Patient information: uses, side effects, how to take - Accrufer
What is ACCRUFER?
ACCRUFER is a prescription medicine used in adults and children 10 years of age and older to treat low iron stores in your body.
It is not known if ACCRUFER is safe and effective in children under 10 years of age.
Do not take ACCRUFER if you:
- are allergic to ferric maltol or any of the ingredients in ACCRUFER. See the end of this leaflet for a complete list of ingredients in ACCRUFER.
- have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron.
- are receiving repeated blood transfusions.
Before taking ACCRUFER, tell your healthcare provider about all your medical conditions, including if you:
- have inflammatory bowel disease (IBD).
are pregnant or plan to become pregnant. It is not known if ACCRUFER will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ACCRUFER passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ACCRUFER.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking ACCRUFER with certain other medicines may affect each other causing serious side effects.
You may need to take ACCRUFER at least 4 hours before or 4 hours after you take certain medicines. Ask your healthcare provider for a list of these medicines if you are not sure if you take one of these medicines.
Especially tell your healthcare provider if you take:
- dimercaprol
- other oral iron tablets or health supplements containing iron
Ask your healthcare provider if you are not sure if you take one of these medicines.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ACCRUFER?
- Take ACCRUFER exactly as your healthcare provider tells you to.
Take ACCRUFER 2 times a day on an empty stomach 1 hour before or 2 hours after meals.
- Swallow ACCRUFER capsules whole. Do not open, break, or chew ACCRUFER capsules.
- In case of accidental overdose, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects of ACCRUFER?
ACCRUFER may cause serious side effects, including:
- Increased risk of inflammatory bowel disease (IBD) flare.You should avoid taking ACCRUFER if you have inflammatory bowel disease (IBD) and are experiencing a flare.
- Too much iron stored in your body (iron overload).Your healthcare provider should check the iron level in your blood before you start and during treatment with ACCRUFER.
- Risk of overdose in children due to accidental swallowing.Accidental overdose of iron-containing products is a leading cause of death from poisoning in children under 6. Keep ACCRUFER in a safe place and out of the reach of children.
The most common side effects of ACCRUFER include:
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These are not all the possible side effects of ACCRUFER.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ACCRUFER?
- Store ACCRUFER at room temperature between 68°F to 77°F (20°C to 25°C).
- ACCRUFER comes in a child-resistant bottle.
Keep ACCRUFER and all medicines out of reach of children.
General information about the safe and effective use of ACCRUFER.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ACCRUFER for a condition for which it was not prescribed. Do not give ACCRUFER to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ACCRUFER that is written for health professionals.
What are the ingredients in ACCRUFER?
Active ingredient: ferric maltol
Inactive ingredients:
Capsule: colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate, sodium lauryl sulfate
Capsule Shell: FD&C Blue No. 1 FD&C Red No. 40, FD&C Yellow 6, hypromellose, titanium dioxide.
Ink: Shellac, ammonium hydroxide, ethanol, iron oxide black, propylene glycol
Distributed by Shield Therapeutics Inc, 7-57 Wells Avenue Newton, MA, 02459
US Patents 7459569, 9248148, 9802973, 10179120
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: December 2025