Aldara Side Effects

Please note - some side effects for Aldara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Aldara - for the Consumer

Aldara

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aldara:

Back pain; changes in skin color; diarrhea; headache; itching, burning, mild pain, or tenderness at the application site; redness, dryness, flaking, swelling, or scabbing at the application site; small sores or mild drainage at the application site; thick or hardened skin at the application site; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Aldara:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); chest pain; fever, chills, or sore throat; irregular heartbeat; muscle pain or weakness; nausea; oozing, blistering, or bleeding at the application site; severe irritation or pain at the application site; sores or ulcers at the application site; swollen lymph glands; trouble urinating; vaginal pain or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Aldara Side Effects - for the Professional

Aldara

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience: Actinic Keratosis

The data described below reflect exposure to Aldara Cream or vehicle in 436 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle to a 25 cm2 contiguous treatment area on the face or scalp 2 times per week for 16 weeks.

Table 2: Selected Adverse Reactions Occurring in > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis)

	Aldara Cream	Vehicle
Preferred Term	(n= 215)	(n= 221)
Application Site Reaction	71 (33%)	32 (14%)
Upper Resp Tract Infection	33 (15%)	27 (12%)
Sinusitis	16 (7%)	14 (6%)
Headache	11 (5%)	7 (3%)
Carcinoma Squamous	8 (4%)	5 (2%)
Diarrhea	6 (3%)	2 (1%)
Eczema	4 (2%)	3 (1%)
Back Pain	3 (1%)	2 ( 1%)
Fatigue	3 (1%)	2 (1%)
Fibrillation Atrial	3 (1%)	2 (1%)
Infection Viral	3 (1%)	2 (1%)
Dizziness	3 (1%)	1 (<1%)
Vomiting	3 (1%)	1 (<1%)
Urinary Tract Infection	3 (1%)	1 (<1%)
Fever	3 (1%)	0 (0%)
Rigors	3 (1%)	0 (0%)
Alopecia	3 (1%)	0 (0%)

Table 3: Application Site Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis)

	Aldara Cream	Vehicle
Included Term	n=215	n=221
Itching	44 (20%)	17 (8%)
Burning	13 (6%)	4 (2%)
Bleeding	7 (3%)	1 (<1%)
Stinging	6 (3%)	2 (1%)
Pain	6 (3%)	2 (1%)
Induration	5 (2%)	3 (1%)
Tenderness	4 (2%)	3 (1%)
Irritation	4 (2%)	0 (0%)

Local skin reactions were collected independently of the adverse reaction "application site reaction" in an effort to provide a better picture of the specific types of local reactions that might be seen. The most frequently reported local skin reactions were erythema, flaking/scaling/ dryness, and scabbing/crusting. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Table 4: Local Skin Reactions in the Treatment Area as Assessed by the Investigator

*Mild, Moderate, or Severe
(Actinic Keratosis)
	Aldara Cream (n=215)		Vehicle (n=220)
	All Grades*	Severe	All Grades*	Severe
Erythema	209 (97%)	38 (18%)	206 (93%)	5 (2%)
Flaking/Scaling/Dryness	199 (93%)	16 (7%)	199 (91%)	7 (3%)
Scabbing/Crusting	169 (79%)	18 (8%)	92 (42%)	4 (2%)
Edema	106 (49%)	0 (0%)	22 (10%)	0 (0%)
Erosion/Ulceration	103 (48%)	5 (2%)	20 (9%)	0 (0%)
Weeping/Exudate	45 (22%)	0 (0%)	3 (1%)	0 (0%)
Vesicles	19 (9%)	0 (0%)	2 (1%)	0 (0%)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions. Overall, in the clinical studies, 2% (5/215) of subjects discontinued for local skin/application site reactions. Of the 215 subjects treated, 35 subjects (16%) on Aldara Cream and 3 of 220 subjects (1%) on vehicle cream had at least one rest period. Of these Aldara Cream subjects, 32 (91%) resumed therapy after a rest period.

In the AK studies, 22 of 678 (3.2%) of Aldara-treated subjects developed treatment site infections that required a rest period off Aldara Cream and were treated with antibiotics (19 with oral and 3 with topical).

Of the 206 Aldara subjects with both baseline and 8-week post-treatment scarring assessments, 6 (2.9%) had a greater degree of scarring scores at 8-weeks post-treatment than at baseline.

Clinical Trials Experience: Superficial Basal Cell Carcinoma

The data described below reflect exposure to Aldara Cream or vehicle in 364 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle 5 times per week for 6 weeks. The incidence of adverse reactions reported by > 1% of subjects during the studies is summarized below.

Table 5: Selected Adverse Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Superficial Basal Cell Carcinoma)

	Aldara Cream	Vehicle
	(n= 185)	(n= 179)
Preferred Term	N %	N %
Application Site Reaction	52 (28%)	5 (3%)
Headache	14 (8%)	4 (2%)
Back Pain	7 (4%)	1 (<1%)
Upper Resp Tract Infection	6 (3%)	2 (1%)
Rhinitis	5 (3%)	1 (<1%)
Lymphadenopathy	5 (3%)	1 (<1%)
Fatigue	4 (2%)	2 (1%)
Sinusitis	4 (2%)	1 (<1%)
Dyspepsia	3 (2%)	2 (1%)
Coughing	3 (2%)	1 (<1%)
Fever	3 (2%)	0 (0%)
Dizziness	2 (1%)	1 (<1%)
Anxiety	2 (1%)	1 (<1%)
Pharyngitis	2 (1%)	1 (<1%)
Chest Pain	2 (1%)	0 (0%)
Nausea	2 (1%)	0 (0%)

The most frequently reported adverse reactions were local skin and application site reactions including erythema, edema, induration, erosion, flaking/scaling, scabbing/crusting, itching and burning at the application site. The incidence of application site reactions reported by > 1% of the subjects during the 6 week treatment period is summarized in the table below.

Table 6: Application Site Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Superficial Basal Cell Carcinoma)

	Aldara Cream	Vehicle
Included Term	n=185	n=179
Itching	30 (16%)	1 (1%)
Burning	11 (6%)	2 (1%)
Pain	6 (3%)	0 (0%)
Bleeding	4 (2%)	0 (0%)
Erythema	3 (2%)	0 (0%)
Papule(s)	3 (2%)	0 (0%)
Tenderness	2 (1%)	0 (0%)
Infection	2 (1%)	0 (0%)

Local skin reactions were collected independently of the adverse reaction "application site reaction" in an effort to provide a better picture of the specific types of local reactions that might be seen. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Table 7: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (Superficial Basal Cell Carcinoma)

*Mild, Moderate, or Severe
	Aldara Cream		Vehicle
	n=184		n=178
	All Grades*	Severe	All Grades*	Severe
Erythema	184 (100%)	57 (31%)	173 (97%)	4 (2%)
Flaking/Scaling	167 (91%)	7 (4%)	135 (76%)	0 (0%)
Induration	154 (84%)	11 (6%)	94 (53%)	0 (0%)
Scabbing/Crusting	152 (83%)	35 (19%)	61 (34%)	0 (0%)
Edema	143 (78%)	13 (7%)	64 (36%)	0 (0%)
Erosion	122 (66%)	23 (13%)	25 (14%)	0 (0%)
Ulceration	73 (40%)	11 (6%)	6 (3%)	0 (0%)
Vesicles	57 (31%)	3 (2%)	4 (2%)	0 (0%)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions; 10% (19/185) of subjects received rest periods. The average number of doses not received per subject due to rest periods was 7 doses with a range of 2 to 22 doses; 79% of subjects (15/19) resumed therapy after a rest period. Overall, in the clinical studies, 2% (4/185) of subjects discontinued for local skin/application site reactions.

In the sBCC studies, 17 of 1266 (1.3%) Aldara -treated subjects developed treatment site infections that required a rest period and treatment with antibiotics.

Clinical Trials Experience: External Genital Warts

In controlled clinical trials for genital warts, the most frequently reported adverse reactions were local skin and application site reactions.

Some subjects also reported systemic reactions. Overall, 1.2% (4/327) of the subjects discontinued due to local skin/application site reactions. The incidence and severity of local skin reactions during controlled clinical trials are shown in the following table.

Table 8: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (External Genital Warts)

*Mild, Moderate, or Severe
	Aldara Cream				Vehicle
	Females		Males		Females		Males
	n=114		n=156		n=99		n=157
	All Grades*	Severe	All Grades*	Severe	All Grades*	Severe	All Grades*	Severe
Erythema	74(65%)	4(4%)	90(58%)	6(4%)	21(21%)	0(0%)	34(22%)	0(0%)
Erosion	35(31%)	1(1%)	47(30%)	2(1%)	8(8%)	0(0%)	10(6%)	0(0%)
Excoriation/ Flaking	21(18%)	0(0%)	40(26%)	1(1%)	8(8%)	0(0%)	12(8%)	0(0%)
Edema	20 (18%)	1(1%)	19(12%)	0(0%)	5(5%)	0(0%)	1(1%)	0(0%)
Scabbing	4(4%)	0(0%)	20(13%)	0(0%)	0(0%)	0(0%)	4(3%)	0(0%)
Induration	6(5%)	0(0%)	11(7%)	0(0%)	2(2%)	0(0%)	3(2%)	0(0%)
Ulceration	9(8%)	3(3%)	7(4%)	0(0%)	1(1%)	0(0%)	1(1%)	0(0%)
Vesicles	3(3%)	0(0%)	3(2%)	0(0%)	0(0%)	0(0%)	0(0%)	0(0%)

Remote site skin reactions were also reported. The severe remote site skin reactions reported for females were erythema (3%), ulceration (2%), and edema (1%); and for males, erosion (2%), and erythema, edema, induration, and excoriation/flaking (each 1%).

Selected adverse reactions judged to be probably or possibly related to Aldara Cream are listed below.

Table 9: Selected Treatment Related Reactions (External Genital Warts)

	Females		Males
	Aldara Cream n=117	Vehicle n=103	Aldara Cream n=156	Vehicle n=158
*Incidences reported without regard to causality with Aldara Cream.
Application Site Disorders:
Application Site Reactions
Wart Site:
Itching	38(32%)	21(20%)	34(22%)	16(10%)
Burning	30(26%)	12(12%)	14(9%)	8(5%)
Pain	9(8%)	2(2%)	3(2%)	1(1%)
Soreness	3(3%)	0(0%)	0(0%)	1(1%)
Fungal Infection*	13(11%)	3(3%)	3(2%)	1(1%)
Systemic Reactions:
Headache	5(4%)	3(3%)	8(5%)	3(2%)
Influenza-like symptoms	4(3%)	2(2%)	2(1%)	0(0%)
Myalgia	1(1%)	0(0%)	2(1%)	1(1%)

Adverse reactions judged to be possibly or probably related to Aldara Cream and reported by more than 1% of subjects included:

Application Site Disorders: burning, hypopigmentation, irritation, itching, pain, rash, sensitivity, soreness, stinging, tenderness
Remote Site Reactions: bleeding, burning, itching, pain, tenderness, tinea cruris
Body as a Whole: fatigue, fever, influenza-like symptoms
Central and Peripheral Nervous System Disorders: headache
Gastro-Intestinal System Disorders: diarrhea
Musculo-Skeletal System Disorders: myalgia.

Clinical Trials Experience: Dermal Safety Studies

Provocative repeat insult patch test studies involving induction and challenge phases produced no evidence that Aldara Cream causes photoallergenicity or contact sensitization in healthy skin; however, cumulative irritancy testing revealed the potential for Aldara Cream to cause irritation, and application site reactions were reported in the clinical studies [see Adverse Reactions (6)].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Aldara Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Application Site Disorder: tingling at the application site.
Body as a Whole: angioedema.
Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope.
Endocrine: thyroiditis.
Gastro-Intestinal System Disorders: abdominal pain.
Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma.
Hepatic: abnormal liver function.
Infections and Infestations: herpes simplex.
Musculo-Skeletal System Disorders: arthralgia.
Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide.
Respiratory: dyspnea.
Urinary System Disorders: proteinuria, dysuria, urinary retention.
Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar.
Vascular: Henoch-Schonlein purpura syndrome.

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Side Effects by Body System - for Healthcare Professionals

General

In general, the side effects associated with imiquimod topical may vary depending on the condition being treated.

Local

Local side effects have included application site reaction (up to 33%), application site pain (up to 7%), application site irritation (up to 6%), application site pruritus (up to 4%), application site bleeding, application site swelling, treatment site infection, scarring, application site rash, application site cellulitis, and application site excoriation. Local skin reactions have included erythema (all grades: up to 100%; severe: up to 31%), scabbing/crusting (all grades: up to 93%; severe: up to 19%), flaking/scaling/dryness (all grades: up to 93%; severe: up to 8%), flaking/scaling (all grades: 91% ; severe: 4%), induration (all grades: up to 84% ; severe: up to 6%), edema (all grades: up to 78%; severe: up to 7%), erosion (all grades: up to 66% ; severe: up to 14%), erosion/ulceration (all grades: up to 62%; severe: up to 13%), weeping/exudates (all grades: up to 51%; severe: 6%), ulceration (all grades: up to 40% ; severe: up to 6%), exudates (all grades: up to 34% ; severe: up to 2%), vesicles (all grades: up to 31%; severe: up to 2%), excoriation/flaking (all grades: up to 26%; severe: up to 1%), and scabbing (all grades: up to 13%). Application site reactions have included itching (up to 20%), burning (6%), bleeding (up to 3%), stinging (3%), pain (3%), erythema (2%), papule(s) (2%), induration (2%), tenderness (up to 2%), irritation (2%), and infection (1%). Application site disorders reported in more than 1% of patients have included burning, hypopigmentation, rash, sensitivity, soreness, stinging, and tenderness. Itching (32% in females, 22% in males), burning (26% in females, 9% in males), pain (8% in females, 2% in males), and soreness (3% in females) were reported at the wart site. Tingling at the application site has been reported during postmarketing experience.

In studies involving treatment of actinic keratosis or superficial basal cell carcinoma, the dermatologic side effects classified as local and application site most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study, treatment site infections requiring treatment with antibiotics).

Flaking/scaling was reported in 40% of males and 26% of females and scabbing/crusting was reported in 34% of males and 18% of females; otherwise, frequency and severity of local skin reactions were similar in both genders.

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 15%), sinusitis (up to 7%), rhinitis (3%), coughing (2%), and pharyngitis (1%). Pulmonary congestion and bronchitis have been reported. Dyspnea and pulmonary edema have been reported during postmarketing experience.

Immunologic

Immunologic side effects have included fungal infection (11% in females, 2% in males), herpes simplex (up to 3%), viral infection (1%), herpes zoster, and infection. Herpes simplex has also been reported during postmarketing experience.

Nervous system

Two cases involving the development of chronic neuropathic pain following initiation of imiquimod topical therapy for the treatment of warts have been reported. In the first case, a 53-year-old man with genital warts reported an erosion with substantial pain on the left lateral glans of the penis approximately 1 week following initiation of therapy with imiquimod applied topically 3 times a week. Imiquimod therapy was discontinued; however, the patient continued to report a burning-like pain and erythema in the area for approximately 2 years. The condition may have been exacerbated by aerobic exercise, sweating, and sexual activity. In the second case report, a 64-year-old woman with plantar warts developed numbness and pain in all toes and the balls of both feet following approximately 5 months of therapy with imiquimod topical applied each night with tape occlusion. Imiquimod topical was discontinued. This condition may have been exacerbated by a daily paring of the warts by the patient prior to imiquimod application. Approximately 2 years later, the patient reported a gradual improvement in the numbness and an absence of the burning-like pain. Neither patient had diabetes mellitus, or any other condition known to result in possible neuropathic pain.

Nervous system side effects have included headache (up to 8%), dizziness (up to 3%), insomnia, and lethargy. Nervous system side effects have rarely included neuropathic pain. Agitation, convulsions (including febrile convulsions), insomnia, multiple sclerosis aggravation, and paresis have been reported during postmarketing experience.

Other

Other side effects have included back pain (up to 4%), fatigue (up to 4%), pyrexia (up to 3%), pain (up to 3%), influenza-like symptoms (3% in females, 1% in males), rigors (1%), chills, and influenza-like illness. Hernia, inflicted injury, and postoperative pain have been reported.

Gastrointestinal

A review of 3 case reports involving patients receiving imiquimod topical applied 2 or 3 times weekly for treatment of actinic cheilitis in the lip region reported the formation of aphthous ulcers approximately 2 to 3 weeks following initiation of treatment. In each case, the aphthous ulcers resolved upon discontinuation of imiquimod topical and treatment with a topical steroid. None of the patients consented to a rechallenge.

Gastrointestinal side effects have included nausea (up to 3%), anorexia (3%), diarrhea (up to 3%), dyspepsia (2%), vomiting (1%), and cheilitis. Gastrointestinal disorder and aphthous ulcers (rare) have been reported. Abdominal pain has been reported during postmarketing experience.

Oncologic

Oncologic side effects have included squamous cell carcinoma (up to 4%). Basal cell carcinoma has been reported. Oncologic side effects reported during non-FDA approved treatment of melanoma in situ have included a single case report of the development of invasive melanoma.

An 87-year-old Caucasian woman developed invasive amelanotic melanoma with satellite lesions within 14 weeks after initiation of treatment with imiquimod three times per week. It is unknown if this was a probable side effect of imiquimod or a progressive event of melanoma in situ.

Hematologic

Hematologic side effects have included lymphadenopathy (up to 3%) and pancytopenia. Decreases in red cell, white cell, and platelet counts (including idiopathic thrombocytopenic purpura), and lymphoma have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included chest pain (up to 2%), atrial fibrillation (1%), and hypertension. Capillary leak syndrome, cardiac failure, cardiomyopathy, cerebrovascular accident, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope, and Henoch-Schonlein purpura syndrome have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included eczema (2%), alopecia (1%), dermatitis, and pruritus. Remote site skin reaction were reported and included erythema (3% in females, 1% in males), ulceration (2% in females), erosion (2% in males), edema (1% in females, 1% in males), induration (1% in males), and excoriation/flaking (1% in males). Remote site reactions reported in more than 1% of patients have included bleeding, burning, itching, pain, tenderness, and tinea cruris. Hyperkeratosis, rash, skin disorder, photosensitivity reaction, verruca, and remote site irritation have been reported. Imiquimod-induced psoriasis and at least 1 case each of vitiligo-like hyperpigmentation, contact pemphigus, pityriasis rubra pilaris exacerbation, erosive pustular dermatosis of the scalp, and eruptive keratoacanthoma have been reported. Exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypopigmentation, and hypertrophic scar have been reported during postmarketing experience.

In the studies involving treatment of genital/perianal warts, the skin reactions reported were more frequent and more intense with daily application of the cream than with the application of the cream three times per week.

In studies involving treatment of actinic keratosis or superficial basal cell carcinoma, the dermatologic side effects classified as local and application site most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study, treatment site infections requiring treatment with antibiotics).

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 1%) and arthralgia. Arthritis and skeletal pain have been reported. Arthralgia has also been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included bacterial vaginitis (up to 3% of females), urinary tract infections (1%), scrotal pain, scrotal erythema, scrotal ulcer, and scrotal edema. Proteinuria, urinary retention, and dysuria have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety (1%). Depression and suicide have been reported during postmarketing experience.

Ocular

Ocular side effects have included conjunctivitis and eye abnormality.

Hypersensitivity

A 61-year-old man developed angioedema 3 weeks into treatment for squamous cell carcinoma in situ located on the right forearm. One week prior he had developed ulceration over the application site. The angioedema started in the right hand at which time the imiquimod therapy was discontinued. Within 36 hours of discontinuation the angioedema had encompassed both hands and feet and the ulcerated application site. Fifty-four hours following discontinuation of therapy the patient was awakened by severe swelling of the tongue, diagnosed by the emergency room physician as angioedema of the tongue. The patient experienced difficulty talking and swallowing, but no respiratory distress. The patient denied presence of chills, fever, or influenza-like symptoms. The patient denied history of urticaria, angioedema, or anaphylaxis. The patient was stable on all medications prior to initiation of imiquimod therapy. The patient improved following treatment with intravenous diphenhydramine and methylprednisolone. It is thought that the large application site (16.7 m2) and the ulceration may have facilitated in the absorption of imiquimod resulting in the angioedema.

Hypersensitivity side effects have included angioedema during postmarketing experience. Aggravation of allergy has been reported.

Metabolic

Metabolic side effects have included hypercholesterolemia and gout.

Hepatic

Hepatic side effects have included abnormal liver function during postmarketing experience.

Endocrine

Endocrine side effects have included thyroiditis during postmarketing experience.

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