Nizoral Side Effects

Generic Name: ketoconazole

Please note - some side effects for Nizoral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nizoral - for the Consumer

Nizoral

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nizoral:

Nausea; stomach pain or upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; dark urine; decreased sexual ability; depression; irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; numbness or tingling of the hands or feet; pale stools; severe or persistent nausea or stomach pain; swollen or tender abdomen; thoughts of suicide; unusual bruising or bleeding; unusual tiredness or fatigue; vision changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Nizoral Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nizoral Cream:

Itching; mild irritation or stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); reddening, blistering, peeling, itching, or burning of your skin.

Nizoral Shampoo

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nizoral Shampoo:

Itching; mild irritation or stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); reddening, blistering, peeling, itching, or burning of your skin.

Nizoral A-D Shampoo

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nizoral A-D Shampoo:

Itching; mild irritation or stinging; oiliness and dryness of hair and scalp.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased or abnormal hair loss; reddening, blistering, peeling, itching, or burning of your skin.

Nizoral Side Effects - for the Professional

Nizoral

In rare cases, anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported. However, the most frequent adverse reactions were nausea and/or vomiting in approximately 3%, abdominal pain in 1.2%, pruritus in 1.5%, and the following in less than 1% of the patients: headache, dizziness, somnolence, fever and chills, photophobia, diarrhea, gynecomastia, impotence, thrombocytopenia, leukopenia, hemolytic anemia, and bulging fontanelles. Oligospermia has been reported in investigational studies with the drug at dosages above those currently approved. Oligospermia has not been reported at dosages up to 400 mg daily, however sperm counts have been obtained infrequently in patients treated with these dosages. Most of these reactions were mild and transient and rarely required discontinuation of Nizoral® (ketoconazole) Tablets. In contrast, the rare occurrences of hepatic dysfunction require special attention.

In worldwide postmarketing experience with Nizoral® Tablets there have been rare reports of alopecia, paresthesia, and signs of increased intracranial pressure including bulging fontanelles and papilledema. Hypertriglyceridemia has also been reported but a causal association with Nizoral® Tablets is uncertain.

Neuropsychiatric disturbances, including suicidal tendencies and severe depression, have occurred rarely in patients using Nizoral® Tablets.

Ventricular dysrhythmias (prolonged QT intervals) have occurred with the concomitant use of terfenadine with ketoconazole tablets. Data suggest that coadministration of ketoconazole tablets and cisapride can result in prolongation of the QT interval and has rarely been associated with ventricular arrhythmias.

Nizoral Shampoo

In 11 double-blind trials in 264 patients using ketoconazole 2% shampoo for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of Nizoral® (ketoconazole) 2% Shampoo (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

In worldwide experience with Nizoral® Shampoo there have been rare reports of hair discoloration.

Side Effects by Body System

Endocrine

Ketoconazole inhibits hydroxylation of deoxycortisol, which results in diminished cortisol production, especially when given in divided doses. In some patients, symptomatic adrenal insufficiency may occur, presenting with hyponatremia, hyperkalemia, hypotension, lethargy, depression, and malaise.

Gynecomastia in males results from decreased steroidogenesis and testosterone production, which leads to an increased estrogen to testosterone ratio.

A 77-year-old male with prostate cancer experienced adrenal crisis coincident with ketoconazole therapy. He presented with progressive right lower extremity weakness, debilitating low back pain, and a serum prostate-specific antigen level of 78.8 ng/mL. He was given ketoconazole 200 mg orally four times daily to reduce serum testosterone levels. Nine days after initiating ketoconazole therapy, he experienced generalized weakness, abdominal pain, nausea with vomiting, and severely diminished mentation. The urology service was advised of the patient's admission and suggested that adrenal insufficiency related to high-dose ketoconazole therapy should be considered in the differential diagnosis. However, a serum cortisol level was not obtained prior to steroid treatment. An ACTH stimulation test performed 2 days later showed no evidence of underlying adrenal insufficiency when the patient was no longer being given ketoconazole.

Endocrine side effects including gynecomastia and breast tenderness have been reported in male patients. Hypoglycemia and hypothyroidism have been reported rarely. Oligospermia has also been reported. Ketoconazole adversely affects the endocrine system through an inhibition of the production of cortisol, which can result in symptomatic adrenal insufficiency. At least one case of adrenal crisis has also been reported.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported in 3% to 10% of treated patients. Abdominal pain has been reported in 1.2% of patients. At least 1 case of stomatitis has also been reported.

Gastrointestinal intolerance may resolve with continued therapy and may improve if ketoconazole is taken with food.

Metabolic

Metabolic side effects have included a transient fall in serum cholesterol accompanied by an increase in triglycerides.

Hepatic

Ketoconazole therapy has commonly been associated with transient elevations in liver enzymes, which have resolved despite continued therapy. However, severe hepatotoxicity (hepatocellular, cholestatic, or mixed) has been reported and generally occurred after one or two months of therapy. Hepatic function usually returned to normal within one month, but cases of hepatic failure and death have occurred. Early signs of hepatotoxicity have included lethargy, dark urine, pale stools, anorexia, malaise, nausea, and jaundice.

Hepatic side effects have been reported. Hepatotoxicity has commonly manifested as transient elevations of liver enzymes but has also, rarely, occurred as hepatitis.

Hypersensitivity

A 72-year-old female with a Candida albicans infection experienced a severe reaction of refractory anaphylactic shock coincident with ketoconazole therapy. She was initially given oral ketoconazole 200 mg twice daily. She developed hypotension over the first 2 days of treatment (BP 136/82 mm Hg at baseline; 90/50 mm Hg on day 2). Severe hypotension (BP 90/49 mm Hg) unresponsive to fluid therapy or high-dose dopamine developed on day 4 of treatment. When laboratory tests revealed a high level of plasma tryptase, anaphylactic redistribution shock was diagnosed. Her vital signs became more stable after therapy with hydrocortisone and epinephrine infusion.

Hypersensitivity side effects have presented as rash, erythema, and pruritus. Anaphylaxis has been reported. Cross-sensitivity between imidazoles has also been demonstrated.

Hematologic

A 23-year-old female with vaginal discharge experienced fatal aplastic anemia coincident with ketoconazole therapy. She was admitted with widespread purpuric lesions on her face, arms, and legs. She had taken ketoconazole 200 mg twice daily for vaginal discharge for 4 days before admission. Ketoconazole was discontinued on admission. The patient was diagnosed with aplastic anemia based on clinical findings. The patient did not respond to therapy and died of disseminated candidiasis 2 months later.

Hematologic side effects including hemolytic anemia have been reported rarely. At least one case of aplastic anemia has been reported.

Nervous system

Nervous system side effects including headache, somnolence, dizziness, confusion, and suicidal tendencies have been reported rarely. Paranoid delusions have been reported in a patient treated with ketoconazole for cutaneous leishmaniasis. At least 1 case of insomnia has also been reported.

Psychiatric

Paranoid delusions have been reported in a patient treated with ketoconazole for cutaneous leishmaniasis.

Dermatologic

Dermatologic side effects have been reported. At least five cases of dry skin have been reported, in addition to one case of bruising, six cases of loss of scalp hair, five cases of worsening loss of scalp hair, six cases of desquamation, and three cases of itching.

Genitourinary

Genitourinary side effects including at least 13 cases of polymenorrhea anovulatory cycles and 14 cases of anovulatory oligomenorrhea have been reported.

Other

Other side effects including at least 4 cases of fatigue and 3 cases of asthenia have been reported.

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