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Dantrium (Dantrolene) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Dantrium (Dantrolene) 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 (50)
Death (5)
Life Threatening Events (13)
Disability (1)

Reports by Reaction Type

Off Label Use (10)Infusion Site Irritation (6)Vomiting (6)Acne (6)Altered State of Consciousness (6)Pyrexia (4)Condition Aggravated (4)Drug Ineffective (3)Diplopia (3)Eye Movement Disorder (3)Blood Creatinine Increased (3)Acute Respiratory Failure (3)

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

Possible Dantrium side effects in

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

Patient:

Reactions: Off Label Use, Tachycardia

Drug(s) suspected as cause:
Famotidine
    Dosage: unk
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2012-07-26

Dantrium
    Dosage: unk
    Administration route: Oral
    Indication: Quadriplegia
    Start date: 2010-01-01
    End date: 2012-07-26

Other drugs received by patient: Corticosteroids (Unspecified)



Possible Dantrium side effects in

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

Patient:

Reactions: Off Label Use, Vomiting

Drug(s) suspected as cause:
Dantrium
    Dosage: 25 mg, tid
    Administration route: Oral
    Indication: Muscle Tightness
    Start date: 2012-03-29
    End date: 2012-05-10

Dantrium
    Dosage: 125 mg, unk
    Administration route: Oral
    Start date: 2012-07-04

Famotidine
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Gastric Haemorrhage
    Start date: 2012-04-05

Dantrium
    Dosage: 125 mg, unk
    Administration route: Oral
    End date: 2012-06-28

Dantrium
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-05-11

Dantrium
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-07-03

Other drugs received by patient: Clarith; Laxoberon; Mucodyne; Rizaben; Depakene; Enteronon R; Berachin



Possible Dantrium side effects in 59 year old female

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

Patient: 59 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Jaundice, Liver Disorder

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Dantrium
    Administration route: Oral
    End date: 2011-08-12

Pramipexole Dihydrochloride
    Administration route: Oral
    End date: 2011-08-05

Other drugs received by patient: Plavix; Atelec; Candesartan Cilexetil and Hydrochlorothiazide



Possible Dantrium side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-10

Patient:

Reactions: Off Label Use, Vomiting, Gastrointestinal Haemorrhage

Drug(s) suspected as cause:
Famotidine
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Gastric Haemorrhage
    Start date: 2012-04-05

Dantrium
    Dosage: 125 mg, unk
    Administration route: Oral
    Start date: 2012-07-04

Dantrium
    Dosage: 125 mg, unk
    Administration route: Oral
    End date: 2012-06-28

Dantrium
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-07-03

Dantrium
    Dosage: 25 mg, tid
    Administration route: Oral
    Indication: Muscle Tightness
    Start date: 2012-03-29
    End date: 2012-05-10

Dantrium
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-05-11

Other drugs received by patient: Mucodyne; Depakene; Berachin; Enteronon R; Rizaben; Laxoberon; Clarithromycin



Possible Dantrium side effects in female

Reported by a physician from Japan on 2012-08-07

Patient: female

Reactions: Atrioventricular Block Complete

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Dantrolene Sodium; Diazepam; Recomodulin; Lansoprazole; Unasyn; Omeprazole; Gasmotin



Possible Dantrium side effects in male

Reported by a physician from Netherlands on 2012-08-07

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Bradycardia, Blood Creatinine Increased

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Forsenid; Lasix; Remitch; Warfarin Potassium; Nexium; Allegra; Allopurinol; Alfarol; Nespo; Sorbitol 50pc INJ



Possible Dantrium side effects in

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

Patient:

Reactions: Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Dantrium

Diazepam



Possible Dantrium side effects in 52 year old female

Reported by a pharmacist from Netherlands on 2012-07-25

Patient: 52 year old female

Reactions: Atrioventricular Block Complete

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dantrium



Possible Dantrium side effects in 40 year old male

Reported by a physician from France on 2012-07-02

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Soriatane
    Administration route: Oral
    Indication: Dermatosis
    Start date: 2011-08-15
    End date: 2011-12-13

Dantrium
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2012-02-01

Trospium Chloride
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Sertraline Hydrochloride
    Dosage: 1ud per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01

Isotretinoin
    Administration route: Oral
    Indication: Acne
    Start date: 2011-12-13

Baclofen
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Dantrium side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-07-02

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Bradycardia, Blood Creatinine Increased

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Alfarol; Sorbitol 50pc INJ; Nexium; Remitch; Forsenid; Warfarin Potassium; Nespo; Lasix; Allegra; Allopurinol



Possible Dantrium side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-22

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Baclofen
    Dosage: 120 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Trospium Chloride
    Dosage: 2 x 20 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 3 x 1 df, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2012-02-01



Possible Dantrium side effects in 48 year old male

Reported by a physician from Japan on 2012-06-15

Patient: 48 year old male

Reactions: Atelectasis, Dyspnoea, Respiratory Failure, Hypercapnia, Respiratory Fatigue, Sputum Retention, Vital Capacity Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Botox
    Dosage: 240 units, single
    Indication: Scoliosis
    Start date: 2012-06-05
    End date: 2012-06-05

Botox
    Dosage: unk
    Start date: 2006-12-14
    End date: 2006-12-14

Lioresal
    Administration route: Oral
    Indication: Muscle Spasms
    End date: 2012-06-07

Dantrium
    Administration route: Oral
    Indication: Muscle Spasms
    End date: 2012-06-07

Diazepam
    Administration route: Oral
    Indication: Muscle Spasms
    End date: 2012-06-07

Other drugs received by patient: Lansoprazole; Neuzym; Cefazolin Sodium; Mucosta; Mucodyne; Gasmotin; Hokunalin:tape; Sennoside



Possible Dantrium side effects in male

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

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Bradycardia, Blood Creatinine Increased

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Nexium; Alfarol; Remitch; Forsenid; Warfarin Potassium; Nespo; Lasix; Allegra; Sorbitol 50pc INJ; Allopurinol



Possible Dantrium side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-25

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Sertraline Hydrochloride
    Dosage: 1ud per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01

Dantrium
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2012-02-01

Baclofen
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Soriatane
    Administration route: Oral
    Indication: Dermatosis
    Start date: 2011-08-15
    End date: 2011-12-13

Isotretinoin
    Administration route: Oral
    Indication: Acne
    Start date: 2011-12-13

Trospium Chloride
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Dantrium side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-17

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Trospium Chloride
    Dosage: 2 x 20 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 3 x 1 df, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2012-02-01

Baclofen
    Dosage: 120 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Dantrium side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-07

Patient: 47 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Withdrawal Syndrome, Neuroleptic Malignant Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pelex
    Dosage: reg1:1g,tid;oral;13apr2012-15apr2012(3d);granules reg2:3gm,daily;oral 20apr2012-unk
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2012-04-13

Calslot
    Dosage: tabs
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-12-26

Medicon
    Dosage: tabs reg1:15mg,tid;oral;13apr2012-15apr2012 reg2:45mg,daily;oral;20apr2012-unk
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2012-04-13

Brotizolam
    Dosage: reg 2-0.5mg-15apr12-ong
    Administration route: Oral
    Indication: Insomnia
    Start date: 2012-04-09
    End date: 2012-04-15

Aripiprazole
    Dosage: inj
    Indication: Schizophrenia
    Start date: 2011-12-12
    End date: 2012-04-02

Potassium Chloride
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2012-04-13
    End date: 2012-04-15

Tathion
    Dosage: injection
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2012-04-13
    End date: 2012-04-15

Diovan
    Dosage: tabs
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-05-09

Abilify
    Dosage: 07aug07-26sep11;12mg,27sep11-02oct11;24mg,03oct11-12apr12;193d
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2007-08-07
    End date: 2012-04-12

NEO-Minophagen C
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2012-04-13
    End date: 2012-04-15

Dantrium
    Dosage: reg 1 reg 2-16apr12-ong
    Administration route: Oral
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2012-04-13
    End date: 2012-04-15

Placebo

Cefoperazone Sodium + Sulbactam Sodium
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2012-04-13
    End date: 2012-04-15

Mucosta
    Dosage: tab
    Administration route: Oral
    Indication: Gastritis
    Start date: 2006-03-22
    End date: 2012-04-15

Other drugs received by patient: Livostin; Risperdal; Famotidine; Olopatadine HCL; Onon; Cleanal



Possible Dantrium side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-04-24

Patient: male

Reactions: Pyrexia

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Diazepam; Sennoside; Akiriden; Valproate Sodium; Dantrium; Cellkam; Clonazepam; Nifedipine; Lithium Carbonate; Pentona; Lemonamin



Possible Dantrium side effects in 71 year old male

Reported by a consumer/non-health professional from Netherlands on 2012-04-23

Patient: 71 year old male, weighing 48.0 kg (105.6 pounds)

Reactions: Dyspnoea, Altered State of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Metformin HCL; Keishikashakuyakudaioutou; Metoprolol Tartrate; Daikentyuto; Rabeprazole Sodium; Kalimate; Magmitt; Cilnidipine; PL Gran.; Tizanidine HCL; Voglibose; Januvia; Aspirin



Possible Dantrium side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-19

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Isotretinoin
    Administration route: Oral
    Indication: Acne
    Start date: 2011-12-13

Sertraline Hydrochloride
    Dosage: 1ud per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01

Soriatane
    Administration route: Oral
    Indication: Dermatosis
    Start date: 2011-08-15
    End date: 2011-12-13

Trospium Chloride
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Baclofen
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Dantrium side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-04-17

Patient: female, weighing 48.4 kg (106.5 pounds)

Reactions: Drug Ineffective, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dantrium
    Dosage: 20 mg, bid
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2011-12-30
    End date: 2012-01-05

Dantrium
    Dosage: 25 mg, tid
    Administration route: Oral
    Start date: 2012-01-06
    End date: 2012-01-08

Dantrium
    Dosage: 20 mg, qd
    Start date: 2012-01-08
    End date: 2012-01-08

Dantrium
    Dosage: 20 mg, tid
    Start date: 2012-01-10
    End date: 2012-01-10

Dantrium
    Dosage: 25 mg, qd
    Administration route: Oral
    Start date: 2012-01-02
    End date: 2012-01-02

Dantrium
    Dosage: 20 mg, bid
    Start date: 2012-01-09
    End date: 2012-01-09

Other drugs received by patient: Phenobarbital TAB; Cefoperazone Sodium; Trihexyphenidyl HCL; Silece; Risperdal; Transfusion



Possible Dantrium side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-13

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Trospium Chloride
    Dosage: 2 x 20 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 3 x 1 df, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Baclofen
    Dosage: 120 mg, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Dantrium side effects in 50 year old female

Reported by a physician from United States on 2012-04-05

Patient: 50 year old female

Reactions: Off Label Use, Urinary Tract Infection, Acute Myocardial Infarction, Infusion Site Irritation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dantrium



Possible Dantrium side effects in 47 year old female

Reported by a physician from United States on 2012-04-05

Patient: 47 year old female

Reactions: Off Label Use, Vomiting, Nausea, Acute Respiratory Failure, Infusion Site Irritation

Drug(s) suspected as cause:
Dantrium



Possible Dantrium side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-04-02

Patient: male

Reactions: Disseminated Intravascular Coagulation, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Probitor; Methylprednisolone Sodium Succinate; Clindamycin; Dopaston; Ceftazidime



Possible Dantrium side effects in 71 year old male

Reported by a consumer/non-health professional from Netherlands on 2012-03-28

Patient: 71 year old male

Reactions: Dyspnoea, Altered State of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Metformin HCL; Metoprolol Tartrate; Keishikashakuyakudaioutou; Aspirin; Rabeprazole Sodium; PL Gran.; Tizanidine HCL; Voglibose; Cilnidipine; Daikentyuto; Januvia; Kalimate; Magmitt



Possible Dantrium side effects in male

Reported by a pharmacist from United States on 2012-03-28

Patient: male

Reactions: Thrombophlebitis

Drug(s) suspected as cause:
Dantrium



Possible Dantrium side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-28

Patient: female

Reactions: NO Adverse Event, Accidental Exposure

Drug(s) suspected as cause:
Dantrium



Possible Dantrium side effects in male

Reported by a pharmacist from United States on 2012-03-28

Patient: male

Reactions: Off Label Use, Infusion Site Necrosis

Drug(s) suspected as cause:
Dantrium
    Dosage: 75 mg, every 6 hours
    Indication: Neuroleptic Malignant Syndrome

Dantrium
    Dosage: 150 mg, every 6 hours
    Indication: Off Label Use



Possible Dantrium side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-03-23

Patient: female, weighing 48.4 kg (106.5 pounds)

Reactions: Drug Ineffective, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dantrium
    Dosage: 20 mg, bid
    Start date: 2012-01-09
    End date: 2012-01-09

Dantrium
    Dosage: 20 mg, qd
    Start date: 2012-01-08
    End date: 2012-01-08

Dantrium
    Dosage: 20 mg, tid
    Start date: 2012-01-10
    End date: 2012-01-10

Dantrium
    Dosage: 25 mg, qd
    Administration route: Oral
    Start date: 2012-01-02
    End date: 2012-01-02

Dantrium
    Dosage: 20 mg, bid
    Indication: Neuroleptic Malignant Syndrome
    Start date: 2011-12-30
    End date: 2012-01-05

Dantrium
    Dosage: 25 mg, tid
    Administration route: Oral
    Start date: 2012-01-06
    End date: 2012-01-08

Other drugs received by patient: Trihexyphenidyl HCL; Silece; Cefoperazone Sodium; Risperdal; Phenobarbital TAB; Transfusion



Possible Dantrium side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-02-27

Patient: male

Reactions: Pneumonia, Disseminated Intravascular Coagulation, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dantrium

Other drugs received by patient: Methylprednisolone Sodium Succinate; Dopaston; Clindamycin; Ceftazidime

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