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Generic Name: Ferrous Sulfate Tablets (FER-us SULL-fate)

Brand Name: Examples include Feosol and Feratab

Ferrous Sulfate is used for:


Preventing or treating low levels of iron in the blood. It also may be used for other
conditions as determined by your doctor.
Ferrous Sulfate is an essential body mineral. It works by replacing iron in your body if
your body does not produce enough on its own.

Do NOT use Ferrous Sulfate if:


• you are allergic to any ingredient in Ferrous Sulfate
• you have high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ferrous Sulfate :


Some medical conditions may interact with Ferrous Sulfate . Tell your doctor or
pharmacist if you have any medical conditions, especially if any of the following apply
to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal
preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have inflammation of the intestines, Crohn disease, digestive
problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)
• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Ferrous Sulfate . Tell your health care provider if
you are taking any other medicines, especially any of the following:

• Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg,


levothyroxine) because their effectiveness may be decreased by Ferrous
Sulfate

This may not be a complete list of all interactions that may occur. Ask your health
care provider if Ferrous Sulfate may interact with other medicines that you take.
Check with your health care provider before you start, stop, or change the dose of
any medicine.

How to use Ferrous Sulfate :


Use Ferrous Sulfate as directed by your doctor. Check the label on the medicine for
exact dosing instructions.

• Take Ferrous Sulfate by mouth with or without food. If stomach upset occurs,
take with food to reduce stomach irritation.
• Swallow Ferrous Sulfate whole. Do not break, crush, or chew before
swallowing.
• Take Ferrous Sulfate with a full glass of water (8 oz/240 mL). Do not lie down
for 30 minutes after taking Ferrous Sulfate .
• If you are also taking a bisphosphonate (eg, alendronate), cephalosporin (eg,
cephalexin), methyldopa, penicillamine, quinolone (eg, ciprofloxacin), or
tetracycline (eg, minocycline) along with Ferrous Sulfate , you may need to
space the doses several hours apart. Ask your doctor or pharmacist how
much time is needed between doses of Ferrous Sulfate and your other
medicines.
• Do not take Ferrous Sulfate within 1 hour before or 2 hours after antacids,
eggs, whole grain breads or cereal, milk, milk products, coffee, or tea.
• If you miss a dose of Ferrous Sulfate , take it as soon as possible. If it is
almost time for your next dose, skip the missed dose and go back to your
regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ferrous
Sulfate .

Important safety information:


• Do not take large doses of vitamins while you use Ferrous Sulfate unless
your doctor tells you to.
• Do NOT take more than the recommended dose or take for longer than 6
months without checking with your doctor.
• Ferrous Sulfate has iron in it. Iron overdose is a leading cause of fatal
poisoning in children younger than 6 years of age. In case of an overdose,
call a doctor or poison control center right away.
• Lab tests, including complete blood cell counts and blood iron levels, may be
performed while you use Ferrous Sulfate . These tests may be used to
monitor your condition or check for side effects. Be sure to keep all doctor
and lab appointments.
• Ferrous Sulfate should be used with extreme caution in CHILDREN; safety
and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your
doctor. You will need to discuss the benefits and risks of using Ferrous
Sulfate while you are pregnant. Ferrous Sulfate is found in breast milk. If you
are or will be breast-feeding while you use Ferrous Sulfate , check with your
doctor. Discuss any possible risks to your baby.

Possible side effects of Ferrous Sulfate :


All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or
streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.
This is not a complete list of all side effects that may occur. If you have questions
about side effects, contact your health care provider. Call your doctor for medical
advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You
may also report side effects at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your
local poison control center (http://www.aapcc.org), or emergency room immediately.
Symptoms may include loss of consciousness; difficulty breathing; seizures; severe
nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast
heartbeat.
Proper storage of Ferrous Sulfate :
Store Ferrous Sulfate at room temperature, between 68 and 77 degrees F (20 and 25
degrees C). Store away from heat, moisture, and light. Do not store in the bathroom.
Keep Ferrous Sulfate out of the reach of children and away from pets.

General information:
• If you have any questions about Ferrous Sulfate , please talk with your
doctor, pharmacist, or other health care provider.
• Ferrous Sulfate is to be used only by the patient for whom it is prescribed.
Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your
doctor.

This information is a summary only. It does not contain all information about Ferrous
Sulfate . If you have questions about the medicine you are taking or would like more
information, check with your doctor, pharmacist, or other health care provider.

Side Effects of Ferrous sulfate - for the consumer

Ferrous Sulfate
All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome when using Ferrous Sulfate:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur when
using Ferrous Sulfate:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or
streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.
This is not a complete list of all side effects that may occur. If you have questions
about side effects, contact your health care provider. Call your doctor for medical
advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You
may also report side effects at http://www.fda.gov/medwatch .

Ferrous Sulfate/Vitamin C
All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome when using Ferrous Sulfate/Vitamin C:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur when
using Ferrous Sulfate/Vitamin C:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or
streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

Ferrous Sulfate Controlled-Release Capsules


All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome when using Ferrous Sulfate Controlled-Release Capsules:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur when
using Ferrous Sulfate Controlled-Release Capsules:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or
streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

Ferrous Sulfate Drops


All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome when using Ferrous Sulfate Drops:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur when
using Ferrous Sulfate Drops:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or
streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.
Ferrous Sulfate Elixir
All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome when using Ferrous Sulfate Elixir:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur when
using Ferrous Sulfate Elixir:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or
streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.
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By body system

Gastrointestinal side effects


Gastrointestinal side effects are generally dose-related and have included nausea,
constipation, anorexia, heartburn, vomiting, and diarrhea. In addition, stools may
appear darker in color in patients taking ferrous sulfate.

Oral preparations of ferrous sulfate may rarely cause Hemoccult-positive stools,


patients with positive tests generally require further work-up.
Gastrointestinal side effects are dose-related with approximately 25% of patients
experiencing side effects at a dosage of 325 mg three times a day.

Gastrointestinal discomfort may be minimized by initiating ferrous sulfate therapy at


smaller doses and gradually titrating upwards until the desired dose is achieved.

Administering each dose with food may also minimize gastrointestinal discomfort.
However, concurrent administration of ferrous sulfate with food may decrease the
amount of iron absorbed.

Due to the small amount of iron released and absorbed, the use of enteric-coated or
delayed release ferrous sulfate preparations may reduce gastrointestinal side effects;
however, these products are not recommended for use.

Constipation may be relieved by administering docusate sodium 100 mg to 200 mg


per day in addition to increasing the intake of oral fluids, such as water.

Other side effects


Other side effects have included stained teeth and iron overload (hemosiderosis).
Secondary hemochromatosis due to prolonged iron ingestion has been reported
rarely.
Stained teeth have primarily occurred following ingestion of ferrous sulfate liquid
preparation. Liquid dosage forms should be diluted in juice or water and sipped
through a straw to aid in prevention of staining.

Iron overload (i.e., hemosiderosis) has been reported in patients genetically


predisposed, or have underlying disorders, that augment the absorption of iron. It has
also occurred following administration of excessive parenteral iron therapy,
combination of oral and parenteral iron, or in patients with hemoglobinopathies that
were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with
repeated phlebotomy or long-term administration of deferoxamine. The liver is
particularly susceptible to toxicity in iron-overload states.

Immunologic side effects


Immunologic side effects have rarely included gastroenteritis associated with Yersinia
enterocolitica and Listeria monocytogenes in patients with iron overload status
receiving treatment with deferoxamine.
It has been hypothesized that gastroenteritis is caused by bacteria that become
virulent in the presence of iron overload resulting in a systemic infection. Treatment
consists of discontinuing deferoxamine and initiating appropriate antimicrobial
therapy.

Local side effects


Local side effects have included gangrene.
Localized corrosion has been reported in a pregnant woman taking ferrous sulfate
(tablet) that lodged in a Meckels diverticulum.

There have also been reports of wax-matrix ferrous sulfate tablets (delayed-release)
lodging in the bowels of patients with strictures.