Dovonex Cream

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

Drug Summary

What Is Dovonex Cream?

Dovonex (calcipotriene) Cream is a vitamin B3 derivative indicated for the treatment of plaque psoriasis.

What Are Side Effects of Dovonex Cream?

Side effects of Dovonex Cream include:

  • skin irritation,
  • rash or itching,
  • skin redness,
  • dry or peeling skin, and
  • worsening psoriasis.

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

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

Dovonex Cream 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 the 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 Cream

Dovonex Cream contains 50 micrograms of calcipotriene monohydrate per gram of cream. Apply a thin layer of Dovonex Cream to the affected skin twice daily and rub in gently and completely.

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

Dovonex Cream may interact with vitamin or mineral supplements that contain calcium or vitamin D. Tell your doctor all medications and supplements you use.

Dovonex Cream During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Dovonex Cream; it is unknown if it will harm a fetus. It is unknown if Dovonex Cream topical passes into breast milk or if it could harm a nursing baby. Do not apply Dovonex Cream topical to your chest area if you are breastfeeding. Consult your doctor before breastfeeding.

Additional Information

Our Dovonex (calcipotriene) Cream 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) Cream, 0.005% contains calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatological use.

Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1a,3b,24-triol monohydrate, with the empirical formula C27H40O3†H2O, a molecular weight of 430.6, and the following structural formula:

Calcipotriene monohydrate is a white or off-white crystalline substance. Dovonex Cream (calcipotriene cream) contains calcipotriene monohydrate equivalent to 50 µg/g anhydrous calcipotriene in a cream base of cetearyl alcohol, ceteth-20, diazolidinyl urea, dichlorobenzyl alcohol, dibasic sodium phosphate, edetate disodium, glycerin, mineral oil, petrolatum, and water.

Indications & Dosage


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


Apply a thin layer of Dovonex Cream (calcipotriene cream) to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex Cream (calcipotriene cream) have been demonstrated in patients treated for eight weeks.


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

60 gram aluminum tubes (NDC 0072-0260-06) 120 gram aluminum tubes (NDC 0072-0260-12)


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

Manufactured by Leo Laboratories Ltd., Dublin, Ireland
Bristol-Myers Squibb Company
Distributed by: Bristol-Myers Squibb Company., Princeton, NJ 08543 USA
U.S. Patent No. 4,866,048 FDA
Rev date: 4/28/05
Side Effects & Drug Interactions


In controlled clinical trials, the most frequent adverse experiences reported for Dovonex (calcipotriene cream) Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.


No information provided.

Warnings & Precautions


No information provided.



Use of Dovonex Cream may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Dovonex Cream (calcipotriene cream) should be discontinued.

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

Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The potential of calcipotriene to induce carcinogenesis in standard long-term animal studies (in the absence of ultra-violet radiation (UVR)) has not been evaluated. 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 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 limit or 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 |ig/kg/day (318 |lg/m /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. Increased rabbit maternal and fetal toxicity was noted at 12 |ig/kg/day (132 |lg/m /day). Rabbits administered 36 |ig/kg/day (396 |lg/m /day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 |ig/kg/day (318 |ig/m /day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures 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 Cream (calcipotriene cream) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

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. Because many drugs are excreted in human milk, caution should be exercised when Dovonex Cream (calcipotriene cream) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Dovonex Cream (calcipotriene cream) 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 cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.

Overdose & Contraindications


Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored. (See PRECAUTIONS.)


Dovonex Cream 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 Cream (calcipotriene cream) 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. Systemic absorption of the cream has not been studied.

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.


Adequate and well-controlled trials of patients treated with Dovonex Cream (calcipotriene cream) have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.

Medication Guide


Patients using Dovonex Cream should receive the following information and instructions:

1.    This medication is to be used only 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 their 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 adverse reactions.

4.   Patients that apply Dovonex 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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