Savella Side Effects

Please note - some side effects for Savella may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Savella - for the Consumer

Savella

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Savella:

Constipation; decreased sexual desire or ability; dizziness; dry mouth; headache; hot flush; increased sweating; loss of appetite; nausea; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Savella:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; bloody or black, tarry stools; confusion; dark urine; decreased concentration; decreased coordination; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; memory problems; muscle pain or weakness; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, restlessness, or inability to sit still; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, or diarrhea; severe or persistent trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Savella Side Effects - for the Professional

Savella

Clinical Trial Data Sources

Savella was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with Savella and 652 patients treated with placebo) for a treatment period up to 29 weeks.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions Leading to Discontinuation

In placebo-controlled trials in patients with fibromyalgia, 23% of patients treated with Savella 100 mg/day, 26% of patients treated with Savella 200 mg/day discontinued prematurely due to adverse reactions, compared to 12% of patients treated with placebo. The adverse reactions that led to withdrawal in ≥ 1% of patients in the Savella treatment group and with an incidence rate greater than that in the placebo treatment group were nausea (milnacipran 6%, placebo 1%), palpitations (milnacipran 3%, placebo 1%), headache (milnacipran 2%, placebo 0%), constipation (milnacipran 1%, placebo 0%), heart rate increased (milnacipran 1%, placebo 0%), and hyperhidrosis (milnacipran 1%, placebo 0%), vomiting (milnacipran 1%, placebo 0%), and dizziness (milnacipran 1% and placebo 0.5%). Discontinuation due to adverse reactions was generally more common among patients treated with Savella 200 mg/day compared to Savella 100 mg/day.

Most Common Adverse Reactions

In the placebo-controlled fibromyalgia patient trials the most frequently occurring adverse reaction in clinical trials was nausea. The most common adverse reactions (incidence ≥ 5% and twice placebo) in patients treated with Savella were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

Table 2 lists all adverse reactions that occurred in at least 2% of patients treated with Savella at either 100 or 200 mg/day and at an incidence greater than that of placebo.

Table 2. Treatment-Emergent Adverse Reaction Incidence in Placebo Controlled Trials in Fibromyalgia Patients (Events Occurring in at Least 2% of All Savella-Treated Patients and Occurring More Frequently in Either Savella Treatment Group Than in the Placebo Treatment Group)

System Organ Class– Preferred Term	Savella 100 mg/day (n = 623) %	Savella 200 mg/day (n = 934) %	All Savella (n = 1557) %	Placebo (n = 652) %
Cardiac Disorders
Palpitations	8	7	7	2
Tachycardia	3	2	2	1
Eye Disorders
Vision blurred	1	2	2	1
Gastrointestinal Disorders
Nausea	35	39	37	20
Constipation	16	15	16	4
Vomiting	6	7	7	2
Dry mouth	5	5	5	2
Abdominal pain	3	3	3	2
General Disorders
Chest pain	3	2	2	2
Chills	1	2	2	0
Chest discomfort	2	1	1	1
Infections
Upper respiratory tract infection	7	6	6	6
Investigations
Heart rate increased	5	6	6	1
Blood pressure increased	3	3	3	1
Metabolism and Nutrition Disorders
Decreased appetite	1	2	2	0
Nervous System Disorders
Headache	19	17	18	14
Dizziness	11	10	10	6
Migraine	6	4	5	3
Paresthesia	2	3	2	2
Tremor	2	2	2	1
Hypoesthesia	1	2	1	1
Tension headache	2	1	1	1
Psychiatric Disorders
Insomnia	12	12	12	10
Anxiety	5	3	4	4
Respiratory Disorders
Dyspnea	2	2	2	1
Skin Disorders
Hyperhidrosis	8	9	9	2
Rash	3	4	3	2
Pruritus	3	2	2	2
Vascular Disorders
Hot flush	11	12	12	2
Hypertension	7	4	5	2
Flushing	2	3	3	1

Weight Changes

In placebo-controlled fibromyalgia clinical trials, patients treated with Savella for up to 3 months experienced a mean weight loss of approximately 0.8 kg in both the Savella 100 mg/day and the Savella 200 mg/day treatment groups, compared with a mean weight loss of approximately 0.2 kg in placebo-treated patients.

Genitourinary Adverse Reactions in Males

In the placebo-controlled fibromyalgia studies, the following treatment-emergent adverse reactions related to the genitourinary system were observed in at least 2% of male patients treated with Savella, and occurred at a rate greater than in placebo-treated male patients: dysuria, ejaculation disorder, erectile dysfunction, ejaculation failure, libido decreased, prostatitis, scrotal pain, testicular pain, testicular swelling, urinary hesitation, urinary retention, urethral pain, and urine flow decreased.

Other Adverse Reactions Observed During Clinical Trials of Savella in Fibromyalgia

Following is a list of frequent (those occurring on one or more occasions in at least 1/100 patients) treatment-emergent adverse reactions reported from 1824 fibromyalgia patients treated with Savella for periods up to 68 weeks. The listing does not include those events already listed in Table 1, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life threatening.

Adverse reactions are categorized by body system and listed in order of decreasing frequency. Adverse reactions of major clinical importance are described in the Warnings and Precautions section (5).

Gastrointestinal Disorders - diarrhea, dyspepsia, gastroesophageal reflux disease, flatulence, abdominal distension

General Disorders - fatigue, peripheral edema, irritability, pyrexia

Infections - urinary tract infection, cystitis

Injury, Poisoning, and Procedural Complications - contusion, fall

Investigations - weight decreased or increased

Metabolism and Nutrition Disorders - hypercholesterolemia

Nervous System Disorders - somnolence, dysgeusia

Psychiatric Disorders - depression, stress

Skin Disorders - night sweats

Postmarketing Spontaneous Reports

The following additional adverse reactions have been identified from spontaneous reports of Savella received worldwide. These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to Savella. However, because these adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include:

Blood and Lymphatic System Disorders - leukopenia, neutropenia, thrombocytopenia

Cardiac Disorders - supraventricular tachycardia

Eye Disorders - accommodation disorder

Endocrine Disorders - hyperprolactinemia

Hepatobiliary Disorders - hepatitis

Metabolism and Nutrition Disorders - anorexia, hyponatremia

Musculoskeletal and Connective Tissue Disorders - rhabdomyolysis

Nervous System Disorders - convulsions (including grand mal), loss of consciousness, neuroleptic malignant syndrome, Parkinsonism, serotonin syndrome

Psychiatric Disorders - delirium, hallucination

Renal and Urinary Disorders - acute renal failure

Reproductive System and Breast Disorders - galactorrhea

Skin Disorders - erythema multiforme, Stevens Johnson syndrome

Vascular Disorders - hypertensive crisis

Top

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects including nausea (37%), constipation (16%), vomiting (7%), dry mouth (5%), abdominal pain (3%), decreased appetite (2%), diarrhea, dyspepsia, gastroesophageal reflux disease, flatulence, and abdominal distension have been reported.

Nervous system

Nervous system side effects including headache (18%), dizziness (10%), migraine (5%), paresthesia (2%), tremor (2%), hypoesthesia (1%), tension headache (1%), somnolence, dysgeusia, convulsions (including grand mal), loss of consciousness, neuroleptic malignant syndrome, Parkinsonism, and serotonin syndrome have been reported.

Psychiatric

Psychiatric side effects including insomnia (12%), anxiety (4%), depression, stress, anorexia, delirium, and hallucination have been reported.

Cardiovascular

Cardiovascular side effects including hot flush (12%), palpitations (7%), increased heart rate (6%), hypertension (5%), flushing (3%), increased blood pressure (3%), tachycardia (2%), supraventricular tachycardia, and hypertensive crisis have been reported. A case of Raynaud's syndrome has also been reported.

Dermatologic

Dermatologic side effects including hyperhidrosis (9%), rash (3%), pruritus (2%), night sweats, erythema multiforme, and Stevens Johnson syndrome have been reported.

Respiratory

Respiratory side effects including upper respiratory tract infection (6%) and dyspnea (2%) have been reported.

General

General side effects including chest pain (2%), chills (2%), chest discomfort (1%), fatigue, peripheral edema, irritability, pyrexia, decreased weight, and increased weight have been reported.

Ocular

Ocular side effects including blurred vision (2%) and accommodation disorder have been reported.

Genitourinary

Genitourinary side effects including dysuria, ejaculation disorder, erectile dysfunction, ejaculation failure, decreased libido, prostatitis, scrotal pain, testicular pain, testicular swelling, urinary hesitation, urinary retention, urethral pain, decreased urine flow, cystitis, and galactorrhea have been reported.

Other

Other side effects including contusion, fall, and physical dependence have been reported.

Milnacipran produces physical dependence, including withdrawal symptoms following drug discontinuation, similar to other SNRIs and SSRIs. These withdrawal symptoms can be severe.

Metabolic

Metabolic side effects including hypercholesterolemia and hyponatremia have been reported.

Renal

Renal side effects including urinary tract infection and acute renal failure have been reported.

Hematologic

Hematologic side effects including leukopenia, neutropenia, and thrombocytopenia have been reported.

Endocrine

Endocrine side effects including hyperprolactinemia have been reported.

Hepatic

Hepatic side effects including hepatitis have been reported.

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have been reported.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.