Note: This document contains side effect information about calcium carbonate. Some dosage forms listed on this page may not apply to the brand name Titralac.

Applies to calcium carbonate: oral tablet. Other dosage forms:

• oral suspension, oral tablet, oral tablet chewable

Serious side effects of Titralac

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, constipation, or bone pain.
• Mood changes.

Other side effects of Titralac

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:

• Constipation.
• Upset stomach or throwing up.
• Stomach pain.
• Not hungry.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to calcium carbonate: compounding powder, oral capsule, oral gum, oral powder, oral suspension, oral tablet, oral tablet chewable.

Metabolic

Uncommon (0.1% to 1%): Hypercalcemia

Very rare (less than 0.01%): Loss of appetite, milk-alkali syndrome

Frequency not reported: Alkalosis^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hypercalciuria

Very rare (less than 0.01%): Urinary frequency^[Ref]

Gastrointestinal

Rare (0.01% to 0.1%): Nausea, diarrhea, constipation, flatulence, eructation, dyspepsia, gastric pain, abdominal pain/discomfort

Very rare (less than 0.01%): Vomiting^[Ref]

Dermatologic

Very rare (less than 0.01%): Pruritus, rash, urticaria^[Ref]

Renal

Very rare (less than 0.01%): Renal impairment^[Ref]

Nervous system

Very rare (less than 0.01%): Continuous headache^[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions, hypersensitivity, anaphylactic reaction, angioedema^[Ref]

Other

Frequency not reported: Unusual tiredness or weakness^[Ref]

Respiratory

Frequency not reported: Asthma^[Ref]

Musculoskeletal

Frequency not reported: Muscular weakness^[Ref]