Aldara
- Generic Name: imiquimod
- Brand Name: Aldara
- Drug Class: Topical Skin Products
Aldara (Imiquimod) side effects drug center
Aldara Side Effects Center
What Is Aldara?
Aldara (imiquimod) topical (for the skin) is an immune response modifier used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp. Aldara is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment. Aldara also treats genital warts that appear on the outside of the body, but is not a cure for genital warts. Aldara topical is available in generic form.
What Are Side Effects of Aldara?
Common side effects of Aldara topical include:
- treatment area reactions such as skin redness, swelling, itching, irritation, dryness, burning, pain, tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid.
- Changes in skin color of the treated area may occur and may not go away.
- Other side effects of Aldara topical include headache,
- dizziness,
- chest pain,
- back pain,
- cold sores,
- fever blisters,
- cold symptoms (such as stuffy nose, sneezing, sore throat),
- flu-like symptoms (such as fever, tiredness, muscle aches),
- nausea,
- diarrhea,
- loss of appetite, or
- vaginal itching or discharge.
Dosage for Aldara
Aldara Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). Before applying the cream, the patient should wash hands and the treatment area with mild soap and water and allow the area to dry thoroughly. Avoid contact with eyes, lips and nostrils.
What Drugs, Substances, or Supplements Interact with Aldara?
It is not likely that other drugs you take orally or inject will have an effect on topically applied Aldara. But many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use.
Aldara During Pregnancy and Breastfeeding
During pregnancy, Aldara should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Aldara (imiquimod) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Aldara Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine was applied.
When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.
Call your doctor at once if you have:
- flu-like symptoms such as fever, chills, nausea, tiredness, body aches, or swollen glands;
- bleeding or swelling where you applied this medicine; or
- symptoms of herpes zoster (shingles)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.
Common side effects may include:
- minor skin pain, irritation, itching, redness, dryness, flaking, scabbing, crusting, scaling, or swelling where the medicine was applied;
- changes in the color of treated skin (may be permanent);
- headache;
- tiredness; or
- nausea.
Read the entire detailed patient monograph for Aldara (Imiquimod)
Aldara Professional Information
SIDE EFFECTS
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)
| Preferred Term | Aldara Cream (n=215) | Vehicle (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)
| Included Term | Aldara Cream (n=215) | Vehicle (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 (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%) |
| *Mild, Moderate, or Severe | ||||
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.
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)
| Preferred Term | Aldara Cream (n=185) N% |
Vehicle (n=179) 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 Table 6.
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)
| Included Term | Aldara Cream (n=185) | Vehicle (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)
| Aldara Cream (n=184) | Vehicle (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%) |
| *Mild, Moderate, or Severe | ||||
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.
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 Table 8.
Table 8: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (External
Genital Warts)
| Aldara Cream | Vehicle | |||||||
| Females (n=114) | Males (n=156) | Females (n=99) | Males (n=157) | |||||
| All | All | All | All | |||||
| Grades* | Severe | Grades* | Severe | Grades* | Severe | 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%) |
| *Mild, Moderate, or Severe | ||||||||
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) |
|
| 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%) |
| *Incidences reported without regard to causality with Aldara Cream. | ||||
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
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].
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 Disorders: 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-Schönlein purpura syndrome
Read the entire FDA prescribing information for Aldara (Imiquimod)
© Aldara Patient Information is supplied by Cerner Multum, Inc. and Aldara Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.