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Androgel Side Effects

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Common Androgel Side Effects


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

Blood Testosterone Decreased (608)
Asthenia (213)
Fatigue (201)
Blood Testosterone Increased (113)
Prostatic Specific Antigen Increased (106)
Incorrect Dose Administered (102)
Acne (101)
Blood Testosterone Abnormal (95)
Weight Increased (93)
Libido Decreased (93)
Alopecia (87)
Erectile Dysfunction (82)
Arthralgia (77)
Insomnia (73)
Dyspnoea (73)
Rash (71)
Pain (70)
Hair Growth Abnormal (70)
Headache (66)
Therapeutic Response Unexpected (66)

➢ 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.

Androgel Side Effects Reported to FDA



Androgel Side Effect Report#9999329
Pulmonary Embolism, Deep Vein Thrombosis
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood testosterone decreased, who was treated with Androgel (dosage: 2 Pumps Ea. Arm Once Daily Applied To A Surface, Usually The Skin, start time:
Jun 01, 2008), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Embolism, Deep Vein Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.
Androgel Side Effect Report#9995454
Cerebral Thrombosis, Brain Injury
This report suggests a potential Androgel Cerebral Thrombosis side effect(s) that can have serious consequences. A 41-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: thrombosis and used Androgel (dosage: NA) starting
Jan 28, 2014. After starting Androgel the patient began experiencing various side effects, including: Cerebral Thrombosis, Brain InjuryAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebral Thrombosis, may still occur.
Androgel Side Effect Report#9988001
Pulmonary Embolism, Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress
This Pulmonary Embolism problem was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased. On NS this consumer started treatment with Androgel (dosage: NA). The following drugs were being taken at the same time: NA. When using Androgel, the patient experienced the following unwanted symptoms/side effects: Pulmonary Embolism, Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional DistressThe 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 Pulmonary Embolism, may become evident only after a product is in use by the general population.
Androgel Side Effect Report#9987609
Cerebrovascular Accident, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress
This Cerebrovascular Accident side effect was reported by a consumer or non-health professional from US. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood testosterone decreased.The patient was prescribed Androgel (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Androgel the consumer reported adverse symptoms, such as: Cerebrovascular Accident, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional DistressThese side effects may potentially be related to Androgel. The patient was hospitalized.
Androgel Side Effect Report#9986920
Pneumonia, Atrial Fibrillation, Dyspnoea, Pallor
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood testosterone decreased,vitamin supplementation,gastrooesophageal reflux disease,blood cholesterol increased, who was treated with Androgel (dosage: NA, start time:
Jun 12, 2013), combined with:
  • Cholecalciferol
  • Omeprazole
  • Simvastatin
  • Sildenafil Fibrate
and developed a serious reaction and side effect(s): Pneumonia, Atrial Fibrillation, Dyspnoea, Pallor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in Pneumonia side effect. The patient was hospitalized.
Androgel Side Effect Report#9986199
Myocardial Infarction, Physical Disability, Emotional Distress, Pain, Pain, Loss Of Employment
This report suggests a potential Androgel Myocardial Infarction side effect(s) that can have serious consequences. A 45-year-old patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood testosterone decreased and used Androgel (dosage: NA) starting 201301. After starting Androgel the patient began experiencing various side effects, including: Myocardial Infarction, Physical Disability, Emotional Distress, Pain, Pain, Loss Of EmploymentAdditional drugs used concurrently: NA. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Androgel Side Effect Report#9985795
Pain, Anxiety, Physical Disability, Emotional Distress, Pulmonary Embolism, Impaired Work Ability
This Pain problem was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased. On NS this consumer started treatment with Androgel (dosage: Multiple Doses). The following drugs were being taken at the same time: NA. When using Androgel, the patient experienced the following unwanted symptoms/side effects: Pain, Anxiety, Physical Disability, Emotional Distress, Pulmonary Embolism, Impaired Work AbilityThe 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 Pain, may become evident only after a product is in use by the general population.
Androgel Side Effect Report#9985495
Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
This Physical Disability side effect was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood testosterone decreased.The patient was prescribed Androgel (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Androgel the consumer reported adverse symptoms, such as: Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary EmbolismThese side effects may potentially be related to Androgel. The patient was hospitalized.
Androgel Side Effect Report#9985441
Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
This is a report of a 42-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood testosterone decreased, who was treated with Androgel (dosage: Multiple Doses, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in Physical Disability side effect. The patient was hospitalized.
Androgel Side Effect Report#9985427
Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
This report suggests a potential Androgel Physical Disability side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood testosterone decreased and used Androgel (dosage: NA) starting NS. After starting Androgel the patient began experiencing various side effects, including: Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary EmbolismAdditional drugs used concurrently: NA.The patient was hospitalized. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Physical Disability, may still occur.
Androgel Side Effect Report#9985377
Cerebrovascular Accident, Physical Disability, Emotional Distress, Pain, Pain, Loss Of Employment, Pulmonary Embolism
This Cerebrovascular Accident problem was reported by a consumer or non-health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased. On NS this consumer started treatment with Androgel (dosage: NA). The following drugs were being taken at the same time: NA. When using Androgel, the patient experienced the following unwanted symptoms/side effects: Cerebrovascular Accident, Physical Disability, Emotional Distress, Pain, Pain, Loss Of Employment, Pulmonary EmbolismThe 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 Cerebrovascular Accident, may become evident only after a product is in use by the general population.
Androgel Side Effect Report#9984783
Pulmonary Embolism, Thrombosis, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This Pulmonary Embolism side effect was reported by a consumer or non-health professional from US. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood testosterone decreased.The patient was prescribed Androgel (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Androgel the consumer reported adverse symptoms, such as: Pulmonary Embolism, Thrombosis, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, AnxietyThese side effects may potentially be related to Androgel. The patient was hospitalized.
Androgel Side Effect Report#9983501
Cerebrovascular Accident, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood testosterone decreased, who was treated with Androgel (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Cerebrovascular Accident, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.
Androgel Side Effect Report#9981224
Cerebrovascular Accident, Hemiplegia
This report suggests a potential Androgel Cerebrovascular Accident side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Androgel (dosage: NA) starting NS. After starting Androgel the patient began experiencing various side effects, including: Cerebrovascular Accident, HemiplegiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Androgel Side Effect Report#9980599
Myocardial Infarction
This Myocardial Infarction problem was reported by a pharmacist from US. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypogonadism. On NS this consumer started treatment with Androgel (dosage: NA). The following drugs were being taken at the same time:
  • Duloxetine
  • Clonazepam
  • Fish Oil
When using Androgel, the patient experienced the following unwanted symptoms/side effects: Myocardial InfarctionThe 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 Myocardial Infarction, may become evident only after a product is in use by the general population.
Androgel Side Effect Report#9978148
Physical Disability, Pulmonary Embolism, Emotional Distress, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety
This Physical Disability side effect was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood testosterone decreased.The patient was prescribed Androgel (drug dosage: Multiple Doses), which was initiated on NS. Concurrently used drugs: NA..After starting to take Androgel the consumer reported adverse symptoms, such as: Physical Disability, Pulmonary Embolism, Emotional Distress, Deep Vein Thrombosis, Impaired Work Ability, Pain, AnxietyThese side effects may potentially be related to Androgel. The patient was hospitalized.
Androgel Side Effect Report#9978048
Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood testosterone decreased, who was treated with Androgel (dosage: Multiple Doses, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in Physical Disability side effect. The patient was hospitalized.
Androgel Side Effect Report#9978037
Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This report suggests a potential Androgel Physical Disability side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood testosterone decreased and used Androgel (dosage: Multiple Doses) starting NS. After starting Androgel the patient began experiencing various side effects, including: Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, AnxietyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Physical Disability, may still occur.
Androgel Side Effect Report#9978025
Physical Disability, Deep Vein Thrombosis, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This Physical Disability problem was reported by a consumer or non-health professional from US. A 46-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased. On NS this consumer started treatment with Androgel (dosage: Multiple Doses). The following drugs were being taken at the same time: NA. When using Androgel, the patient experienced the following unwanted symptoms/side effects: Physical Disability, Deep Vein Thrombosis, Emotional Distress, Impaired Work Ability, Pain, AnxietyThe 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 Physical Disability, may become evident only after a product is in use by the general population.
Androgel Side Effect Report#9969837
Pulmonary Embolism
This Pulmonary Embolism side effect was reported by a consumer or non-health professional from US. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Androgel (drug dosage: 4 Pumps Daily; Applied To A Surface, Usually The Skin), which was initiated on
Jan 01, 2010. Concurrently used drugs: NA..After starting to take Androgel the consumer reported adverse symptoms, such as: Pulmonary EmbolismThese side effects may potentially be related to Androgel. The patient was hospitalized and became disabled.
Androgel Side Effect Report#9969692
Chest Pain, Pulmonary Thrombosis
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Androgel 1 % (dosage: 2 Pumps Per Day Applied To A Surface, Usually The Skin, start time:
Jan 01, 2004), combined with: NA. and developed a serious reaction and side effect(s): Chest Pain, Pulmonary Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel 1 % treatment in male patients, resulting in Chest Pain side effect. The patient was hospitalized and became disabled.
Androgel Side Effect Report#9960096
Prostatic Specific Antigen Increased, Biopsy Prostate Abnormal
This report suggests a potential Androgel Prostatic Specific Antigen Increased side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypogonadism and used Androgel (dosage: NA) starting NS. After starting Androgel the patient began experiencing various side effects, including: Prostatic Specific Antigen Increased, Biopsy Prostate AbnormalAdditional drugs used concurrently: NA. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Prostatic Specific Antigen Increased, may still occur.
Androgel Side Effect Report#9958374
Tendon Rupture, Bundle Branch Block Right, Pain In Extremity, Limb Injury
This Tendon Rupture problem was reported by a physician from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased,hypertension,blood cholesterol increased,migraine,vitamin supplementation. On 201311 this consumer started treatment with Androgel (dosage: 4 Pumps). The following drugs were being taken at the same time:
  • Amlodipine
  • Simvastatin
  • Sumatriptan
  • Multivitamin
  • Fish Oil
  • Baby Aspirin
When using Androgel, the patient experienced the following unwanted symptoms/side effects: Tendon Rupture, Bundle Branch Block Right, Pain In Extremity, Limb InjuryAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tendon Rupture, may become evident only after a product is in use by the general population.
Androgel Side Effect Report#9958327
Arterial Occlusive Disease
This Arterial Occlusive Disease side effect was reported by a physician from US. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Androgel (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Androgel the consumer reported adverse symptoms, such as: Arterial Occlusive DiseaseThese side effects may potentially be related to Androgel.
Androgel Side Effect Report#9952354
Abdominal Pain, Gallbladder Perforation, Appendicitis, Cholecystitis, Abdominal Infection, Unevaluable Event, Musculoskeletal Pain, Pain In Extremity, Abdominal Pain
This is a report of a 40-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: blood testosterone decreased, who was treated with Androgel (dosage: 2 Pumps Daily, start time: 2013), combined with:
  • Testosterone
  • Amitriptyline
  • Elavil
  • Robaxin
  • Xanax
  • Effexor
  • Wellbutrin (Took 15 Pills)
  • Buprenorphine
and developed a serious reaction and side effect(s): Abdominal Pain, Gallbladder Perforation, Appendicitis, Cholecystitis, Abdominal Infection, Unevaluable Event, Musculoskeletal Pain, Pain In Extremity, Abdominal Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in Abdominal Pain side effect. The patient was hospitalized.


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The appearance of Androgel 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.

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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.

    Androgel 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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    Discuss Androgel Side Effects

    Did You Have a Androgel Side Effect?

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    How Effective is Androgel for You?

    Exceeded Expectations
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    Androgel Safety Alerts, Active Ingredients, Usage Information

    NDC0051-8425
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAndrogel
    NameTestosterone
    Dosage FormGEL
    RouteTRANSDERMAL
    On market since20110314
    LabelerAbbVie Inc.
    Active Ingredient(s)TESTOSTERONE
    Strength(s)10
    Unit(s)mg/g
    Pharma ClassAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]

    Androgel Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2967

    Androgel safety alerts: 2009

    Reported deaths: 32

    Reported hospitalizations: 249

    Testosterone gel products (AndroGel 1% and Testim 1% )

    Audience: Urological and Endocrinological healthcare professionals, pediatricians 

    [Posted 05/07/2009] FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the productsâ?? labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.

    [May 07, 2009 - News Release - FDA]

    [May 07, 2009 - Testosterone Gel Safety Information Page - FDA]

    Latest Androgel clinical trials