Ferro-Sequels

Ferrous fumarate is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Ferrous fumarate is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body).

Ferrous fumarate may also be used for purposes not listed in this medication guide.

You should not use ferrous fumarate if you are allergic to it, or if you have:

• iron overload syndrome;

• anemia (a lack of red blood cells); or

• thalassemia (a genetic disorder of red blood cells).

To make sure ferrous fumarate is safe for you, tell your doctor if you have:

• liver or kidney disease;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• if you are an alcoholic; or

• if you receive regular blood transfusions.

It is not known whether ferrous fumarate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Your dose needs may be different during pregnancy.

It is not known whether ferrous fumarate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give ferrous fumarate to a child without the advice of a doctor.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take ferrous fumarate on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid taking antacids or antibiotics within 2 hours before or after taking ferrous fumarate.

Take this medication with a full glass of water.

Do not crush, chew, or break a ferrous fumarate tablet. Swallow it whole.

Store at room temperature away from moisture, heat, and light.

Ferrous fumarate is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat to make sure you get enough iron from both your diet and your medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bright red blood in your stools; or

• pain in your chest or throat when swallowing a ferrous fumarate tablet.

Common side effects may include:

• constipation, diarrhea;

• nausea, vomiting, heartburn;

• loss of appetite; or

• black or dark-colored stools or urine.

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.

Applies to ferrous fumarate: oral capsule, oral tablet, oral tablet extended release

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Black, tarry, or bloody stools.
• Fever.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Change in color of stool to green.
• Not hungry.
• Upset stomach or throwing up.
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to ferrous fumarate: compounding powder, oral liquid, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Frequency not reported: Nausea, vomiting, gastrointestinal discomfort, constipation, diarrhea, discolored (blackened) stools, tooth discoloration, anorexia, epigastric pain, fecal impaction[Ref]

Hematologic

Frequency not reported: Hemosiderosis[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction[Ref]

Some side effects of ferrous fumarate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.