Common Aldara Side Effects


The most commonly reported Aldara side effects (click to view or check a box to report):

Application Site Erythema (50)
Fatigue (46)
Influenza Like Illness (40)
Application Site Reaction (37)
Headache (33)
Dizziness (30)
Erythema (24)
Application Site Pain (23)
Application Site Irritation (22)
Application Site Scab (19)
Pyrexia (18)
Arthralgia (18)
Back Pain (18)
Lymphadenopathy (18)
Nausea (17)
Diarrhoea (17)
Dyspnoea (17)
Application Site Inflammation (16)
Pain (16)
Asthenia (16)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Aldara Side Effects Reported to FDA



Aldara Side Effect Report#9890463
Stevens-johnson Syndrome, Toxic Epidermal Necrolysis
This is a report of a 72-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aldara (dosage: 1 Packet?qd?topical, start time:
Jan 06, 2014), combined with: NA. and developed a serious reaction and side effect(s): Stevens-johnson Syndrome, Toxic Epidermal Necrolysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in male patients, resulting in Stevens-johnson Syndrome side effect.
Aldara Side Effect Report#9645962
Asthenia, Decreased Appetite, Weight Decreased, Application Site Reaction
This report suggests a potential Aldara Asthenia side effect(s) that can have serious consequences. A 90-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: acne and used Aldara (dosage: NA) starting 201205. After starting Aldara the patient began experiencing various side effects, including: Asthenia, Decreased Appetite, Weight Decreased, Application Site ReactionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Aldara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthenia, may still occur.
Aldara Side Effect Report#9496152
Lichen Planus
This Lichen Planus problem was reported by a health professional from CN. A 37-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: anogenital warts. On NS this consumer started treatment with Aldara (dosage: Every Other Night). The following drugs were being taken at the same time:
  • Laser Treatment
When using Aldara, the patient experienced the following unwanted symptoms/side effects: Lichen PlanusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lichen Planus, may become evident only after a product is in use by the general population.
Aldara Side Effect Report#9496151
Vitiligo
This Vitiligo side effect was reported by a health professional from CN. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: anogenital warts.The patient was prescribed Aldara (drug dosage: Every Other Night), which was initiated on NS. Concurrently used drugs: NA..After starting to take Aldara the consumer reported adverse symptoms, such as: VitiligoThese side effects may potentially be related to Aldara.
Aldara Side Effect Report#9413388
Basal Cell Carcinoma
This is a report of a 62-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Aldara (dosage: Five Times A Week, Topical, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Basal Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in male patients, resulting in Basal Cell Carcinoma side effect.
Aldara Side Effect Report#9159483
Dizziness, Dizziness, Balance Disorder
This report suggests a potential Aldara Dizziness side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: basosquamous carcinoma and used Aldara (dosage: Pin Head Size, Qd 5 Days 6 Weeks) starting
Feb 06, 2013. After starting Aldara the patient began experiencing various side effects, including: Dizziness, Dizziness, Balance DisorderAdditional drugs used concurrently: NA. Although Aldara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dizziness, may still occur.
Aldara Side Effect Report#8760074
Application Site Pain, Movement Disorder, Fall, Head Injury, Mental Impairment, Depressed Level Of Consciousness, Speech Disorder, Blood Test Abnormal
This Application Site Pain problem was reported by a consumer or non-health professional from US. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: skin cancer. On
Jun 01, 2012 this consumer started treatment with Aldara (dosage: NA). The following drugs were being taken at the same time: NA. When using Aldara, the patient experienced the following unwanted symptoms/side effects: Application Site Pain, Movement Disorder, Fall, Head Injury, Mental Impairment, Depressed Level Of Consciousness, Speech Disorder, Blood Test AbnormalThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Application Site Pain, may become evident only after a product is in use by the general population.
Aldara Side Effect Report#8464789-7
Vision Blurred, Pain, Haemorrhage, Eyelid Oedema, Retinal Vein Occlusion
This Vision Blurred side effect was reported by a health professional from Australia. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: basal cell carcinoma.The patient was prescribed Aldara (drug dosage: Qd;top), which was initiated on NS. Concurrently used drugs: NA..After starting to take Aldara the consumer reported adverse symptoms, such as: Vision Blurred, Pain, Haemorrhage, Eyelid Oedema, Retinal Vein OcclusionThese side effects may potentially be related to Aldara.
Aldara Side Effect Report#8317078-5
Candidiasis, Dermatitis, Postictal State, Dysuria, Grand Mal Convulsion, White Blood Cell Count Increased, Cellulitis, Application Site Erythema, Vomiting
This is a report of a 2-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: molluscum contagiosum, who was treated with Aldara (dosage: Qd;top, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Candidiasis, Dermatitis, Postictal State, Dysuria, Grand Mal Convulsion, White Blood Cell Count Increased, Cellulitis, Application Site Erythema, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in female patients, resulting in Candidiasis side effect. The patient was hospitalized.
Aldara Side Effect Report#8312646-9
Pleural Effusion, Pulmonary Embolism
This report suggests a potential Aldara Pleural Effusion side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: basal cell carcinoma and used Aldara (dosage: ;5x/wk;top) starting NS. After starting Aldara the patient began experiencing various side effects, including: Pleural Effusion, Pulmonary EmbolismAdditional drugs used concurrently: NA. Although Aldara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pleural Effusion, may still occur.
Aldara Side Effect Report#8268829-X
Erythema, Pneumonitis
This Erythema problem was reported by a health professional from United States. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: skin lesion. On
Jul 01, 2011 this consumer started treatment with Aldara (dosage: Apply Thin Layer). The following drugs were being taken at the same time: NA. When using Aldara, the patient experienced the following unwanted symptoms/side effects: Erythema, PneumonitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Erythema, may become evident only after a product is in use by the general population.
Aldara Side Effect Report#8214331-0
Deep Vein Thrombosis, Pulmonary Embolism
This Deep Vein Thrombosis side effect was reported by a health professional from United States. A 22-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aldara (drug dosage: NA), which was initiated on
Apr 01, 2005. Concurrently used drugs:
  • Yaz (Unk)
  • Celebrex (200 Mg, Daily)
  • Multi-vitamins
  • Toprol-xl
  • Yasmin (Unk)
  • Inderal (60 Mg, Daily)
  • Vicodin (1-2 Tablets Every 6 Hours Or As Needed)
.After starting to take Aldara the consumer reported adverse symptoms, such as: Deep Vein Thrombosis, Pulmonary EmbolismThese side effects may potentially be related to Aldara.
Aldara Side Effect Report#8138126-1
Fatigue, Headache, Oropharyngeal Pain, Swollen Tongue, Neck Pain, Back Pain, Pulmonary Congestion, Influenza
This is a report of a 42-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: basal cell carcinoma, who was treated with Aldara (dosage: One Packet/dose, start time:
Dec 20, 2011), combined with: NA. and developed a serious reaction and side effect(s): Fatigue, Headache, Oropharyngeal Pain, Swollen Tongue, Neck Pain, Back Pain, Pulmonary Congestion, Influenza after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in female patients, resulting in Fatigue side effect.
Aldara Side Effect Report#8132351-1
Aphasia, Viith Nerve Paralysis, Hyperaesthesia, Balance Disorder, Dizziness, Reading Disorder, Emotional Distress, Anxiety, Mobility Decreased
This report suggests a potential Aldara Aphasia side effect(s) that can have serious consequences. A 19-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Aldara (dosage: Unk) starting
May 29, 2009. After starting Aldara the patient began experiencing various side effects, including: Aphasia, Viith Nerve Paralysis, Hyperaesthesia, Balance Disorder, Dizziness, Reading Disorder, Emotional Distress, Anxiety, Mobility DecreasedAdditional drugs used concurrently:
  • Acetaminophen
  • Fluconazole (150 Mg, Unk)
  • Yaz (1 Df, Qd)
  • Amoxicillin (500 Mg, Unk)
  • Nitrofurantoin (100 Mg, Unk)
The patient was hospitalized. Although Aldara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aphasia, may still occur.
Aldara Side Effect Report#8094191-1
Thyroiditis
This Thyroiditis problem was reported by a health professional from United States. A 41-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: squamous cell carcinoma. On
Mar 03, 2011 this consumer started treatment with Aldara (dosage: As Prescribed On Package). The following drugs were being taken at the same time: NA. When using Aldara, the patient experienced the following unwanted symptoms/side effects: ThyroiditisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thyroiditis, may become evident only after a product is in use by the general population.
Aldara Side Effect Report#8090277-6
Pigmentation Disorder, Arthralgia, Neoplasm Malignant, Myalgia, Fatigue
This Pigmentation Disorder side effect was reported by a physician from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aldara (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Lexapro
  • Humira
  • Proair Hfa (Hsa 90 Mcg)
.After starting to take Aldara the consumer reported adverse symptoms, such as: Pigmentation Disorder, Arthralgia, Neoplasm Malignant, Myalgia, FatigueThese side effects may potentially be related to Aldara.
Aldara Side Effect Report#8087417
Decreased Appetite, Influenza Like Illness, Dyspnoea, Body Temperature Increased, Fatigue, Upper Respiratory Tract Infection
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: skin papilloma, who was treated with Aldara (dosage: 5 Pct; Qod;top, start time:
Jul 02, 2011), combined with: NA. and developed a serious reaction and side effect(s): Decreased Appetite, Influenza Like Illness, Dyspnoea, Body Temperature Increased, Fatigue, Upper Respiratory Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in male patients, resulting in Decreased Appetite side effect. The patient was hospitalized.
Aldara Side Effect Report#8003029-X
Hair Growth Abnormal
This report suggests a potential Aldara Hair Growth Abnormal side effect(s) that can have serious consequences. A 88-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Aldara (dosage: NA) starting NS. After starting Aldara the patient began experiencing various side effects, including: Hair Growth AbnormalAdditional drugs used concurrently:
  • Clonidine
  • Cosopt
  • Travatan
  • Alphagan
Although Aldara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hair Growth Abnormal, may still occur.
Aldara Side Effect Report#7898009-9
Blood Glucagon Increased, Dizziness, Arrhythmia, Lymphadenopathy, Lymph Node Pain, Feeling Abnormal, Mucosal Dryness, Muscular Weakness, Suicidal Ideation
This Blood Glucagon Increased problem was reported by a consumer or non-health professional from United States. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: skin papilloma. On NS this consumer started treatment with Aldara (dosage: To Rub It With The Creme). The following drugs were being taken at the same time: NA. When using Aldara, the patient experienced the following unwanted symptoms/side effects: Blood Glucagon Increased, Dizziness, Arrhythmia, Lymphadenopathy, Lymph Node Pain, Feeling Abnormal, Mucosal Dryness, Muscular Weakness, Suicidal IdeationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Glucagon Increased, may become evident only after a product is in use by the general population.
Aldara Side Effect Report#7792224-0
Breast Mass, Loss Of Employment, Hypotension, Dysuria, Breast Swelling, Activities Of Daily Living Impaired, Fatigue, Malaise, Myalgia
This Breast Mass side effect was reported by a consumer or non-health professional from United States. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: anogenital warts.The patient was prescribed Aldara (drug dosage: 1 Application Sachet), which was initiated on NS. Concurrently used drugs: NA..After starting to take Aldara the consumer reported adverse symptoms, such as: Breast Mass, Loss Of Employment, Hypotension, Dysuria, Breast Swelling, Activities Of Daily Living Impaired, Fatigue, Malaise, MyalgiaThese side effects may potentially be related to Aldara.
Aldara Side Effect Report#7658498-1
Influenza Like Illness, Dyspnoea, Decreased Appetite, Body Temperature Increased, Fatigue, Upper Respiratory Tract Infection
This is a report of a 58-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: skin papilloma, who was treated with Aldara (dosage: 5 Pct; Qod;top, start time:
Jul 02, 2011), combined with: NA. and developed a serious reaction and side effect(s): Influenza Like Illness, Dyspnoea, Decreased Appetite, Body Temperature Increased, Fatigue, Upper Respiratory Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in male patients, resulting in Influenza Like Illness side effect. The patient was hospitalized.
Aldara Side Effect Report#7583001-4
Asthenia, Autoimmune Disorder
This report suggests a potential Aldara Asthenia side effect(s) that can have serious consequences. A 24-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: papilloma viral infection and used Aldara (dosage: 1 5 Days Top) starting
Jun 09, 2011. After starting Aldara the patient began experiencing various side effects, including: Asthenia, Autoimmune DisorderAdditional drugs used concurrently: NA.The patient was hospitalized. Although Aldara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthenia, may still occur.
Aldara Side Effect Report#7570877-X
Skin Warm, Skin Depigmentation
This Skin Warm problem was reported by a physician from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: actinic keratosis. On
May 12, 2005 this consumer started treatment with Aldara (dosage: 3x/wk Cutaneous/trial). The following drugs were being taken at the same time: NA. When using Aldara, the patient experienced the following unwanted symptoms/side effects: Skin Warm, Skin DepigmentationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Skin Warm, may become evident only after a product is in use by the general population.
Aldara Side Effect Report#7539420-5
Skin Depigmentation
This Skin Depigmentation side effect was reported by a physician from United States. A female patient (weight:NA) experienced the following symptoms/conditions: actinic keratosis.The patient was prescribed Aldara (drug dosage: 3x/week Cutaneous/topical), which was initiated on
May 12, 2005. Concurrently used drugs: NA..After starting to take Aldara the consumer reported adverse symptoms, such as: Skin DepigmentationThese side effects may potentially be related to Aldara.
Aldara Side Effect Report#7502041-4
Penis Disorder, Vitiligo
This is a report of a 25-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: anogenital warts, who was treated with Aldara (dosage: 3x/week Topical, start time:
Jan 01, 2010), combined with: NA. and developed a serious reaction and side effect(s): Penis Disorder, Vitiligo after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aldara treatment in male patients, resulting in Penis Disorder side effect.


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The appearance of Aldara on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Aldara Side Effects for Women?

Women Side Effects Reports
Application Site Erythema 30
Influenza Like Illness 23
Fatigue 21
Application Site Pain 19
Application Site Reaction 19
Headache 19
Erythema 15
Dizziness 14
Application Site Irritation 13
Pain 12

What are common Aldara Side Effects for Men?

Men Side Effects Reports
Fatigue 25
Application Site Erythema 20
Application Site Reaction 18
Influenza Like Illness 17
Dizziness 16
Headache 14
Back Pain 11
Dyspnoea 10
Lymphadenopathy 10
Pyrexia 10

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Aldara reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Aldara Safety Alerts, Active Ingredients, Usage Information

    Aldara Dosage, Warnings, Usage.

    Side Effects reported to FDA: 344

    Aldara safety alerts: No

    Reported deaths: 8

    Reported hospitalizations: 104

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