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Shoulder (18)
Gout (16)
Atrial Fibrillation (16)
Anger (14)
WEIGHT GAIN (12)
Cough (8)
Sweating (7)
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Androgel Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 704 

Respiratory Tract Congestion, Cough, Insomnia, Depressed Mood, Pneumonia (8393156-X)
on May 05, 2012 Male from UNITED STATES , 55 years of age, weighting 300.3 lb, was diagnosed with
  • blood testosterone decreased
and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: respiratory tract congestion, cough, insomnia, depressed mood, pneumonia. Androgel dosage: N/A.

Fatigue (8393150-9)
Patient was taking Androgel. Patient felt the following Androgel side effects: fatigue on May 01, 2012 from UNITED STATES Additional patient health information: Male , weighting 212.2 lb, was diagnosed with
  • blood testosterone decreased
and. Androgel dosage: 2 Pumps Daily.
Multiple prescriptions taken:
  • Fish Oil
  • Crestor
  • Centrum
  • Aspirin
  • Allopurinol
  • Blueberry Juice
  • Lemon Juice


Nocturia (8393145-5)
Adverse event was reported on Apr 16, 2012 by a Male taking Androgel (Dosage: 3 Pumps Per Day Applies To Shoulders) was diagnosed with
  • blood testosterone decreased
and. Location: UNITED STATES , weighting 248.2 lb, After Androgel was administered, patient encountered several Androgel side effects: nocturia.

Musculoskeletal Pain (8393135-2)
on May 04, 2012 Male from UNITED STATES , 49 years of age, weighting 238.2 lb, was diagnosed with
  • blood testosterone decreased
  • hypertension
and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: musculoskeletal pain. Androgel dosage: N/A.
Associated medications used:
  • Lisinopril



Weight Increased, Blood Testosterone Decreased (8393134-0)
on Apr 25, 2012 Male from UNITED STATES , weighting 312.3 lb, was diagnosed with
  • blood testosterone decreased
  • prophylaxis
  • neuropathy peripheral
  • hypertension
and was treated with Androgel. Patient felt the following Androgel side effects: weight increased, blood testosterone decreased. Androgel dosage: 2 Pumps Per Day.
Multiple prescriptions taken:
  • Banana Or Orange Juice
  • Anti-fungal


Blood Testosterone Decreased (8393133-9)
Patient was taking Androgel. After Androgel was administered, patient encountered several Androgel side effects: blood testosterone decreased on Apr 11, 2012 from UNITED STATES Additional patient health information: Male , 59 years of age, was diagnosed with
  • blood testosterone decreased
and. Androgel dosage: 2 Pumps.

Pelvic Pain, Groin Pain, Impaired Driving Ability (8393131-5)
Adverse event was reported on Apr 26, 2012 by a Male taking Androgel (Dosage: 3 Pumps Per Day) was diagnosed with
  • blood testosterone decreased
and. Location: UNITED STATES , 54 years of age, weighting 170.2 lb, Directly after, patient experienced the unwanted or unexpected Androgel side effects: pelvic pain, groin pain, impaired driving ability.
Associated medications used:
  • Testosterone


Application Site Dryness, Application Site Pruritus (8393129-7)
on Apr 25, 2012 Male from UNITED STATES , weighting 200.2 lb, was treated with Androgel. Patient felt the following Androgel side effects: application site dryness, application site pruritus. Androgel dosage: 3 Pumps Per Day.

Blood Testosterone Decreased (8393124-8)
on Apr 16, 2012 Male from UNITED STATES , weighting 215.2 lb, was diagnosed with
  • blood testosterone decreased
  • insomnia
  • diabetes mellitus
  • hypothyroidism
and was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: blood testosterone decreased. Androgel dosage: N/A.
Multiple concurrent drugs taken:
  • Ativa
  • Januvia
  • Synthroid


Erectile Dysfunction, Weight Increased, Spontaneous Penile Erection (8393121-2)
Patient was taking Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: erectile dysfunction, weight increased, spontaneous penile erection on Apr 03, 2012 from UNITED STATES Additional patient health information: Male , weighting 305.3 lb, was diagnosed with
  • blood testosterone decreased
  • medical diet
  • blood cholesterol increased
  • diabetes mellitus
  • hypertension
  • vitamin supplementation
and. Androgel dosage: N/A.
Associated medications used:
  • Fish Oil
  • Simvastatin
  • Metformin Hcl
  • Lisinopril
  • Multi-vitamin
  • Ageless Male


Oedema Peripheral (8393119-4)
Adverse event was reported on May 01, 2012 by a Male taking Androgel (Dosage: 2 Pumps Per Day 2 Pumps Per Day) was diagnosed with
  • blood testosterone decreased
  • hypertension
and. Location: UNITED STATES , 69 years of age, weighting 210.2 lb, Patient felt the following Androgel side effects: oedema peripheral.
Multiple prescriptions taken:
  • Amlodipine Besylate
  • Diovan


Blood Testosterone Decreased, Feeling Abnormal (8393117-0)
on Apr 10, 2012 Male from UNITED STATES , weighting 180.2 lb, was diagnosed with
  • blood testosterone decreased
and was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: blood testosterone decreased, feeling abnormal. Androgel dosage: 4 Pumps Per Day.

Weight Increased (8393111-X)
on Apr 23, 2012 Male from UNITED STATES , weighting 200.2 lb, was diagnosed with
  • blood testosterone decreased
and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: weight increased. Androgel dosage: N/A.

Dysuria (8393109-1)
Patient was taking Androgel. Patient felt the following Androgel side effects: dysuria on Apr 19, 2012 from UNITED STATES Additional patient health information: Male , weighting 195.2 lb, was diagnosed with
  • blood testosterone decreased
and. Androgel dosage: 2 Pumps, 1 In 12 Hours.
Multiple prescriptions taken:
  • Fluconazole
  • Metoprolol Tartrate
  • Kaletra
  • Viread
  • Allegra
  • Intelog
  • Acyclovir
  • Lisinopril


Dyspnoea, Erythema, Sensory Disturbance, Chest Discomfort, Feeling Hot (8393103-0)
Adverse event was reported on Apr 17, 2012 by a Male taking Androgel (Dosage: N/A) was diagnosed with
  • blood testosterone decreased
  • anxiety
and. Location: UNITED STATES , weighting 260.2 lb, After Androgel was administered, patient encountered several Androgel side effects: dyspnoea, erythema, sensory disturbance, chest discomfort, feeling hot.
Multiple concurrent drugs taken:
  • Clonopin


Blood Testosterone Decreased (8393101-7)
on Apr 03, 2012 Male from UNITED STATES , weighting 185.2 lb, was diagnosed with
  • blood testosterone decreased
and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: blood testosterone decreased. Androgel dosage: N/A.
Associated medications used:
  • Suboxone
  • Klonopin


Abdominal Pain Lower, Off Label Use, Back Pain (8393100-5)
on Apr 16, 2012 Female from UNITED STATES , weighting 125.1 lb, was diagnosed with
  • libido decreased
and was treated with Androgel. Patient felt the following Androgel side effects: abdominal pain lower, off label use, back pain. Androgel dosage: 1/4 Of One Pump Actuation.

Painful Defaecation, Gynaecomastia (8393099-1)
Patient was taking Androgel. After Androgel was administered, patient encountered several Androgel side effects: painful defaecation, gynaecomastia on Apr 25, 2012 from UNITED STATES Additional patient health information: Male , weighting 195.2 lb, was diagnosed with
  • blood testosterone decreased
and. Androgel dosage: 2 Pumps In The Morning.

Benign Prostatic Hyperplasia, Nocturia, Micturition Urgency, Pollakiuria, Fatigue (8393098-X)
Adverse event was reported on Apr 20, 2012 by a Male taking Androgel (Dosage: One Pump Per Side, Once Daily) was diagnosed with
  • blood testosterone decreased
  • fatigue
and. Location: UNITED STATES , weighting 190.2 lb, Directly after, patient experienced the unwanted or unexpected Androgel side effects: benign prostatic hyperplasia, nocturia, micturition urgency, pollakiuria, fatigue.

Prostatic Specific Antigen Increased, Semen Volume Decreased, Blood Testosterone Decreased (8393094-2)
on Apr 18, 2012 Male from UNITED STATES , weighting 225.2 lb, was treated with Androgel. Patient felt the following Androgel side effects: prostatic specific antigen increased, semen volume decreased, blood testosterone decreased. Androgel dosage: 3 Pumps Daily.
Multiple prescriptions taken:
  • Trimix Compound (Draw Up In Injection For Ed)
  • Lisinopril


Asthenia, Incorrect Dose Administered (8393079-6)
on Mar 21, 2012 Male from UNITED STATES , 64 years of age, weighting 185.2 lb, was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: asthenia, incorrect dose administered. Androgel dosage: 2 Pumps Per Day.
Multiple concurrent drugs taken:
  • Simvastatin


Libido Decreased, Unevaluable Event (8393073-5)
Patient was taking Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: libido decreased, unevaluable event on Apr 02, 2012 from UNITED STATES Additional patient health information: Male , weighting 198.2 lb, was diagnosed with
  • blood testosterone decreased
and. Androgel dosage: N/A.

Acne, Libido Decreased (8393064-4)
Adverse event was reported on Apr 02, 2012 by a Male taking Androgel (Dosage: One Pump On Each Shoulder) was diagnosed with
  • blood testosterone decreased
and. Location: UNITED STATES , weighting 225.2 lb, Patient felt the following Androgel side effects: acne, libido decreased.

Myalgia (8393063-2)
on Mar 28, 2012 Male from UNITED STATES , weighting 185.2 lb, was diagnosed with
  • blood testosterone decreased
and was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: myalgia. Androgel dosage: 2 Pumps Per Day.

Blood Pressure Decreased (8393044-9)
on Mar 22, 2012 Male from UNITED STATES , 61 years of age, weighting 235.2 lb, was diagnosed with
  • blood testosterone decreased
  • hypertension
and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: blood pressure decreased. Androgel dosage: Twice,1 Pump In Am + 1 Pump In Pm, 1 In 12 Hrs.
Associated medications used:
  • Amlodipine Besylate
  • Aspirin
  • Carvedilol


Showing 1-25 of 704 

Androgel Health Episodes

How Can Androgel Affect You?

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative ANDROGEL Names:TESTOSTER

Active Ingredient: TESTOSTER

Androgel Dosage, Warnings, Usage.

Side Effects reported to FDA: 704. View Androgel Adverse Reports

Androgel safety alerts: 2009

Reported deaths: 13

Reported hospitalizations: 103

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]

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