Does rosuvastatin contain wheat or gluten as an excipient?

We cross-check each rosuvastatin 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 18 product labels we checked, 10 are clean, 1 are confirmed gluten-free by the maker, and 7 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 rosuvastatin 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 rosuvastatin 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 May 17, 2026 · 18 product labels screened

Is rosuvastatin 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, 1 are confirmed gluten-free by the maker, and 7 contain an inactive ingredient (typically a source-ambiguous starch) whose botanical origin isn't fully disclosed. None contained confirmed gluten.

Drug context

About rosuvastatin

Rosuvastatin is a high-intensity statin used to lower LDL cholesterol, sold under brand names including Crestor.

Why this matters

Different manufacturers, different ingredients

Generics of rosuvastatin 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

01

Mylan manufacturer-attested gluten-free

Plogsted list · Rosuvastatin all strengths [Mylan] · label dated 2019-04-23

Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label →
02

Actavis worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Actavis] · label dated 2019-04-23
View source label →
03

Apotex worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Apotex] · label dated 2019-04-23
View source label →
04

Ascend worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Ascend] · label dated 2019-04-23
View source label →
05

Aurobindo worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Aurobindo] · label dated 2019-04-23
View source label →
06

Cadila worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Cadila] · label dated 2019-04-23
View source label →
07

Camber worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Camber] · label dated 2019-04-23
View source label →
08

Glenmark worth a call to confirm

Plogsted list · Rosuvastatin all strengths [Glenmark] · label dated 2019-04-23
View source label →
09

Aurobindo Pharma Limited nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · label dated Jun 29, 2026

Inactive ingredients ANHYDROUS DIBASIC CALCIUM PHOSPHATE · CROSPOVIDONE (120 .MU.M) · FERRIC OXIDE RED · HYPROMELLOSE 2910 (15 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE · TRIACETIN
View source label →
10

NorthStar Rx, LLC nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET [NORTHSTAR RX, LLC] · label dated Jun 22, 2026

Inactive ingredients CROSPOVIDONE, UNSPECIFIED · FERRIC OXIDE RED · HYPROMELLOSE 2910 (15 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · SODIUM BICARBONATE · TITANIUM DIOXIDE · TRIACETIN
View source label →
11

Camber Pharmaceuticals, Inc. nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN (ROSUVASTATIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · label dated Jun 18, 2026

Inactive ingredients CROSPOVIDONE · FD&C BLUE NO. 2 · FD&C RED NO. 40 · FD&C YELLOW NO. 5 · FD&C YELLOW NO. 6 · HYDROXYPROPYL CELLULOSE · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · SODIUM BICARBONATE · TALC · TITANIUM DIOXIDE · TRIACETIN
View source label →
12

Torrent Pharmaceuticals Limited nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET, COATED [TORRENT PHARMACEUTICALS LIMITED] · label dated Jun 18, 2026

Inactive ingredients CELLULOSE, MICROCRYSTALLINE · CROSPOVIDONE (15 MPA.S AT 5%) · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · TITANIUM DIOXIDE · TRIACETIN
View source label →
13

Macleods Pharmaceuticals Limited nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN TABLET [MACLEODS PHARMACEUTICALS LIMITED] · label dated Jun 08, 2026

Inactive ingredients CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS · CELLULOSE, MICROCRYSTALLINE · CROSPOVIDONE · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYPROMELLOSES · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · TITANIUM DIOXIDE · TRIACETIN
View source label →
14

Umedica Laboratories USA Inc. nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET [UMEDICA LABORATORIES USA INC.] · label dated Jun 05, 2026

Inactive ingredients CROSPOVIDONE, UNSPECIFIED · FERRIC OXIDE RED · HYPROMELLOSE 2910 (15 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · SODIUM BICARBONATE · TITANIUM DIOXIDE · TRIACETIN
View source label →
15

Shandong New Time Pharmaceutical Co., Ltd. nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET, FILM COATED [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] · label dated May 28, 2026

Inactive ingredients CROSPOVIDONE · FERRIC OXIDE RED · HYPROMELLOSE 2910 (5 MPA.S) · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MEGLUMINE · MICROCRYSTALLINE CELLULOSE · POLYETHYLENE GLYCOL 1000 · TITANIUM DIOXIDE · TRIACETIN
View source label →
16

QPharma, Inc. nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET, FILM COATED [QPHARMA, INC.] · label dated May 25, 2026

Inactive ingredients CROSPOVIDONE (120 .MU.M) · FERRIC OXIDE RED · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · SODIUM BICARBONATE · TITANIUM DIOXIDE · TRIACETIN
View source label →
17

AstraZeneca Pharmaceuticals LP nothing flagged on the label

US label (DailyMed) · CRESTOR (ROSUVASTATIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] · label dated May 13, 2026

Inactive ingredients CROSPOVIDONE (120 .MU.M) · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE · TRIACETIN · TRIBASIC CALCIUM PHOSPHATE
View source label →
18

Northwind Health Company, LLC nothing flagged on the label

US label (DailyMed) · ROSUVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND HEALTH COMPANY, LLC] · label dated Mar 04, 2026

Inactive ingredients CROSPOVIDONE (120 .MU.M) · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM OXIDE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE · TRIACETIN
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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