a given subject. 32 29 Intraventricular Hemorrhage, Grades 1/2 15 13 Intraventricular Hemorrhage, Grades 3/4 15 10 Other Bleeding 6 13 Intraventricular Hemorrhage, All Grades 29 24 Apnea 28 26 Gastrointestinal Disorders 22 18 non-Necrotizing Enterocolitis Total Renal Events 21 15 Renal Failure 1 3 Renal Insufficiency, Impairment 6 4 Urine Output Reduced 3 1 Blood Creatinine Increased 3 1 Blood Urea Increased with Hematuria 1 1 Blood Urea…

Who shouldn’t take ibuprofen lysine

Ibuprofen Lysine is contraindicated in: Preterm infants with proven or suspected infection that is untreated; Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; Preterm infants with thrombocytopenia; Preterm infants with coagulation defects; Preterm infants with or who are suspected of having necrotizing enterocolitis; Preterm infants with significant impairment of renal function. Ibuprofen Lysine is contraindicated in preterm infants: With proven or suspected infection that is untreated (4) With congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (4) With impaired renal function (4) With thrombocytopenia, coagulation defects or who are bleeding (4) With or who are suspected of having necrotizing enterocolitis (4)

Ibuprofen Lysine drug interactions

Diuretics: Ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. Monitor renal function in patients receiving concomitant diuretics. Amikacin: Ibuprofen may decrease the clearance of amikacin. Diuretics: Increased risk of renal dysfunction. (7)

Every ibuprofen lysine product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Neoprofen.

How long ibuprofen lysine keeps

No ibuprofen lysine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does ibuprofen lysine expire? The in-use limits and storage rules from its labels

What people report to the FDA about ibuprofen lysine

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 126 reports naming ibuprofen lysine, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • dizziness18 reports
  • headache15 reports
  • nausea13 reports
  • somnolence13 reports
  • diarrhoea12 reports
  • insomnia12 reports
  • pancreatitis acute10 reports
  • anxiety8 reports

Read these as a signal, not a rate. A report does not mean ibuprofen lysine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

How long ibuprofen lysine stays in your system

The elimination half-life of ibuprofen lysine is about 1.8 to 2.0 hours. The label states a single serum half-life of 1.8 to 2.0 hours — it does not split the curve into a distribution and a terminal phase, so this is the elimination figure. Ibuprofen is not a prodrug, and the label names no active metabolite that outlasts the parent: the two major urinary metabolites (metabolite A, a hydroxymethyl-propyl derivative, and metabolite B, a carboxypropyl derivative) are described only as excretion products, and the label notes that excretion is virtually complete 24 hours after the last dose. This label does not report a different half-life for older adults or for people with kidney or liver impairment; it only advises caution in patients 65 and older and in those with impaired renal or hepatic function, so any change in clearance in those groups is not quantified here. This is a pharmacokinetic figure about how fast the drug leaves the blood — it is not a dosing instruction and not a drug-test detection window.

Ibuprofen tablets USP — FDA label, Clinical Pharmacology (DailyMed)

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Can you drink alcohol on ibuprofen lysine?

The label says use caution

The label addresses alcohol inside its Stomach bleeding warning. Ibuprofen is an NSAID that may cause severe stomach bleeding, and the label lists having 3 or more alcoholic drinks every day while using the product as one of the factors that raises that chance (alongside taking it longer than directed, blood thinners or steroids, prior ulcers, or being 60 or older). The label directs anyone to whom the stomach bleeding warning applies to ask a doctor before use. This is a gastrointestinal bleeding risk, not a disulfiram-like reaction or CNS/respiratory depression.

Ibuprofen (Ibuprofen Dye Free) tablet, oral — DailyMed label

Is ibuprofen lysine safe during pregnancy?

The label states a known risk

The label names a specific fetal risk: as an NSAID, ibuprofen can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios (low amniotic fluid) and, in some cases, neonatal kidney impairment. Because of this, the label says to limit use between about 20 and 30 weeks of gestation and to avoid it at about 30 weeks and later. For the first and second trimesters, the label calls observational data on other embryofetal risks inconclusive and says the background risk of birth defects/miscarriage for this population is unknown. This is not medical advice for your situation — a pregnant person should consult their prescriber about the label's guidance.

This is what ibuprofen lysine’s FDA label says — not a recommendation to take or stop it. In pregnancy, that decision is your prescriber’s; do not start or stop a medicine on your own.

Ibuprofen tablets — DailyMed FDA label (§8.1 Pregnancy)

Does ibuprofen lysine cause weight gain?

The label reports no established weight effect

The label does not establish a weight-change effect from ibuprofen. Its only mention of weight is 'unexplained weight gain' listed as a warning sign of congestive heart failure and fluid retention (edema) to watch for and report — i.e., a symptom of a cardiac/fluid complication, not a systematically measured weight effect of the drug.

Only what the FDA label reports — many drugs blamed for weight change online have no weight effect in their label, and we say so rather than repeat the folklore.

Ibuprofen tablets — DailyMed FDA label (§8.1 Pregnancy)

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Frequently asked questions

What is ibuprofen lysine?

Ibuprofen Lysine is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration.

Is ibuprofen lysine safe during pregnancy?

The label names a specific fetal risk: as an NSAID, ibuprofen can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios (low amniotic fluid) and, in some cases, neonatal kidney impairment. Because of this, the label says to limit use between about 20 and 30 weeks of gestation and to avoid it at about 30 weeks and later. For the first and second trimesters, the label calls observational data on other embryofetal risks inconclusive and says the background risk of birth defects/miscarriage for this population is unknown. This is not medical advice for your situation — a pregnant person should consult their prescriber about the label's guidance. This is what ibuprofen lysine's FDA label says; whether to use it in pregnancy is your prescriber's decision.

Does ibuprofen lysine cause weight gain?

The label does not establish a weight-change effect from ibuprofen. Its only mention of weight is 'unexplained weight gain' listed as a warning sign of congestive heart failure and fluid retention (edema) to watch for and report — i.e., a symptom of a cardiac/fluid complication, not a systematically measured weight effect of the drug.

Can you drink alcohol while taking ibuprofen lysine?

The label addresses alcohol inside its Stomach bleeding warning. Ibuprofen is an NSAID that may cause severe stomach bleeding, and the label lists having 3 or more alcoholic drinks every day while using the product as one of the factors that raises that chance (alongside taking it longer than directed, blood thinners or steroids, prior ulcers, or being 60 or older). The label directs anyone to whom the stomach bleeding warning applies to ask a doctor before use. This is a gastrointestinal bleeding risk, not a disulfiram-like reaction or CNS/respiratory depression. This is what ibuprofen lysine's FDA label says; alcohol advice depends on your dose and health, so confirm with your pharmacist.

How long does ibuprofen lysine stay in your system?

The elimination half-life of ibuprofen lysine is about 1.8 to 2.0 hours — that is how long the body takes to clear half of a dose. The label states a single serum half-life of 1.8 to 2.0 hours — it does not split the curve into a distribution and a terminal phase, so this is the elimination figure. Ibuprofen is not a prodrug, and the label names no active metabolite that outlasts the parent: the two major urinary metabolites (metabolite A, a hydroxymethyl-propyl derivative, and metabolite B, a carboxypropyl derivative) are described only as excretion products, and the label notes that excretion is virtually complete 24 hours after the last dose. This label does not report a different half-life for older adults or for people with kidney or liver impairment; it only advises caution in patients 65 and older and in those with impaired renal or hepatic function, so any change in clearance in those groups is not quantified here. This is a pharmacokinetic figure about how fast the drug leaves the blood — it is not a dosing instruction and not a drug-test detection window. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take ibuprofen lysine with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ibuprofen lysine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does ibuprofen lysine come in?

Across the brands we track, ibuprofen lysine is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic ibuprofen lysine?

We do not currently list a generic-labelled ibuprofen lysine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

What should I avoid while taking ibuprofen lysine?

Alcohol: the FDA label flags alcohol as something to be careful with — see the alcohol section above for what it actually says. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.

What are the most common side effects of ibuprofen, and do they go away?

Stomach-related complaints lead the list: heartburn, indigestion, nausea, stomach pain, and gas. Dizziness, headache, and mild rash also show up. Most of these are dose-related and fade once you stop or drop to a lower dose, but they do not fade while you keep taking it — ibuprofen blocks the prostaglandins that protect your stomach lining for as long as it is in your system. Taking it with food or milk helps the burning, but food does not lower the risk of a real ulcer or bleed. This answers for oral ibuprofen (Advil, Motrin, generics).

When is an ibuprofen side effect an emergency?

Call 911 for chest pain, shortness of breath, weakness on one side, or slurred speech — ibuprofen carries an FDA boxed warning for heart attack and stroke, and the risk can begin in the first weeks of use. Go to an emergency room for black or tarry stools, vomit that looks like coffee grounds, or vomiting blood: that is a GI bleed, the second boxed warning, and the FDA label notes it can happen at any time, without warning symptoms. Also urgent: a spreading blistering rash or peeling skin, facial or throat swelling and wheezing, or a sharp drop in how much you're urinating along with swollen ankles.

Who should not take ibuprofen, and who has the highest risk of serious problems?

Do not take it at all if aspirin or another NSAID has ever given you asthma, hives, or an allergic-type reaction — NSAIDs are contraindicated in those people, and severe, sometimes fatal bronchospasm has occurred. The FDA also warns against using it right after coronary bypass surgery. Highest risk among people who can take it: adults 60 and over, anyone with a past ulcer or GI bleed, and anyone having 3 or more alcoholic drinks every day (the threshold on the OTC label's own stomach-bleeding warning). Risk multiplies when ibuprofen is combined with a blood thinner (warfarin, apixaban), a steroid like prednisone, an SSRI antidepressant, or aspirin. For kidneys, the highest-risk group is people already on a diuretic plus an ACE inhibitor or ARB — adding an NSAID to that pair is a known trigger for acute kidney injury, especially when you're dehydrated with a stomach bug or heat illness. People with heart failure, cirrhosis, or existing kidney disease should treat ibuprofen as a doctor's-decision drug, not a grab-off-the-shelf one.

How do I take ibuprofen to keep the risk down?

Lowest dose that works, for the shortest time. The OTC Drug Facts label caps self-treatment at 200-400 mg every 4 to 6 hours, no more than 1,200 mg in 24 hours, and no more than 10 days for pain or 3 days for fever without seeing a doctor — higher daily doses are prescription territory and carry more risk. Never stack it with another NSAID (naproxen, diclofenac, many cold and sinus combos hide one). If you take low-dose aspirin for your heart, ibuprofen can block aspirin's anti-clotting effect: FDA advice is to take ibuprofen at least 30 minutes after immediate-release aspirin, or more than 8 hours before it. Acetaminophen is the alternative that spares the stomach and kidneys, though it has its own liver limit.

Is ibuprofen safe during pregnancy or while breastfeeding?

Avoid it from 20 weeks of pregnancy onward. FDA issued a 2020 warning that NSAIDs taken at or after 20 weeks can cause low amniotic fluid (oligohydramnios) from fetal kidney problems, and after 30 weeks they can close a fetal blood vessel (the ductus arteriosus) that must stay open until birth. Before 20 weeks, use only if your obstetrician tells you to. Breastfeeding is different: very little ibuprofen passes into milk, and it is generally considered one of the more compatible pain relievers, per MedlinePlus and LactMed — confirm with your clinician for your situation.

Cite this page
APA
pharmaranks. (2026, July 24). Ibuprofen Lysine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ibuprofen-lysine
MLA
“Ibuprofen Lysine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ibuprofen-lysine.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for ibuprofen lysine on DailyMed (NIH) ↗.