The following serious adverse reactions are discussed in
greater detail in other sections of the labeling:
- Hypersensitivity [see CONTRAINDICATIONS and WARNINGS
- Hypotension [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical studies are conducted under widely
varying conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to rates in the clinical studies of another
drug and may not reflect the rates observed in practice.
The most commonly reported adverse reactions ( ≥ 10%)
in adult patients were nausea, vomiting and/or diarrhea, injection site
reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (e.g.,
changes in morphology, color, or number of red blood cells), dyspnea, chest
pain, leg cramps and pain. In patients 6 to 15 years of age the most common
adverse reactions ( ≥ 10%) were hypotension, headache, hypertension,
tachycardia and vomiting.
Studies A And B
In multiple dose Studies A and B (total 126 adult
patients), the most frequent treatment emergent adverse reactions following
Body as a Whole: injection site reaction (33%),
chest pain (10%), pain (10%), asthenia (7%), headache (7%), fatigue (6%), fever
(5%), malaise, infection, abscess, chills, rigors, carcinoma, flu-like
syndrome, sepsis, lightheadedness, weakness.
Nervous System: cramps (25%), dizziness (13%), paresthesias
(6%), agitation, somnolence, decreased level of consciousness.
Respiratory System: dyspnea (11%), coughing (6%),
upper respiratory infections (6%), rhinitis, pneumonia.
Cardiovascular System: hypotension (29%),
hypertension (13%), syncope (6%), tachycardia (5%), bradycardia,
vasodilatation, angina pectoris, myocardial infarction, pulmonary edema.
Gastrointestinal System: nausea, vomiting and/or
diarrhea (35%), anorexia, abdominal pain (6%), rectal disorder, dyspepsia,
eructation, flatulence, gastrointestinal disorder, melena.
Musculoskeletal System: leg cramps (10%), myalgia,
arthralgia, back pain, arm pain.
Skin and Appendages: pruritus (6%), rash,
Genitourinary System: urinary tract infection, and
Special Senses: conjunctivitis, rolling of the
eyes, watery eyes, puffy eye lids, arcus senilis, redness of the eye, diplopia,
Metabolic and Nutritional Disorders: hyperkalemia
(6%), generalized edema (5%), leg edema, peripheral edema, hypoglycemia, edema,
Hematologic System: abnormal erythrocytes (11%)
(changes in morphology, color, or number of red blood cells), anemia,
Study C – Pediatric
Pediatric Patients: In a clinical trial of 66
iron-deficient pediatric hemodialysis patients, 6 to 15 years of age,
inclusive, who were receiving a stable erythropoietin dosing regimen, the most
common adverse reactions, occurring in ≥ 5%, regardless of treatment
dosage, were: hypotension (35%), headache (24%), hypertension (23%),
tachycardia (17%), vomiting (11%), fever (9%), nausea (9%), abdominal pain
(9%), pharyngitis (9%), diarrhea (8%), infection (8%), rhinitis (6%), and thrombosis
(6%). More patients in the higher dose group (3.0 mg/kg) than in the lower dose
group (1.5 mg/kg) experienced the following adverse events: hypotension (41%
vs. 28%), tachycardia (21% vs. 13%), fever (15% vs. 3%), headache (29% vs.
19%), abdominal pain (15% vs. 3%), nausea (12% vs. 6%), vomiting (12% vs. 9%),
pharyngitis (12% vs. 6%), and rhinitis (9% vs. 3%).
Post Marketing Experience
In the single-dose, postmarketing safety study, 11% of
patients who received Ferrlecit and 9.4% of patients who received placebo
reported adverse reactions. The most frequent adverse reactions following
Ferrlecit were: hypotension (2%), nausea, vomiting and/or diarrhea (2%), pain (0.7%),
hypertension (0.6%), allergic reaction (0.5%), chest pain (0.5%), pruritus
(0.5%), and back pain (0.4%). The following additional events were reported in
two or more patients: hypertonia, nervousness, dry mouth, and hemorrhage.
In the multiple-dose, open-label surveillance study, 28%
of the patients received concomitant angiotensin converting enzyme inhibitor
(ACEi) therapy. The incidences of both drug intolerance or suspected allergic events
following first dose Ferrlecit administration were 1.6% in patients with
concomitant ACEi use compared to 0.7% in patients without concomitant ACEi use.
The patient with a life-threatening event was not on ACEi therapy. One patient
had facial flushing immediately on Ferrlecit exposure. No hypotension occurred
and the event resolved rapidly and spontaneously without intervention other
than drug withdrawal.
The following additional adverse reactions have been
identified with the use of Ferrlecit from postmarketing spontaneous reports:
anaphylactictype reactions, shock, loss of consciousness, convulsion, skin discoloration,
pallor, phlebitis, dysgeusia, and hypoesthesia.
Individual doses exceeding 125 mg may be associated with
a higher incidence and/or severity of adverse events based on information from postmarketing
spontaneous reports. These adverse events included hypotension, nausea,
vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain,
paresthesia, and peripheral swelling.
Because these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.
Drug-drug interactions involving Ferrlecit have not been
studied. Ferrlecit may reduce the absorption of concomitantly administered oral