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Humira Adverse Events Reported to the FDA Over Time

How are Humira adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Humira, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Humira is flagged as the suspect drug causing the adverse event.

Most Common Humira Adverse Events Reported to the FDA

What are the most common Humira adverse events reported to the FDA?

Age 10-19 Years

Injection Site Pain
478 (.1%)
Pyrexia
258 (.05%)
Incorrect Dose Administered
248 (.05%)
Drug Ineffective
215 (.04%)
Abdominal Pain
209 (.04%)
Diarrhoea
161 (.03%)
Headache
156 (.03%)
Pain
146 (.03%)
Nausea
142 (.03%)
Fatigue
139 (.03%)
Vomiting
136 (.03%)
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Arthralgia
133 (.03%)
Injection Site Erythema
133 (.03%)
Drug Dose Omission
103 (.02%)
Oropharyngeal Pain
86 (.02%)
Rash
84 (.02%)
Weight Decreased
83 (.02%)
Injection Site Irritation
80 (.02%)
Nasopharyngitis
77 (.02%)
Malaise
76 (.02%)
Injection Site Haemorrhage
72 (.01%)
Cough
71 (.01%)
Injection Site Swelling
69 (.01%)
Wrong Technique In Drug Usage Proce...
68 (.01%)
Abdominal Pain Upper
67 (.01%)
Injection Site Pruritus
67 (.01%)
Injection Site Haematoma
66 (.01%)
Haematochezia
65 (.01%)
Injection Site Reaction
57 (.01%)
Pruritus
57 (.01%)
Dizziness
55 (.01%)
Device Malfunction
54 (.01%)
Injection Site Extravasation
54 (.01%)
Psoriasis
54 (.01%)
Urticaria
52 (.01%)
Injection Site Urticaria
49 (.01%)
Joint Swelling
48 (.01%)
Intestinal Obstruction
45 (.01%)
Infection
44 (.01%)
Drug Delivery System Malfunction
43 (.01%)
Dyspnoea
43 (.01%)
Oedema Peripheral
43 (.01%)
Dehydration
41 (.01%)
Erythema
41 (.01%)
Injection Site Nodule
41 (.01%)
Constipation
40 (.01%)
Decreased Appetite
40 (.01%)
Pain In Extremity
39 (.01%)
Sinusitis
39 (.01%)
Alopecia
37 (.01%)
Chest Pain
37 (.01%)
Fistula
36 (.01%)
Hypoaesthesia
35 (.01%)
Paraesthesia
35 (.01%)
Rhinorrhoea
35 (.01%)
Diarrhoea Haemorrhagic
32 (.01%)
Injection Site Papule
32 (.01%)
Intestinal Stenosis
32 (.01%)
Nasal Congestion
32 (.01%)
Back Pain
31 (.01%)
Injection Site Rash
31 (.01%)
Myalgia
31 (.01%)
Gastrointestinal Inflammation
30 (.01%)
Pharyngitis Streptococcal
30 (.01%)
Rectal Haemorrhage
30 (.01%)
Tremor
30 (.01%)
Frequent Bowel Movements
29 (.01%)
Acute Monocytic Leukaemia
28 (.01%)
Convulsion
28 (.01%)
Injection Site Warmth
28 (.01%)
Arthritis
27 (.01%)
Insomnia
27 (.01%)
Transfusion Reaction
27 (.01%)
Abdominal Pain Lower
26 (.01%)
Accidental Exposure
26 (.01%)
Chills
26 (.01%)
Condition Aggravated
26 (.01%)
Viral Infection
26 (.01%)
Anal Fistula
25 (.01%)
Anxiety
25 (.01%)
Haemoglobin Decreased
25 (.01%)
Off Label Use
25 (.01%)
Small Intestinal Obstruction
25 (.01%)
Gait Disturbance
24 (0%)
Inflammation
24 (0%)
Lymphadenopathy
24 (0%)
Rash Papular
24 (0%)
Acne
23 (0%)
Anal Stenosis
23 (0%)
Colitis Ulcerative
23 (0%)
Influenza Like Illness
23 (0%)
Anaemia
22 (0%)
Syncope
22 (0%)
White Blood Cell Count Increased
22 (0%)
Asthenia
21 (0%)
Clostridial Infection
21 (0%)
Influenza
21 (0%)
Multi-organ Failure
21 (0%)
Rash Pustular
21 (0%)
Weight Increased
21 (0%)
Bone Pain
20 (0%)

All Ages and Genders

Injection Site Pain
12763 (2.62%)
Drug Ineffective
9183 (1.88%)
Arthralgia
8406 (1.72%)
Incorrect Dose Administered
7883 (1.62%)
Pain
7058 (1.45%)
Pyrexia
6748 (1.38%)
Fatigue
5996 (1.23%)
Headache
5670 (1.16%)
Nausea
5191 (1.06%)
Diarrhoea
4919 (1.01%)
Injection Site Erythema
4848 (.99%)
Show More Show More
Psoriasis
4648 (.95%)
Cough
4308 (.88%)
Dyspnoea
4158 (.85%)
Rash
4150 (.85%)
Pain In Extremity
4111 (.84%)
Abdominal Pain
4106 (.84%)
Nasopharyngitis
4081 (.84%)
Oedema Peripheral
3964 (.81%)
Accidental Exposure
3948 (.81%)
Pneumonia
3609 (.74%)
Vomiting
3528 (.72%)
Rheumatoid Arthritis
3403 (.7%)
Drug Dose Omission
3381 (.69%)
Injection Site Haematoma
3231 (.66%)
Malaise
3197 (.66%)
Pruritus
3197 (.66%)
Injection Site Irritation
3029 (.62%)
Injection Site Haemorrhage
3018 (.62%)
Asthenia
2957 (.61%)
Sinusitis
2947 (.6%)
Dizziness
2926 (.6%)
Joint Swelling
2859 (.59%)
Injection Site Pruritus
2783 (.57%)
Weight Decreased
2721 (.56%)
Wrong Technique In Drug Usage Proce...
2673 (.55%)
Back Pain
2446 (.5%)
Fall
2386 (.49%)
Injection Site Swelling
2374 (.49%)
Paraesthesia
2160 (.44%)
Injection Site Reaction
2118 (.43%)
Hypoaesthesia
2112 (.43%)
Urinary Tract Infection
2001 (.41%)
Erythema
1985 (.41%)
Chest Pain
1834 (.38%)
Oropharyngeal Pain
1769 (.36%)
Arthritis
1764 (.36%)
Gait Disturbance
1666 (.34%)
Infection
1659 (.34%)
Anaemia
1646 (.34%)
Chills
1587 (.33%)
Device Malfunction
1577 (.32%)
Injection Site Extravasation
1560 (.32%)
Abdominal Pain Upper
1536 (.32%)
Bronchitis
1528 (.31%)
Alopecia
1490 (.31%)
Urticaria
1418 (.29%)
Weight Increased
1385 (.28%)
Influenza
1363 (.28%)
Sepsis
1343 (.28%)
Hypertension
1322 (.27%)
Feeling Abnormal
1309 (.27%)
Injection Site Nodule
1286 (.26%)
Drug Delivery System Malfunction
1248 (.26%)
Muscle Spasms
1243 (.26%)
Contusion
1228 (.25%)
Myalgia
1225 (.25%)
Influenza Like Illness
1210 (.25%)
Drug Effect Decreased
1198 (.25%)
Musculoskeletal Stiffness
1195 (.25%)
Intestinal Obstruction
1165 (.24%)
Cerebrovascular Accident
1148 (.24%)
Staphylococcal Infection
1142 (.23%)
Dehydration
1124 (.23%)
Decreased Appetite
1118 (.23%)
Herpes Zoster
1110 (.23%)
Mobility Decreased
1104 (.23%)
Myocardial Infarction
1104 (.23%)
Depression
1064 (.22%)
Rhinorrhoea
1045 (.21%)
Lymphadenopathy
1035 (.21%)
Upper Respiratory Tract Infection
1013 (.21%)
Pulmonary Embolism
1012 (.21%)
Abdominal Distension
1010 (.21%)
Inflammation
1007 (.21%)
Musculoskeletal Pain
1005 (.21%)
Rash Pruritic
997 (.2%)
Injection Site Rash
989 (.2%)
Osteoarthritis
980 (.2%)
Condition Aggravated
977 (.2%)
Impaired Healing
974 (.2%)
Death
970 (.2%)
Vision Blurred
963 (.2%)
Injection Site Warmth
946 (.19%)
Nasal Congestion
944 (.19%)
Muscular Weakness
940 (.19%)
Cellulitis
937 (.19%)
Insomnia
931 (.19%)
Injection Site Urticaria
929 (.19%)
Hypersensitivity
925 (.19%)
Hyperhidrosis
905 (.19%)

ExportShare/Embed GraphExport Export Data

This graph shows the top adverse events submitted to the FDA for Humira, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Humira is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Humira

What are the most common Humira adverse events reported to the FDA?

Age 10-19 Years

Show More Show More

All Ages and Genders

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ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Humira, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Humira is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Humira According to Those Reporting Adverse Events

Why are people taking Humira, according to those reporting adverse events to the FDA?

Rheumatoid Arthritis
57720
Crohns Disease
28455
Psoriasis
14721
Psoriatic Arthropathy
10404
Ankylosing Spondylitis
5428
Drug Use For Unknown Indication
5085
Show More Show More
Product Used For Unknown Indication
4525
Colitis Ulcerative
1835
Juvenile Arthritis
834
Arthritis
513
Drug Exposure During Pregnancy
428
Polyarthritis
251
Spondylitis
231
Osteoarthritis
231
Uveitis
210
Maternal Exposure Timing Unspecifie...
177
Colitis
169
Inflammatory Bowel Disease
158
Systemic Lupus Erythematosus
115
Seronegative Arthritis
109
Spondyloarthropathy
105
Hidradenitis
90
Behcets Syndrome
89
Pustular Psoriasis
87
Sarcoidosis
69
Fistula
63
Fibromyalgia
61
Maternal Exposure During Pregnancy
59
Musculoskeletal Pain
58
Pyoderma Gangrenosum
57
Sjogrens Syndrome
44
Paternal Drugs Affecting Foetus
40
Arthritis Reactive
38
Intestinal Fistula
37
Arthritis Enteropathic
35
Arthralgia
35
Prostatic Specific Antigen
34
Arthropathy
32
Reiters Syndrome
31
Irritable Bowel Syndrome
29
Polychondritis
28
Spinal Osteoarthritis
24
Erythrodermic Psoriasis
23
Autoimmune Disorder
22
Sacroiliitis
22
Leukocyte Antigen B-27 Positive
22
Polymyalgia Rheumatica
21
Transmission Of Drug Via Semen
20
Vasculitis
19
Ill-defined Disorder
19
Iritis
18

Child Safety Precautions


Drug Labels

LabelLabelerEffective
HumiraAbbott Laboratories11-OCT-12
HumiraAbbVie Inc.24-APR-13

Humira Case Reports

What Humira safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Humira. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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