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Humira (Adalimumab) - Incorrect Dose Administered - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Incorrect Dose Administered ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Humira (Adalimumab) where reactions include incorrect dose administered. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of    Next >>

Possible Humira side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 55.4 kg (121.9 pounds)

Reactions: Nasal Turbinate Abnormality, Injection Site Erythema, Incorrect Dose Administered, Injection Site Pain, Nasal Septum Deviation, Injection Site Papule

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Areva ONE; Vitamin D; Lysine; Lysine; Prilosec; Birth Control Pills



Possible Humira side effects in 31 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 31 year old female

Reactions: Rheumatoid Arthritis, Injection Site Mass, Wrong Technique in Drug Usage Process, Subcutaneous Abscess, Incorrect Dose Administered, Cervical Dysplasia

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2005-01-01
    End date: 2012-04-01

Humira
    Start date: 2012-06-15

Other drugs received by patient: Toprol-XL



Possible Humira side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: male, weighing 101.2 kg (222.7 pounds)

Reactions: Skin Injury, Injection Site Discolouration, Crohn's Disease, Incorrect Dose Administered, Injection Site Urticaria, Injection Site Erythema, Petit MAL Epilepsy, Drug Level Decreased, Device Malfunction, Blood Glucose Increased

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease

Lamictal
    Indication: Convulsion

Prednisone TAB
    Indication: Crohn's Disease

Other drugs received by patient: Pravachol; Tylenol; Lisinopril; Methotrexate; Cyclobenzaprine; Folic Acid; Prilosec; Phenergan HCL; Clonazepam; Clonazepam; Phenergan HCL



Possible Humira side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 59.9 kg (131.8 pounds)

Reactions: Upper Limb Fracture, Fatigue, Upper Respiratory Tract Infection, Injection Site Extravasation, Injection Site Reaction, Sinusitis, Device Malfunction, Thrombosis in Device, Colitis Ischaemic, Cataract, Anaemia, Incorrect Dose Administered, Injection Site Pain, Rhinitis Allergic, Renal Failure, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2012-01-01

Humira
    Indication: Rheumatoid Arthritis
    End date: 2010-01-01

Other drugs received by patient: Medrol; Imodium; Elavil; Orudis; Actonel; Allegra D 24 Hour; Folic Acid; Prilosec; Methotrexate



Possible Humira side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 69 year old female

Reactions: Injection Site Haemorrhage, Incorrect Dose Administered, Injection Site Pain, Vision Blurred, Device Malfunction

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Timolol Maleate; Potassium; Furosemide; Triamcinolone



Possible Humira side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female, weighing 79.5 kg (174.8 pounds)

Reactions: Drug Ineffective, Injection Site Haemorrhage, Incorrect Dose Administered, Injection Site Pain, Cartilage Injury, Anxiety, Osteoarthritis, Arthralgia, Depression, Device Malfunction

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2007-01-01
    End date: 2012-05-04

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2005-03-01
    End date: 2005-03-01

Humira
    Start date: 2012-07-23

Other drugs received by patient: Simvastatin; Hydrochlorothiazide; Methotrexate; Omeprazole; Trazodone Hydrochloride; Prednisone TAB; Amlodipine Besylate and Benazepril HCL



Possible Humira side effects in male

Reported by a physician from United Kingdom on 2012-08-17

Patient: male, weighing 104.0 kg (228.8 pounds)

Reactions: Confusional State, Adverse Drug Reaction, Pain, Rectal Haemorrhage, Potentiating Drug Interaction, Pyrexia, Oropharyngeal Pain, Headache, Hyperhidrosis, Diplopia, Malaise, C-Reactive Protein Increased, Chest Pain, Dizziness, Hiccups, Immunosuppression, White Blood Cell Count Increased, Vomiting, Incorrect Dose Administered, Crohn's Disease, Toxicity To Various Agents, Tremor, Aggression, Dysuria, Vision Blurred, Diffuse Alveolar Damage

Adverse event resulted in: death

Drug(s) suspected as cause:
Clarithromycin
    Administration route: Oral
    Indication: Pharyngitis
    Start date: 2011-10-28

Humira
    Indication: Crohn's Disease
    Start date: 2011-10-05

Other drugs received by patient: Ensure; Methadone Hydrochloride; Methadone Hydrochloride; Oramorph SR; MS Contin; Lansoprazole; Diazepam; Ventolin; Hydroxycobalamin; Ascorbic Acid; Acetaminophen; Oramorph SR; Adcal D3; Vitamin BPC Capsules



Possible Humira side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 60 year old female

Reactions: Confusional State, Injection Site Vesicles, Injection Site Haematoma, Chills, Vaginal Fistula, Pyrexia, Somnolence, Abdominal Discomfort, Oedema Peripheral, Blood Cholesterol Increased, Device Malfunction, Pneumonia, Dyspnoea, Injection Site Scar, Incorrect Dose Administered, Injection Site Pain, Delirium, Gastritis Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2006-01-01
    End date: 2012-05-01

Humira
    Start date: 2012-05-01

Other drugs received by patient: Motifene; Vagifem; Carafate; Flurazepam; Xanax; Activella; Nizatidine; Crestor; Afrin



Possible Humira side effects in 61 year old male

Reported by a physician from United States on 2012-08-16

Patient: 61 year old male

Reactions: Eyelid Disorder, Incorrect Dose Administered, DRY Mouth, Injection Site Pain, Device Malfunction, DRY Eye

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Methotrexate; Celebrex



Possible Humira side effects in female

Reported by a physician from United States on 2012-08-14

Patient: female, weighing 62.2 kg (136.8 pounds)

Reactions: Small Intestinal Obstruction, Injection Site Urticaria, Incorrect Dose Administered, Abdominal Distension, Injection Site Pain, Small Intestinal Stenosis

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2005-01-01
    End date: 2010-10-01

Humira
    Start date: 2010-12-01

Other drugs received by patient: Welchol



Possible Humira side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 54 year old female

Reactions: Incorrect Dose Administered, Injection Site Urticaria, Crohn's Disease, Pain, Dehydration, Colitis, Device Malfunction, Enteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira



Possible Humira side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: female

Reactions: Injection Site Mass, Pain in Extremity, Incorrect Dose Administered, Injection Site Pain, Injection Site Extravasation, Arthralgia, Carpal Tunnel Syndrome, Cough, Post Procedural Infection, Aphonia

Drug(s) suspected as cause:
Humira
    Indication: Mucosal Ulceration

Humira
    Indication: Behcet's Syndrome

Other drugs received by patient: Naproxen; Flexeril; Tricor; Trazodone Hydrochloride; Lexapro; Ambien; Mirapex; Cymbalta; Claritin; Neurontin; Janumet; Lipitor; Benicar HCT; Vitamin D



Possible Humira side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: female

Reactions: Injection Site Mass, Pain in Extremity, Incorrect Dose Administered, Injection Site Pain, Arthralgia, Injection Site Extravasation, Carpal Tunnel Syndrome, Aphonia, Cough, Post Procedural Infection

Drug(s) suspected as cause:
Humira
    Indication: Behcet's Syndrome

Humira
    Indication: Mucosal Ulceration

Other drugs received by patient: Claritin; Lexapro; Naproxen; Flexeril; Vitamin D; Cymbalta; Benicar HCT; Lipitor; Trazodone Hydrochloride; Neurontin; Janumet; Mirapex; Ambien; Tricor



Possible Humira side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 36 year old female

Reactions: Myalgia, Malaise, Incorrect Dose Administered, Gastrointestinal Disorder, Injection Site Pain, Device Malfunction

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Unknown Pain Medication



Possible Humira side effects in 46 year old female

Reported by a physician from United States on 2012-08-06

Patient: 46 year old female

Reactions: Malabsorption, Gastrointestinal Infection, Injection Site Extravasation, Incorrect Dose Administered, Injection Site Pain, Injection Site Papule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: EYE Drops; Levothyroxine Sodium; Vitamin A; Calcium Citrate



Possible Humira side effects in female

Reported by a physician from United States on 2012-08-06

Patient: female, weighing 48.1 kg (105.9 pounds)

Reactions: Wrong Technique in Drug Usage Process, Rhabdomyolysis, Nausea, Rectal Ulcer, Incorrect Dose Administered, Compartment Syndrome, Nerve Compression, Abdominal Pain Upper, Malaise, Peroneal Nerve Palsy, Dehydration, Tendonitis, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote ER
    Dosage: two 500 mg capsules at bedtime
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Crohn's Disease
    Start date: 2009-03-01

Humira
    Start date: 2010-05-01

Klonopin
    Dosage: 2mg at bedtime

Klonopin
    Dosage: 2.5mg qpm
    Indication: Anxiety

Klonopin
    Dosage: prn
    Indication: Bipolar Disorder

Seroquel
    Dosage: 400mg qpm
    Indication: Product Used FOR Unknown Indication

Seroquel
    Dosage: 300mg at bedtime

Other drugs received by patient: Canasa; Pentasa; VFL #3; Dexilant; Mirapex; VFL #3; Flexeril; Vyvanse; Stool Softener



Possible Humira side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 60 year old female

Reactions: Confusional State, Pneumonia, Injection Site Vesicles, Dyspnoea, Injection Site Scar, Chills, Incorrect Dose Administered, Vaginal Fistula, Pyrexia, Gastritis Haemorrhagic, Delirium, Somnolence, Abdominal Discomfort, Blood Cholesterol Increased, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Afrin; Activella; Flurazepam; Carafate; Crestor; Nizatidine; Vagifem; Xanax; Motifene



Possible Humira side effects in female

Reported by a physician from United States on 2012-08-02

Patient: female

Reactions: Nasal Turbinate Abnormality, Injection Site Erythema, Incorrect Dose Administered, Injection Site Pain, Nasal Septum Deviation, Injection Site Papule

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Lysine; Birth Control Pills; Prilosec; Vitamin D; Areva ONE; Lysine



Possible Humira side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 54 year old female

Reactions: Abdominal Pain, Postoperative Adhesion, Injection Site Haematoma, Incorrect Dose Administered, Intestinal Resection, Injection Site Swelling, Injection Site Erythema, Dyspepsia, Incision Site Abscess, Cholecystectomy, Appendicectomy, Device Malfunction, Inguinal Hernia

Drug(s) suspected as cause:
Humira
    Start date: 2012-05-03
    End date: 2012-05-17

Humira
    Start date: 2012-07-08

Humira
    Indication: Crohn's Disease
    Start date: 2010-06-01
    End date: 2012-03-14

Other drugs received by patient: Several Chinese Herbs



Possible Humira side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 70 year old female

Reactions: Diarrhoea, Upper Limb Fracture, Injection Site Extravasation, Incorrect Dose Administered, Injection Site Reaction, Injection Site Pain, Colitis, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    End date: 2010-01-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2012-01-01

Other drugs received by patient: Methotrexate



Possible Humira side effects in 58 year old male

Reported by a pharmacist from United States on 2012-07-23

Patient: 58 year old male

Reactions: Injection Site Haemorrhage, Spinal Fracture, Incorrect Dose Administered, Injection Site Pain

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Simvastatin; Aspirin; Atenolol



Possible Humira side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female, weighing 88.5 kg (194.8 pounds)

Reactions: Injection Site Haemorrhage, Injection Site Haematoma, Crohn's Disease, Incorrect Dose Administered, Injection Site Urticaria, Injection Site Pain, Injection Site Swelling, Hypoaesthesia, Paraesthesia, Neuropathy Peripheral, Injection Site Erythema, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Ranitidine; Levothyroxine Sodium; Yasmin; Amlodipine



Possible Humira side effects in female

Reported by a physician from United States on 2012-07-19

Patient: female, weighing 48.6 kg (106.9 pounds)

Reactions: Rhabdomyolysis, Wrong Technique in Drug Usage Process, Nausea, Incorrect Dose Administered, Rectal Ulcer, Compartment Syndrome, Nerve Compression, Abdominal Pain Upper, Malaise, Peroneal Nerve Palsy, Dehydration, Tendonitis, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote ER
    Dosage: two 500 mg capsules at bedtime
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Crohn's Disease
    Start date: 2009-03-01

Humira
    Start date: 2010-05-01

Klonopin
    Dosage: 2.5mg qpm
    Indication: Anxiety

Klonopin
    Dosage: prn
    Indication: Bipolar Disorder

Klonopin
    Dosage: 2mg at bedtime

Seroquel
    Dosage: 300mg at bedtime

Seroquel
    Dosage: 400mg qpm
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Stool Softener; Pentasa; Mirapex; VFL #3; Canasa; Dexilant; Vyvanse; VFL #3; Flexeril



Possible Humira side effects in 60 year old female

Reported by a physician from United States on 2012-07-17

Patient: 60 year old female

Reactions: Ligament Rupture, Incorrect Dose Administered, Injection Site Pain, Fall, Tendinous Contracture, Injection Site Extravasation, Tendon Disorder, Device Malfunction

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2009-01-01

Levaquin
    Dosage: took only 2 doses
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Calcium; Prednisone; Immune Globulin NOS; Nexium; Zyrtec; Plaquenil; Citalopram Hydrobromide; Fish OIL; Citalopram Hydrobromide



Possible Humira side effects in 60 year old female

Reported by a physician from United States on 2012-07-16

Patient: 60 year old female

Reactions: Ligament Rupture, Tendinous Contracture, Incorrect Dose Administered, Tendon Disorder, Injection Site Pain, Device Malfunction, Fall

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2009-01-01

Levaquin
    Dosage: took only 2 doses
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Fish OIL; Immune Globulin NOS; Calcium; Nexium; Citalopram Hydrobromide; Citalopram Hydrobromide; Plaquenil; Zyrtec; Prednisone



Possible Humira side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: 49 year old female

Reactions: Weight Decreased, Vomiting, Drug Ineffective, Pain, Incorrect Dose Administered, Diarrhoea, Central Venous Catheterisation, Deep Vein Thrombosis, Injection Site Papule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2011-12-01

Humira

Other drugs received by patient: Prilosec; Prednisone TAB



Possible Humira side effects in female

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

Patient: female, weighing 86.3 kg (189.8 pounds)

Reactions: Injection Site Haematoma, Injection Site Haemorrhage, Pain, Rheumatoid Arthritis, Malaise, Sjogren's Syndrome, Device Malfunction, Fluid Retention, Vascular Neoplasm, Nausea, Incorrect Dose Administered, Faecal Incontinence, Injection Site Pain, Nerve Compression, Gastroenteritis, DRY Eye, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Female Hormone Patch; Xanax



Possible Humira side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: female, weighing 39.0 kg (85.9 pounds)

Reactions: Pyoderma Gangrenosum, Weight Decreased, Ileostomy, Injection Site Haematoma, Drug Ineffective, Pain, Anal Fistula, Fibromyalgia, Adhesion, Rectal Abscess, Inappropriate Schedule of Drug Administration, Subcutaneous Abscess, Crohn's Disease, Incorrect Dose Administered, Joint Dislocation, Injection Site Pain, Female Genital Tract Fistula, Tremor, Anxiety, Cholelithiasis, Renal Failure, Arthralgia, Conjunctivitis Infective, Fungal Skin Infection, Arthritis

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease

Humira
    End date: 2010-08-01

Humira
    Start date: 2010-11-05
    End date: 2011-10-01

Humira
    Start date: 2009-01-01

Welchol
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Vitamin B-12; Benefiber; Prednisone TAB; Multi-Vitamin; Ambien; Probiotic; Vitamin D; Oxycodone HCL; Morphine; Fish OIL; Prednisone TAB; Prilosec; Fentanyl-100; Zinc Sulfate; Vancomycin; Anti-Diarrheal



Possible Humira side effects in male

Reported by a physician from United States on 2012-06-20

Patient: male, weighing 74.5 kg (163.8 pounds)

Reactions: Abdominal Pain, Nasopharyngitis, Wound, Incisional Hernia, Off Label Use, Large Intestinal Ulcer, Ileitis, Decreased Appetite, Haematoma, Vomiting, Nausea, Incorrect Dose Administered, Crohn's Disease, Nasal Congestion, Skin Tightness, Abscess Intestinal, Gastrointestinal Disorder, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2010-10-01
    End date: 2010-12-01

Humira
    Start date: 2011-02-01

Humira
    Start date: 2012-06-05

Remicade
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Vicodin; Ativan; Lorazepam; Hydrocodone



Possible Humira side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female, weighing 86.3 kg (189.8 pounds)

Reactions: Injection Site Haemorrhage, Injection Site Haematoma, Pain, Rheumatoid Arthritis, Malaise, Device Malfunction, Sjogren's Syndrome, Fluid Retention, Vascular Neoplasm, Nausea, Incorrect Dose Administered, Injection Site Pain, Faecal Incontinence, Nerve Compression, Gastroenteritis, DRY Eye, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Female Hormone Patch; Xanax



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