Soma Side Effects

Generic Name: carisoprodol

Please note - some side effects for Soma 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 Soma - for the Consumer

Somatropin (rDNA origin - Refrigerated)

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 Somatropin (rDNA origin - Refrigerated):

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Somatropin (rDNA origin - Refrigerated):

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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.

Somavert

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 Somavert:

Back pain; diarrhea; dizziness; flu-like symptoms (eg, mild fever or chills, muscle aches, weakness); nausea; pain, redness, or itching at the injection site; sinus inflammation.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; swelling of the legs and feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual tiredness, severe or persistent nausea or stomach pain, loss of appetite); thickening of the skin or lumps at the injection site; unusual weight gain.

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.

Soma

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 Soma:

Dizziness; drowsiness; headache.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); fainting; fast heartbeat; fever, chills, or persistent sore throat; loss of coordination; mood or mental changes (eg, agitation, depression, irritability); seizures; severe or persistent dizziness; severe or persistent trouble sleeping; tremors.

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.

Soma Compound with Codeine

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 Soma Compound with Codeine:

Constipation; diarrhea; dizziness; drowsiness; headache; indigestion; lightheadedness; nausea; mild stomach pain or upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Soma Compound with Codeine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blurred vision; fainting; fast heartbeat; fever, chills, or persistent sore throat; loss of coordination; mood or mental changes (eg, agitation, depression, irritability); ringing in the ears; seizures; severe or persistent dizziness, drowsiness, or stomach pain; severe or persistent trouble sleeping; shallow or very slow breathing; tremors; unusual bruising or bleeding; vomit that looks like coffee grounds; wheezing.

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.

Somatropin (rDNA origin - Nonrefrigerated)

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 Somatropin (rDNA origin - Nonrefrigerated):

Headache; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; nausea; nerve tingling; numbness; runny or stuffy nose; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Somatropin (rDNA origin - Nonrefrigerated):

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; constant feeling of need to empty the bowel; curvature of the spine; depression; ear infection; excessive thirst or hunger; fast heartbeat; fever; frequent urination; infection; nausea; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; severe, persistent, or unusual headaches; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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.

Soma Compound

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 Soma Compound:

Constipation; diarrhea; dizziness; drowsiness; headache; indigestion; nausea; mild stomach pain or upset; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; change in the amount of urine produced; fainting; fast heartbeat; fever, chills, or persistent sore throat; loss of appetite; loss of coordination; mood or mental changes (eg, agitation, depression, irritability); painful urination; ringing in the ears; seizures; severe or persistent dizziness or stomach pain; severe or persistent trouble sleeping; tremors; unusual bruising or bleeding; vomit that looks like coffee grounds; weight loss; wheezing.

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.

Somatuline Depot

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 Somatuline Depot:

Constipation; diarrhea; gas; headache; joint pain; mild stomach pain or discomfort; minor redness, pain, or swelling at the injection site; nausea; vomiting; weight loss.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dizziness; severe or persistent headache; severe or persistent nausea, stomach pain, or vomiting; slow or irregular heartbeat; symptoms of gallstones (eg, sudden pain around the upper right stomach area, right shoulder area, or between your shoulder blades; yellowing of the skin or eyes; fever with chills); unusual tiredness or weakness.

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.

Somatropin (rDNA origin - Refrigerated) Cartridge

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 Somatropin (rDNA origin - Refrigerated) Cartridge:

Back pain; headache; increased cough; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; redness or itching at the injection site; sore throat; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Somatropin (rDNA origin - Refrigerated) Cartridge:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; nausea or vomiting; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

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.

Somatropin (rDNA origin - Refrigerated) Vial

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 Somatropin (rDNA origin - Refrigerated) Vial:

Back pain; headache; increased cough; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; redness or itching at the injection site; sore throat; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Somatropin (rDNA origin - Refrigerated) Vial:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; nausea or vomiting; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

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.

Somatropin (rDNA origin - Refrigerated) Vials

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 Somatropin (rDNA origin - Refrigerated) Vials:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Somatropin (rDNA origin - Refrigerated) Vials:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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.

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Soma Side Effects - for the Professional

Soma

Clinical Studies Experience

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

The data described below are based on 839 patients pooled from a double blind, randomized, multicenter, placebo controlled, one-week trial in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14)]. In the study, patients were treated with 350 mg of carisoprodol or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in the trial. In the study, 2.7% and 5.4% of patients treated with placebo and 350 mg of carisoprodol, respectively, discontinued due to adverse events; 0.5% and 1.8% of patients treated with placebo and 350 mg of carisoprodol, respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with carisoprodol in the trial described above.

Table 1. Patients with Adverse Reactions in the Controlled Study

Adverse Reaction	Placebo (n=560) n (%)	Carisoprodol 350 mg (n=279) n (%)
Drowsiness	31 (6)	47 (17)
Dizziness	11 (2)	19 (7)
Headache	11 (2)	9 (3)

Postmarketing Experience

The following events have been reported during postapproval use of carisoprodol. Because these reactions are 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.

Cardiovascular:  Tachycardia, postural hypotension, and facial flushing [see Overdosage (10)].

Central Nervous System:  Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10)].

Gastrointestinal:  Nausea, vomiting, and epigastric discomfort.

Hematologic:  Leukopenia, pancytopenia.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects are common and include drowsiness and sedation most often. There have been postmarketing reports of motor vehicle accidents associated with the use of carisoprodol. Dizziness, headache, tremor, agitation, insomnia, syncope and ataxia have also been reported.

Central respiratory depression may occur, particularly at high doses.

Other

Psychologic dependence and abuse of carisoprodol (often in combination with alcohol and other CNS depressants) have been reported.

Withdrawal symptoms after abrupt cessation of carisoprodol have been reported and may be due to dependency on the meprobamate metabolite. Such symptoms include abdominal pain, agitation, tremor, restlessness, anxiety, depression, insomnia, nausea, and sweating. Seizures have been reported rarely.

Hypersensitivity

Hypersensitivity effects include rash, pruritus and erythema multiforme. Asthma, fever, hypotension and anaphylaxis have been reported rarely.

Gastrointestinal

Gastrointestinal symptoms include nausea, vomiting, hiccups and epigastric distress.

Cardiovascular

Cardiovascular effects include tachycardia, hypotension, postural hypotension, and facial flushing.

Oncologic

Oncologic side effects have included mutagenicity and clastogenicity reported from in vitro animal cell assays.

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