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Lortab (Hydrocodone / Acetaminophen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lortab (Hydrocodone / Acetaminophen) 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 (155)
Death (16)
Life Threatening Events (7)
Disability (3)

Reports by Reaction Type

Headache (27)Vomiting (27)Fatigue (21)Abdominal Pain (19)Nausea (19)Malaise (18)Cognitive Disorder (18)Drug Ineffective (17)Anxiety (17)Pain (15)Feeling Abnormal (14)Toxicity To Various Agents (11)

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

Possible Lortab side effects in 69 year old female

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

Patient: 69 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Fentanyl
    Dosage: unk

Lortab
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Percocet
    Dosage: unk



Possible Lortab side effects in female

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

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: LIP Swelling, Adverse Drug Reaction, Drug Prescribing Error, Somnolence, Fall, Cystitis Interstitial, Hypokinesia, Mental Disorder, Abnormal Loss of Weight, Depression, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-01-01

Lortab
    Indication: Cystitis Interstitial
    Start date: 2012-08-14

Paxil
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Remeron
    Indication: Depression

Trazodone Hydrochloride
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Wellbutrin
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Lortab side effects in male

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

Patient: male

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Lortab
    Dosage: unk
    Indication: Headache

Methadone HCL
    Dosage: unk
    Indication: Headache

Oxycodone HCL
    Dosage: unk
    Indication: Headache



Possible Lortab side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 36 year old female

Reactions: Drug Screen Positive, Cervix Disorder, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Excedrin (Migraine)
    Dosage: 2 geltabs starting in 2007 or 2008
    Administration route: Oral
    Indication: Migraine

Excedrin Extra Strength Caplets
    Dosage: 2 doses starting in 2007 or 2008
    Administration route: Oral
    Indication: Migraine

Excedrin Tension Headache Caplets
    Dosage: 2 gel capsules as needed
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-06-01

Fenofibrate
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lortab
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Lortab side effects in 43 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 43 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Vomiting, Pain in Extremity, Pain, Headache, Anxiety, Malaise, Diarrhoea, Withdrawal Syndrome, Feeling Abnormal, Cold Sweat, Nervousness

Drug(s) suspected as cause:
Clonazepam
    Dosage: 1 mg, 3x/day (1/2-1 prn)
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-11-11

Klonopin
    Dosage: 1mg, 1/2 to 1 tablet, 3 times a day
    Administration route: Oral
    Indication: Stress

Klonopin
    Indication: Anxiety

Lortab
    Indication: Arthritis

Lortab
    Indication: Pain

Lortab
    Indication: Spondylitis

Lortab
    Dosage: 10-500 mg, take 1-2 tablets every 6-8 hours as needed
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2012-06-08

Lyrica
    Dosage: 150 mg, 3x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2011-03-04
    End date: 2012-05-01

Other drugs received by patient: Ranitidine; Tizanidine; Tizanidine; Citalopram; Zantac; Loratadine; Hydrochlorothiazide; Tizanidine; Citalopram; Tizanidine; Ranitidine; Claritin



Possible Lortab side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 36 year old female

Reactions: Drug Screen Positive, Cervix Disorder, Scar

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Excedrin (Migraine)
    Dosage: unk
    Administration route: Oral
    Indication: Migraine

Excedrin (Migraine)
    Dosage: unk
    Administration route: Oral
    Indication: Migraine

Excedrin Sinus Headache Caplets
    Dosage: 2 df, prn
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-06-01

Fenofibrate
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lortab
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Lortab side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 36 year old female

Reactions: Drug Screen Positive, Cervix Disorder, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor

Excedrin (Migraine)
    Dosage: 2 unknown dose
    Administration route: Oral
    Indication: Migraine

Excedrin (Migraine)
    Dosage: 2 df
    Administration route: Oral
    Indication: Migraine

Excedrin Tension Headache Caplets
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-06-01

Fenofibrate

Lisinopril

Lortab



Possible Lortab side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 36 year old female

Reactions: Drug Screen Positive, Cervix Disorder, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Excedrin (Migraine)
    Administration route: Oral
    Indication: Migraine

Excedrin (Migraine)
    Administration route: Oral
    Indication: Migraine

Excedrin Tension Headaches
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-06-01

Fenofibrate

Lisinopril
    Administration route: Oral

Lortab



Possible Lortab side effects in 54 year old male

Reported by a physician from United States on 2012-08-03

Patient: 54 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Cyst, Lower Limb Fracture, Prostatic Disorder, Fall, Loss of Consciousness, Foot Fracture, Osteonecrosis, Syncope, Arthropathy, Carpal Tunnel Syndrome

Drug(s) suspected as cause:
Avalide
    Dosage: 1df = 300/12.5 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-07-05

Cimzia
    Indication: Depression

Lortab
    Dosage: 1df:10/500 units nos
    Indication: Pain

Lyrica
    Indication: Fibromyalgia

Other drugs received by patient: Synthroid; Crestor; Zanaflex



Possible Lortab side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Ambien CR

Amoxicillin
    Dosage: 0.5, qd

Arthrotec
    Administration route: Oral

Biaxin

Cefzil

Lipitor
    Administration route: Oral

Livalo

Lortab

Oxacillin Sodium

PCE

Pravachol

Provigil

Sulfamethoxazole

Ultram

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral



Possible Lortab side effects in 36 year old female

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

Patient: 36 year old female

Reactions: Drug Screen Positive, Cervix Disorder, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: unk, unk

Excedrin (Migraine)
    Dosage: 2 unk, unk
    Administration route: Oral
    Indication: Migraine

Excedrin (Migraine)
    Dosage: 2 df, unk
    Administration route: Oral
    Indication: Migraine

Excedrin Tension Headache Caplets
    Dosage: 2 df, prn
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-06-01

Fenofibrate
    Dosage: unk, unk

Lisinopril
    Dosage: unk, unk

Lortab
    Dosage: unk, unk



Possible Lortab side effects in female

Reported by a physician from United States on 2012-07-30

Patient: female

Reactions: Pain, Rash, Secondary Progressive Multiple Sclerosis, Status Epilepticus, Multiple Sclerosis Relapse, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Desitin

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-01-13

Lortab
    Dosage: 10 - 325 mg bid prn
    Indication: Pain

Other drugs received by patient: Lamictal; Keppra; Nuedexta; Prednisone; Skelaxin



Possible Lortab side effects in female

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

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Weight Decreased, Pain, Musculoskeletal Discomfort, Headache, Hypoaesthesia, Paraesthesia, Muscle Strain, Insomnia, Musculoskeletal Stiffness, Feeling Abnormal

Drug(s) suspected as cause:
Cyclobenzaprine
    Indication: Muscle Tightness

Cyclobenzaprine
    Dosage: 10 mg, 2x/day
    Indication: Brachial Plexopathy
    Start date: 2012-05-16
    End date: 2012-05-20

Cyclobenzaprine
    Indication: Nerve Compression

Lortab
    Dosage: unk
    Indication: Pain
    Start date: 2012-01-01

Skelaxin
    Dosage: 800 mg, 4x/day
    Indication: Brachial Plexopathy
    Start date: 2012-05-20
    End date: 2012-01-01

Skelaxin
    Indication: Nerve Compression

Skelaxin
    Indication: Muscle Tightness

Other drugs received by patient: Klonopin; Klonopin; Effexor XR



Possible Lortab side effects in 47 year old male

Reported by a physician from United States on 2012-07-27

Patient: 47 year old male, weighing 98.9 kg (217.5 pounds)

Reactions: Overdose, Potentiating Drug Interaction, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Amitriptyline Hydrochloride
    Administration route: Oral
    Indication: Anxiety
    Start date: 2008-06-01

Fentanyl-100
    Dosage: change q3d
    Indication: Pain
    End date: 2008-06-09

Lortab
    Indication: Pain

Other drugs received by patient: Ibuprofen; Ranitidine; Xanax



Possible Lortab side effects in 47 year old male

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

Patient: 47 year old male, weighing 98.9 kg (217.5 pounds)

Reactions: Overdose, Potentiating Drug Interaction, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Amitriptyline Hydrochloride
    Administration route: Oral
    Indication: Anxiety
    Start date: 2008-06-01

Fentanyl-100
    Dosage: change q3d
    Indication: Pain
    End date: 2008-06-09

Lortab
    Indication: Pain

Other drugs received by patient: Xanax; Ranitidine; Ibuprofen



Possible Lortab side effects in 47 year old male

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

Patient: 47 year old male, weighing 98.9 kg (217.5 pounds)

Reactions: Overdose, Potentiating Drug Interaction, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Amitriptyline Hydrochloride
    Administration route: Oral
    Indication: Anxiety
    Start date: 2008-06-01

Fentanyl-100
    Dosage: change q3d
    Indication: Pain
    End date: 2008-06-09

Lortab
    Indication: Pain

Other drugs received by patient: Ranitidine; Ibuprofen; Xanax



Possible Lortab side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Nausea, Circumstance or Information Capable of Leading To Medication Error, Pain, Aggression, Irritability, Anxiety, Euphoric Mood, Diarrhoea, Insomnia, Dizziness, Depression, Feeling Abnormal, Drug Dependence, Asthenia

Drug(s) suspected as cause:
Lorazepam
    Dosage: 10 mg, 3x/day
    Indication: Anxiety

Lorazepam
    Indication: Muscle Relaxant Therapy

Lortab
    Dosage: unk
    Indication: Pain

Lyrica
    Dosage: 300 mg, 3x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-01
    End date: 2012-01-01

Lyrica
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-07-17

Lyrica
    Dosage: 200 mg, 3x/day
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Lortab side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: 36 year old female

Reactions: Drug Screen Positive, Cervix Disorder, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: unk, unk

Excedrin (Migraine)
    Dosage: 2 df, unk
    Administration route: Oral
    Indication: Migraine

Excedrin (Migraine)
    Dosage: 2 unk, unk
    Administration route: Oral
    Indication: Migraine

Excedrin Tension Headache Caplets
    Dosage: 2 df, prn
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-06-01

Fenofibrate
    Dosage: unk, unk

Lisinopril
    Dosage: unk, unk

Lortab
    Dosage: unk, unk



Possible Lortab side effects in female

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

Patient: female

Reactions: Suicide Attempt, Multiple Drug Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benadryl
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lortab
    Administration route: Oral
    Indication: Pain

Percocet
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Wellbutrin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zanaflex
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Neurontin



Possible Lortab side effects in 48 year old female

Reported by a physician from United States on 2012-07-13

Patient: 48 year old female, weighing 82.0 kg (180.4 pounds)

Reactions: Suicide Attempt, Multiple Drug Overdose Intentional

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Dosage: overdose
    Start date: 2011-08-18

Hydrocodone Bitartrate
    Dosage: overdose
    Start date: 2011-08-18

Lortab
    Dosage: overdose
    Start date: 2011-08-18

Viibryd
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-08-12
    End date: 2011-08-18

Other drugs received by patient: Lamictal; Wellbutrin



Possible Lortab side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: 55 year old female, weighing 84.4 kg (185.6 pounds)

Reactions: Liver Injury, Drug Administration Error, Toxicity To Various Agents, Abdominal Cavity Drainage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    Indication: Breakthrough Pain
    End date: 2011-10-31

Extra Strength Tylenol
    Administration route: Oral
    Indication: Breakthrough Pain
    End date: 2011-10-31

Lortab
    Indication: Analgesic Therapy

Other drugs received by patient: Flexeril; Anti-Hypertensive; Potassium Chloride; Other Drugs (Unspecified); Other Drugs (Unspecified); Lasix; Other Drugs (Unspecified); Metoprolol Succinate; Other Drugs (Unspecified)



Possible Lortab side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient: female

Reactions: Pain, Secondary Progressive Multiple Sclerosis, Status Epilepticus, Rash, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Desitin

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-01-13

Lortab
    Dosage: 10 - 325 mg bid prn
    Indication: Pain

Other drugs received by patient: Nuedexta; Skelaxin; Keppra; Lamictal; Prednisone



Possible Lortab side effects in 26 year old female

Reported by a physician from United States on 2012-07-06

Patient: 26 year old female, weighing 51.5 kg (113.3 pounds)

Reactions: Liver Function Test Abnormal, Multiple Drug Overdose, Intentional Self-Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral

Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bactrim
    Administration route: Oral
    Indication: Cystitis

Clonazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lortab
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Valproate Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Lortab side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 55 year old female, weighing 84.4 kg (185.6 pounds)

Reactions: Liver Injury, Toxicity To Various Agents, Abdominal Cavity Drainage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    Indication: Breakthrough Pain
    End date: 2011-10-31

Extra Strength Tylenol
    Administration route: Oral
    Indication: Breakthrough Pain
    End date: 2011-10-31

Lortab
    Indication: Analgesic Therapy

Other drugs received by patient: Potassium; Flexeril; Other Drugs (Unspecified); Other Drugs (Unspecified); Other Drugs (Unspecified); Lasix; Metoprolol; Anti-Hypertensive; Other Drugs (Unspecified)



Possible Lortab side effects in female

Reported by a physician from United States on 2012-06-29

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Multiple Drug Overdose Intentional, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien

Hydrocodone Bitartrate

Lortab

RUM

Viibryd
    Dosage: 10 mg
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-08-12
    End date: 2011-08-18

Wine

Other drugs received by patient: Wellbutrin; Lamictal



Possible Lortab side effects in female

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

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Clonazepam
    Dosage: unk

COD-Liver OIL
    Dosage: unk

Flexeril
    Dosage: unk

Lortab
    Dosage: unk

Potassium Penicillin G
    Dosage: unk

Valium
    Dosage: unk



Possible Lortab side effects in female

Reported by a physician from United States on 2012-06-26

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Ambien CR
    Dosage: unk

Amoxicillin
    Dosage: 0.5 unk, 1x/day

Arthrotec
    Dosage: unk
    Administration route: Oral

Biaxin
    Dosage: unk

Cefzil
    Dosage: unk

Lipitor
    Dosage: unk
    Administration route: Oral

Livalo
    Dosage: unk

Lortab
    Dosage: unk

Oxacillin Sodium
    Dosage: unk

PCE
    Dosage: unk

Pravachol
    Dosage: unk

Provigil
    Dosage: unk

Sulfamethoxazole
    Dosage: unk

Ultram
    Dosage: unk

Zetia
    Dosage: unk

Zocor
    Dosage: unk



Possible Lortab side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26

Patient: 64 year old female, weighing 134.1 kg (295.0 pounds)

Reactions: Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Investigational Drug
    Dosage: high dose
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2010-08-12
    End date: 2010-11-08

Investigational Drug
    Dosage: high dose
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2010-08-12
    End date: 2010-11-08

Investigational Drug
    Dosage: low dose
    Administration route: Oral
    Start date: 2010-07-15
    End date: 2010-08-11

Investigational Drug
    Dosage: low dose
    Administration route: Oral
    Start date: 2010-07-15
    End date: 2010-08-11

Lortab
    Dosage: 10/500 mg
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2010-02-10
    End date: 2010-11-08

Other drugs received by patient: Potassium Chloride; Restoril; Potassium Chloride; Nexium; Ventolin HFA; Lasix; Temazepam; Lisinopril; Advair Diskus 100 / 50



Possible Lortab side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Lortab
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Vicodin
    Dosage: unk



Possible Lortab side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-07

Patient: male

Reactions: Dysuria, Prostatomegaly

Drug(s) suspected as cause:
Lortab

Other drugs received by patient: Butrans

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