Drug Safety Information for KLARON (Sulfacetamide sodium)

Adverse Drug Reactions for KLARON* (Sulfacetamide sodium)

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 KLARON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity39
2Pain36
3Injury27
4Dyspnoea26
5Nausea23
6Drug ineffective*23
7Rash18
8Headache18
9Erythema*17
10Vomiting17
11Diarrhoea16
12Abdominal pain16
13Back pain16
14Anxiety16
15Fatigue15
16Asthenia14
17Condition aggravated14
18Emotional distress14
19Hypertension13
20Economic problem13

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

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

Reason # of FDA Reports
1Product used for unknown indication255
2Acne*159
3Rosacea*56
4Eye infection48
5Conjunctivitis37
6Open wound28
7Conjunctivitis allergic25
8Urinary tract infection17
9Eye infection staphylococcal12
10Therapeutic skin care topical12

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


Types of Adverse Events for KLARON

Total Reports Filed with FDA: 2417


Number of FDA Adverse Event Reports by Patient Age for KLARON

Total Reports Filed with FDA: 2417*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sulfacetamide sodium (Sulf-10, Bleph-10, Sulfair 10, Sulfacel-15, Sulf-15, Bleph-30, Sulfair forte, Ocusulf-30, Sulfair-15, Isopto cetamide, Ocusulf-10, Sulten-10, Perrigo seb prev, Re 10, Seb prev, Sodium sulfacetamide, Ovaceplus, Ovace plus, Sulfacetamide, Bleph, Ovace, Sulfacetamide sodium, Sulphacetamide, Sodium sulamyd, Klaron, Cetamide)

Charts are based on 2417 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 KLARON 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.