Drug Safety Information for CELESTONE (Betamethasone)

Safety-related Labeling Changes for CELESTONE SOLUSPAN (BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE) Rx Drug: FDA Link

Safety-related Labeling Changes for DIPROLENE (BETAMETHASONE DIPROPIONATE) Rx Drug: FDA Link

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

Safety-related Labeling Changes for DIPROLENE AF (BETAMETHASONE DIPROPIONATE) Rx Drug: FDA Link

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 CELESTONE* (Betamethasone)

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 CELESTONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea62
2Pruritus60
3Pain*56
4Rash55
5Erythema52
6Nausea47
7Premature baby40
8Headache*38
9Dizziness37
10Diarrhoea37
11Vomiting37
12Fatigue37
13Pyrexia37
14Insomnia37
15Drug ineffective34
16Oedema peripheral33
17Abdominal pain33
18Hypersensitivity33
19Fall33
20Anxiety32

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

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

Reason # of FDA Reports
1Product used for unknown indication527
2Dermatitis atopic174
3Bronchitis86
4Eczema84
5Rheumatoid arthritis76
6Asthma74
7Psoriasis73
8Pruritus73
9Tendinous contracture70
10Rash56

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


Types of Adverse Events for CELESTONE

Total Reports Filed with FDA: 6600


Number of FDA Adverse Event Reports by Patient Age for CELESTONE

Total Reports Filed with FDA: 6600*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Betamethasone (Celeston, Betnovate, Celestone, Bettamousse, Betnelan, Celestona)

Charts are based on 6600 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 CELESTONE 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.