What the label lists and what reports show
Ibuprofen lysine side effects
Ibuprofen lysine's FDA label: “Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure.” FAERS holds 564 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is bronchopulmonary dysplasia (113 reports).
- Generic listed
Check it at the source: the ibuprofen lysine FDA label on DailyMed (effective October 15, 2024, Recordati Rare Diseases Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure.
Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study*
| Reaction | Adverse Event NeoProfen | % Incidence Placebo |
|---|---|---|
| Sepsis | 43 | 37 |
| Anemia | 32 | 25 |
| Total Bleeding | 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 |
| 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 Increased | 7 | 4 |
| Respiratory Infection | 19 | 13 |
| Skin Lesion/Irritation | 16 | 6 |
| Hypoglycemia | 12 | 6 |
| Hypocalcemia | 12 | 9 |
| Respiratory Failure | 10 | 4 |
| Urinary Tract Infection | 9 | 4 |
| Adrenal Insufficiency | 7 | 1 |
| Hypernatremia | 7 | 4 |
| Edema | 4 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost 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 Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The most frequently reported adverse events with NeoProfen were as shown in Table 1. Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study* Adverse Event % Incidence NeoProfen Placebo * Within 30 days of therapy, with an event rate greater on NeoProfen than on placebo, and greater than 2 events on NeoProfen. ** 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.
Source: FDA drug label, Recordati Rare Diseases Inc., effective October 15, 2024 (SPL set 6f5ede6f-b0b7-4fc8-969e-652f60ead047), via openFDA; the full label on DailyMed
What do FAERS reports show?
564 reports list ibuprofen lysine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 134 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ibuprofen lysine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions