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Aldara (Imiquimod) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 CreamVehicle
Preferred Term(n= 215)(n= 221)
 
Application Site Reaction71 (33%)32 (14%)
Upper Resp Tract Infection33 (15%)27 (12%)
Sinusitis16 (7%)14 (6%)
Headache11 (5%)7 (3%)
Carcinoma Squamous8 (4%)5 (2%)
Diarrhea6 (3%)2 (1%)
Eczema4 (2%)3 (1%)
Back Pain3 (1%)2 (1%)
Fatigue3 (1%)2 (1%)
Fibrillation Atrial3 (1%)2 (1%)
Infection Viral3 (1%)2 (1%)
Dizziness3 (1%)1 (<1%)
Vomiting3 (1%)1 (<1%)
Urinary Tract Infection3 (1%)1 (<1%)
Fever3 (1%)0 (0%)
Rigors3 (1%)0 (0%)
Alopecia3 (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 CreamVehicle
Included Termn=215n=221
 
Itching44 (20%)17 (8%)
Burning13 (6%)4 (2%)
Bleeding7 (3%)1 (<1%)
Stinging6 (3%)2 (1%)
Pain6 (3%)2 (1%)
Induration5 (2%)3 (1%)
Tenderness4 (2%)3 (1%)
Irritation4 (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*SevereAll Grades*Severe
Erythema209 (97%)38 (18%)206 (93%)5 (2%)
Flaking/Scaling/Dryness199 (93%)16 (7%)199 (91%)7 (3%)
Scabbing/Crusting169 (79%)18 (8%)92 (42%)4 (2%)
Edema106 (49%)0 (0%)22 (10%)0 (0%)
Erosion/Ulceration103 (48%)5 (2%)20 (9%)0 (0%)
Weeping/Exudate45 (22%)0 (0%)3 (1%)0 (0%)
Vesicles19 (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 CreamVehicle
 
(n= 185)(n= 179)
Preferred TermN %N %
 
 
Application Site Reaction52 (28%)5 (3%)
Headache14 (8%)4 (2%)
Back Pain7 (4%)1 (<1%)
Upper Resp Tract Infection6 (3%)2 (1%)
Rhinitis5 (3%)1 (<1%)
Lymphadenopathy5 (3%)1 (<1%)
Fatigue4 (2%)2 (1%)
Sinusitis4 (2%)1 (<1%)
Dyspepsia3 (2%)2 (1%)
Coughing3 (2%)1 (<1%)
Fever3 (2%)0 (0%)
Dizziness2 (1%)1 (<1%)
Anxiety2 (1%)1 (<1%)
Pharyngitis2 (1%)1 (<1%)
Chest Pain2 (1%)0 (0%)
Nausea2 (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 CreamVehicle
Included Termn=185n=179
 
Itching30 (16%)1 (1%)
Burning11 (6%)2 (1%)
Pain6 (3%)0 (0%)
Bleeding4 (2%)0 (0%)
Erythema3 (2%)0 (0%)
Papule(s)3 (2%)0 (0%)
Tenderness2 (1%)0 (0%)
Infection2 (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 CreamVehicle
n=184n=178
All Grades*SevereAll Grades*Severe
 
Erythema184 (100%)57 (31%)173 (97%)4 (2%)
Flaking/Scaling167 (91%)7 (4%)135 (76%)0 (0%)
Induration154 (84%)11 (6%)94 (53%)0 (0%)
Scabbing/Crusting152 (83%)35 (19%)61 (34%)0 (0%)
Edema143 (78%)13 (7%)64 (36%)0 (0%)
Erosion122 (66%)23 (13%)25 (14%)0 (0%)
Ulceration73 (40%)11 (6%)6 (3%)0 (0%)
Vesicles57 (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 CreamVehicle
FemalesMalesFemalesMales
n=114n=156n=99n=157
All Grades*SevereAll Grades*SevereAll Grades*SevereAll Grades*Severe
 
Erythema74(65%)4(4%)90(58%)6(4%)21(21%)0(0%)34(22%)0(0%)
Erosion35(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%)
Edema20 (18%)1(1%)19(12%)0(0%)5(5%)0(0%)1(1%)0(0%)
Scabbing4(4%)0(0%)20(13%)0(0%)0(0%)0(0%)4(3%)0(0%)
Induration6(5%)0(0%)11(7%)0(0%)2(2%)0(0%)3(2%)0(0%)
Ulceration9(8%)3(3%)7(4%)0(0%)1(1%)0(0%)1(1%)0(0%)
Vesicles3(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:
Itching38(32%)21(20%)34(22%)16(10%)
Burning30(26%)12(12%)14(9%)8(5%)
Pain9(8%)2(2%)3(2%)1(1%)
Soreness3(3%)0(0%)0(0%)1(1%)
Fungal Infection* 13(11%)3(3%)3(2%)1(1%)
Systemic Reactions:
Headache5(4%)3(3%)8(5%)3(2%)
Influenza-like symptoms4(3%)2(2%)2(1%)0(0%)
Myalgia1(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.

  •   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.
  •   Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura) , lymphoma
  •   Hepatic: abnormal liver function
  •   Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide.
  •   Respiratory: dyspnea.
  •   Urinary System Disorders: proteinuria.
  •   Skin and Appendages: exfoliative dermatitis, erythema multiforme , hyperpigmentation.
  •   Vascular: Henoch-Schonlein purpura syndrome


REPORTS OF SUSPECTED ALDARA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Aldara. The information is not vetted and should not be considered as verified clinical evidence.

Possible Aldara side effects / adverse reactions in 29 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 29 year old female weighing 78.0 kg (171.6 pounds)

Reactions: Incorrect Dose Administered, Hypotension, Breast Mass, Headache, Myalgia, Fatigue, Breast Swelling, Malaise, Loss of Employment, Activities of Daily Living Impaired, Dysuria

Suspect drug(s):
Aldara



Possible Aldara side effects / adverse reactions in 43 year old male

Reported by a consumer/non-health professional from United States on 2011-11-07

Patient: 43 year old male weighing 75.0 kg (165.0 pounds)

Reactions: Lymphadenopathy, Head Discomfort, Blood Glucagon Increased, Muscular Weakness, Mucosal Dryness, Swollen Tongue, Suicidal Ideation, Arrhythmia, Lymph Node Pain, DRY Mouth, Heart Rate Increased, Insomnia, Anger, Dizziness, Feeling Abnormal

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldara



Possible Aldara side effects / adverse reactions in 62 year old female

Reported by a physician from United States on 2011-12-09

Patient: 62 year old female weighing 72.7 kg (159.9 pounds)

Reactions: Thrombosis, Drug Ineffective, Oedema Peripheral

Suspect drug(s):
Paxil
    Indication: Depression

Wellbutrin
    Indication: Depression

Cymbalta
    Indication: Depression

Aldara
    Indication: Precancerous Cells Present

Other drugs received by patient: Nardil; Prozac; Pamelor; Abilify; Zoloft; Pristiq; Ambien; Remeron



See index of all Aldara side effect reports >>

Drug label data at the top of this Page last updated: 2007-04-10

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