does the lurasidone label say to take it with at least 350 calories?
“Luracidone needs a meal of at least 350 calories.”
a host said on Psychopharmacology and Psychiatry Updates, 2026-10-28, at 11:09. hear it in context →
the episode: First-Episode Psychosis in Women (at 11:09). we link the show's own page; we do not re-host audio.
first, the part that holds
the host has it right. the US prescribing information for lurasidone says, in its dosing section and again in its highlights, that the tablets "should be taken with food (at least 350 calories)."
what we found when we went and looked
we read the FDA-approved label in three copies: the 2019 reference label on accessdata.fda.gov, a generic label revised 2023-11-01, and a current generic label on DailyMed. all three say in section 2.3 that lurasidone "should be taken with food (at least 350 calories)." section 12.3 explains why. in the label's food-effect study, peak level (Cmax) was about 3 times higher and total exposure (AUC) about 2 times higher with food than when fasting. the label also says exposure "was not affected as meal size was increased from 350 to 1000 calories and was independent of meal fat content." the 350 figure is a US-label detail: the EU product information we read says only "together with a meal" and gives no calorie number.
assertion by assertion
| assertion | verdict | what the record says |
|---|---|---|
| the lurasidone label says to take it with a meal of at least 350 calories | confirmed | US prescribing information, section 2.3 and highlights: "should be taken with food (at least 350 calories)." the wording is the same in the 2019 reference label and in the generic labels we read (one revised 2023-11-01). the label says "should", which is a dosing instruction. it is not a contraindication, so "requires" is a fair paraphrase but a little stronger than the text. [1][2][3] |
| taking it with food makes a large difference to how much drug is absorbed | confirmed | US label, section 12.3: with food, mean Cmax was about 3 times and AUC about 2 times the fasting levels. the EU product information gives a range of about 2-3 times for Cmax and 1.5-2 times for AUC. [1][4] |
| bigger or fattier meals push levels higher still | false | US label, section 12.3: exposure "was not affected as meal size was increased from 350 to 1000 calories and was independent of meal fat content." the 350 figure is the smallest meal tested, and going above it added nothing in that study. [1] |
| the 350-calorie figure appears in every regulator's label | overstated | EU product information, section 4.2: "to be taken once daily together with a meal. If taken without food, it is anticipated that lurasidone exposure will be significantly lower." the sections we read (4.2 and the food-effect paragraph in 5.2) give no calorie number. both regulators require food, but the 350 number comes from the US label. [4] |
both directions
for the speaker: the 350-calorie wording is in the US label's highlights, section 2.3 and section 12.3, and it is the same in the 2019 reference label and in generic labels revised as recently as 2023. the label also says patients in the pivotal trials were told to take their dose with food, so the efficacy data come from people taking it with a meal. the food effect is large (about 3 times the peak level, 2 times total exposure), which explains why the label treats this as a dosing instruction and not a footnote.
against: little cuts against the speaker. the label says "should", not "must", so "requires" is a slightly stronger word than the text uses. the number also tends to get misread. 350 calories is a floor, the smallest meal tested. the label reports no extra absorption from meals up to 1000 calories and no effect of fat content, so a heavier or fattier meal does not help. outside the US, the EU product information asks for "a meal" and does not name a calorie threshold in the sections we read.
what this cannot say
the label reports the food-effect study as a summary: it does not give the number of participants, the meals or the variability. the label does not say what happens with meals under 350 calories, between none and 350, because they were not tested. for the EU document we read sections 4.2 and the food-effect paragraph of 5.2, not every page, and we read a current EU version, not its revision history. we did not read the underlying FDA clinical pharmacology review. our check covers what the label says. it does not cover whether any one person's response changes with meal size.
sources, each one fetched and read
- US FDA, lurasidone hydrochloride tablets prescribing information, NDA 200603, revised 12/2019 (Reference ID 4528369) What we read there: highlights: "should be taken with food (at least 350 calories)." section 12.3: "In a food effect study, [lurasidone] mean Cmax and AUC were about 3-times and 2-times, respectively, when administered with food compared to the levels observed under fasting conditions. [Lurasidone] exposure was not affected as meal size was increased from 350 to 1000 calories and was independent of meal fat content." Fetched 2026-10-29 (HTTP 200). https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf
- US FDA structured product label, lurasidone hydrochloride tablets (generic), revised 2023-11-01 What we read there: section 2.3: "Lurasidone hydrochloride tablets should be taken with food (at least 350 calories)." "Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold." "In the clinical studies, lurasidone hydrochloride tablets were administered with food." Fetched 2026-10-29 (HTTP 200). https://www.accessdata.fda.gov/spl/data/5c5f8dc7-3941-42be-8e7f-3c5027ac570e/5c5f8dc7-3941-42be-8e7f-3c5027ac570e.xml
- NLM DailyMed, lurasidone hydrochloride tablets prescribing information (generic), setid 1989d512-e568-468f-e063-6294a90a5c22 What we read there: section 2.3: "Lurasidone hydrochloride tablets should be taken with food (at least 350 calories)." "Administration with food substantially increases the absorption of lurasidone." Fetched 2026-10-29 (HTTP 200). https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1989d512-e568-468f-e063-6294a90a5c22&type=display
- European Medicines Agency, lurasidone EPAR product information (summary of product characteristics), EU/1/14/913 What we read there: section 4.2: "to be taken once daily together with a meal. If taken without food, it is anticipated that lurasidone exposure will be significantly lower as compared to when taken with food." section 5.2: "lurasidone mean Cmax and AUC increased approximately by 2-3-times and 1.5-2-times, respectively, when administered with food." Fetched 2026-10-29 (HTTP 200). https://www.ema.europa.eu/en/documents/product-information/latuda-epar-product-information_en.pdf
speakers are described by role, not named. one sentence is quoted under fair use, with attribution and a link to the original at the timestamp; we do not re-host audio or video. nothing on this page is a reason to start, stop or change a medication. if you have the file behind anything marked unverifiable, the research board is where people can answer. adam