Ferric Maltol

Ferric maltol is an iron replacement product indicated for the treatment of iron deficiency in adults.

• Ferric maltol is available under the following different brand names: Accrufer

Common side effects of Ferric maltol include:

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

Serious side effects of Ferric maltol include:

• hives
• difficulty breathing 
• swelling of the face, lips, tongue, or throat
• inflammatory bowel disease flares symptoms such as diarrhea, stomach cramps, blood in your stools, loss of appetite, or weight loss

Rare side effects of Ferric maltol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms include sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 30 mg

Iron deficiency

Adult dosage

• 30 mg orally two times a day
• Continue as long as necessary until ferritin levels are within the normal range
• Treatment duration depends on the severity of iron deficiency but generally, at least 12 weeks of treatment is required

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Ferric maltol has severe interactions with no other drugs
• Ferric maltol has serious interactions with the following drugs:
  • baloxavir marboxil
  • demeclocycline
  • dimercaprol
  • doxycycline
  • eltrombopag
  • fleroxacin
  • gemifloxacin
  • levofloxacin
  • lymecycline
  • minocycline
  • moxifloxacin
  • mycophenolate
  • ofloxacin
  • oxytetracycline
  • tetracycline
• Ferric maltol has moderate interactions with at least 71 other drugs
• Ferric maltol has minor interactions with the following drugs:
  • acetohydroxamic acid
  • calcium acetate
  • calcium carbonate
  • calcium chloride
  • calcium citrate
  • calcium gluconate
  • carbidopa
  • didanosine
  • gymnema
  • manganese

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to the active substance or any of the excipients
• Hemochromatosis and other iron overload syndromes
• Patients receiving repeated blood transfusions

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ferric maltol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ferric maltol?”

Cautions

• Avoid use in patients with an active inflammatory bowel disease flare, as there is a potential risk for increased inflammation in the gastrointestinal tract
• Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children aged 6 years and younger; keep this product out of reach of children
• Iron overload
  • Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis; do not administer to patients with evidence of iron overload or patients receiving IV iron
  • Assess iron parameters before initiating treatment and monitor during therapy
• Drug interaction overview
  • Oral medications
    • There are no empirical data on avoiding drug interactions between ferric maltol and concomitant oral medication
    • Concomitant use of some oral drugs may reduce the bioavailability of iron after ferric maltol administration
    • Separate the administration of ferric maltol from these drugs; duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate- or extended-release product; monitor clinical response to ferric maltol
    • Coadministration of ferric maltol with some oral medications may also decrease the bioavailability of some drugs
    • For oral drugs for which reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate ferric maltol administration by at least 4 hours; monitor clinical responses to concomitant drugs as appropriate
  • Dimercaprol
    • Coadministration of iron products with dimercaprol may increase the risk for nephrotoxicity
    • Avoid use with dimercaprol

Pregnancy and Lactation

• Not absorbed systemically as an intact complex after oral administration
• Maternal use is not expected to result in fetal exposure to the drug
• Clinical considerations
  • Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia
  • Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight
• Lactation
  • There are no data on the presence of ferric maltol in human milk, the effects on the breastfed child, or milk production