Applies to gadodiamide: intravenous solution.

Serious side effects of Gadodiamide

Along with its needed effects, gadodiamide 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 or nurse immediately if any of the following side effects occur while taking gadodiamide:

Rare

• Agitation
• bloody, black, or tarry stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in consciousness
• changes in skin color
• chest pain or discomfort
• clumsiness or unsteadiness
• confusion
• cough
• decreased awareness or responsiveness
• decreased urine output
• depression
• difficult or labored breathing
• difficulty controlling your bladder or bowels
• difficulty swallowing
• difficulty walking
• dilated neck veins
• dizziness
• extreme tiredness or weakness
• fainting
• fast, slow, or irregular heartbeat
• feeling of warmth or heat
• feeling sad or depressed
• feeling unusually cold
• flushing or redness of the skin, especially on the face and neck
• forgetful
• general feeling of discomfort or illness
• headache
• headache, severe and throbbing
• hives, itching, skin rash
• hostility
• irregular breathing
• irritability
• loss of bladder control
• loss of consciousness
• muscle cramps or twitching
• nausea
• numbness or tingling in your arms, legs, or face
• pain or discomfort in the arms, jaw, back, or neck
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• severe sleepiness
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• shivering
• slurred speech or problems swallowing
• sudden sweating
• sweating
• swelling of the face, fingers, feet, ankles, or lower legs
• tenderness
• tightness in the chest
• total body jerking
• trembling or shaking of the hands or feet
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• weight gain

Incidence not known

• Burning or itching of the skin
• decreased or uncontrolled urination
• incoordination
• joint stiffness
• lack or loss of strength
• limited range of motion in the arms and legs
• muscle pain, spasms, stiffness, or weakness
• pain that is deep in the hip bone or ribs
• paralysis or severe weakness of the legs
• partial or slight paralysis
• red or dark patches on the skin
• skin swelling, hardening, or tightening
• small, abnormal patch or build-up
• stiffness of the arms or legs
• uncontrolled movements of the body

Other side effects of Gadodiamide

Some side effects of gadodiamide 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:

Rare

• Bad, unusual, or unpleasant (after) taste
• belching
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bloated or full feeling
• change in taste
• changes in vision
• continuing ringing or buzzing or other unexplained noise in the ears
• diarrhea
• difficulty with moving
• dry mouth
• excess air or gas in the stomach
• hearing loss
• increased sweating
• joint pain or swelling
• runny nose
• sneezing
• stomach pain
• stuffy nose

For Healthcare Professionals

Applies to gadodiamide: injectable solution.

Cardiovascular

Cardiovascular side effects have included cardiac failure, arrhythmia and myocardial infarction. Also reported include vasodilation, flushing, chest pain, deep thrombophlebitis, and rarely, arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease.^[Ref]

Nervous system

Nervous system side effects have included headache, tinnitus, taste loss, taste perversion, and dizziness. Convulsions including grand mal, ataxia, abnormal coordination, paresthesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), and aggravated migraine have been reported.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, abdominal pain, diarrhea, eructation, dry mouth, vomiting, and melena.^[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms).^[Ref]

General

General side effects have included fever, hot flushes, rigors, fatigue, malaise, pain, and syncope.^[Ref]

Hepatic

Hepatic side effects have included abnormal hepatic function.^[Ref]

Respiratory

Respiratory side effects have included rhinitis and dyspnea.^[Ref]

Ocular

Ocular side effects have included abnormal vision.^[Ref]

Renal

Renal side effects have included acute reversible renal failure.^[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia.^[Ref]

Dermatologic

Dermatologic side effects have included pruritus, rash, erythematous rash, increased sweating, and urticaria.^[Ref]