Vectical Side Effects

Please note - some side effects for Vectical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Vectical - for the Consumer

Vectical Ointment

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 Vectical Ointment:

Mild skin discomfort at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation (eg, blistered skin, flushing, itching, burning, severe discomfort or redness); symptoms of hypercalcemia (weakness, nausea, constipation, excessive thirst, confusion, fast, slow, or irregular heartbeat).

Vectical Side Effects - for the Professional

Vectical

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

Vectical Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to Vectical Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year.

Four hundred and nineteen subjects were treated with Vectical Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis.

Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevations were less than 10% above the upper limit of normal [see WARNINGS AND PRECAUTIONS (5.1)]

The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Vectical Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hypercalciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two.

Postmarketing Experience

The following adverse reactions have been identified during world-wide post-approval use of Vectical Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Side Effects by Body System - for Healthcare Professionals

Metabolic

Metabolic side effects have included hypercalcemia which was reported in 24% of the subjects exposed to active drug and 16% of the subjects exposed to the vehicle.

In the subjects reported to have hypercalcemia, the elevations were less than 10% above the upper limit of normal.

Other

Other side effects including lab test abnormality (8%) have been reported.

Dermatologic

Dermatologic side effects including psoriasis (4%), skin discomfort (3%), pruritus (up to 3%), acute blistering dermatitis, erythema, and skin burning sensation.

The drug was being used in the treatment of psoriasis.

Renal

Kidney stones were reported in three subjects and confirmed in two.

Renal side effects including urine abnormality (4%), hypercalciuria (3%), and kidney stones have been reported.

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