Note: This document contains side effect information about omega-3 polyunsaturated fatty acids. Some dosage forms listed on this page may not apply to the brand name Smart Heart.

Applies to omega-3 polyunsaturated fatty acids: oral capsule liquid filled.

Serious side effects of Smart Heart

Along with its needed effects, omega-3 polyunsaturated fatty acids (the active ingredient contained in Smart Heart) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking omega-3 polyunsaturated fatty acids:

Incidence not known

• Bleeding gums
• cough
• coughing up blood
• difficulty with breathing or swallowing
• dizziness
• fast or irregular heartbeat
• headache
• hives, itching, or skin rash
• increased menstrual flow or vaginal bleeding
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools
• red or dark brown urine
• sweating
• tightness in the chest
• unusual tiredness or weakness

Other side effects of Smart Heart

Some side effects of omega-3 polyunsaturated fatty acids may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• bloated or full feeling
• change in taste
• excess air or gas in the stomach
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Incidence not known

• Diarrhea
• difficulty having a bowel movement (stool)
• loss of appetite
• nausea or vomiting
• passing of gas
• stomach fullness

For Healthcare Professionals

Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable.

Gastrointestinal

Common (1% to 10%): Eructation, dyspepsia, nausea, gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gastroesophageal reflux disease, vomiting)

Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastroenteritis

Rare (less than 0.1%): Gastrointestinal pain

Very rare (less than 0.01%): Lower gastrointestinal hemorrhage^[Ref]

General

The most common adverse events were eructation, dyspepsia, and taste perversion^[Ref]

Other

Common (1% to 10%): Infection, pain

Uncommon (0.1% to 1%): Death^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Atopic dermatitis

Rare (less than 0.1%): Urticaria, acne, rash pruritic

Frequency not reported: Pruritus^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, gout, high triglycerides

Very rare (less than 0.01%): Blood lactate dehydrogenase increased^[Ref]

Nervous system

Common (1% to 10%): Taste perversion

Uncommon (0.1% to 1%): Dizziness, dysgeusia, headache, hyperactivity^[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis

Very rare (less than 0.01%): Nasal dryness

Frequency not reported: Influenza^[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity

Postmarketing reports: Anaphylactic reaction^[Ref]

Hematologic

Very rare (less than 0.01%): White blood count increased,

Frequency not reported: Slight prolongation of bleeding time

Postmarketing reports: Hemorrhagic diathesis^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Tics, tantrum, insomnia^[Ref]

Hepatic

Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)^[Ref]