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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 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 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 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 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 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 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 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 2012-08-13
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 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 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 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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