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Testim (Testosterone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Testim (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 (42)
Death (1)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Oedema Peripheral (6)Fatigue (4)Prostate Cancer (4)Drug Ineffective (3)Dyspepsia (3)Blood Testosterone Decreased (3)Transient Ischaemic Attack (3)Nausea (3)Mitochondrial Myopathy Acquired (3)Gait Disturbance (3)Blood Creatine Phosphokinase Increased (2)Hepatic Neoplasm Malignant (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Testim (Testosterone). For a complete list or a specific selection of reports, please use the links above.

Possible Testim side effects in 62 year old male

Reported by a physician from United States on 2012-08-10

Patient: 62 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Neoplasm Prostate

Drug(s) suspected as cause:
Testim



Possible Testim side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-04

Patient:

Reactions: Dyspepsia, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Tizanidine Hydrochloride

Imitrex

Meloxicam

Prilosec
    Administration route: Oral

Oxybutynin

Wellbutrin XL

Baclofen

Zocor
    Administration route: Oral

Betaseron

Testim



Possible Testim side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 57 year old male, weighing 136.1 kg (299.4 pounds)

Reactions: Incorrect Product Storage

Drug(s) suspected as cause:
Testim



Possible Testim side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 59 year old male, weighing 128.8 kg (283.4 pounds)

Reactions: Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Testim

Other drugs received by patient: Indomethacin; Furosemide; Aspirin; Potassiuim (Potassium); Lipitor; Antithrombotic Agents (Antithrombotic Agents); Quinapril HCL; Carvedilol



Possible Testim side effects in 78 year old male

Reported by a individual with unspecified qualification from United States on 2012-06-21

Patient: 78 year old male

Reactions: Oedema Peripheral, Platelet Count Decreased, Multiple Myeloma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Testim

Other drugs received by patient: Multivitamin (Ascorbic Acid); Ascorbic Acid; Vitamin D; Atacand; Prilosec; Rythmol; Digoxin; Vitamin E; Coumadin



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: male, weighing 72.6 kg (159.6 pounds)

Reactions: Liver Function Test Abnormal

Drug(s) suspected as cause:
Lipitor
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2008-01-01

Testim
    Dosage: 50 mg, 1 in 1 d
    Indication: Blood Testosterone Decreased

Other drugs received by patient: Coumadin; Aspirin; Propranolol; Prilosec; Celebrex



Possible Testim side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: 47 year old male

Reactions: Blood Creatine Phosphokinase Increased, Mitochondrial Myopathy Acquired, Muscular Weakness, Hemiparesis, Exercise Tolerance Decreased, Myopathy, Mitochondrial Cytopathy, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Epzicom
    Indication: HIV Infection

Reyataz
    Indication: HIV Infection

Selzentry
    Indication: HIV Infection

Testim
    Dosage: 50mg per day
    Indication: Blood Testosterone Decreased
    Start date: 2010-12-01
    End date: 2012-01-01

Intelence
    Indication: HIV Infection

Truvada
    Indication: HIV Infection



Possible Testim side effects in 74 year old male

Reported by a consumer/non-health professional from Canada on 2012-05-25

Patient: 74 year old male

Reactions: Prostate Cancer

Drug(s) suspected as cause:
Alfuzosin HCL
    Dosage: at bedtime
    Administration route: Oral
    Indication: Urinary Tract Disorder
    Start date: 2007-01-01
    End date: 2012-05-15

Testim
    Administration route: Topical
    Start date: 2011-07-01
    End date: 2011-12-12

Lantus
    Dosage: 36iu in morning, 38iu at bedtime
    Indication: Diabetes Mellitus
    Start date: 2007-01-01

Altace
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Avalide
    Dosage: 1 df= 300/12.5mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Other drugs received by patient: Clonidine; Novorapid; Avodart; Atenolol; Amlodipine Besylate



Possible Testim side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 47 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Mitochondrial Myopathy Acquired

Drug(s) suspected as cause:
Reyataz
    Indication: HIV Infection

Truvada
    Indication: HIV Infection

Intelence
    Indication: HIV Infection

Epzicom
    Indication: HIV Infection

Selzentry
    Indication: HIV Infection

Testim
    Dosage: gel
    Indication: Blood Testosterone Decreased
    Start date: 2010-12-01
    End date: 2012-01-01

Testim
    Dosage: gel
    Indication: Myopathy
    Start date: 2010-12-01
    End date: 2012-01-01



Possible Testim side effects in 74 year old male

Reported by a consumer/non-health professional from Canada on 2012-05-24

Patient: 74 year old male

Reactions: Prostate Cancer, Drug Administration Error

Drug(s) suspected as cause:
Alfuzosin HCL
    Dosage: 10 mg, at bedtime
    Administration route: Oral
    Indication: Urinary Tract Disorder
    Start date: 2007-01-01
    End date: 2012-05-15

Lantus
    Dosage: 74 iu daily, (36 iu in the morning and 38 iu at bedtime)
    Indication: Diabetes Mellitus
    Start date: 2007-01-01

Altace
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Avalide
    Dosage: 24 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Testim
    Dosage: unk
    Administration route: Topical
    Indication: Hormone Replacement Therapy
    Start date: 2011-07-01
    End date: 2011-12-12

Other drugs received by patient: Novorapid; Avodart; Clonidine; Atenolol; Amlodipine



Possible Testim side effects in 42 year old male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: 42 year old male

Reactions: Dyspepsia, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Testim

Prilosec
    Administration route: Oral

Baclofen

Simvastatin

Meloxicam

Tizanidine Hydrochloride

Wellbutrin XL

Oxybutynin

Imitrex

Betaseron



Possible Testim side effects in 74 year old male

Reported by a consumer/non-health professional from Canada on 2012-05-21

Patient: 74 year old male

Reactions: Prostate Cancer, Drug Administration Error

Drug(s) suspected as cause:
Alfuzosin HCL
    Administration route: Oral
    Indication: Urinary Tract Disorder
    Start date: 2007-01-01
    End date: 2012-05-15

Lantus
    Dosage: dose- 36 iu in the morning and 38 iu at bedtime
    Start date: 2007-01-01

Altace
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Avalide
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Testim
    Administration route: Topical
    Indication: Hormone Replacement Therapy
    Start date: 2011-07-01
    End date: 2011-12-12

Other drugs received by patient: Avodart; Atenolol; Clonidine; Amlodipine Besylate; Novorapid



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Meniscus Lesion, Oedema Peripheral, Blood Testosterone Decreased, Onychomycosis, Peripheral Embolism

Drug(s) suspected as cause:
Lamisil
    Indication: Onychomycosis
    Start date: 2012-02-01
    End date: 2012-04-30

Androgel
    Indication: Blood Testosterone Decreased

Testim
    Dosage: 1-1/2 tubes daily
    Indication: Blood Testosterone Decreased
    Start date: 2012-02-01

Other drugs received by patient: Lexapro; Aspirin; Simvastatin; Fosamax; Nasacort AQ; Allopurinol; Calcium Citrate



Possible Testim side effects in male

Reported by a individual with unspecified qualification from United States on 2012-05-17

Patient: male

Reactions: Thrombosis, Joint Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel

Lamisil
    Indication: Onychomycosis
    Start date: 2012-02-01
    End date: 2012-04-30

Testim
    Dosage: 50 mg, one and half tubes daily
    Indication: Blood Testosterone Decreased
    Start date: 2012-02-01

Other drugs received by patient: Simvastatin; Allopurinol; Lexapro; Nasacort AQ; Aspirin; Fosamax; Citracal



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-14

Patient: male, weighing 190.0 kg (418.0 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Mitochondrial Myopathy Acquired

Drug(s) suspected as cause:
Testim
    Indication: Myopathy
    Start date: 2010-12-01
    End date: 2012-01-01

Epzicom
    Indication: HIV Infection

Reyataz
    Indication: HIV Infection

Intelence
    Administration route: Oral
    Indication: HIV Infection

Testim
    Indication: Blood Testosterone Decreased
    Start date: 2010-12-01
    End date: 2012-01-01

Truvada
    Indication: HIV Infection

Selzentry
    Indication: HIV Infection



Possible Testim side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: 56 year old male, weighing 97.5 kg (214.6 pounds)

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Testim

Other drugs received by patient: Atenolol; Lipitor



Possible Testim side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: 64 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Postoperative Thrombosis, NO Therapeutic Response

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Testim
    Dosage: 50 mg, 1 1/2 tubes daily, transdermal
    Indication: Blood Testosterone Decreased
    Start date: 2012-02-01

Lamisil
    Indication: Onychomycosis
    Start date: 2012-02-01
    End date: 2012-04-30

Androgel

Other drugs received by patient: Aspirin; Allopurinol; Citracal Calcium (Calcium Citrate); Simvastatin; Fosamax; Lexapro; Nasacort AQ (Triamcinolone Acetonide)



Possible Testim side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: 48 year old male, weighing 158.8 kg (349.3 pounds)

Reactions: Fatigue, Hepatic Neoplasm Malignant, Somnolence, Hepatic Neoplasm

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hydrochlorothiazide
    Indication: Hypertension
    End date: 2012-02-23

Testim
    Dosage: 1 in 1 d, transdermal
    Start date: 2012-01-14

Other drugs received by patient: Carvedilol; Simvastatin; Meloxicam; Digoxin; Diltiazem; Acetaminophen



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: male, weighing 94.4 kg (207.8 pounds)

Reactions: Drug Ineffective, Oedema Peripheral, Oedema, Gait Disturbance, Erectile Dysfunction, Rash Pruritic, Rash Macular

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Androgel
    Indication: Product Used FOR Unknown Indication

Testim
    Dosage: 1 tube daily
    Administration route: Topical
    Indication: Hypogonadism
    Start date: 2011-12-01

Testim
    Indication: Bone Loss

Testim
    Indication: Erectile Dysfunction

Other drugs received by patient: Metformin HCL; Simvastatin; Metoprolol Tartrate; Losartan Potassium; Levothyroxine Sodium; Vitamin D



Possible Testim side effects in 48 year old male

Reported by a individual with unspecified qualification from United States on 2012-04-10

Patient: 48 year old male, weighing 158.8 kg (349.3 pounds)

Reactions: Fatigue, Hepatic Neoplasm Malignant, Impaired Work Ability, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrochlorothiazide
    Indication: Hypertension
    End date: 2012-02-23

Testim
    Dosage: 1 in 1 d, transdermal
    Start date: 2012-01-14

Other drugs received by patient: Acetaminophen; Carvedilol; Simvastatin; Simvastatin; Diltiazem; Meloxicam; Digoxin



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: male

Reactions: Blood Pressure Increased, Coronary Artery Occlusion, Transient Ischaemic Attack, Back Disorder

Drug(s) suspected as cause:
Plavix
    Dosage: unk
    Indication: Angioplasty

Testim
    Dosage: 50 mg, 1x/day
    Indication: Blood Testosterone Decreased
    Start date: 2010-01-01
    End date: 2011-04-01

Lipitor
    Dosage: unk
    Indication: Angioplasty



Possible Testim side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06

Patient: male, weighing 94.8 kg (208.6 pounds)

Reactions: Product Packaging Issue, Blood Testosterone Decreased

Drug(s) suspected as cause:
Testim
    Dosage: 1 tube (50mg) daily topical
    Administration route: Topical
    Indication: Blood Testosterone Decreased
    Start date: 2010-08-04

Testim
    Dosage: 1 tube (50mg) daily topical
    Administration route: Topical
    Indication: Blood Testosterone Decreased
    Start date: 2012-03-08



Possible Testim side effects in 9 year old male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 9 year old male

Reactions: Vomiting, Lymphoma, Accidental Exposure

Drug(s) suspected as cause:
Testim



Possible Testim side effects in 76 year old male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 76 year old male

Reactions: Blood Pressure Increased, Coronary Artery Occlusion, Transient Ischaemic Attack, Back Disorder

Drug(s) suspected as cause:
Testim
    Dosage: 50 mg, 1 in 1 d, transdermal
    Indication: Blood Testosterone Decreased
    Start date: 2010-01-01
    End date: 2011-04-01

Plavix
    Indication: Angioplasty

Lipitor
    Indication: Angioplasty



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male, weighing 99.9 kg (219.7 pounds)

Reactions: Calcinosis

Drug(s) suspected as cause:
Androgel
    Indication: Blood Testosterone Decreased
    Start date: 2008-01-01
    End date: 2011-01-01

Testim
    Indication: Blood Testosterone Decreased
    End date: 2008-01-01

Androgel

Testim
    Start date: 2011-07-01

Other drugs received by patient: Lisinopril; Celebrex; Zetia; Allegra; Prilosec; Afrin; Metformin HCL; Lipitor; Actos; Gemfibrozil; Hydrocodone Bitartrate; Benadryl



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male, weighing 61.3 kg (134.8 pounds)

Reactions: Drug Administered AT Inappropriate Site, Prostate Cancer

Drug(s) suspected as cause:
Androgel
    Indication: Blood Testosterone Decreased

Testim
    Dosage: 50 mg, gel
    Indication: Blood Testosterone Decreased



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male, weighing 99.0 kg (217.7 pounds)

Reactions: Oedema Peripheral

Drug(s) suspected as cause:
Testim
    Indication: Blood Testosterone Decreased
    Start date: 2011-09-01

Androgel
    Indication: Blood Testosterone Decreased
    Start date: 2010-09-01
    End date: 2011-08-01

Other drugs received by patient: Vitamin D; Simvastatin; Aspirin; Synthroid; Amitriptyline HCL; Lumigan; Toprol-XL



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male

Reactions: Blood Testosterone Abnormal, Blood Luteinising Hormone Abnormal, Libido Decreased, Asthenia

Drug(s) suspected as cause:
Androgel
    Indication: Blood Testosterone Decreased

Testim
    Dosage: started approximately 5 weeks ago
    Indication: Blood Testosterone Decreased
    Start date: 2011-05-01

Testim

Other drugs received by patient: Multiple Unknown Medications; Nuvigil



Possible Testim side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-30

Patient: male, weighing 127.0 kg (279.4 pounds)

Reactions: Back Pain, Pain in Extremity, Skin Odour Abnormal, Chromaturia, Gait Disturbance, Transient Ischaemic Attack, Fall

Drug(s) suspected as cause:
Testim

Other drugs received by patient: Nsulin (Insulin)



Possible Testim side effects in 48 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-13

Patient: 48 year old male, weighing 158.8 kg (349.3 pounds)

Reactions: Drug Administered AT Inappropriate Site, Fatigue, Somnolence, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrochlorothiazide
    Indication: Hypertension
    End date: 2012-02-23

Testim
    Dosage: 1 in 1 d, transdermal
    Start date: 2012-01-14

Other drugs received by patient: Diltiazem; Carvedilol; Acetaminophen; Simvastatin; Meloxicam; Digoxin

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