Triferic Side Effects Center

Last updated on RxList: 11/11/2022
Triferic Side Effects Center

What Is Triferic?

Triferic (ferric pyrophosphate citrate) solution is an iron replacement product used for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

What Are Side Effects of Triferic?

Triferic may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • lightheadedness,
  • bleeding around your dialysis vein access point,
  • blue-colored skin,
  • bulging purple-colored veins that you can see through your skin,
  • swelling in your arms, legs, or fingers,
  • unusual bleeding or bruising,
  • coughing up blood,
  • lightheadedness,
  • fever, and
  • pain or burning when you urinate

Get medical help right away, if you have any of the symptoms listed above.

Common side effects include:

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

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

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Triferic

The dosage of Triferic is expressed as mg of iron (III). Each mL of Triferic contains 5.44 mg of iron as iron (III).

What Drugs, Substances, or Supplements Interact with Triferic?

Triferic may interact with other drugs. Tell your doctor all medications and supplements you use.

Triferic During Pregnancy or Breastfeeding

During pregnancy, Triferic should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Triferic (ferric pyrophosphate citrate) solution 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.

QUESTION

The only purpose of the kidneys is to filter blood. See Answer
Triferic Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • bleeding around your dialysis vein access point;
  • blue-colored skin, bulging purple-colored veins that you can see through your skin;
  • swelling in your arms, legs, or fingers;
  • unusual bleeding or bruising, coughing up blood;
  • a light-headed feeling, like you might pass out;
  • fever; or
  • pain or burning when you urinate.

Common side effects may include:

  • headache, dizziness;
  • swelling in your hands or feet;
  • weakness, tiredness;
  • muscle pain;
  • feeling short of breath; or
  • pain in your back, arms, or legs.

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.

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow
Triferic Professional Information

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in the labeling:

  • Hypersensitivity Reactions. [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 may not reflect the rates observed in practice.

In two randomized, placebo-controlled clinical trials a total of 292 patients were administered Triferic for periods of up to 1 year [see Clinical Studies]. The mean total exposure in the randomized treatment period was 5 months. A total of 296 patients received placebo treatment for a similar time period. In the two studies, 64% were male and 54% were Caucasian. The median age of patients was 60 years (range, 20 to 89 years).

Adverse reactions occurring in 3% or greater of patients treated with Triferic in the randomized clinical trials are listed in Table 1.

Table 1: Adverse Reactions Reported in Two Clinical Trials in at Least 3% of Patients Receiving Triferic and at an Incidence at Least 1% Greater than Placebo.

Body System
Adverse Reaction
Triferic
N=292
n (%)
Placebo
N=296
n (%)
Number of patients with at least one adverse reaction 229 (78.4) 223 (75.3)
General Disorders and Administration Site Conditions
Peripheral edema 20 (6.8) 11 (3.7)
Pyrexia 13 (4.5) 9 (3.0)
Asthenia 12 (4.1) 9 (3.0)
Fatigue 11 (3.8) 6 (2.0)
Infections and Infestations
Urinary tract infection 13 (4.5) 4 (1.4)
Injury, Poisoning, and Procedural Complications
Procedural hypotension 63 (21.6) 57 (19.3)
Arteriovenous fistula thrombosis 10 (3.4) 6 (2.0)
Arteriovenous fistula site hemorrhage 10 (3.4) 5 (1.7)
Musculoskeletal and Connective Tissue Disorders
Muscle spasms 28 (9.6) 24 (8.1)
Pain in extremity 20 (6.8) 17 (5.7)
Back pain 13 (4.5) 10 (3.4)
Nervous System Disorders
Headache 27 (9.2) 16 (5.4)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 17 (5.8) 13 (4.4)

Adverse Reactions Leading To Treatment Discontinuation

In clinical trials, adverse reactions leading to treatment discontinuation included headache, asthenia, dizziness, constipation, nausea, hypersensitivity reactions, intradialytic hypotension, pruritus, and pyrexia.

Adverse reactions reported in the treatment extension period were similar to those observed in the randomized clinical studies.

Read the entire FDA prescribing information for Triferic (Ferric Pyrophosphate Citrate Solution, for Addition to Bicarbonate Concentrate)

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

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