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Fractal adverse events reported to FDA.

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Summary

FDA Adverse Reports: 27. View All

Fractal FDA safety alerts: No

Reported deaths: 3

Reported hospitalizations: 13

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Often additional risks of using a medication, such as Fractal, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Fractal users, Learn more about unwanted side effects & find ways to reduce them. Browse Fractal Adverse Reports reported to FDA and participate in Fractal discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Fractal. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Fractal Adverse Effect Reports (FDA)

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7001622-4 | Aphasia, Cerebrovascular Accident, Convulsion, Haemorrhagic Stroke, Hemiplegia, Lung Disorder
on Aug 30, 2010 Male patient from FRANCE , 78 years of age, was diagnosed with hypercholesterolaemia and was treated with Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: aphasia (What is aphasia?), cerebrovascular accident, convulsion, haemorrhagic stroke, hemiplegia, lung disorder. Fractal dosage: 40 Mg, Qd. During the same period patient was treated with PERMIXON (Unk) (View Permixon Review and Permixon Label ). Patient was hospitalized.

6762227-3 | Musculoskeletal Pain, Periarthritis, Tendon Rupture
Patient was taking Fractal (View Usage). Patient had the following side effects: musculoskeletal pain, periarthritis, tendon rupture on May 26, 2010 from FRANCE Additional patient health information: Male patient , 67 years of age, weighting 163.1 lb, was diagnosed with hypercholesterolaemia, hypertension, type 2 diabetes mellitus and. Fractal dosage: 20 Mg, Qd. During the same period patient was treated with RAMIPRIL (10 Mg, Qd) (View Ramipril Review and Ramipril Label ), LERCAN (10 Mg, Qd) (View Lercan Review and Lercan Label ), GLICLAZIDE (30 Mg, Qd) (View Gliclazide Review and Gliclazide Label ), KARDEGIC (75 Mg, Qd) (View Kardegic Review and Kardegic Label ).

6729724-8 | Blood Creatine Phosphokinase Increased, Blood Creatinine Increased, Monoplegia, Muscle Spasms, Paraesthesia, Sciatic Nerve Neuropathy
Adverse event was reported on Apr 28, 2010 by a Female patient taking Fractal (View Usage) (Dosage: 80 Mg, Qd) was diagnosed with hypercholesterolaemia, hypertension, hypothyroidism and. Location: FRANCE , 65 years of age, After Fractal was administered, patient had the following side effects: blood creatine phosphokinase increased, blood creatinine increased, monoplegia, muscle spasms, paraesthesia, sciatic nerve neuropathy. During the same period patient was treated with LOGROTON (1 Df Per Day) (View Logroton Review and Logroton Label ), LEVOTHYROXINE SODIUM (75 Ug, Unk) (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ).

6723939-0 | Blood Creatine Phosphokinase Increased, Blood Creatinine Increased, Monoplegia, Muscle Spasms, Paraesthesia, Sciatic Nerve Neuropathy
on Apr 28, 2010 Female patient from FRANCE , 65 years of age, was diagnosed with hypercholesterolaemia, hypertension, hypothyroidism and was treated with Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatine phosphokinase increased, blood creatinine increased, monoplegia, muscle spasms, paraesthesia, sciatic nerve neuropathy. Fractal dosage: 80 Mg, Qd. During the same period patient was treated with LOGROTON (1 Df Per Day) (View Logroton Review and Logroton Label ), LEVOTHYROXINE SODIUM (75 Ug, Unk) (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ).


6601106-9 | Musculoskeletal Pain, Periarthritis, Tendon Rupture
on Feb 02, 2010 Male patient from FRANCE , 67 years of age, weighting 163.1 lb, was diagnosed with hypercholesterolaemia, hypertension, type 2 diabetes mellitus and was treated with Fractal (View Usage). Patient had the following side effects: musculoskeletal pain, periarthritis, tendon rupture. Fractal dosage: 20 Mg, Qd. During the same period patient was treated with RAMIPRIL (10 Mg, Qd) (View Ramipril Review and Ramipril Label ), LERCAN (10 Mg, Qd) (View Lercan Review and Lercan Label ), GLICLAZIDE (30 Mg, Qd) (View Gliclazide Review and Gliclazide Label ), KARDEGIC (75 Mg, Qd) (View Kardegic Review and Kardegic Label ).

6390022-6 | Aortic Valve Incompetence, Hypertension, Low Density Lipoprotein Increased, Mitral Valve Incompetence, Muscle Spasms, Renal Failure Acute, Rhabdomyolysis, Serum Ferritin Increased
Patient was taking Fractal (View Usage). After Fractal was administered, patient had the following side effects: aortic valve incompetence, hypertension, low density lipoprotein increased, mitral valve incompetence, muscle spasms, renal failure acute, rhabdomyolysis, serum ferritin increased on Sep 22, 2009 from FRANCE Additional patient health information: Female patient , weighting 119.0 lb, was diagnosed with hypercholesterolaemia and. Fractal dosage: 80 Mg Daily.

6326949-0 | Blood Creatine Phosphokinase Increased, Blood Creatinine Increased, Monoplegia, Muscle Spasms, Paraesthesia
Adverse event was reported on Aug 12, 2009 by a Female patient taking Fractal (View Usage) (Dosage: 80 Mg, Qd) was diagnosed with hypercholesterolaemia, hypertension, hypothyroidism and. Location: FRANCE , 65 years of age, Patient experienced the following unwanted or unexpected effects: blood creatine phosphokinase increased, blood creatinine increased, monoplegia, muscle spasms, paraesthesia. During the same period patient was treated with LOGROTON (1 Df Per Day) (View Logroton Review and Logroton Label ), LEVOTHYROX (75 Ug, Unk) (View Levothyrox Review and Levothyrox Label ).

6302726-1 | Muscle Spasms, Renal Failure Acute, Rhabdomyolysis
on Jul 30, 2009 Female patient from FRANCE , 79 years of age, weighting 119.0 lb, was diagnosed with hypercholesterolaemia and was treated with Fractal (View Usage). Patient had the following side effects: muscle spasms, renal failure acute, rhabdomyolysis. Fractal dosage: 80 Mg Daily.

5970895-9 | Confusional State
on Nov 17, 2008 Female patient from FRANCE , 85 years of age, was treated with Fractal (View Usage). After Fractal was administered, patient had the following side effects: confusional state. Fractal dosage: 80mg, Unk. During the same period patient was treated with NEXIUM (40mg, Unk) (View Nexium Review and Nexium Label ), ALDALIX (View Aldalix Review and Aldalix Label ).

5585192-3 | Anaemia, Back Pain, Blood Creatinine Increased, Depression, Leukocyturia, Nephritis Interstitial
Patient was taking Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, back pain (What is back pain?), blood creatinine increased, depression (What is depression?), leukocyturia, nephritis interstitial on Dec 31, 2007 from FRANCE Additional patient health information: Female patient , 89 years of age, was diagnosed with hypercholesterolaemia, hypertension and. Fractal dosage: 20 Mg, Qd. During the same period patient was treated with COAPROVEL (300 Mg Per Day) (View Coaprovel Review and Coaprovel Label ), ZANIDIP (20 Mg Per Day) (View Zanidip Review and Zanidip Label ). Patient was hospitalized.

5364692-5 | Nausea, Paraesthesia, Vertigo
Adverse event was reported on Jun 11, 2007 by a Male patient taking Fractal (View Usage) (Dosage: 80 Mg, Qd) . Location: FRANCE , 56 years of age, Patient had the following side effects: nausea (What is nausea?), paraesthesia, vertigo. During the same period patient was treated with COTAREG (1 Df, Qd) (View Cotareg Review and Cotareg Label ). Patient was hospitalized.

5023280-0 | Areflexia, Asthenia, Blood Creatine Phosphokinase Increased, Guillain-barre Syndrome, Hip Surgery, Muscular Weakness, Renal Failure Acute, Renal Tubular Necrosis, Rhabdomyolysis
on Jun 02, 2006 Male patient from FRANCE , 63 years of age, was diagnosed with staphylococcal infection (What is staphylococcal infection?) and was treated with Fractal (View Usage). After Fractal was administered, patient had the following side effects: areflexia, asthenia, blood creatine phosphokinase increased, guillain-barre syndrome (What is guillain-barre syndrome?), hip surgery, muscular weakness, renal failure acute, renal tubular necrosis, rhabdomyolysis. Fractal dosage: 80 Mg/day. During the same period patient was treated with OFLOCET (200 Mg, Unk) (View Oflocet Review and Oflocet Label ), FUCIDINE CAP (250 Mg, Unk) (View Fucidine Cap Review and Fucidine Cap Label ). Patient was hospitalized.

4938674-9 | Muscle Haemorrhage, Muscle Injury, Myalgia
on Feb 28, 2006 Male patient from FRANCE , 78 years of age, was diagnosed with hypercholesterolaemia, cerebrovascular accident prophylaxis and was treated with Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: muscle haemorrhage, muscle injury, myalgia. Fractal dosage: 20 Mg, Qd. During the same period patient was treated with PLAVIX (View Plavix Review and Plavix Label ).

4906510-2 | Blood Immunoglobulin E Increased, Dermatitis Bullous, Pemphigus, Pruritus, Rash
Patient was taking Fractal (View Usage). Patient had the following side effects: blood immunoglobulin e increased, dermatitis bullous, pemphigus (What is pemphigus?), pruritus, rash (What is rash?) on Jul 05, 2005 from FRANCE Additional patient health information: Male patient , 64 years of age, was diagnosed with hypercholesterolaemia, back pain (What is back pain?) and. Fractal dosage: 1 Df, Qd. During the same period patient was treated with TRAMADOL HCL (View Tramadol Hcl Review and Tramadol Hcl Label ), THIOCOLCHICOSIDE (View Thiocolchicoside Review and Thiocolchicoside Label ), NEXEN (View Nexen Review and Nexen Label ), EUPANTOL (View Eupantol Review and Eupantol Label ), AMLOR (Unk, Unk) (View Amlor Review and Amlor Label ). Patient was hospitalized.

4838871-7 | Acute Respiratory Distress Syndrome, Alopecia, Antinuclear Antibody Positive, Arthralgia, Arthritis, Complement Factor Decreased, Cytolytic Hepatitis, Dermatomyositis, Dyspnoea
Adverse event was reported on Nov 18, 2005 by a Male patient taking Fractal (View Usage) (Dosage: 40 Mg, Qd) was diagnosed with hypercholesterolaemia, erythema and. Location: FRANCE , 42 years of age, After Fractal was administered, patient had the following side effects: acute respiratory distress syndrome, alopecia, antinuclear antibody positive, arthralgia, arthritis (What is arthritis?), complement factor decreased, cytolytic hepatitis, dermatomyositis, dyspnoea. During the same period patient was treated with SOLU MEDROL (Unk, Unk) (View Solu-medrol Review and Solu-medrol Label ), TAHOR (40 Mg, Qd) (View Tahor Review and Tahor Label ). Patient was hospitalized.

4838472-0 | Acute Respiratory Distress Syndrome, Alopecia, Antinuclear Antibody Positive, Arthralgia, Arthritis, Complement Factor Decreased, Cytolytic Hepatitis, Dermatomyositis, Dyspnoea
on Nov 18, 2005 Male patient from FRANCE , 42 years of age, was diagnosed with hypercholesterolaemia, erythema and was treated with Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: acute respiratory distress syndrome, alopecia, antinuclear antibody positive, arthralgia, arthritis (What is arthritis?), complement factor decreased, cytolytic hepatitis, dermatomyositis, dyspnoea. Fractal dosage: 40 Mg, Qd. During the same period patient was treated with SOLU MEDROL (Unk, Unk) (View Solu-medrol Review and Solu-medrol Label ), TAHOR (40 Mg, Qd) (View Tahor Review and Tahor Label ). Patient was hospitalized.

4838470-7 | Acute Respiratory Distress Syndrome, Alopecia, Antinuclear Antibody Positive, Arthralgia, Arthritis, Complement Factor Decreased, Cytolytic Hepatitis, Dermatomyositis, Dyspnoea
on Nov 18, 2005 Male patient from FRANCE , 42 years of age, was diagnosed with hypercholesterolaemia, erythema and was treated with Fractal (View Usage). Patient had the following side effects: acute respiratory distress syndrome, alopecia, antinuclear antibody positive, arthralgia, arthritis (What is arthritis?), complement factor decreased, cytolytic hepatitis, dermatomyositis, dyspnoea. Fractal dosage: 40 Mg, Qd. During the same period patient was treated with SOLU MEDROL (Unk, Unk) (View Solu-medrol Review and Solu-medrol Label ), TAHOR (40 Mg, Qd) (View Tahor Review and Tahor Label ). Patient was hospitalized.

4802120-6 | Blood Creatine Phosphokinase Increased, Myalgia, Myoglobin Blood Increased, Sjogren's Syndrome
Patient was taking Fractal (View Usage). After Fractal was administered, patient had the following side effects: blood creatine phosphokinase increased, myalgia, myoglobin blood increased, sjogren's syndrome (What is sjogren's syndrome?) on Oct 10, 2005 from FRANCE Additional patient health information: Female patient , 74 years of age, was diagnosed with hypercholesterolaemia, hypertension and. Fractal dosage: 80 Mg, Qd. During the same period patient was treated with VITAMIN A (View Vitamin A Review and Vitamin A Label ), REFRESH (View Refresh Review and Refresh Label ), NORMACOL (View Normacol Review and Normacol Label ), CORTANCYL (View Cortancyl Review and Cortancyl Label ), SELOKEN SLOW RELEASE (200 Mg, Qd) (View Seloken - Slow Release Review and Seloken - Slow Release Label ), EFFERALGAN (500 Mg, Tid) (View Efferalgan Review and Efferalgan Label ), ALPRAZOLAM (0.5 Mg, Qd) (View Alprazolam Review and Alprazolam Label ), LAROXYL (View Laroxyl Review and Laroxyl Label ). Patient was hospitalized.

4710718-9 | Blood Immunoglobulin E Increased, Dermatitis Bullous, Pemphigus, Pruritus, Rash
Adverse event was reported on Jul 05, 2005 by a Male patient taking Fractal (View Usage) (Dosage: 1 Df, Qd) was diagnosed with hypercholesterolaemia, back pain (What is back pain?) and. Location: FRANCE , 64 years of age, Patient experienced the following unwanted or unexpected effects: blood immunoglobulin e increased, dermatitis bullous, pemphigus (What is pemphigus?), pruritus, rash (What is rash?). During the same period patient was treated with TRAMADOL HCL (View Tramadol Hcl Review and Tramadol Hcl Label ), THIOCOLCHICOSIDE (View Thiocolchicoside Review and Thiocolchicoside Label ), NEXEN (View Nexen Review and Nexen Label ), EUPANTOL (View Eupantol Review and Eupantol Label ), AMLODIPINE BESYLATE (Unk, Unk) (View Amlodipine Besylate Review and Amlodipine Besylate Label ). Patient was hospitalized.

4700358-X | Hyperkalaemia
on Jun 17, 2005 Male patient from , 70 years of age, was diagnosed with hypercholesterolaemia and was treated with Fractal (View Usage). Patient had the following side effects: hyperkalaemia. Fractal dosage: 40 Mg, Qd. Patient was hospitalized.

4690893-5 | Parotitis, Salivary Gland Calculus, Salivary Gland Enlargement
on Jun 03, 2005 Female patient from , 43 years of age, was treated with Fractal (View Usage). After Fractal was administered, patient had the following side effects: parotitis, salivary gland calculus, salivary gland enlargement. Fractal dosage: 80 Mg, Qd.

4647963-7 | Gait Disturbance, Tendon Disorder, Tendonitis
Patient was taking Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: gait disturbance, tendon disorder, tendonitis on Apr 22, 2005 from Additional patient health information: Female patient , 70 years of age, was diagnosed with hypercholesterolaemia and. Fractal dosage: 20 Mg, Qd. During the same period patient was treated with LEVOTHYROXINE SODIUM (50 A?g/day) (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ), KARDEGIC (1 Df, Qd) (View Kardegic Review and Kardegic Label ), TRIVASTAL (50 Mg, Qd) (View Trivastal Review and Trivastal Label ).

4630334-7 | Angioneurotic Oedema, Burning Sensation, Flushing, Rash, Tachycardia
Adverse event was reported on Mar 09, 2005 by a Female patient taking Fractal (View Usage) (Dosage: 80 Mg, Qd) was diagnosed with hypercholesterolaemia, osteoporosis (What is osteoporosis?) and. Location: , 62 years of age, Patient had the following side effects: angioneurotic oedema, burning sensation, flushing, rash (What is rash?), tachycardia. During the same period patient was treated with ACTONEL (35 Mg/day) (View Actonel Review and Actonel Label ), OESTRODOSE (View Oestrodose Review and Oestrodose Label ).

4608747-9 | Angioneurotic Oedema, Burning Sensation, Flushing, Tachycardia
on Mar 09, 2005 Female patient from , 62 years of age, was diagnosed with hypercholesterolaemia and was treated with Fractal (View Usage). After Fractal was administered, patient had the following side effects: angioneurotic oedema, burning sensation, flushing, tachycardia. Fractal dosage: 80 Mg, Qd. During the same period patient was treated with ACTONEL (View Actonel Review and Actonel Label ).

4594063-0 | Tendon Operation, Tendon Rupture, Tendonitis
on Feb 21, 2005 Male patient from , 60 years of age, was diagnosed with hypercholesterolaemia and was treated with Fractal (View Usage). Patient experienced the following unwanted or unexpected effects: tendon operation, tendon rupture, tendonitis. Fractal dosage: 80 Mg, Qd. Patient was hospitalized.

4556458-0 | Rotator Cuff Syndrome
Patient was taking Fractal (View Usage). Patient had the following side effects: rotator cuff syndrome on Nov 26, 2004 from Additional patient health information: Male patient , 60 years of age, was diagnosed with hypercholesterolaemia and. Fractal dosage: 80 Mg, Qd.

4554133-X | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Cholestasis, Eosinophil Count Increased, Gamma-glutamyltransferase Increased, Hepatocellular Damage, Inflammation, Platelet Count Increased
Adverse event was reported on Jan 07, 2005 by a Male patient taking Fractal (View Usage) (Dosage: 40 Mg/day) was diagnosed with hypercholesterolaemia and. Location: , 54 years of age, weighting 154.3 lb, After Fractal was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cholestasis, eosinophil count increased, gamma-glutamyltransferase increased, hepatocellular damage, inflammation, platelet count increased. During the same period patient was treated with ASPEGIC 325 (100 Mg/day) (View Aspegic 325 Review and Aspegic 325 Label ), MOPRAL (20 Mg/day) (View Mopral Review and Mopral Label ), LOVENOX (0.6 Ml, Bid) (View Lovenox Review and Lovenox Label ). Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Fractal risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Fractal quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Fractal use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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... Male patient , weighting 145.5 lb, . Daflon dosage: Unk, Unk. During the same period patient was treated with FRACTAL (80 Mg, Qd) (View Fractal Review and Fractal Label ).

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Fractal Reactions
Acute Respiratory Distress Syndrome
Alopecia
Angioneurotic Oedema
Antinuclear Antibody Positive
Arthralgia
ArthritisWhat is Arthritis?
Blood Creatine Phosphokinase Increased
Blood Creatinine Increased
Blood Immunoglobulin E Increased
Burning Sensation
Complement Factor Decreased
Cytolytic Hepatitis
Dermatitis Bullous
Dermatomyositis
Dyspnoea
Flushing
Monoplegia
Muscle Spasms
Musculoskeletal Pain
Myalgia
Paraesthesia
PemphigusWhat is Pemphigus?
Periarthritis
Pruritus
RashWhat is Rash?
Renal Failure Acute
Rhabdomyolysis
Sciatic Nerve Neuropathy
Tachycardia
Tendon Rupture
Fractal Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Fractal adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!