Is montelukast gluten-free?
Looks mostly clean — worth verifying with the maker. Mostly yes — but worth a quick call to the manufacturer for some generics. Of 18 product labels we checked, 10 are clean, 5 are confirmed gluten-free by the maker, and 3 contain an inactive ingredient (typically a source-ambiguous starch) whose botanical origin isn't fully disclosed. None contained confirmed gluten.
Drug context
About montelukast
Montelukast is a leukotriene receptor antagonist used for asthma and allergic rhinitis, sold under brand names including Singulair.
Why this matters
Different manufacturers, different ingredients
Generics of montelukast 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 18 we checked
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01Mylan manufacturer-attested gluten-free
Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label → -
02Teva manufacturer-attested gluten-free
Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label → -
03Mylan manufacturer-attested gluten-free
Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label → -
04Teva manufacturer-attested gluten-free
Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
Worth a call to the maker: Maltodextrin
View source label → -
05Mylan manufacturer-attested gluten-free
Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label → -
06Accord worth a call to confirmView source label →
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07Apotex worth a call to confirmView source label →
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08Aurobindo worth a call to confirmView source label →
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09Aurobindo Pharma Limited nothing flagged on the label
Inactive ingredients ASPARTAME · CARNAUBA WAX · CHERRY · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE
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10Unichem Pharmaceuticals (USA), Inc. nothing flagged on the label
Inactive ingredients ASPARTAME · CARNAUBA WAX · CHERRY · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE, UNSPECIFIED · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE 112 · TITANIUM DIOXIDE
View source label → -
11Amneal Pharmaceuticals LLC nothing flagged on the label
Inactive ingredients CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · FERROSOFERRIC OXIDE · HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED · HYPROMELLOSES · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · TITANIUM DIOXIDE
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12Coupler LLC nothing flagged on the label
Inactive ingredients CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · EDETATE DISODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE, UNSPECIFIED · HYPROMELLOSE 2910 (6 MPA.S) · ISOPROPYL ALCOHOL · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · TITANIUM DIOXIDE
View source label → -
13Torrent Pharmaceuticals Limited nothing flagged on the label
Inactive ingredients ASPARTAME · CELLULOSE, MICROCRYSTALLINE · CHERRY · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · SODIUM PHOSPHATE, TRIBASIC · TITANIUM DIOXIDE
View source label → -
14Rising Pharma Holdings, Inc. nothing flagged on the label
Inactive ingredients ASPARTAME · CARNAUBA WAX · CHERRY · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE
View source label → -
15Redpharm Drug nothing flagged on the label
Inactive ingredients CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · EDETATE DISODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE, UNSPECIFIED · HYPROMELLOSE 2910 (6 MPA.S) · ISOPROPYL ALCOHOL · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · TITANIUM DIOXIDE
View source label → -
16Ajanta Pharma USA Inc. nothing flagged on the label
Inactive ingredients ASPARTAME · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE
View source label → -
17Redpharm Drug nothing flagged on the label
Inactive ingredients CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (TYPE L) · HYPROMELLOSE 2910 (6 MPA.S) · MAGNESIUM STEARATE · POLYETHYLENE GLYCOL 6000 · TITANIUM DIOXIDE
View source label → -
18Chartwell RX, LLC nothing flagged on the label
Inactive ingredients BUTYLATED HYDROXYANISOLE · CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSES · MANNITOL · SILICON DIOXIDE · SODIUM STEARYL FUMARATE · SUCRALOSE
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.
Matson, Forbes and Burton (J Pediatr Pharmacol Ther, Jun 2025) asked every manufacturer of 689 NDCs behind the top 100 US pediatric medicines: 1.5% (10 NDCs) contained gluten, 25.7% could not be confirmed either way, and 95 of the 100 medicines had at least one confirmed gluten-free option. Dosage form is not a safe proxy — eight of the nine gluten-containing NDCs the paper names are tablets or capsules. Full methodology →
Questions this page answers
Which sources does Gluten Screen check for montelukast?
Four: DailyMed (FDA Structured Product Labels, fetched live and cached up to 7 days), the European Medicines Agency's centrally-authorised leaflets (1,777 products, re-parsed October 2026), the Plogsted curated list (structured list last updated 23 April 2019), and the NDC prefixes published by Matson, Forbes and Burton in J Pediatr Pharmacol Ther 2025;30(3):367–371. Each label's inactive ingredients are matched against a 163-entry dictionary of 489 name patterns and 155 FDA UNII substance codes covering wheat, barley, rye, malt and source-ambiguous starches.
Can different manufacturers' generic versions of montelukast 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 montelukast 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 on this page corresponds to a separately-filed product label.
Should I stop taking montelukast if a label is flagged?
No. Do not stop a prescribed medicine because of a label flag; stopping abruptly is usually far more dangerous than trace gluten. Take the result to your pharmacist or prescriber and ask whether another manufacturer of the same drug can be ordered. A flagged result means the label named a gluten source or left a starch source unstated; a "nothing flagged" result means it did not, which is not a certification.
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