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Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Avoid with known allergy or hypersensitivity to arginine. Symptoms may include rash, itching, or shortness of breath. Anaphylaxis has occurred after arginine injections. In clinical research, one patient experienced a mild allergic skin reaction to intravenous L-arginine. Hives have also been reported.

For treatment of allergy to arginine, epinephrine and antihistamines have been suggested.

Side Effects and Warnings

Note : According to the U.S. Food and Drug Administration (FDA) website, pediatric overdosing of arginine hydrochloride injection (R-Gene 10®) has been reported, due to packaging and labeling confusion. Revisions have since been made to the product's packaging. The new label warns that R-Gene 10® infusions should be used cautiously in children to prevent overdose, which may result in hyperchloremic metabolic acidosis, cerebral edema, or possibly death.

There is no current suggested daily intake or tolerable upper intake for arginine. This amino acid is considered to be nonessential. The therapeutic dosage (maximum dose considered to be safe) is 400-6,000 milligrams.

In general, L-arginine is well tolerated when taken by mouth, delivered intravenously, or applied to the skin.

Arginine may cause bloating; diarrhea; endocrine changes; gastrointestinal discomfort; hives; increased blood urea nitrogen, serum creatine, and serum creatinine; increased inflammatory response; leg restlessness, lower back pain; nausea, numbness (with arginine injection); rash; reduction in hematocrit; severe tissue necrosis with extravasation; systemic acidosis; or venous irritation. In heart disease patients, arginine may cause high white blood cell count, increased post-heart attack deaths, lack of energy and strength, and vertigo or increased blood pressure (in heart transplant patients).

Arginine may increase the risk of bleeding. Caution is advised in patients with bleeding disorders or those taking drugs that may increase the risk of bleeding. Dosing adjustments may be necessary.

Arginine may change blood sugar levels. Caution is advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Blood glucose levels may need to be monitored by a qualified healthcare professional, including a pharmacist, and medication adjustments may be necessary.

Use cautiously in patients with impaired kidney function or those at risk for hyperkalemia (abnormally high levels of blood potassium), including those with diabetes or using drugs that elevate potassium levels, such as potassium-sparing diuretics and potassium supplements, as arginine may cause hyperkalemia. Fatal cardiac arrhythmia occurred in one patient.

Use caution with phosphodiesterase inhibitors (e.g., sildenafil [Viagra®]), due to a theoretical risk of additive blood vessel widening and blood pressure lowering.

Use with caution in postmenopausal patients, as night sweats and flushing have been reported.

Use with caution in patients with herpes virus, as L-arginine may worsen this condition. L-arginine may increase the risk of herpes simplex cold sores.

Use with caution in individuals at risk for headaches, as headache has been a reported side effect. In mountain climbers, L-arginine increased the risk of developing a headache.

Use with caution in patients with immunological disorders.

Use cautiously in patients with acrocyanosis, sickle cell anemia, and hyperchloremic acidosis, as arginine may cause worsening of symptoms.

Use cautiously in patients with guanidinoacetate methyltransferase (GAMT) deficiency. This enzyme is involved in the conversion of amino acids such as arginine to creatine.

Avoid in women with high-risk pregnancies, as, in women with multiple diseases, intravenous arginine resulted in premature delivery, pre-eclampsia, and death in two cases.

Avoid use in those with low blood pressure or those using blood pressure-lowering agents, due to the reported blood vessel-widening and blood pressure-lowering effects of L-arginine.

Avoid with nitrates, as concurrent use may result in additive blood pressure-lowering and blood vessel-widening effects.

Avoid use in patients given spironolactone, because arginine monohydrochloride has resulted in abnormally high potassium levels and fatal cardiac arrhythmia.

Avoid use in patients with asthma, as arginine may cause an allergic and response, aggravate airway inflammation, and amplify inflammatory airway response. In human research, L-arginine increased exhaled nitric oxide, suggesting increased inflammatory response in asthmatic and cystic fibrosis subjects.

Avoid use in patients at risk for or with a history of heart attack, as arginine may worsen outcomes and increase the risk of mortality.

Avoid use in breast cancer patients.

Avoid with known allergy or hypersensitivity to arginine. Symptoms may include rash, itching, or shortness of breath. Anaphylaxis has occurred after arginine injections. In clinical research, one patient experienced a mild allergic skin reaction to intravenous L-arginine. Hives have been reported.

Avoid in pregnant or breastfeeding women, due to a lack of sufficient available safety and efficacy data.

Pregnancy and Breastfeeding

Avoid in pregnant or breastfeeding women, due to a lack of sufficient available safety and efficacy data.

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