Dovonex Ointment

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/25/2022

Drug Summary

What Is Dovonex Ointment?

Dovonex (calcipotriene) is a synthetic topical (for the skin) form of vitamin D used to treat plaque psoriasis (psoriasis with scaly patches). Dovonex is available in generic form.

What Are Side Effects of Dovonex Ointment?

Common side effects of Dovonex include:

  • burning,
  • itching,
  • rash,
  • irritation,
  • redness,
  • dry skin, or
  • peeling at the application site.

Tell your doctor if you have unlikely but serious side effects of Dovonex including:

  • skin thinning or discoloration,
  • stretch marks,
  • "hair bumps" (folliculitis),
  • unusual tiredness,
  • mental/mood changes, or
  • unexplained constipation.

Dovonex Ointment may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe burning, stinging, skin rash, or other irritation after applying the medicine,
  • worsening of your skin condition,
  • confusion,
  • tiredness,
  • nausea,
  • vomiting,
  • loss of appetite,
  • constipation,
  • increased thirst or urination, and
  • weight loss

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Dovonex Ointment

Apply a thin layer of Dovonex ointment in a once or twice daily dose and rub in gently and completely. Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.

What Drugs, Substances, or Supplements Interact with Dovonex Ointment?

Other medicines, especially other topical medicines, may interact with Dovonex topical. Tell your doctor about any prescription or over-the-counter medicines or supplements you use.

Dovonex Ointment During Pregnancy or Breastfeeding

During pregnancy, Dovonex should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Dovonex (calcipotriene) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Drug Description

Not for Ophthalmic, Oral or Intravaginal Use.


Dovonex® (calcipotriene ointment), 0.005% contains the compound calcipotriene, a synthetic vitamin D3 derivative, for topical dermatological use.

Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1α,3β,24-triol-, with the empirical formula C27H40O3, a molecular weight of 412.6, and the following structural formula:

Dovonex® (calcipotriene ointment) structural formula illustration

Calcipotriene is a white or off-white crystalline substance. Dovonex® ointment contains calcipotriene 50 µg/g in an ointment base of dibasic sodium phosphate, edetate disodium, mineral oil, petrolatum, propylene glycol, tocopherol, steareth-2 and water.

Indications & Dosage


Dovonex® (calcipotriene ointment), 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.


Apply a thin layer of Dovonex® (calcipotriene ointment) ointment once or twice daily and rub in gently and completely.


Dovonex® (calcipotriene ointment), 0.005% is available in:

60 gram aluminum tubes N 0430-3010-15
120 gram aluminum tubes N 0430-3010-17


Store at controlled room temperature 15° C - 25° C (59° F - 77° F). Do not freeze.

Manufactured by LEO Laboratories Ltd. Dublin, Ireland. Marketed by: Warner Chilcott (US), Inc. Rockaway, NJ 07866 USA. 1-800-521-8813. Revised November 2007. FDA Rev date: 9/26/2007

Side Effects & Drug Interactions


In controlled clinical trials, the most frequent adverse reactions reported for Dovonex® (calcipotriene ointment) were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.


No information provided.

Warnings & Precautions


No information provided.



Use of Dovonex® (calcipotriene ointment) may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, Dovonex® (calcipotriene ointment) should be discontinued.

For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.

Transient, rapidly reversible elevation of serum calcium has occurred with use of Dovonex® (calcipotriene ointment) . If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Carcinogenesis, Mutagenesis, Impairment of Fertility

When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 µg/kg/day (corresponding to 9, 30 and 90 µg/m2/day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply Dovonex® (calcipotriene ointment) to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to avoid use of phototherapy in patients that use Dovonex®.

Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.

Studies in rats at doses up to 54 µg/kg/day (324 µg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.


Teratogenic Effects: Pregnancy Category C

Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 µg/kg/day (132 µg/m2/day); a dosage of 36 µg/kg/day (396 µg/m2/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 µg/kg/day (318 µg/m2/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels in the rat (43.2 µg/m2/day) and rabbit (17.6 µg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 µg/m2/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Dovonex® (calcipotriene ointment) ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dovonex® (calcipotriene ointment), 0.005% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Dovonex® (calcipotriene ointment) in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.

Geriatric Use

Of the total number of patients in clinical studies of calcipotriene ointment, approximately 12% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).

Overdose & Contraindications


Topically applied Dovonex® (calcipotriene ointment) can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of Dovonex® (calcipotriene ointment) ointment.


Dovonex® (calcipotriene ointment) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Dovonex® (calcipotriene ointment) should not be used on the face.

Clinical Pharmacology


In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D3.

Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application.

Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone. The primary metabolites are much less potent than the parent compound.

There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin.

Clinical Studies

Adequate and well-controlled trials of patients treated with Dovonex® (calcipotriene ointment) ointment have demonstrated improvement usually beginning after two weeks of therapy. This improvement continued in patients using Dovonex® (calcipotriene ointment) once daily and twice daily. After 8 weeks of once daily Dovonex® (calcipotriene ointment) , 56.7% of patients showed at least marked improvements (6.4% showed complete clearing). After 8 weeks of twice daily Dovonex® (calcipotriene ointment) , 70.0% of patients showed at least marked improvement (11.3% showed complete clearing).

Subtracting percentages of patients using placebo (vehicle only) from percentages of patients using Dovonex® (calcipotriene ointment) who had at least marked improvements after 8 weeks yields 39.9% for once daily and 49.6% for twice daily. This adjustment for placebo effect indicates that what might appear to be differences between once daily and twice daily use may reflect differences in the studies independent from the frequency of dosing. Although there was a numerical difference in comparison across studies, twice daily dosing has not been shown to be superior in efficacy to once daily dosing.

Over 400 patients have been treated in open label clinical studies of Dovonex® (calcipotriene ointment) for periods of up to one year. In half of these studies, patients who previously had not responded well to Dovonex® (calcipotriene ointment) were excluded. The adverse events in these extended studies included skin irritation in approximately 25% of patients and worsening of psoriasis in approximately 10% of patients. In one of these open label studies, half of the patients no longer required Dovonex® (calcipotriene ointment) by 16 weeks of treatment, because of satisfactory therapeutic results.

Medication Guide


Patients using Dovonex® (calcipotriene ointment) should receive the following information and instructions:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash hands after application.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. Patients should report to their physician any signs of local adverse reactions.
  4. Patients that apply Dovonex® (calcipotriene ointment) to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
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