Accrufer

Last updated on RxList: 1/20/2021
Accrufer Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Accrufer?

Accrufer (ferric maltol) is an iron replacement product indicated for the treatment of iron deficiency in adults.

What Are Side Effects of Accrufer?

Common side effects of Accrufer include:

  • gas (flatulence),
  • diarrhea,
  • constipation,
  • discolored feces,
  • abdominal pain,
  • nausea,
  • vomiting, and
  • abdominal discomfort/distension

Dosage for Accrufer

The dose of Accrufer is 30 mg twice daily on an empty stomach.

What Drugs, Substances, or Supplements Interact with Accrufer?

Accrufer may interact with dimercaprol. Use of Accrufer with other oral drugs may decrease the bioavailability of some drugs. Separate the administration of Accrufer from these drugs. Tell your doctor all medications and supplements you use.

Accrufer During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using Accrufer; it is not expected to be harmful to a fetus. Breastfeeding is not expected to result in exposure of the child to the drug.

Additional Information

Our Accrufer (ferric maltol) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Accrufer Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Increased Risk of Inflammatory Bowel Disease Flare [see WARNINGS AND PRECAUTIONS]
  • Iron Overload [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to ACCRUFER in 175 patients in the placebo-controlled phase of three randomized studies conducted in patients with anemia and quiescent inflammatory bowel disease (IBD) (Studies AEGIS 1 & 2) or non-dialysis dependent chronic kidney disease (CKD) (AEGIS 3). The pooled patient population had a mean age of 58 years, 67.4% were female (n=118), and 81.7% (n=143) were Caucasian.

Table 1 presents all adverse reactions occurring in the placebo-controlled period of the pooled randomized studies [see Clinical Studies] occurring at a rate of > 1% in the treated group, and for which the rate for ACCRUFER exceeds the rate for placebo.

Table 1. Adverse Reactions Reported by ≥1% of Patients Treated with ACCRUFER During Placebo-Controlled Period of Pooled Studies (Studies AEGIS 1 & 2 and AEGIS 3)

Body System
Adverse Reaction
ACCRUFER
30 mg bid
(N = 175)
Placebo
(N = 120)
Gastrointestinal
  Flatulence 4.6% 0%
  Diarrhea 4% 1.7%
  Constipation 4% 0.8%
  Feces discolored 4% 0.8%
  Abdominal pain 2.9% 2.5%
  Nausea 1.7% 0.8%
  Vomiting 1.7% 0%
  Abdominal Discomfort 1.1% 0%
  Abdominal Distension 1.1% 0%

The proportion of patients who discontinued treatment due to adverse reactions during the doubleblind, placebo-controlled portion of studies was 4.6% for patients taking ACCRUFER. The most common adverse reaction leading to discontinuation of ACCRUFER in these studies was abdominal pain (1.7% of patients).

Read the entire FDA prescribing information for Accrufer (Ferric Maltol Capsules)

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© Accrufer Patient Information is supplied by Cerner Multum, Inc. and Accrufer Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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