What the label lists and what reports show
Alanine, arginine and 22 other ingredients side effects
Alanine, arginine and 22 other ingredients's FDA label: “The most common adverse reactions (≥3%) are hyperglycemia, hypokalemia, pyrexia, and increased blood triglycerides.” FAERS holds 398 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 chills (30 reports).
- No generic listed
Check it at the source: the alanine, arginine and 22 other ingredients FDA label on DailyMed (effective September 15, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥3%) are hyperglycemia, hypokalemia, pyrexia, and increased blood triglycerides.
Table 3: Adverse Reactions in >2% of Patients Treated with PERIKABIVEN
| Adverse reaction | * Terms as reported in clinical studies PERIKABIVEN N=93 (%) |
|---|---|
| Hyperglycemia | 5 (5) |
| Hypokalemia | 4 (4) |
| Pyrexia | 4 (4) |
| Blood triglycerides increased | 3 (3) |
| Phlebitis | 2 (2) |
| Nausea | 2 (2) |
| Pruritus | 2 (2) |
| Gamma-glutamyltransferase increased | 2 (2) |
| Blood alkaline phosphatase increased | 2 (2) |
| Alanine aminotransferase increased | 2 (2) |
| Blood glucose increased | 2 (2) |
| C-reactive protein increased | 2 (2) |
| Blood urea increased | 2 (2) |
| Hypoalbuminemia | 2 (2) |
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, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )]. • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions ( 5.2 )]. • Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )]. • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )]. • Precipitation with Ceftriaxone [see Warnings and Precautions ( 5.5 )]. • Infections [see Warnings and Precautions ( 5.6 )]. • Fat Overload Syndrome [see Warnings and Precautions ( 5.7 )]. • Refeeding Syndrome [see Warnings and Precautions ( 5.8 )]. • Diabetes and Hyperglycemia [see Warnings and Precautions ( 5.9 )]. • Hypertriglyceridemia [see Warnings and Precautions ( 5.10 )]. • Vein Damage and Thrombosis [see Warnings and Precautions ( 5.11 )]. • Electrolyte Imbalance and Fluid Overload in Patients with Decreased Renal Function [see Warnings and Precautions ( 5.12 )]. • Aluminum Toxicity [see Warnings and Precautions ( 5.13 )]. The most common adverse reactions (≥3%) are hyperglycemia, hypokalemia, pyrexia, and increased blood triglycerides.
Source: FDA drug label, Fresenius Kabi USA, LLC, effective September 15, 2025 (SPL set c2eb5522-8572-45f4-869d-42f9fd251bb6), via openFDA; the full label on DailyMed
What do FAERS reports show?
398 reports list alanine, arginine and 22 other ingredients among the medicines taken, each a report of something that happened, not proof the medicine caused it; 75 are coded as a death and 212 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 24 reactions below, 9 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.
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?
- Alanine, arginine and 22 other ingredients: 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