Applies to hydroxocobalamin: intravenous powder for solution.

Serious side effects of Hydroxocobalamin

Along with its needed effects, hydroxocobalamin 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 hydroxocobalamin:

More common

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• redness of the skin
• slow or fast heartbeat

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• cough
• difficult or labored breathing
• difficulty with swallowing
• feeling of warmth
• hives or welts, itching, or skin rash
• large, hive-like swelling on the , eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• 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
• sudden sweating
• tightness in the chest
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Other side effects of Hydroxocobalamin

Some side effects of hydroxocobalamin 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:

More common

• Blemishes on the skin
• dry, red, hot, or irritated skin
• nausea
• pimples
• red colored urine

Incidence not known

• Acid or sour stomach
• being forgetful
• belching
• diarrhea
• heartburn
• indigestion
• redness or swelling of the eyes
• restlessness
• stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to hydroxocobalamin: compounding powder, injectable solution, intravenous powder for injection.

Cardiovascular

Very common (10% or more): Blood pressure increased (28% with 10 gram dose)

Frequency not reported: Increased blood pressure (particularly diastolic), hot flush, ventricular extrasystoles, electrocardiogram repolarization abnormality, heart rate increased^[Ref]

Ventricular extrasystoles, electrocardiogram repolarization abnormality, and heart rate increased were seen in known/suspected cyanide poisoning patients.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (11% with 10 gram dose)

Frequency not reported: Dysphagia, abdominal discomfort, vomiting, diarrhea, dyspepsia, hematochezia^[Ref]

Dermatologic

Very common (10% or more): Erythema (100% with 10 gram dose), rash (primarily acneiform) (44% with 10 gram dose)

Frequency not reported: Urticaria, pruritus^[Ref]

Genitourinary

Very common (10% or more): Chromaturia (red colored urine) (100% with 5 or 10 gram dose), oxalate crystals in urine (61% with 5 gram dose)

Postmarketing reports: Urine calcium oxalate crystals^[Ref]

Hematologic

Very common (10% or more): Lymphocyte count decreased (17% with 10 gram dose)^[Ref]

Local

Very common (10% or more): Infusion site reaction (39% with 10 gram dose)^[Ref]

Renal

Postmarketing reports: Acute renal failure with acute tubular necrosis, renal impairment^[Ref]

Nervous system

Very common (10% or more): Headache (33% with 10 gram dose)

Frequency not reported: Memory impairment, dizziness^[Ref]

Respiratory

Frequency not reported: Dyspnea, throat tightness, dry throat, pleural effusion^[Ref]

Pleural effusion was seen in known/suspected cyanide poisoning patients.^[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction^[Ref]

Ocular

Frequency not reported: Swelling, irritation, redness^[Ref]

Other

Frequency not reported: Peripheral edema, chest discomfort^[Ref]

Psychiatric

Frequency not reported: Restlessness^[Ref]