Drug Safety Information for ALDARA (Imiquimod)

Adverse Drug Reactions for ALDARA* (Imiquimod)

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 ALDARA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Fatigue	109
2	Application site erythema	93
3	Influenza like illness*	91
4	Nausea	78
5	Headache*	78
6	Pyrexia	77
7	Pain*	73
8	Application site pain	68
9	Erythema*	59
10	Dizziness	57
11	Scab	53
12	Malaise	53
13	Myalgia	48
14	Application site reaction	48
15	Asthenia	43
16	Back pain	42
17	Diarrhoea	42
18	Rash	40
19	Pruritus*	40
20	Lymphadenopathy	39

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

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

	Reason	# of FDA Reports
1	Actinic keratosis*	1301
2	Basal cell carcinoma*	708
3	Anogenital warts*	470
4	Skin papilloma*	223
5	Skin cancer*	194
6	Precancerous cells present	175
7	Precancerous skin lesion	174
8	Product used for unknown indication	170
9	Squamous cell carcinoma*	83
10	Bowen's disease	62

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

Types of Adverse Events for ALDARA

Total Reports Filed with FDA: 5974

Number of FDA Adverse Event Reports by Patient Age for ALDARA

Total Reports Filed with FDA: 5974*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Imiquimod (Zyclara, Aldara, Imiquimod)

Charts are based on 5974 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.

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.