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Is Lithium Orotate safe?

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Lithium Orotate is gaining traction as a supplement, yet it remains relatively poorly studied. It’s not surprising when you think about it. Studies into supplements and medications are funded by pharmaceutical companies, and when it comes to Lithium Orotate there is little financial gain to be had.

As it stands, we just don’t know for sure exactly how the body absorbs and utilises Lithium Orotate. But we can extrapolate from existing data and draw reasonable conclusions. First, let’s take a look at what we do know about Lithium Carbonate, the most extensively studied form of Lithium.

What are the side effects of Lithium Carbonate?

Lithium occurs naturally in the soil, and therefore in foods. With soil nutrient depletion and extensive water filtration, the levels we naturally consume have decreased, but back in 1985 the US Environmental Protection Agency (EPA) suggested that a normal adult intake was up to 3.1 mg per day. It’s reasonable to expect, then, that at these levels – levels which are comparable to those contained in Lithium Orotate supplements – side effects would not be expected.

On the other hand, prescribed doses of Lithium Carbonate – the formulation of choice for most doctors – massively exceed natural levels of exposure, and a range of side effects have been documented, including increased thirst and urination, dry mouth, hand tremors, confusion, impaired memory, headaches, and muscle weakness.

Lithium Carbonate can also increase intestinal inflammation, causing nausea, vomiting and diarrhoea, and has been associated with weight gain. Lithium Carbonate use during pregnancy has been loosely associated with occasional birth defects, though a clear link has not been established. Lithium Carbonate has also been shown to alter blood electrolyte levels and increase cortisol production, though the clinical significance of this is unclear.

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What are the side effects of Lithium Orotate?

Thankfully, the side-effect profile for Lithium Orotate appears to be much milder. While no peer-reviewed studies have properly evaluated its side effects, Jonathan V. Wright, M.D., a doctor at the Tahoma Clinic, has been using and prescribing Lithium Orotate at doses of 5 to 20 mg elemental Lithium per day for around 30 years and has observed no significant side effects. A 2015 report on Lithium as a nutrient mentions an unpublished case where a patient reported using Lithium Orotate at a dose rate of 10 mg elemental Lithium per day for self-diagnosed bipolar disorder, with no signs of toxicity. And that’s to say nothing of the thousands of anecdotal reports of its safety scattered across the internet.

That’s not to say side effects aren’t possible. In 1986 Sartori documented mild apathy, inappetence, and weakness in eight of forty-two patients receiving Lithium Orotate at a dose rate of 150 mg once daily. However, the author reported that these effects disappeared when the frequency of dosing was reduced to four to five times weekly.

One case report documents nausea, vomiting, and slight tremors resulting from Lithium Orotate ingestion, but these side effects occurred after consumption of 18 standard doses (a total dose of 68.9 mg elemental Lithium – comparable to a standard dose of Lithium Carbonate) and resolved within three hours.

It’s true that the safety of Lithium Orotate has not been proven. But it’s also true that, since the beginnings of its use over four decades ago, no instances of death or severe side effects of Lithium Orotate have ever been reported.

Can Lithium Orotate cause organ damage?

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Most medications and supplements have a margin of safety beyond which their use becomes unsafe, and Lithium is no different, no matter what form it comes in.

We know that long-term Lithium Carbonate use at the levels prescribed by doctors can have deleterious effects on the kidneys, thyroid gland, and parathyroid glands. Lithium inhibits thyroid hormone release, and studies show that up to 47% of patients on long-term Lithium treatment will develop clinical hypothyroidism. Renal damage is not uncommon; in a 2015 study of almost 5000 patients who had taken Lithium for 10–29 years, about one-third of patients showed evidence of renal compromise, with 5% classified as severe or very severe.

So is this effect the same for Lithium Orotate? A 1979 study attempted to answer this question and found that kidney function was lower in rats injected with Lithium Orotate than in those given Lithium Carbonate, leading the authors to conclude that Lithium Orotate should not be considered safe. But this study had a serious flaw: the dose of Lithium Orotate was a whole order of magnitude higher than the recommended dose. It remains to be proved, but there’s a good chance that such an effect would not be observed at routinely used doses.

Lithium Carbonate, on the other hand, is routinely prescribed at very high doses. A typical dose is 900–1800 mg, of which around 170–340 mg is elemental Lithium (compared with 5 mg elemental Lithium in common Lithium Orotate supplements). The aim of Lithium Carbonate therapy is to achieve 0.6 to 1.2 mmol/L of Lithium in the blood. Yet the toxic level of Lithium is considered to be anything above 1.2–1.4 mmol/L. This means we are operating within an extremely narrow safety margin – if it can even be considered a margin at all!

Why is it that the different forms of Lithium are used at such wildly different dose levels? Some scientists believe that Lithium Orotate is likely to be absorbed and utilised by the cells of the body much more effectively than Lithium Carbonate, meaning lower concentrations are required to give the same effect. This certainly seems to be many users’ experience. However, this too remains unproven, and one study presents evidence that appears to contradict this theory. For more on the differences between Lithium Carbonate and Lithium Orotate, see ‘What are the different forms of Lithium?

What about the Orotate component?

Despite the fact that Orotate naturally occurs in our diet and is actually synthesised by the human body, opponents of the use of Lithium Orotate claim that Orotate may be dangerous. According to a report by the European Food Safety Authority, multiple studies have shown an association between repeated administration of Orotate to rats and tumour formation. However, this effect was seen only when Orotate was given as 0.2–1.0% of the diet; at 0.1%, no such effect was observed. The report determined a No Observed Adverse Effect Level (NOEL) of 50 mg/kg body weight per day. The amount of Orotate in standard Lithium Orotate supplements is 116.17 mg per day – a drop in the water compared with the NOEL.

So should we all be supplementing with Lithium Orotate?

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According to a 2002 article in the Journal of the American College of Nutrition, yes: “The available experimental evidence now appears to be sufficient to accept Lithium as essential; a provisional RDA for a 70 kg adult of 1,000 microg/day is suggested.” Indeed, a large body of research has found that Lithium consumption has a range of neurotrophic and neuroprotective effects that may reduce the risk of suicide, improve mood, reduce the incidence of psychiatric disease, and even prolong our lives. For more information on the benefits of Lithium supplementation, see ‘Lithium for Brain Health’.

With no definitive evidence to prove the safety of Lithium Orotate, it comes down to a personal decision as to how you choose to interpret the evidence. But no matter what, it’s important to remember the old adage ‘the dose makes the poison’. The levels of both Lithium and Orotate in supplemental doses are well below levels that have been shown to be harmful.

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