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Dilaudid (Hydromorphone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Dilaudid (Hydromorphone) 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 (181)
Death (19)
Life Threatening Events (13)
Disability (5)

Reports by Reaction Type

Drug Hypersensitivity (35)Nausea (29)Abdominal Pain (25)Vomiting (23)Constipation (18)Weight Decreased (16)Drug Ineffective (15)Dyspnoea (15)Confusional State (14)Headache (14)Malaise (14)Inflammation (13)

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

Possible Dilaudid side effects in

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

Patient:

Reactions: Vomiting, Metabolic Acidosis, Nausea, Antiphospholipid Antibodies Positive, Pulmonary Embolism, Hypercoagulation, Meningitis Viral, Pulmonary Infarction, Ear Pain, Pharyngitis Streptococcal, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid

Nuvaring
    Indication: Contraception
    Start date: 2010-02-10
    End date: 2010-03-01



Possible Dilaudid side effects in 72 year old female

Reported by a physician from Canada on 2012-08-21

Patient: 72 year old female

Reactions: Abdominal Pain, Weight Decreased, Tinnitus, Onychoclasis, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Intestinal Obstruction, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Sleep Apnoea Syndrome, Asthenia, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava

Cymbalta

Dilaudid

Lyrica
    Dosage: also taken 150mg

Orencia
    Dosage: lastdose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-q4wk,exp:ma2014,sep14
    Indication: Rheumatoid Arthritis
    Start date: 2011-08-01

Prednisone TAB
    Dosage: also taken 15 mg

Other drugs received by patient: Nexium; Hydromorphone Hydrochloride; Alendronate Sodium; Pramipexole Dihydrochloride; Calcium; Atenolol; Acetaminophen; Oxybutynin; Amiloride Hydrochloride; Calcitonin Salmon; Naproxen



Possible Dilaudid side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Aphagia, Dyspnoea, Kidney Enlargement, Cardiac Disorder, Cardiomegaly, Ileus, Respiratory Failure, DRY Mouth, Sedation, Abdominal Distension, Splenomegaly, Laryngeal Disorder

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Dilaudid
    Indication: Pain

Propofol
    Indication: Pain



Possible Dilaudid side effects in 41 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-16

Patient: 41 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Abdominal Pain, Hallucination, Auditory

Drug(s) suspected as cause:
Dilaudid



Possible Dilaudid side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-10

Patient: 72 year old female

Reactions: Abdominal Pain, Weight Decreased, Vomiting, Tinnitus, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Onychoclasis, Sleep Apnoea Syndrome, Asthenia, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava

Cymbalta

Dilaudid

Lyrica
    Dosage: also taken 150mg

Orencia
    Dosage: last dose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-also every 4 week,exp:ma2014
    Indication: Rheumatoid Arthritis
    Start date: 2011-08-01

Prednisone TAB
    Dosage: also taken 15 mg

Other drugs received by patient: Nexium; Calcium; Amiloride Hydrochloride; Calcitonin Salmon; Hydromorphone Hydrochloride; Acetaminophen; Oxybutynin Chloride; Atenolol; Alendronate Sodium; Naproxen; Pramipexole Dihydrochloride



Possible Dilaudid side effects in male

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

Patient: male, weighing 43.1 kg (94.8 pounds)

Reactions: Drug Hypersensitivity, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1500 unit, unk
    Indication: Prophylaxis
    Start date: 2010-08-01
    End date: 2012-03-01

Dilaudid
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-01



Possible Dilaudid side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 95.3 kg (209.7 pounds)

Reactions: Pruritus Generalised, Medical Device Removal, Angioedema, Drug Ineffective, Drug Hypersensitivity, Gastrectomy, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid
    Indication: Surgery

Dilaudid
    Dosage: administered via pca pump in hospital
    Indication: Prophylaxis
    Start date: 2012-02-01
    End date: 2012-02-01

Humira
    Indication: Psoriasis
    Start date: 2009-01-01
    End date: 2011-09-01

Humira
    Indication: Psoriatic Arthropathy
    Start date: 2012-04-01
    End date: 2012-06-22



Possible Dilaudid side effects in 20 year old female

Reported by a consumer/non-health professional on 2012-08-02

Patient: 20 year old female

Reactions: Loss of Consciousness, Substance Abuse

Adverse event resulted in: death

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

Dilaudid
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Dilaudid side effects in female

Reported by a physician from United States on 2012-07-31

Patient: female

Reactions: Rheumatoid Arthritis, Drug Ineffective, Poisoning, Joint Dislocation, Arthritis Bacterial, Bone Disorder, White Blood Cell Count Increased, Inflammation

Adverse event resulted in: hospitalization

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

Medrol
    Dosage: unk
    Indication: Rheumatoid Arthritis

Methotrexate Sodium
    Dosage: unk
    Indication: Rheumatoid Arthritis



Possible Dilaudid side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: female

Reactions: Drug Hypersensitivity

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

Morphine Sulfate
    Dosage: unk



Possible Dilaudid side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Overdose, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid
    Dosage: 8 mg
    Indication: Pain

Dilaudid
    Dosage: 60- 8mg tablets all at once

Pristiq
    Dosage: 50 mg, unk
    Indication: Depression



Possible Dilaudid side effects in 38 year old male

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

Patient: 38 year old male

Reactions: Drug Dependence, Somnolence, Aggression, Substance Abuse

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

Morphine Sulfate
    Indication: Product Used FOR Unknown Indication



Possible Dilaudid side effects in 53 year old male

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

Patient: 53 year old male, weighing 99.5 kg (218.9 pounds)

Reactions: Cardio-Respiratory Arrest, Pulse Absent, Blood Pressure Decreased, Cardiac Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid

Other drugs received by patient: Procardin XL; Colchicine; Insulin; Phoslo; Aspirin; Sensipar; Atenolol; Parachol



Possible Dilaudid side effects in 41 year old female

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

Patient: 41 year old female, weighing 75.2 kg (165.4 pounds)

Reactions: Dysarthria, Somnolence, Accidental Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Dosage: chronic
    Indication: Back Pain

Dilaudid
    Dosage: chronic
    Indication: Back Pain

Fentanyl
    Dosage: chronic
    Indication: Back Pain

Klonopin
    Dosage: chronic
    Indication: Back Pain

Lorazepam
    Dosage: chronic
    Indication: Back Pain

Morphine
    Dosage: chronic
    Indication: Back Pain

Tofranil
    Dosage: chronic
    Indication: Back Pain

Tramadol HCL
    Dosage: chronic
    Indication: Back Pain

Other drugs received by patient: Synthroid; Lotemax; Prednisone TAB; Reglan; Depakote; Restasis; Seasonale; Zofran; Colace



Possible Dilaudid side effects in 60 year old male

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

Patient: 60 year old male, weighing 89.8 kg (197.6 pounds)

Reactions: Respiratory Rate Decreased, Unresponsive To Stimuli

Drug(s) suspected as cause:
Dilaudid



Possible Dilaudid side effects in 85 year old female

Reported by a pharmacist from United States on 2012-07-25

Patient: 85 year old female, weighing 67.6 kg (148.7 pounds)

Reactions: Respiratory Rate Decreased, PH Body Fluid Decreased, Small Intestinal Obstruction, Pco2 Decreased, Ileus, Blood Bicarbonate Increased, Somnolence, Abdominal Adhesions

Drug(s) suspected as cause:
Dilaudid
    Dosage: 0.2 mg in 0.06 mg doses inj
    Indication: Pain
    Start date: 2011-08-13
    End date: 2011-08-13

Reglan
    Dosage: 5 mg q6h iv
    Indication: Ileus
    Start date: 2011-08-13
    End date: 2011-08-13



Possible Dilaudid side effects in 82 year old male

Reported by a pharmacist from United States on 2012-07-25

Patient: 82 year old male, weighing 92.5 kg (203.6 pounds)

Reactions: Pco2 Decreased, Respiratory Rate Decreased, Blood PH Decreased, Obstructive Airways Disorder, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Dilaudid
    Dosage: 1.1 mg pca iv
    Indication: Pain
    Start date: 2011-10-17
    End date: 2011-10-17

Fentanyl Citrate
    Dosage: 100 mcg iv
    Indication: Pain
    Start date: 2011-10-17
    End date: 2011-10-17



Possible Dilaudid side effects in 78 year old female

Reported by a pharmacist from United States on 2012-07-25

Patient: 78 year old female, weighing 87.5 kg (192.6 pounds)

Reactions: Respiratory Rate Decreased, Hypopnoea, Miosis, Somnolence

Drug(s) suspected as cause:
Dilaudid
    Dosage: 2 mg once iv bolus
    Indication: Pain
    Start date: 2011-08-22
    End date: 2011-08-22

Morphine
    Dosage: 10 mg once intrasynovial
    Indication: Pain
    Start date: 2011-08-22
    End date: 2011-08-22



Possible Dilaudid side effects in female

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

Patient: female

Reactions: Miosis, Hypotension, Delusion

Drug(s) suspected as cause:
Dilaudid



Possible Dilaudid side effects in 74 year old female

Reported by a pharmacist from United States on 2012-07-25

Patient: 74 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Lethargy, Pco2 Increased

Drug(s) suspected as cause:
Dilaudid



Possible Dilaudid side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female, weighing 89.4 kg (196.6 pounds)

Reactions: Drug Effect Decreased, Tendon Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid
    Dosage: as needed
    Administration route: Oral
    Indication: Pain
    Start date: 2011-10-01
    End date: 2012-01-01

Nucynta
    Administration route: Oral
    Indication: Pain

Nucynta
    Dosage: every 6 hours
    Administration route: Oral
    Start date: 2011-06-01

Other drugs received by patient: Lovastatin; Lisinopril; Metformin Hydrochloride; Toprol-XL



Possible Dilaudid side effects in 72 year old female

Reported by a physician from Canada on 2012-07-24

Patient: 72 year old female

Reactions: Abdominal Pain, Weight Decreased, Vomiting, Tinnitus, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Onychoclasis, Sleep Apnoea Syndrome, Asthenia, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava

Cymbalta

Dilaudid

Lyrica
    Dosage: also taken 150mg

Orencia
    Dosage: last dose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-also every 4 week,exp:ma2014
    Indication: Rheumatoid Arthritis
    Start date: 2011-08-01

Prednisone
    Dosage: also taken 15 mg

Other drugs received by patient: Nexium; Pramipexole Dihydrochloride; Amiloride Hydrochloride; Alendronate Sodium; Oxybutynin; Naproxen; Atenolol; Acetaminophen; Calcium; Calcitonin Salmon; Hydromorphone HCL



Possible Dilaudid side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 70 year old female

Reactions: Incoherent, Confusional State

Drug(s) suspected as cause:
Dilaudid

Ifosfamide
    Indication: Chemotherapy

Viibryd
    Dosage: 10 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2012-07-01
    End date: 2012-07-01

Viibryd
    Dosage: 40 mg
    Administration route: Oral
    Start date: 2012-07-17

Viibryd
    Dosage: 20 mg
    Administration route: Oral
    Start date: 2012-07-01
    End date: 2012-07-16



Possible Dilaudid side effects in 79 year old male

Reported by a pharmacist from United States on 2012-07-20

Patient: 79 year old male, weighing 47.6 kg (104.8 pounds)

Reactions: Unresponsive To Stimuli, Apnoea

Drug(s) suspected as cause:
Dilaudid



Possible Dilaudid side effects in 53 year old female

Reported by a pharmacist from United States on 2012-07-20

Patient: 53 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Respiratory Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dilaudid



Possible Dilaudid side effects in 64 year old female

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

Patient: 64 year old female, weighing 58.1 kg (127.7 pounds)

Reactions: HIP Fracture, Procedural Pain, Miosis, Hypotension, Drug Withdrawal Syndrome, Delusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid
    Indication: Procedural Pain

Dilaudid
    Indication: HIP Fracture

Morphine Sulfate
    Indication: Spinal Fusion Surgery

Morphine Sulfate
    Indication: Procedural Pain

Other drugs received by patient: Fentanyl



Possible Dilaudid side effects in 70 year old female

Reported by a pharmacist from United States on 2012-07-20

Patient: 70 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Respiratory Rate Decreased

Drug(s) suspected as cause:
Dilaudid
    Dosage: 1.4 mg or, 0.4 mg pacu iv
    Indication: Pain
    Start date: 2011-04-25
    End date: 2011-04-25

Morphine Sulfate
    Dosage: 20 mg total intrasynovial
    Indication: Pain
    Start date: 2011-04-24
    End date: 2011-04-25



Possible Dilaudid side effects in 79 year old female

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

Patient: 79 year old female, weighing 102.1 kg (224.5 pounds)

Reactions: Hypopnoea, Blood Pressure Systolic Increased, Depressed Level of Consciousness, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Dilaudid
    Dosage: 0.1 mg h6min iv
    Indication: Procedural Pain
    Start date: 2011-01-03
    End date: 2011-01-03

Phenergan HCL
    Dosage: 6.25 mg once iv bolus
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2011-01-03
    End date: 2011-01-03



Possible Dilaudid side effects in male

Reported by a consumer/non-health professional from Canada on 2012-07-17

Patient: male

Reactions: Euphoric Mood, Sexually Inappropriate Behaviour, Aggression, Substance Abuse

Drug(s) suspected as cause:
Dilaudid

Effexor

Effexor

Marijuana

Morphine Sulfate (Avinza ER)

Ritalin



Possible Dilaudid side effects in 51 year old female

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

Patient: 51 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Respiratory Rate Decreased, Post Procedural Complication, Apnoea

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dilaudid

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