This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Axiron (Testosterone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (60)
Death (4)
Life Threatening Events (6)
Reports by Reaction Type
Pulmonary Embolism (7),
Thrombosis (6),
Deep Vein Thrombosis (6),
Blood Testosterone Decreased (5),
Confusional State (3),
Urticaria (3),
Skin Burning Sensation (3),
Dyspnoea (3),
Syncope (3),
Prostatitis (2),
Drug Ineffective (2),
Chronic Obstructive Pulmonary Disease (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Axiron (Testosterone). For a complete list or a specific selection of reports, please use the links above.
Possible Axiron side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Urticaria, Dermatitis Exfoliative
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 53 year old male
Reported by a physician from United States on 2012-08-23
Patient: 53 year old male
Reactions: Polycythaemia, Cerebral Venous Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Metformin; Toprol-XL
Possible Axiron side effects in 59 year old male
Reported by a lawyer from United States on 2012-08-21
Patient: 59 year old male, weighing 95.3 kg (209.6 pounds)
Reactions: Product Quality Issue, Incorrect Dose Administered, Device Difficult To Use
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a physician from United States on 2012-08-16
Patient: male, weighing 118.8 kg (261.4 pounds)
Reactions: Pulmonary Embolism, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Antipsychotics; Lotril / 00574902 /; Lozal; M.v.i.; Lipitor
Possible Axiron side effects in 61 year old male
Reported by a physician from United States on 2012-08-16
Patient: 61 year old male, weighing 126.8 kg (279.0 pounds)
Reactions: Thrombosis, Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: male
Reactions: Urticaria, Dermatitis Exfoliative
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 58 year old male
Reported by a physician from United States on 2012-08-15
Patient: 58 year old male, weighing 118.8 kg (261.4 pounds)
Reactions: Pulmonary Embolism, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Antipsychotics; Lotril / 00574902 /; M.v.i.; Lipitor; Lozal
Possible Axiron side effects in 28 year old male
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 28 year old male
Reactions: Tendon Injury, Muscle Strain, Skin Burning Sensation
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Testosterone
Possible Axiron side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 49 year old male
Reactions: Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 61 year old male, weighing 126.8 kg (279.0 pounds)
Reactions: Thrombosis, Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 44 year old male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 44 year old male, weighing 95.0 kg (209.0 pounds)
Reactions: Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Testosterone
Possible Axiron side effects in 60 year old male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 60 year old male
Reactions: Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: male
Reactions: Testicular Atrophy
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in female
Reported by a physician from United States on 2012-07-26
Patient: female
Reactions: Supraventricular Extrasystoles, Acne, Breast Tenderness, Ventricular Tachycardia, Injury
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: male
Reactions: Pruritus, Skin Exfoliation, Urticaria, Skin Burning Sensation, Rash, Skin Warm, Erythema
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: male
Reactions: Testicular Atrophy
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: male
Reactions: Confusional State, Visual Acuity Reduced, Somnolence, Suicidal Ideation, Fatigue, Dizziness, Anger, Blood Testosterone Decreased, Depression, Emotional Disorder, Migraine, Libido Decreased, Dysarthria, Blood Testosterone Increased, Insomnia, Vertigo, Feeling Abnormal, Asthenia
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 42 year old male
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: 42 year old male, weighing 83.5 kg (183.6 pounds)
Reactions: Testicular Disorder, Testicular Pain
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 75 year old
Reported by a physician from United States on 2012-07-12
Patient: 75 year old
Reactions: Cerebrovascular Accident, Blindness
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: male, weighing 106.6 kg (234.5 pounds)
Reactions: Drug Ineffective, Blood Testosterone Abnormal
Drug(s) suspected as cause:
Axiron
Dosage: 30 mg alternate 1 and 2 pumps
Axiron
Dosage: 30 mg 2 pumps qd
End date: 2012-06-23
Axiron
Dosage: 30 mg each axilla qd
Indication: Hypogonadism
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: male
Reactions: Dyspnoea, Serum Ferritin Increased, Generalised Oedema
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Vivanza
Possible Axiron side effects in 37 year old male
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: 37 year old male
Reactions: Bladder Cancer
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 37 year old male
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: 37 year old male
Reactions: Bladder Cancer Recurrent
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: male
Reactions: Stevens-Johnson Syndrome
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 52 year old male
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: 52 year old male, weighing 112.5 kg (247.4 pounds)
Reactions: Syncope, Blood Testosterone Decreased, Sinus Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Metformin HCL; Omeprazole; Lantus; Lisinopril; Januvia; Reglan; Seroquel
Possible Axiron side effects in 63 year old male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: 63 year old male, weighing 92.1 kg (202.6 pounds)
Reactions: Thrombosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 49 year old
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: 49 year old
Reactions: Loss of Consciousness
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 82 year old male
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: 82 year old male
Reactions: Dyspnoea, Atrial Fibrillation
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Atenolol; Aspirin; Cordarone; Plavix; Flomax; Captopril; Multi-Vitamin; Fish OIL; Tricor; Lipitor; Magnesium
Possible Axiron side effects in 52 year old male
Reported by a physician from United States on 2012-04-26
Patient: 52 year old male
Reactions: Syncope, Tachycardia, Blood Testosterone Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Axiron
Possible Axiron side effects in 58 year old male
Reported by a physician from United States on 2012-04-25
Patient: 58 year old male
Reactions: Mania, Overdose
Drug(s) suspected as cause:
Axiron
Other drugs received by patient: Tramadol Hydrochloride
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