Immune & Inflammation · Dosing reference

PEA dosage

What the human evidence does and does not show, how long studies ran, and the arithmetic for working with vials.

Not approved — research use onlyAHuman trial evidenceNone established

Full research page Cycle-length evidence Compare Prefer Amiravo on Google

Regulatory status: Not approved — research use only
Human amounts: None established in humans
Route studied: Oral in the human trials reviewed (micronized, ultramicronized and water-dispersible formulations), with topical formulations in dermatology studies
Frequency: Not established
Half-life: Not established
Evidence grade: Grade A · Human trial evidence
Vial sizes on the market: Not recorded
Other forms seen: Oral capsules 400 mg · Oral capsules 600 mg

What PEA is

Palmitoylethanolamide, an endogenous fatty acid amide, investigated in laboratory models of inflammation and nociceptive signaling through PPAR-alpha related pathways.

PEA is an N-acylethanolamine: the amide formed between palmitic acid and ethanolamine, structurally related to the endocannabinoid anandamide but saturated and without appreciable direct affinity for the classical cannabinoid receptors ^1,13. PPAR-alpha In cell assays PEA selectively activated the nuclear receptor peroxisome proliferator-activated receptor-alpha (PPAR-alpha), and topical application induced… How it works →

Key evidence

Lo Verme et al., Mol Pharmacol · 2005 · Mice and cell assays
PEA activated PPAR-alpha in vitro and reduced oedema in wild-type but not PPAR-alpha-deficient mice, identifying PPAR-alpha as the receptor mediating its anti-inflammatory action. ³
Lang-Illievich et al., Nutrients · 2023 · Humans (adults with chronic pain)
Pooled pain intensity scores were lower with PEA than with placebo or active comparators; the authors reported that no major side effects were attributed to PEA in the included studies. ²
Bortoletto et al., Brain Behav Immun Health · 2025 · Humans (mixed patient populations)
48 outputs from 47 randomized trials were extracted across neuropsychiatric, neurological, somatic and visceral conditions; the authors judged the strongest evidence to be in pain management and general wellbeing, chiefly with micronized, ultramicronized or cold-water-dispersible formulations. ⁴

All studies on the research page

What the human evidence shows

No approved or established human dose

Human studies of PEA are listed below by design, population and duration. None was designed or powered to establish an amount, and Amiravo does not reproduce their amounts for a compound approved nowhere.

A single-site, comparative, double-blind, placebo-controlled trial randomized 111 adults with mild to moderate knee osteoarthritis to two oral palmitoylethanolamide levels or placebo in divided doses for 8 weeks, with the WOMAC index as the primary outcome and numerical rating scales for pain and the Depression Anxiety Stress Scale as secondary outcomes; WOMAC total, pain and stiffness scores fell more than placebo in both active groups ^19.
A single-centre, quadruple-blinded, placebo-controlled trial gave 70 participants with type 1 or type 2 diabetes and peripheral neuropathic pain an oral palmitoylethanolamide formulation or placebo for 8 weeks (94% completion), measuring BPI-DPN and NPSI pain scores, MOS sleep scale, DASS-21, glucose metabolism and inflammatory markers; pain scores, depression scores, interleukin-6 and C-reactive protein fell in the treated group ^20.
A randomized, double-blind, placebo-controlled, parallel multicentre trial randomized 73 individuals with neuropathic pain after spinal cord injury (68 analysed) to ultramicronized palmitoylethanolamide or placebo as add-on therapy for 12 weeks; there was no difference in mean pain intensity (p = 0.46) and no effect on spasticity, insomnia or psychological functioning ^21.
A randomized, double-blind, placebo-controlled trial randomized 58 patients with major depressive disorder and a Hamilton Depression Rating Scale score of 19 or more to oral palmitoylethanolamide or placebo added to citalopram for six weeks (54 completed), with HAM-D assessed at baseline and weeks 2, 4 and 6; the treated group showed greater reduction in HAM-D scores ^22.
A randomized, parallel-group, double-blind placebo-controlled trial randomized 70 children aged 4 to 12 with autism and moderate to severe irritability to risperidone plus palmitoylethanolamide or risperidone plus placebo over 10 weeks, with the Aberrant Behavior Checklist-Community Edition as the outcome measure ^23.
A randomized, double-blind, placebo-controlled trial in patients in the acute phase of mania added palmitoylethanolamide or placebo to lithium and risperidone for 6 weeks (63 completed), assessing the Young Mania Rating Scale, Hamilton Depression Rating Scale and Extrapyramidal Symptom Rating Scale at baseline and weeks 1, 2, 4 and 6 ^24.
A double-blind randomized placebo-controlled trial conducted October 2020 to March 2021 (NCT04912921) randomized unvaccinated, non-hospitalised adults aged 19 to 53 recently diagnosed with COVID-19 to an oral palmitoylethanolamide preparation or placebo for 4 weeks, with 60 completing; soluble P-selectin, IL-1beta and IL-2 concentrations fell relative to placebo ^25.
A double-blind, randomised, placebo-controlled trial in 426 participants assessed an oral palmitoylethanolamide preparation against placebo for the incidence, duration and severity of upper respiratory tract infections, recorded with the Upper Respiratory Symptom Survey 24 questionnaire; fewer episodes were reported in the treated group (39 versus 64) ^26.
A randomized, double-blinded, placebo-controlled crossover trial in 14 healthy volunteers gave oral palmitoylethanolamide or placebo for 4 weeks each and used a repetitive phasic heat pain model to assess peripheral and central sensitization and pain modulation; repetitive heat pain, wind-up ratio and allodynia distance decreased and cold, pressure and heat pain tolerance increased after the active period ^7.
A double-blind crossover study in 11 healthy men gave oral palmitoylethanolamide or maltodextrin placebo around an acute bout of eccentric knee-extensor exercise, with maximal voluntary contraction, jump height, blood samples and muscle biopsies to 120 hours; the supplement did not affect muscle soreness, strength, jump performance or markers of muscle damage ^8.
A randomized, double-blind, placebo-controlled crossover study in Australia from May to December 2023 gave adults oral palmitoylethanolamide or placebo at the onset of menstrual pain, with numerical rating scale pain scores every 30 minutes for up to 4 hours and a second dose permitted after 2 hours; pain scores were lower than placebo at several time points ^9.
A randomized, placebo-controlled trial assigned 60 patients with DSM-5 post-traumatic stress disorder to ultramicronized palmitoylethanolamide, that preparation plus cognitive behavioural therapy, placebo, or placebo plus therapy, with assessment at five time points over 18 months using the PCL-5 and the Hamilton Anxiety Rating Scale ^10.

How long did human studies run?

The knee osteoarthritis and diabetic neuropathic pain trials each treated for 8 weeks ^19,20; the spinal cord injury trial treated for 12 weeks with a 1-week baseline diary period ^21.
The major depressive disorder trial ran 6 weeks, the autism trial 10 weeks with an interim assessment at week 5, and the acute mania trial 6 weeks ^22,23,24.
The COVID-19 inflammation trial supplemented for 4 weeks with blood sampling at baseline and week 4 ^25; the healthy-volunteer pain-model crossover used 4-week periods ^7.
The menstrual pain crossover used single administrations at pain onset with observation for up to 4 hours; the PTSD trial followed participants for 18 months ^9,10.

Cycle-length evidence for PEA

Who was excluded from the studies

A registry record for a phase IIA study of an ultramicronized palmitoylethanolamide product (FSD201, NCT04619706) is listed on ClinicalTrials.gov; populations in the trials above were defined by condition, with the autism trial limited to children aged 4 to 12 and the COVID-19 inflammation trial limited to unvaccinated, non-hospitalised adults aged 19 to 53 ^17.
The PTSD trial enrolled only patients meeting DSM-5 criteria for post-traumatic stress disorder, and the spinal cord injury trial only individuals with neuropathic pain due to spinal cord injury, as add-on therapy to existing treatment ^10,21.

Side effects reported in studies

No major adverse events attributed to PEA in pooled double-blind trials
Not quantified · 11 double-blind randomized trials, 774 patients with chronic pain ²
Adverse events described as mild and self-limited
Not quantified; safety data described by the authors as limited · 3 trials, 188 patients with diabetic neuropathic pain ⁶
Adverse events did not differ from placebo
No between-arm difference reported · Randomized crossover trial in adults with menstrual pain ⁹
No serious adverse events reported
0 reported · Randomized PTSD trial, 60 participants over 18 months ¹⁰

Full adverse-event data

PEA draw calculator

Pick the vial strength and the water added, enter an amount, and see the concentration, the units to draw and how many draws the vial holds. Arithmetic only.

1 · Vial strength

2 · Water added

3 · Amount per draw

4 · Syringe

Your mix

10 mg + 2 mL water = 5 mg/mL

10 units holds 0.5 mg (500 mcg)

Draw toEnter an amount in step 3

U-100 syringe · 100 units = 1 mL

Computed from your inputs. Not a dose or a recommendation.

Compare water volumes for this vialShow

More water = lower concentration = a larger, easier-to-measure draw. Tap a row to use it.

Water	mg/mL	Draw
0.5 mL	20	—
1 mL	10	—
1.5 mL	6.667	—
2 mL	5	—
2.5 mL	4	—
3 mL	3.333	—
5 mL	2	—

Supplies and handling

Lyophilized vial
Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
Sterile diluent
The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
Graduated syringes
Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
Alcohol prep pads
For wiping vial stoppers before each puncture.
Nitrile gloves
Clean gloves for aseptic handling.
Sharps container
Puncture-resistant container for used needles.

Step-by-step reconstitution guide Storage and transport accessories

Storage

General research-context handling only. PEA is supplied as a crystalline solid rather than a lyophilised peptide, and is poorly soluble in water ^12. Keep containers closed, dry and protected from light and heat, and follow the storage conditions and retest date given in the supplier's documentation for the specific lot and grade; nothing here is a preparation or handling instruction.

Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent: The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed: Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles: Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution: This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed: Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status: Palmitoylethanolamide has no approved drug application in the United States; openFDA queries of Drugs@FDA application data for "palmitoylethanolamide" and "palmidrol" returned no records on 22 October 2026 ^14. It is, however, widely marketed in the United States as a dietary supplement ingredient: a Dietary Supplement Label Database search returned 718 US supplement labels containing it ^15. In Europe it has been marketed under food law rather than drug law, and peer-reviewed sources describe it as sold as a "dietary food for special medical purposes" ^7,11. An ultramicronized PEA preparation has separately been taken into registered interventional drug trials under the code FSD201 ^17.
United States (FDA): Not approved as a drug. openFDA queries of Drugs@FDA application data for "palmitoylethanolamide" and for the synonym "palmidrol" returned no matching applications on 22 October 2026 ^14. Palmitoylethanolamide does not appear in FDA's document "Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act" (updated May 14, 2026) in category 1, 2 or 3 ^18. Separately, it is marketed in the United States as a dietary supplement ingredient rather than as a drug: a Dietary Supplement Label Database search returned 718 US labels containing palmitoylethanolamide ^15. An ultramicronized preparation has been studied as an investigational drug under the code FSD201 in a registered phase IIA trial that was terminated for recruitment difficulties ^17. This page states no dosing for PEA in any of these settings.
Sport (WADA): Not named. Full-document searches of the WADA 2026 Prohibited List for "palmitoylethanolamide" and "ethanolamide" return nothing, so PEA is not a named prohibited substance for 2026 ^16. The list's categories are written as open classes, so the absence of a name is hedged negative evidence and not a clearance; athletes should consult their anti-doping organisation.

Status varies by country and changes over time. How we describe regulatory status.

PEA compared with related compounds

Compound	Status	Evidence	Human amounts	Half-life
PEA	Not approved — research use only	A	None established	—
Thymulin	Not approved — research use only	C	None established	Not located in the sources reviewed for
Larazotide	Investigational	B	Trial doses	—
LL-37	Not approved — research use only	B	None established	—
KPV	Not approved — research use only	C	None established	—
Thymosin Alpha-1	Approved outside the US	B	None established	—

Frequently asked questions

What doses of PEA have been studied in humans?

None that establish an amount. PEA is not approved anywhere and the human studies that exist are small and were not designed to find a dose. Amiravo does not publish community or vendor figures.

Is there an established PEA cycle length?

No cycle length or break has been established. Human studies administered PEA for the periods listed on this page; those are study durations, not a recommended course.

How much bacteriostatic water should be added to a PEA vial?

There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.

How many units is a given amount on an insulin syringe?

On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.

Is PEA FDA-approved?

Not approved — research use only. Palmitoylethanolamide has no approved drug application in the United States; openFDA queries of Drugs@FDA application data for "palmitoylethanolamide" and "palmidrol" returned no records on 22 October 2026 ^14. It is, however, widely marketed in the United States as a dietary supplement ingredient: a Dietary Supplement Label Database search returned 718 US supplement labels containing it ^15. In Europe it has been marketed under food law rather than drug law, and peer-reviewed sources describe it as sold as a "dietary food for special medical purposes" ^7,11. An ultramicronized PEA preparation has separately been taken into registered interventional drug trials under the code FSD201 ^17.

References

Last reviewed October 23, 2026 by the Amiravo editorial team. Editorial policy · Report an error