Drug Safety Information for CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (Betamethasone dipropionate; clotrimazole)

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

Adverse Drug Reactions for CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE* (Betamethasone dipropionate; clotrimazole)

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 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fatigue47
2Pain47
3Nausea47
4Headache43
5Anxiety41
6Drug ineffective39
7Dyspnoea39
8Rash37
9Diarrhoea36
10Dizziness34
11Asthenia30
12Back pain30
13Chest pain30
14Hypertension29
15Arthralgia28
16Insomnia28
17Oedema peripheral28
18Pain in extremity28
19Anaemia27
20Fall27

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

Top 10 Reasons for Taking CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication341
2Rash207
3Skin disorder53
4Dermatitis42
5Vulvovaginal pruritus39
6Tinea cruris*26
7Fungal infection*25
8Dermatosis17
9Testicular disorder14
10Psoriasis14

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


Types of Adverse Events for CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Total Reports Filed with FDA: 4713


Number of FDA Adverse Event Reports by Patient Age for CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Total Reports Filed with FDA: 4713*


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

Charts are based on 4713 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 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Reviews and Review Summary .

Historical 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.