# Fibromyalgia syndrome - Category: chronic - Review status: reviewed (every claim checked against a document named on this page) - Sources: Amitriptyline SmPC (https://www.medicines.org.uk/emc/product/4491/smpc) · Duloxetine US prescribing information, Dosage and Administration (DailyMed SetID fb37745f-fb40-4f7f-8143-ea1874c38e1b) · LYRICA (pregabalin) US prescribing information, Indications and Dosage and Administration (DailyMed SetID d4734e7d-5079-455e-8ff5-8f4539c998a9) · MSF Essential Drugs 2024 (tramadol oral monograph, moderate pain) · Fibromyalgia - disease-level clinical article (fibromyalgia-full.txt) - Verified date: 2026-08 ## Verified against - Amitriptyline SmPC (https://www.medicines.org.uk/emc/product/4491/smpc) - Duloxetine US prescribing information, Dosage and Administration (DailyMed SetID fb37745f-fb40-4f7f-8143-ea1874c38e1b) - LYRICA (pregabalin) US prescribing information, Indications and Dosage and Administration (DailyMed SetID d4734e7d-5079-455e-8ff5-8f4539c998a9) - Fibromyalgia - disease-level clinical article (fibromyalgia-clinical.txt) - MSF Essential Drugs 2024 (tramadol oral monograph, moderate pain) - Fibromyalgia - disease-level clinical article (fibromyalgia-full.txt) ## Treatment metadata - Amitriptyline — 25 mg — oral.solid - Pregabalin — 75 mg — oral.solid - Referral & safety-netting (no drug therapy) - Duloxetine — 60 mg — oral.solid - Tramadol — 50 mg — oral.solid ## Complete treatment card ```text FIBROMYALGIA SYNDROME Sources: Amitriptyline SmPC (https://www.medicines.org.uk/emc/product/4491/smpc) · Duloxetine US prescribing information, Dosage and Administration (DailyMed SetID fb37745f-fb40-4f7f-8143-ea1874c38e1b) · LYRICA (pregabalin) US prescribing information, Indications and Dosage and Administration (DailyMed SetID d4734e7d-5079-455e-8ff5-8f4539c998a9) · MSF Essential Drugs 2024 (tramadol oral monograph, moderate pain) · Fibromyalgia - disease-level clinical article (fibromyalgia-full.txt) Review status: REVIEWED against Amitriptyline SmPC (https://www.medicines.org.uk/emc/product/4491/smpc), Duloxetine US prescribing information, Dosage and Administration (DailyMed SetID fb37745f-fb40-4f7f-8143-ea1874c38e1b), LYRICA (pregabalin) US prescribing information, Indications and Dosage and Administration (DailyMed SetID d4734e7d-5079-455e-8ff5-8f4539c998a9), Fibromyalgia - disease-level clinical article (fibromyalgia-clinical.txt), MSF Essential Drugs 2024 (tramadol oral monograph, moderate pain), Fibromyalgia - disease-level clinical article (fibromyalgia- full.txt) (2026-08) IS IT THIS? - reference only, to read alongside your own examination SYMPTOMS - what the patient reports (6) - Widespread, aching muscle pain lasting at least 3 months is the defining feature [muscle pain] - Pain often starts in the neck and shoulders, but by definition spreads to at least 6 soft- tissue sites across the upper and lower body, with morning stiffness that even mild activity worsens [joint stiffness] - Light, easily-broken sleep with early waking and not feeling rested on waking is a common complaint - Trouble concentrating and slowed mental processing are frequent cognitive complaints [poor concentration] - Depression or anxiety affects roughly a third to half of patients with this condition [anxiety · low mood] - Tension, cluster, or migraine headaches affect close to half of patients, and tingling in the arms and legs is common despite a normal neurological exam [tingling] SIGNS - what you find (2) - The current diagnostic exam finding is widespread soft-tissue tenderness across at least 4 of 5 body regions, not a specific tender-point count - Palpation finds more tenderness in soft tissue than in joints, with no synovitis present TESTS (6) - No blood test or imaging study can confirm this diagnosis; testing is mainly done to exclude other conditions - Adults are typically checked with a complete blood count and either CRP or ESR - Rheumatoid factor and ANA testing should be skipped unless the exam suggests an inflammatory rheumatic disease - A sleep study is warranted when obstructive sleep apnea or another primary sleep disorder is suspected - The 2010 ACR criteria require a widespread pain index of 7 or more with a symptom severity score of 5 or more, or a pain index of 3 to 6 with a severity score of 9 or more - The Yunis and Masi criteria require meeting all 4 major criteria plus at least 3 of 10 minor criteria IF NOT THIS - what else fits (4) - Polymyalgia rheumatica and spondyloarthritis are also on the differential - Hypothyroidism and hyperparathyroidism can mimic these symptoms and are considered - Vitamin B12 deficiency and vitamin D deficiency are also on the list - Chronic fatigue syndrome is also considered Source StatPearls "Fibromyalgia" - disease-level clinical article Status traced to the source above Rx: Main treatment | Refractory symptoms - short-term opioid analgesic MAIN TREATMENT - choose one 1. AMITRIPTYLINE [1st line] Adult 10-25 mg at bedtime, titrate by 10-25 mg every 1-2 weeks to 25-50 mg nightly (max 75 mg nightly) - long-term Peds Specialist pediatric rheumatology referral required Choice Sourced preference. The entry cites EULAR, whose strongest recommendation here is amitriptyline, for the sleep disturbance as much as the pain. Source Amitriptyline SmPC (https://www.medicines.org.uk/emc/product/4491/smpc) Why Strongest EULAR recommendation for sleep disturbance and centralized pain modulation in fibromyalgia Caution Anticholinergic side effects include dry mouth, blurred vision, constipation, and urinary retention. Contraindicated in severe cardiovascular disease, heart block, or recent MI. Sedation is common, so take the dose 1-2 hours before bedtime. Avoid in elderly patients, and in severe cardiovascular disease or arrhythmias. Amitriptyline - StatPearls - NCBI Bookshelf (NBK537225) puts amitriptyline on the American Geriatrics Society's Beers list, to be avoided in the elderly because its anticholinergic effect is so strong. Egypt TRYPTIZOL 25 MG 30 TABS. KAHIRA 33.00 EGP (1.10/unit) GRANITYLLIN 25MG/5ML SYP. 120 ML GRAND PHARMA ... 5.00 EGP -> ? strength differs, ? different route - not oral solid ZINOTRAVAL 25MG/5ML SYP. 120 ML DEBEIKY > PHA... 10.00 EGP -> ? strength differs, ? different route - not oral solid 2. PREGABALIN [1st line] Adult 300 to 450 mg/day. Start at 75 mg twice daily (150 mg/day); it may be increased to 150 mg twice daily (300 mg/day) within one week on efficacy and tolerability, and if 300 mg/day is not enough, to 225 mg twice daily (450 mg/day). Do not exceed 450 mg/day. - long-term Peds Safety not established in pediatric fibromyalgia Source LYRICA (pregabalin) US prescribing information, Indications and Dosage and Administration (DailyMed SetID d4734e7d-5079-455e-8ff5-8f4539c998a9) Why Modulates voltage-gated calcium channels in the central nervous system, reducing excitatory neurotransmitter release and dampening the abnormal central pain processing that characterises fibromyalgia. Caution 450 mg/day is the ceiling for fibromyalgia, not the 600 mg/day used in neuropathic pain and epilepsy. 600 mg/day was studied in fibromyalgia: the label says it gave no additional benefit and was less well tolerated, and that doses above 450 mg/day are not recommended. Weight gain, peripheral edema, and dizziness are common. Taper gradually when stopping. Fibromyalgia is not a licensed indication for pregabalin in the UK or Europe - the European label covers peripheral and central neuropathic pain, partial seizures and generalised anxiety, so prescribing here is off-label by those labels and should be discussed as such. It IS an approved US indication, and the figures here are that label's. Dose reduction is required in renal impairment. Egypt FORPREGAB 75 MG 30 CAPS. GRAND PHARMA ... 45.00 EGP (1.50/unit) SNAPGAB 75 MG 30 CAPS. MASH PREMIERE... 49.50 EGP (1.65/unit) LYRIBALIN 75MG 10 CAPS. BORG 18.00 EGP (1.80/unit) NEURAGABALIN 75 MG 10 CAPS. DELTA GRAND P... 23.00 EGP (2.30/unit) NERVATYCA 75 MG 20 CAPS. ALFACURE PHAR... 48.75 EGP (2.44/unit) QUEENLEPT 75 MG 30 CAPS. FUTURE PHARMA... 93.00 EGP (3.10/unit) LYRICA 75MG 20 CAPS. PFIZER 232.00 EGP (11.60/unit) PREGABEDIUM 75 MG 20 H.G. CAPS. SABAA > ACTIV... 56.66 EGP LOCIKASWAB 100MG/5ML 20 UNIDOSE ORAL SOLN. UNISWAB > VODACHEM 43.50 EGP -> ? strength differs, ? different route - not oral solid AVEROPREG 100MG/5ML SYRUP 60 ML AVERROES PHAR... 55.50 EGP -> ? strength differs, ? different route - not oral solid 3. REFERRAL & SAFETY-NETTING (NO DRUG THERAPY) [1st line] Adult Source Fibromyalgia - disease-level clinical article (fibromyalgia-clinical.txt) Why Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen. Caution RED FLAG - Suicide risk is elevated in fibromyalgia patients, which is relevant to screening given the high rate of comorbid depression and anxiety. 4. DULOXETINE [2nd line] Adult 30 mg once daily for 1 week, then increase to 60 mg once daily - long-term Peds Not indicated in children Source Duloxetine US prescribing information, Dosage and Administration (DailyMed SetID fb37745f-fb40-4f7f-8143-ea1874c38e1b) Why Serotonin-norepinephrine reuptake inhibitor used as a second-line option for fibromyalgia; it enhances descending pain-inhibitory pathways in the central nervous system to reduce pain that has not responded to first-line therapy. Caution Avoid in severe renal impairment (eGFR < 30 mL/min) or chronic liver disease. Monitor blood pressure. Nausea, dry mouth, somnolence, and constipation are common. Egypt DULOPRESSIVE 60 MG 30 CAPS. GLOBAL NAPI P... 174.00 EGP (5.80/unit) DEPRETREVE 60MG 20 CAPS. INTERNATIONAL... 148.00 EGP (7.40/unit) DULOXEPRIN 60 MG 28 CAPS. FUTURE PHARMA... 214.00 EGP (7.64/unit) CYMBATEX 60 MG 30 CAPS. EVA PHARMA 295.50 EGP (9.85/unit) DUCANDES 60 MG 28 CAPSULES MASH PREMIERE... 280.00 EGP (10.00/unit) CYMBALTA 60 MG 28 CAPS. ELI LILLY 544.00 EGP (19.43/unit) DUXNORZET 60 MG 30 DEL. REL. H.G. CAPS. ZETA PHARMA 231.00 EGP WADILOXTIN 60 MG 28 DEL. REL. CAPS. WADI ELNEEL BENTA 280.00 EGP REFRACTORY SYMPTOMS - SHORT-TERM OPIOID ANALGESIC 5. TRAMADOL [3rd line] Adult 50 to 100 mg every 4 to 6 hours (maximum 400 mg daily) - As short as possible Peds MSF states the dose for child over 12 years and adult together and gives no figure below 12 years. Source MSF Essential Drugs 2024 (tramadol oral monograph, moderate pain) Why The disease article names tramadol as a carved-out exception to its general opioid- avoidance advice, for patients with refractory symptoms. MSF Essential Drugs doses it for moderate pain and is explicit that it is for short-term treatment only, which sits in real tension with a chronic pain condition - so the restriction is carried onto the row verbatim rather than dropped. Placed at line 3, behind all three incumbent agents; nothing was re-ranked. Caution Use for short term treatment (risk of dependence and tolerance). According to clinical evolution; as short as possible. Do not administer in the event of severe respiratory depression and to patients that risk seizures. Do not combine with opioid analgesics, including codeine. Reduce doses by half and administer every 12 hours in elderly patients and in patients with severe renal or hepatic impairment (risk of accumulation). Egypt TRAMAL 50MG 20 CAPS. MINA PHARM > ... 18.00 EGP (0.90/unit) TRAMADOL 50 MG 20 CAPS. MEMPHIS 22.00 EGP (1.10/unit) AMADOL 50 MG 20 CAPS. ADWIA 29.00 EGP (1.45/unit) CONTRAMAL 100MG/ML ORAL DROPS 10 ML SIGMA 9.00 EGP -> ? strength differs, ? different route - not oral solid TRAMAL 100MG/ML ORAL DROPS. 10 ML MINA PHARM > GRUNENTHAL-GERMANY 18.00 EGP -> ? strength differs, ? different route - not oral solid Prices are indicative (dataset snapshot 2026-06); verify with the pharmacy. ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)