Does fluoxetine contain wheat or gluten as an excipient?

We cross-check each fluoxetine product label against four data sources: DailyMed (FDA Structured Product Labels), the European Medicines Agency centrally-authorised medicines database, the Plogsted curated gluten-free drug list, and the 2024 Mangione et al. pediatric pharmacy NDC analysis. Inactive ingredients are scanned against a 146-entry red-flag dictionary covering wheat, barley, rye, malt, source-ambiguous starches, and FDA gluten-free attestation phrases. Mostly yes — but worth a quick call to the manufacturer for some generics. Of 11 product labels we checked, 10 are clean, 0 are confirmed gluten-free by the maker, and 1 contain an inactive ingredient (typically a source-ambiguous starch) whose botanical origin isn't fully disclosed. None contained confirmed gluten.

Can different manufacturers' generic versions of fluoxetine have different gluten status?

Yes. Generics in the United States must use the same active ingredient as the brand, but they are not required to use the same inactive ingredients. Two generics of fluoxetine from different manufacturers can use entirely different starch sources, binders, and fillers. A pharmacy may also switch which manufacturer it dispenses between fills without notifying you. Each manufacturer-specific entry below corresponds to a separately-filed product label.

DailyMed checked live · reference data updated August 19, 2026 · 11 product labels screened

Is fluoxetine gluten-free?

By Ned Walsch

Founder and maintainer of Gluten Screen

Updated August 20, 2026

Not clinically reviewed — verify with your pharmacist

Looks mostly clean — worth verifying with the maker. Mostly yes — but worth a quick call to the manufacturer for some generics. Of 11 product labels we checked, 10 are clean, 0 are confirmed gluten-free by the maker, and 1 contain an inactive ingredient (typically a source-ambiguous starch) whose botanical origin isn't fully disclosed. None contained confirmed gluten.

Drug context

About fluoxetine

Fluoxetine is an SSRI antidepressant for depression, OCD, bulimia, and panic disorder, sold under brand names including Prozac.

Why this matters

Different manufacturers, different ingredients

Generics of fluoxetine use the same active ingredient, but they aren't required to use the same inactive ingredients. Your pharmacy may switch which manufacturer they dispense between fills, sometimes without telling you. The list below shows each manufacturer's product label as a separate entry, because that's the granularity that actually matters when you're celiac.

The labels

The 11 we checked

01

Barr worth a call to confirm

Plogsted list · Fluoxetine-all strengths/forms (Barr, Par, Sandoz) · label dated 2017-04-28
View source label →
02

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. nothing flagged on the label

US label (DailyMed) · FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · label dated Aug 13, 2026

Inactive ingredients AMMONIA · BUTYL ALCOHOL · FD&C BLUE NO. 1 · FD&C YELLOW NO. 6 · FERRIC OXIDE YELLOW · FERROSOFERRIC OXIDE · GELATIN · ISOPROPYL ALCOHOL · MAGNESIUM STEARATE · PROPYLENE GLYCOL · SHELLAC · STARCH, CORN · TITANIUM DIOXIDE
View source label →
03

Aphena Pharma Solutions - Tennessee, LLC nothing flagged on the label

US label (DailyMed) · FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · label dated Aug 07, 2026

Inactive ingredients AMMONIA · D&C YELLOW NO. 10 · FD&C BLUE NO. 1 · FERROSOFERRIC OXIDE · GELATIN, UNSPECIFIED · POTASSIUM HYDROXIDE · PROPYLENE GLYCOL · SHELLAC · SILICON DIOXIDE · SODIUM LAURYL SULFATE · STARCH, CORN · TITANIUM DIOXIDE
View source label →
04

Dr.Reddy's Laboratories Limited nothing flagged on the label

US label (DailyMed) · FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMI… · label dated Aug 06, 2026

Inactive ingredients HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) · ferric oxide red · ferric oxide yellow · ferrosoferric oxide · gelatin · glycine · hypromelloses · isopropyl alcohol · methylene chloride · povidone · raw sugar · talc · titanium dioxide · triethyl citrate
View source label →
05

Aurobindo Pharma Limited nothing flagged on the label

US label (DailyMed) · FLUOXETINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · label dated Jul 21, 2026

Inactive ingredients HYPROMELLOSE 2910 (5 MPA.S) · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · POLYETHYLENE GLYCOL 400 · POVIDONE K30 · STARCH, CORN · TITANIUM DIOXIDE
View source label →
06

Aurobindo Pharma Limited nothing flagged on the label

US label (DailyMed) · FLUOXETINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · label dated Jul 21, 2026

Inactive ingredients GLYCERIN · HYPROMELLOSE 2910 (6 MPA.S) · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · POLYSORBATE 80 · POVIDONE K30 · STARCH, CORN · SUCROSE · TITANIUM DIOXIDE
View source label →
07

Sun Pharmaceutical Industries, Inc. nothing flagged on the label

US label (DailyMed) · FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [SUN PHARMACEUT… · label dated Jul 16, 2026

Inactive ingredients HYPROMELLOSE 2910 (3 MPA.S) · HYPROMELLOSE 2910 (6 MPA.S) · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · POLYETHYLENE GLYCOL 400 · POLYSORBATE 80 · POVIDONE K30 · STARCH, CORN · TITANIUM DIOXIDE
View source label →
08

Par Health USA, LLC nothing flagged on the label

US label (DailyMed) · FLUOXETINE HYDROCHLORIDE TABLET, COATED [PAR HEALTH USA, LLC] · label dated Jun 26, 2026

Inactive ingredients CELLULOSE, MICROCRYSTALLINE · CROSPOVIDONE · MAGNESIUM STEARATE · POLYETHYLENE GLYCOL, UNSPECIFIED · POLYVINYL ALCOHOL, UNSPECIFIED · SILICON DIOXIDE · STARCH, CORN · TALC · TITANIUM DIOXIDE
View source label →
09

Unit Dose Solutions, Inc. nothing flagged on the label

US label (DailyMed) · FLUOXETINE CAPSULE [UNIT DOSE SOLUTIONS, INC.] · label dated Jun 23, 2026

Inactive ingredients AMMONIA · FD&C BLUE NO. 1 · FERRIC OXIDE YELLOW · FERROSOFERRIC OXIDE · GELATIN, UNSPECIFIED · POTASSIUM HYDROXIDE · PROPYLENE GLYCOL · SHELLAC · SODIUM LAURYL SULFATE · STARCH, CORN · TITANIUM DIOXIDE
View source label →
10

Direct_rx nothing flagged on the label

US label (DailyMed) · FLUOXETINE HCL CAPSULE [DIRECT_RX] · label dated Jun 18, 2026

Inactive ingredients AMMONIA · D&C YELLOW NO. 10 · FD&C BLUE NO. 1 · FERROSOFERRIC OXIDE · GELATIN, UNSPECIFIED · POTASSIUM HYDROXIDE · PROPYLENE GLYCOL · SHELLAC · SILICON DIOXIDE · SODIUM LAURYL SULFATE · STARCH, CORN · TITANIUM DIOXIDE
View source label →
11

Par Health USA, LLC nothing flagged on the label

US label (DailyMed) · FLUOXETINE TABLET, FILM COATED [PAR HEALTH USA, LLC] · label dated Jun 15, 2026

Inactive ingredients CROSPOVIDONE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · POLYETHYLENE GLYCOL 3350 · POLYVINYL ALCOHOL, UNSPECIFIED · SILICON DIOXIDE · STARCH, CORN · TALC · TITANIUM DIOXIDE
View source label →

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Background

What “gluten in a medication” actually means

Gluten enters drugs through their excipients — the inactive ingredients used to bind, coat, fill, or stabilize the dose. The main concern is wheat starch as a filler. Source-ambiguous starches (plain “starch”, pregelatinized starch, sodium starch glycolate, modified starch) get flagged for verification because their botanical origin isn't always disclosed on the label.

The 2024 Mangione et al. pediatric NDC analysis (689 NDCs across the top 100 pediatric medications) found 1.5% contained gluten outright; another 25.7% couldn't be confirmed either way. Liquid and oral-suspension formulations carry disproportionate risk because wheat starch is a common thickener. Full methodology →

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