Baclofen Side Effects summary

Total Baclofen reports: 379. View

Baclofen FDA safety alerts: 2002 .

Reported deaths: 45

Reported hospitalizations: 210.

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Recently reported Baclofen Side Effects

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Common Baclofen Side Effects
Overdose 49
Coma 47
Hypertension 34
Delirium 28
Confusional state 27
Bradycardia 26
Hallucination 23
Intentional overdose 22
Agitation 21
Somnolence 21
Hypotension 20
Loss of consciousness 20
Mental status changes 18
Fatigue 17
Muscle spasticity 16
Blood creatine phosphokinase increased 15
Convulsion 14
Pyrexia 14
Blood pressure increased 13
Condition aggravated 13
Hypotonia 13
Muscle spasms 13
Pneumonia  What is  Pneumonia                                                                                                                                                                                               13
Suicide attempt 13
Death 12
Depressed level of consciousness 12
Dyspnoea 12
Psychotic disorder  What is  Psychotic disorder                                                                                                                                                                                      12
Blood creatinine increased 11
Acute respiratory failure 10
Asthenia 10
Dizziness  What is  Dizziness                                                                                                                                                                                               10
Dysphagia 10
Tachycardia 10
Tremor 10

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Baclofen Side Effects Report #5135071-0
Physician from UNITED STATES reported Baclofen side effect on Oct 17, 2005. Female patient, 24 years of age, was treated with Baclofen. After drug was administered, patient experienced the following side effects: pyrexia. Baclofen dosage: 10 MG , TID , ORAL. During the same period patient was treated with LORAZEPAM. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5135072-2
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Nov 11, 2005. Female patient, 16 years of age, was diagnosed with muscle spasms and was treated with Baclofen. After drug was administered, patient experienced the following side effects: flatulence, grand mal convulsion. Baclofen dosage: 10 MG )3/8 TABLET) PO QID. Patient recovered.



Baclofen Side Effects Report #5139879-7
Pharmacist from UNITED STATES reported Baclofen side effect on Oct 26, 2006. Male patient, weighting 165.3 lb, was diagnosed with pain What is  pain and was treated with Baclofen. After drug was administered, patient experienced the following side effects: activities of daily living impaired, gait disturbance, speech disorder, tremor, unevaluable event. Baclofen dosage: 10MG QHS PO. During the same period patient was treated with GABAPENTIN, CYCLOBENZAPRINE, AMITRIPTYLINE. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5197374-3
Baclofen side effect was reported by a Pharmacist from UNITED STATES on Oct 11, 2005. Male patient was diagnosed with cerebral palsy and was treated with Baclofen. After drug was administered, patient experienced the following side effects: dizziness What is  dizziness, dyspnoea, overdose, petit mal epilepsy, rash What is  rash. Baclofen dosage: 3 MG, BID, PO. During the same period patient was treated with GLYCOLAX. Patient recovered.




Baclofen Side Effects Report #5152026-0
Health Professional from INDIA reported Baclofen side effect on Nov 03, 2006. Male patient, 32 years of age, was diagnosed with muscle spasms and was treated with Baclofen. After drug was administered, patient experienced the following side effects: emotional distress, fear, hallucination, auditory, persecutory delusion, psychotic disorder What is  psychotic disorder. Baclofen dosage: 10 MG, BID. During the same period patient was treated with ANTIBIOTICS, ANTIINFLAMMATORY. Patient recovered.



Baclofen Side Effects Report #5158235-9
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Nov 21, 2006. Female patient, 77 years of age, weighting 160.0 lb, was diagnosed with myelitis transverse and was treated with Baclofen. After drug was administered, patient experienced the following side effects: activities of daily living impaired, anorexia, asthenia, dizziness What is  dizziness, impaired driving ability, malaise, musculoskeletal stiffness, nausea What is  nausea, neoplasm malignant. Baclofen dosage: 10 MG EVERY NIGHT ORAL. During the same period patient was treated with COUMADIN, LEVOXYL. Patient recovered.



Baclofen Side Effects Report #5169365-X
Consumer or non-health professional from UNITED STATES reported Baclofen side effect on Nov 21, 2006. Female patient, 41 years of age, weighting 179.9 lb, was diagnosed with muscle spasms and was treated with Baclofen. After drug was administered, patient experienced the following side effects: blood pressure increased, loss of consciousness, nausea What is  nausea. Baclofen dosage: unknown. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5169718-X
Baclofen side effect was reported by a Health Professional from UNITED KINGDOM on Nov 30, 2006. Male patient, 80 years of age, was diagnosed with muscle spasms, blood cholesterol increased and was treated with Baclofen. After drug was administered, patient experienced the following side effects: aphasia What is  aphasia, dysarthria, dyspnoea, dysstasia, hyporeflexia, salivary hypersecretion, urine output decreased, visual disturbance. Baclofen dosage: 5 MG, TID. During the same period patient was treated with ENALAPRIL MALEATE, FUROSEMIDE, MONOSORB, SIMVASTATIN, WARFARIN. Patient was hospitalized and became disabled. Patient recovered.



Baclofen Side Effects Report #5170828-1
Consumer or non-health professional from UNITED STATES reported Baclofen side effect on Dec 06, 2006. Female patient, child 8 years of age, was treated with Baclofen. After drug was administered, patient experienced the following side effects: discomfort, incorrect dose administered, musculoskeletal stiffness. Baclofen dosage: unknown. Patient recovered.




Baclofen Side Effects Report #5175320-6
Baclofen side effect was reported by a Pharmacist from UNITED STATES on Dec 11, 2006. Male patient, 57 years of age, was diagnosed with muscle spasms, neck injury and was treated with Baclofen. After drug was administered, patient experienced the following side effects: musculoskeletal pain. Baclofen dosage: unknown. During the same period patient was treated with CELEBREX, LIPITOR, GLIPIZIDE, METFORMIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, DARVOCET. Patient recovered.



Baclofen Side Effects Report #5176737-6
Pharmacist from UNITED STATES reported Baclofen side effect on Dec 11, 2006. Female patient, 54 years of age, was diagnosed with stiff-man syndrome and was treated with Baclofen. After drug was administered, patient experienced the following side effects: balance disorder, decreased activity. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5187410-2
Baclofen side effect was reported by a Health Professional from SPAIN on Dec 05, 2006. Male patient, 66 years of age, was treated with Baclofen. After drug was administered, patient experienced the following side effects: neuromuscular blockade. Baclofen dosage: unknown. During the same period patient was treated with AMIKACIN. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5191323-X
Pharmacist from UNITED STATES reported Baclofen side effect on Dec 11, 2006. Female patient, 55 years of age, was diagnosed with multiple sclerosis What is  multiple sclerosis and was treated with Baclofen. After drug was administered, patient experienced the following side effects: chest pain What is  chest pain. Baclofen dosage: 10MG TO 20MG BY MOUTH EVERY 4 HOURS AS NEEDED. During the same period patient was treated with OXYBUTYNIN, SYNTHROID, DIOVAN. Patient recovered.



Baclofen Side Effects Report #5196526-6
Baclofen side effect was reported by a Physician from JAPAN on Dec 05, 2006. Female patient, 87 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: depressed level of consciousness, device related infection. Baclofen dosage: unknown. Patient died on 12/04/2006.




Baclofen Side Effects Report #5319758-2
Physician from UNITED STATES reported Baclofen side effect on Apr 23, 2007. Male patient was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: catheter related complication, catheter site pain, granuloma. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5385995-4
Baclofen side effect was reported by a Health Professional from UNITED KINGDOM on June 04, 2007. Male patient, 30 years of age, was diagnosed with muscle spasms and was treated with Baclofen. After drug was administered, patient experienced the following side effects: loss of consciousness. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5386607-6
Consumer or non-health professional from UNITED STATES reported Baclofen side effect on July 02, 2007. Male patient, 32 years of age, was diagnosed with muscle spasms, tetanus What is  tetanus and was treated with Baclofen. After drug was administered, patient experienced the following side effects: agitation, delusion, fear, hallucination, auditory, psychotic disorder What is  psychotic disorder, social avoidant behaviour. Baclofen dosage: 10 MG, BID. During the same period patient was treated with ANTIBIOTICS, OLANZAPINE, NSAID. Patient recovered.



Baclofen Side Effects Report #5388809-1
Baclofen side effect was reported by a Physician from UNITED STATES on July 02, 2007. Male patient, 49 years of age, was diagnosed with hepatitis c What is  hepatitis c, depression What is  depression and was treated with Baclofen. After drug was administered, patient experienced the following side effects: aggression, blood pressure diastolic increased, delirium, fatigue, frequent bowel movements, incorrect dose administered. Baclofen dosage: unknown. During the same period patient was treated with PEGASYS, EFFEXOR, CELEXA, OPIATE NOS, WELLBUTRIN, ZITHROMAX Z, HYDROCHLOROTHIAZIDE, TOPROL. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5391841-5
Physician from UNITED STATES reported Baclofen side effect on July 09, 2007. Male patient, 51 years of age, was diagnosed with multiple sclerosis What is  multiple sclerosis, progressive multiple sclerosis and was treated with Baclofen. After drug was administered, patient experienced the following side effects: myocardial infarction. Baclofen dosage: 120 MG (40 MG, 3 IN 1 D), ORAL. During the same period patient was treated with MITOXANTRONE, AMANTADINE. Patient died on 06/18/2007.




Baclofen Side Effects Report #5412299-3
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Aug 10, 2007. Female patient, 34 years of age, weighting 121.3 lb, was treated with Baclofen. After drug was administered, patient experienced the following side effects: dyspnoea, gastric ulcer. Baclofen dosage: 10 MG. 2 PO. Patient recovered.



Baclofen Side Effects Report #5429592-0
Consumer or non-health professional from UNITED STATES reported Baclofen side effect on Aug 09, 2007. Male patient, child 5 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: cerebral ventriculogram abnormal, feeding disorder, shunt malfunction, shunt occlusion. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5452444-7
Baclofen side effect was reported by a Physician from JAPAN on Dec 04, 2006. Male patient was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: meningitis What is  meningitis. Baclofen dosage: unknown. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5453583-7
Physician from JAPAN reported Baclofen side effect on May 31, 2006. Male patient, 52 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: hypertonia. Baclofen dosage: 60 MG, DAILY, INTRATHECAL. Patient recovered.



Baclofen Side Effects Report #5454233-6
Baclofen side effect was reported by a Physician from JAPAN on Sept 22, 2006. Male patient was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: dysphagia. Baclofen dosage: unknown. Patient recovered.




Baclofen Side Effects Report #5458405-6
Physician from JAPAN reported Baclofen side effect on Feb 20, 2007. Male patient was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: hypertonia. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5441610-2
Baclofen side effect was reported by a Health Professional from UNITED KINGDOM on Aug 24, 2007. Male patient, 23 years of age, was diagnosed with ill-defined disorder, blood testosterone decreased and was treated with Baclofen. After drug was administered, patient experienced the following side effects: body temperature increased, disorientation, dizziness What is  dizziness, hypertension, nausea What is  nausea, skin reaction. Baclofen dosage: unknown. During the same period patient was treated with TESTOSTERONE, CALCICHEW D, CLARITIN, FENTANYL, FLIXOTIDE, SEREVENT. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5448236-5
Health Professional from UNITED STATES reported Baclofen side effect on Sept 03, 2007. Male patient, 48 years of age, weighting 176.4 lb, was treated with Baclofen. After drug was administered, patient experienced the following side effects: apnoea, blood ph increased, blood pressure increased, depression What is  depression, electroencephalogram abnormal, faecal incontinence, grand mal convulsion, intentional overdose. Baclofen dosage: unknown. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5448270-5
Baclofen side effect was reported by a Health Professional from SLOVENIA on Sept 04, 2007. Male patient, 60 years of age, weighting 163.1 lb, was diagnosed with diabetes mellitus and was treated with Baclofen. After drug was administered, patient experienced the following side effects: anuria, blood creatinine increased, brain scan abnormal, coma, creatinine renal clearance decreased, depressed level of consciousness, dyspnoea, glasgow coma scale abnormal. Baclofen dosage: 25 MG, Q12H. During the same period patient was treated with INSULIN. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5474386-3
Physician from UNITED STATES reported Baclofen side effect on Mar 29, 2007. Female patient, 60 years of age, weighting 170.0 lb, was diagnosed with muscle spasms, muscle spasticity, pain in extremity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abasia, activities of daily living impaired, asthenia, back pain What is  back pain, contusion, fall What is  fall, hallucination, head injury, headache What is  headache. Baclofen dosage: QID PRN (20 MG). Patient recovered.




Baclofen Side Effects Report #5474405-4
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 10, 2007. Female patient, 27 years of age, was treated with Baclofen. After drug was administered, patient experienced the following side effects: loss of consciousness. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5474410-8
Physician from UNITED STATES reported Baclofen side effect on Feb 13, 2007. Female patient, 49 years of age, weighting 173.0 lb, was diagnosed with muscle spasticity, multiple sclerosis What is  multiple sclerosis and was treated with Baclofen. After drug was administered, patient experienced the following side effects: grand mal convulsion. Baclofen dosage: unknown. During the same period patient was treated with INTERFERON BETA. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5483520-0
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Sept 25, 2007. Female patient, 32 years of age, was diagnosed with multiple sclerosis What is  multiple sclerosis, insomnia, migraine What is  migraine, fatigue, bladder disorder, sweat gland infection and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abortion spontaneous, pregnancy What is  pregnancy. Baclofen dosage: unknown. During the same period patient was treated with INTERFERON BETA, QUETIAPINE FUMARATE, ELETRIPTAN HYDROBROMIDE, MODAFINIL, SOLIFENACIN, MINOCYCLINE, CITALOPRAM HYDROBROMIDE. Patient recovered.



Baclofen Side Effects Report #5486831-8
Pharmacist from UNITED STATES reported Baclofen side effect on Oct 12, 2007. Male patient, 78 years of age, was diagnosed with muscle spasms and was treated with Baclofen. After drug was administered, patient experienced the following side effects: confusional state, mental status changes. Baclofen dosage: 5MG TID PO. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5490477-5
Baclofen side effect was reported by a Pharmacist from UNITED STATES on Oct 17, 2007. Male patient, 54 years of age, was diagnosed with hiccups and was treated with Baclofen. After drug was administered, patient experienced the following side effects: confusional state, pneumonia What is  pneumonia, renal failure, respiratory distress, somnolence. Baclofen dosage: 20MG TID PO. Patient was hospitalized. Patient recovered.




Baclofen Side Effects Report #5497887-0
Physician from CANADA reported Baclofen side effect on Oct 10, 2007. Male patient, 53 years of age, was diagnosed with relapsing-remitting multiple sclerosis and was treated with Baclofen. After drug was administered, patient experienced the following side effects: convulsion, incontinence, multiple sclerosis What is  multiple sclerosis, pneumonia What is  pneumonia. Baclofen dosage: unknown. During the same period patient was treated with BETASERON. Patient was hospitalized. Patient died on 05/03/2002.



Baclofen Side Effects Report #5498478-8
Baclofen side effect was reported by a Pharmacist from UNITED STATES on Oct 25, 2007. Male patient, 21 years of age, weighting 129.0 lb, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: confusional state, hallucination, incorrect dose administered, pyrexia. Baclofen dosage: 80 MG QID PO 20 MG QID PO. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5507257-4
Health Professional from AUSTRALIA reported Baclofen side effect on Oct 29, 2007. Male patient, 51 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: muscular weakness, orthostatic hypotension, somnolence. Baclofen dosage: 25 MG, QID. During the same period patient was treated with DIAZEPAM, TRAMADOL, GABAPENTIN, HYDROMORPHONE, CLONIDINE, OPIOIDS. Patient recovered.



Baclofen Side Effects Report #5519054-4
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Nov 14, 2007. Female patient, 69 years of age, was treated with Baclofen. After drug was administered, patient experienced the following side effects: balance disorder, fall What is  fall, hallucination, injury, nervous system disorder, overdose, therapeutic agent toxicity. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5520351-7
Health Professional from SPAIN reported Baclofen side effect on Nov 15, 2007. Male patient, 61 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abnormal behaviour, altered state of consciousness, back pain What is  back pain, csf bacteria identified, csf glucose increased, csf protein increased, dysarthria, headache What is  headache, irritability. Baclofen dosage: unknown. Patient was hospitalized. Patient recovered.




Baclofen Side Effects Report #5524497-9
Baclofen side effect was reported by a Physician from UNITED STATES on Nov 14, 2007. Male patient, 46 years of age, was diagnosed with polysubstance dependence and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abdominal distension, abdominal pain upper, gastric dilatation, oesophageal disorder. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5524716-9
Consumer or non-health professional from SLOVENIA reported Baclofen side effect on Nov 13, 2007. Male patient, 60 years of age, weighting 163.1 lb, was diagnosed with diabetes mellitus and was treated with Baclofen. After drug was administered, patient experienced the following side effects: anuria, blood creatinine increased, brain scan abnormal, coma, creatinine renal clearance decreased, depressed level of consciousness, dyspnoea, glasgow coma scale abnormal. Baclofen dosage: 25 MG, Q12H. During the same period patient was treated with INSULIN. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5525055-2
Baclofen side effect was reported by a Physician from UNITED STATES on Oct 31, 2007. Male patient, 53 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abdominal distension, abdominal pain What is  abdominal pain, abdominal tenderness, angiogram abnormal, blood creatinine increased, blood pressure decreased, body temperature decreased, escherichia infection, haematocrit decreased. Baclofen dosage: unknown. During the same period patient was treated with PREDNISONE, LOVENOX, PREVACID, NPH INSULIN. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5528193-3
Consumer or non-health professional from UNITED KINGDOM reported Baclofen side effect on Nov 09, 2007. Male patient, 72 years of age, was diagnosed with hiccups and was treated with Baclofen. After drug was administered, patient experienced the following side effects: dysarthria, loss of consciousness, malaise, muscle twitching, viral diarrhoea, vomiting. Baclofen dosage: 10 MG (5 MG, 2 IN 1 D), ORAL. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5530472-0
Baclofen side effect was reported by a Pharmacist from UNITED STATES on Nov 27, 2007. Male patient, 54 years of age, was diagnosed with muscle spasms, pain What is  pain and was treated with Baclofen. After drug was administered, patient experienced the following side effects: sedation. Baclofen dosage: 10MG TID PO. Patient recovered.



Baclofen Side Effects Report #5533950-3
Consumer or non-health professional from SPAIN reported Baclofen side effect on Nov 15, 2007. Male patient, 61 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abnormal behaviour, altered state of consciousness, cerebral ventricle dilatation, csf bacteria identified, csf glucose increased, csf protein increased, device related infection, dysarthria, escherichia infection. Baclofen dosage: unknown. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5557390-6
Baclofen side effect was reported by a Health Professional from IRELAND on Nov 08, 2007. Female patient was treated with Baclofen. After drug was administered, patient experienced the following side effects: adverse event, anorexia, anxiety What is  anxiety, depression What is  depression, diarrhoea, diplopia, dry mouth, dysgeusia. Baclofen dosage: 20 MG; 5 MG; 1 MG; 0.5 MG; 5 MG. During the same period patient was treated with CLONAZEPAM, CYCLIZINE. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5563795-X
Consumer or non-health professional from SOUTH AFRICA reported Baclofen side effect on Dec 07, 2007. Female patient, 57 years of age, was diagnosed with neck pain and was treated with Baclofen. After drug was administered, patient experienced the following side effects: back pain What is  back pain, bronchitis What is  bronchitis, chest discomfort, chest pain What is  chest pain, confusional state, dizziness What is  dizziness, dyspnoea, fatigue, feeling abnormal. Baclofen dosage: 25MG/D. During the same period patient was treated with TOPIRAMATE, LAMICTAL. Patient was hospitalized. Patient recovered.



Baclofen Side Effects Report #5583894-6
Baclofen side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 02, 2008. Female patient, weighting 132.0 lb, was diagnosed with muscle contractions involuntary and was treated with Baclofen. After drug was administered, patient experienced the following side effects: fall What is  fall, insomnia, therapeutic response unexpected, tremor. Baclofen dosage: unknown. Patient recovered.



Baclofen Side Effects Report #5591085-8
Health Professional from SPAIN reported Baclofen side effect on Jan 11, 2008. Male patient, 61 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: abnormal behaviour, altered state of consciousness, back pain What is  back pain, csf bacteria identified, csf glucose increased, csf protein increased, dysarthria, headache What is  headache, irritability. Baclofen dosage: unknown. Patient was hospitalized. Patient recovered.




Baclofen Side Effects Report #5597994-8
Baclofen side effect was reported by a Physician from JAPAN on Jan 08, 2008. Female patient, 79 years of age, was diagnosed with muscle spasticity and was treated with Baclofen. After drug was administered, patient experienced the following side effects: cerebral haemorrhage. Baclofen dosage: unknown. Patient was hospitalized. Patient died on 01/01/2008.



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