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Campral (Acamprosate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Campral (Acamprosate) 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 (15)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Intentional Drug Misuse (4)Nervousness (4)Foetal Alcohol Syndrome (3)Tachycardia (2)Colitis Microscopic (2)Ejaculation Delayed (2)Ataxia (2)Dysarthria (2)Suicide Attempt (2)Confusional State (1)Weight Decreased (1)Hepatic Function Abnormal (1)

Possible Campral side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-18

Patient: 40 year old male

Reactions: Drug Interaction, Toxicity To Various Agents, Antipsychotic Drug Level Above Therapeutic

Adverse event resulted in: death

Drug(s) suspected as cause:
Ethanol (Ethanol)
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Ripped Freak
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Vitamin D
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Wellbutrin XL
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Super Vita VIM
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Pantoprazole
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Vitamin B1 (Vitamin B1)
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Atenolol
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Hoodia
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Hydroxycut (Hydroxycut) (Not Specified)
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Rapid Lean
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Seroquel
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Campral
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Creatine (Creatine)
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Hydrashred
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Xenadrine RFA-1 / 01521201 / (Xenadrine) (Not Specified)
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Lithium Carbonate
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Ephedrine HCL 1PC SOL
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication



Possible Campral side effects in female

Reported by a physician from United Kingdom on 2012-05-10

Patient: female, weighing 3.1 kg (6.9 pounds)

Reactions: Foetal Alcohol Syndrome

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

Campral
    Dosage: unk
    Indication: Alcoholism
    Start date: 2010-03-01
    End date: 2010-07-01

Thiamine
    Dosage: 200 mg, 1x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-01

Venlafaxine HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Vitamin B Complex CAP
    Dosage: 2 df, 1x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-01



Possible Campral side effects in female

Reported by a physician from United Kingdom on 2012-05-03

Patient: female, weighing 3.1 kg (6.9 pounds)

Reactions: Foetal Alcohol Syndrome

Drug(s) suspected as cause:
Vitamin B Complex CAP
    Dosage: 2 df, 1x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-01

Venlafaxine HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Inderal
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Thiamine HCL
    Dosage: 200 mg, 1x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-01

Campral
    Dosage: unk
    Indication: Alcoholism
    Start date: 2010-03-01
    End date: 2010-07-01



Possible Campral side effects in female

Reported by a physician from United Kingdom on 2012-05-02

Patient: female, weighing 3.1 kg (6.9 pounds)

Reactions: Foetal Alcohol Syndrome, Maternal Exposure Timing Unspecified

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

Vitamin B Complex CAP
    Dosage: 1 df, 2x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-03-01

Thiamine
    Dosage: 200 mg daily
    Start date: 2010-03-01

Inderal
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Campral
    Dosage: unk
    Indication: Alcoholism
    Start date: 2010-03-01
    End date: 2010-07-01



Possible Campral side effects in male

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

Patient: male

Reactions: Ejaculation Delayed

Drug(s) suspected as cause:
Campral



Possible Campral side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-18

Patient: male

Reactions: Ejaculation Delayed

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campral



Possible Campral side effects in 41 year old female

Reported by a physician from United States on 2012-04-18

Patient: 41 year old female, weighing 54.9 kg (120.7 pounds)

Reactions: Confusional State, Weight Decreased, Grand MAL Convulsion, Vomiting, Hepatic Function Abnormal, Nausea, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Campral

Other drugs received by patient: Cymbalta; Ortho TRI-Cyclen; Trasadone; Atenolol



Possible Campral side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-07

Patient: 71 year old female

Reactions: Colitis Microscopic

Drug(s) suspected as cause:
Campral

Other drugs received by patient: Tramadol HCL; Citalopram (Citalopram Hydrobromide) (Citalopram Hydrobromide)



Possible Campral side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-03

Patient: female

Reactions: Restlessness, Rash Pruritic

Drug(s) suspected as cause:
Campral



Possible Campral side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-30

Patient: female

Reactions: Colitis Microscopic

Drug(s) suspected as cause:
Campral

Other drugs received by patient: Tramadol HCL; Citalopram (Citalopram Hydrobromide) (Citalopram Hydrobromide)



Possible Campral side effects in male

Reported by a physician from Germany on 2012-01-10

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Dysarthria, Tachycardia, Ataxia, Suicide Attempt, Intentional Drug Misuse, Nervousness

Adverse event resulted in: hospitalization

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

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

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

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

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



Possible Campral side effects in male

Reported by a physician from Germany on 2012-01-06

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Dysarthria, Tachycardia, Suicide Attempt, Ataxia, Intentional Drug Misuse, Nervousness

Adverse event resulted in: hospitalization

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

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

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

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

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



Possible Campral side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-27

Patient: female, weighing 87.1 kg (191.6 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Campral
    Dosage: unk
    Administration route: Oral
    Indication: Alcoholism

Chantix
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2011-11-21



Possible Campral side effects in male

Reported by a physician from Germany on 2011-12-13

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Intentional Drug Misuse, Nervousness

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

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

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

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

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



Possible Campral side effects in male

Reported by a physician from Germany on 2011-10-20

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Intentional Drug Misuse, Nervousness

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

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

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

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

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

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