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What the label lists and what reports show

Arginine side effects

Arginine's FDA label lists its adverse reactions in its own words. FAERS holds 101 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 hypotension (10 reports).

  • No generic listed

Check it at the source: the arginine FDA label on DailyMed (effective April 2, 2024, Pharmacia & Upjohn Company LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions associated with 1670 infusions in premarketing studies were as follows: Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients. One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered. One patient had an apparent decrease in platelet count from 150,000 to 60,000. One patient with a history of acrocyanosis had an exacerbation of this condition following infusion of R-Gene ® 10. …

Source: FDA drug label, Pharmacia & Upjohn Company LLC, effective April 2, 2024 (SPL set 6accf33f-9841-4327-8923-93c42020ef12), via openFDA; the full label on DailyMed

What do FAERS reports show?

101 reports list arginine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 40 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 22 reactions below, 3 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

  • Hypotension10
  • Off Label Use (a use or a product term, not a reaction)8
  • Haematuria (named in the label)7
  • Vomiting (named in the label)7
  • Diarrhoea6
  • Drug Ineffective (a use or a product term, not a reaction)5
  • Malaise5
  • Nausea (named in the label)5
  • Atrial Fibrillation4
  • Cardiac Disorder4
  • Cough4
  • Fatigue4
  • Pyrexia4
  • Renal Impairment4
  • Acidosis Hyperchloraemic3
  • Blood Pressure Increased3
  • Blood Urine Present3
  • Dehydration3
  • Feeling Abnormal3
  • Metabolic Acidosis3
  • Oedema3
  • Pneumonia3
  • Product Use Issue (a use or a product term, not a reaction)3
  • Throat Irritation3
  • Alanine Aminotransferase Increased2

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Arginine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions