Drug Safety Information for TACLONEX SCALP (Betamethasone dipropionate; calcipotriene)

Safety-related Labeling Changes for TACLONEX (BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TACLONEX (BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ENSTILAR (BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE) Rx Drug: FDA Link

Adverse Drug Reactions for TACLONEX SCALP* (Betamethasone dipropionate; calcipotriene)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TACLONEX SCALP
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Psoriasis53
2Injection site pain27
3Drug ineffective25
4Headache14
5Pruritus13
6Nasopharyngitis13
7Arthralgia12
8Injection site erythema11
9Back pain11
10Pain10
11Sinusitis10
12Pain in extremity10
13Dizziness10
14Nausea9
15Erythema9
16Fatigue9
17Joint swelling8
18Pyrexia8
19Injection site haematoma7
20Injection site swelling6

* This side effect also appears in "Top 10 Side Effects of TACLONEX SCALP " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TACLONEX SCALP
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Psoriasis369
2Product used for unknown indication199
3Skin lesion11
4Pustular psoriasis9
5Scab6
6Skin disorder2
7Eczema1

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TACLONEX SCALP

Total Reports Filed with FDA: 875


Number of FDA Adverse Event Reports by Patient Age for TACLONEX SCALP

Total Reports Filed with FDA: 875*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Betamethasone dipropionate; calcipotriene (Taclonex scalp)

Charts are based on 875 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and TACLONEX SCALP Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on TACLONEX SCALP's side effects.