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Sirdalud Side Effects submitted to FDA
Total Sirdalud reports: 23.Sirdalud FDA safety alerts: No.
Reported hospitalizations: 4.
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FDA Reported Sirdalud Side Effects: syncope, muscular weakness, dizziness, hallucination, feeling abnormal, asthenia, bradycardia, tachycardia, retching, nausea, malaise,
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Sirdalud Side Effects Report #5588257-5
Health Professional from SWITZERLAND reported SIRDALUD problem on Dec 23, 2007. Male patient was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: atrioventricular block complete, blood creatine phosphokinase increased, coma, hypotension, incorrect dose administered, suicide attempt. SIRDALUD dosage: (829 MG 1X ORAL). During the same period patient was treated with LEXOTANIL, METHADON STREULI. Patient was hospitalized. Patient recovered.
Sirdalud Side Effects Report #5593242-3
SIRDALUD problem was reported by a Consumer or non-health professional from BRAZIL on Dec 29, 2007. Female patient, weighting 163.1 lb, was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: abdominal pain, back pain, convulsion, nephrolithiasis, sensory disturbance, somnolence, syncope. SIRDALUD dosage: (2 MG 1X/8 HOURS ORAL), (2 TABS ORAL). During the same period patient was treated with BUSCOPAN, CEPHALEXIN. Patient recovered.
Sirdalud Side Effects Report #5545380-9
Consumer or non-health professional from BRAZIL reported SIRDALUD problem on Nov 25, 2007. Female patient was diagnosed with back pain and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. SIRDALUD dosage: unknown. During the same period patient was treated with LIORESAL, DICLOFENAC POTASSIUM. Patient recovered.
Sirdalud Side Effects Report #5569920-9
SIRDALUD problem was reported by a Consumer or non-health professional from ITALY on Nov 29, 2007. Female patient was diagnosed with back pain and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: malaise, throat tightness. SIRDALUD dosage: unknown. During the same period patient was treated with COUMADIN. Patient recovered.

Sirdalud Side Effects Report #5513522-7
Consumer or non-health professional from GERMANY reported SIRDALUD problem on Oct 24, 2007. Female patient was diagnosed with pain in extremity and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, blood glucose fluctuation, hepatic enzyme increased. SIRDALUD dosage: 6 MG QD; ORAL. During the same period patient was treated with HUMALOG, LEVEMIR. Patient recovered.
Sirdalud Side Effects Report #5513683-X
SIRDALUD problem was reported by a Consumer or non-health professional from DENMARK on Oct 25, 2007. Female patient was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, ileus, nephrolithiasis. SIRDALUD dosage: unknown. During the same period patient was treated with BETOLVEX, CENTYL MITE W, PRIMPERAN, VOLTAREN. Patient was hospitalized. Patient recovered.
Sirdalud Side Effects Report #5485992-4
Consumer or non-health professional from MEXICO reported SIRDALUD problem on Sept 28, 2007. Female patient was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, nausea, paraesthesia. SIRDALUD dosage: unknown. During the same period patient was treated with NORFLEX. Patient recovered.
Sirdalud Side Effects Report #5494854-8
SIRDALUD problem was reported by a Consumer or non-health professional from FINLAND on Oct 05, 2007. Female patient was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: emotional distress, hemiparesis. SIRDALUD dosage: (2 MG QD). Patient recovered.
Sirdalud Side Effects Report #5448314-0
Health Professional from SWITZERLAND reported SIRDALUD problem on Aug 23, 2007. Male patient was diagnosed with benign prostatic hyperplasia, hypertension and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: bradycardia, disease recurrence, hypotension, nodal rhythm, sinoatrial block, syncope. SIRDALUD dosage: 4 MG QD. During the same period patient was treated with PRADIF, BLOPRESS. Patient was hospitalized. Patient recovered.

Sirdalud Side Effects Report #5406740-X
SIRDALUD problem was reported by a Consumer or non-health professional from BRAZIL on July 17, 2007. Male patient, 31 years of age, was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, depressed level of consciousness, emotional disorder, fall, mouth injury, social avoidant behaviour, syncope. SIRDALUD dosage: unknown. Patient recovered.
Sirdalud Side Effects Report #5419748-5
Consumer or non-health professional from BRAZIL reported SIRDALUD problem on July 30, 2007. Female patient, 63 years of age, weighting 158.7 lb, was diagnosed with hypertension and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, hypertension. SIRDALUD dosage: unknown. During the same period patient was treated with DIOVAN, SUBLINGUALLET. Patient recovered.
Sirdalud Side Effects Report #5419750-3
SIRDALUD problem was reported by a Consumer or non-health professional from BRAZIL on July 31, 2007. Female patient, 25 years of age, weighting 125.7 lb, was diagnosed with arthralgia and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: genital haemorrhage, headache, vaginal haemorrhage. SIRDALUD dosage: unknown. Patient recovered.
Sirdalud Side Effects Report #5400572-4
Consumer or non-health professional from BRAZIL reported SIRDALUD problem on July 08, 2007. Female patient, 57 years of age, weighting 154.3 lb, was diagnosed with back pain and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: condition aggravated, confusional state, cough, crying, depression, hallucination, influenza, nasopharyngitis. SIRDALUD dosage: (2 MG PRN ORAL). During the same period patient was treated with PAROXETINE HYDROCHLORIDE, CAPTOPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE. Patient recovered.
Sirdalud Side Effects Report #5400572-4
SIRDALUD problem was reported by a Consumer or non-health professional from BRAZIL on July 08, 2007. Female patient, 57 years of age, weighting 154.3 lb, was diagnosed with back pain and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: condition aggravated, confusional state, cough, crying, depression, hallucination, influenza, nasopharyngitis. SIRDALUD dosage: (2 MG PRN ORAL). During the same period patient was treated with PAROXETINE HYDROCHLORIDE, CAPTOPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE. Patient recovered.

Sirdalud Side Effects Report #5736657-2
Consumer or non-health professional from BRAZIL reported SIRDALUD problem on Apr 23, 2008. Male patient, 35 years of age, weighting 198.4 lb, was diagnosed with preoperative care and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: chromaturia, joint swelling, oedema peripheral, pruritus, urticaria. SIRDALUD dosage: (2 MG BID ORAL). Patient recovered.
Sirdalud Side Effects Report #5361377-6
SIRDALUD problem was reported by a Consumer or non-health professional from BRAZIL on May 28, 2007. Female patient, 69 years of age, weighting 176.4 lb, was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: abasia, activities of daily living impaired, condition aggravated, decreased appetite, muscle disorder, muscular weakness, oral intake reduced. SIRDALUD dosage: unknown. During the same period patient was treated with ATENOLOL, AMLODIPINE BESYLATE, LEXOTAN. Patient recovered.
Sirdalud Side Effects Report #5373229-6
Physician from GUATEMALA reported SIRDALUD problem on June 19, 2007. Male patient, 27 years of age, was diagnosed with muscle spasms, pain and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: autonomic nervous system imbalance, hypertension. SIRDALUD dosage: 4 MG, Q8H. During the same period patient was treated with CATAFLAM, NIMOTOP, RANITIDINE, DORIXINA RELAX. Patient recovered.
Sirdalud Side Effects Report #5290367-7
SIRDALUD problem was reported by a Consumer or non-health professional from GERMANY on Mar 26, 2007. Male patient, 74 years of age, was diagnosed with muscle spasticity and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: circulatory collapse, muscular weakness. SIRDALUD dosage: 2 MG/DAY. During the same period patient was treated with LIORESAL. Patient recovered.
Sirdalud Side Effects Report #5302428-4
Health Professional from SWITZERLAND reported SIRDALUD problem on Mar 28, 2007. Male patient, 44 years of age, was diagnosed with intervertebral disc displacement, intervertebral disc operation and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, blood albumin decreased, cholestasis, chromaturia, hepatic necrosis, hepatic steatosis, hepatitis. SIRDALUD dosage: 6 MG QDAY. During the same period patient was treated with TILUR. Patient was hospitalized. Patient died.

Sirdalud Side Effects Report #5306198-5
SIRDALUD problem was reported by a Consumer or non-health professional from PORTUGAL on Apr 02, 2007. Female patient was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, muscle rigidity, syncope. SIRDALUD dosage: unknown. Patient recovered.
Sirdalud Side Effects Report #5311090-6
Consumer or non-health professional from GERMANY reported SIRDALUD problem on Apr 06, 2007. Male patient, 74 years of age, was diagnosed with muscle spasticity and was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: circulatory collapse, muscular weakness. SIRDALUD dosage: 2 MG ORAL. During the same period patient was treated with LIORESAL. Patient recovered.
Sirdalud Side Effects Report #5262159-6
SIRDALUD problem was reported by a Consumer or non-health professional from MEXICO on Feb 20, 2007. Female patient was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. SIRDALUD dosage: unknown. Patient recovered.
Sirdalud Side Effects Report #5290060-0
Physician from GERMANY reported SIRDALUD problem on Mar 15, 2007. Male patient, child 11 years of age, was treated with SIRDALUD. After drug was administered, patient experienced the following problems/side effects: disinhibition, hyperkinesia. SIRDALUD dosage: unknown. Patient recovered.
Sirdalud Side Effects


